Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00395512
Registration number
NCT00395512
Ethics application status
Date submitted
1/11/2006
Date registered
3/11/2006
Date last updated
27/03/2013
Titles & IDs
Public title
Efficacy of Alogliptin With Pioglitazone (Actos®) in Subjects With Type 2 Diabetes Mellitus
Query!
Scientific title
A Multicenter, Double-Blind Study to Determine the Efficacy and Safety of SYR-322 Plus Pioglitazone HCl (Actos®), SYR-322 Alone or Pioglitazone HCl Alone in Subjects With Type 2 Diabetes
Query!
Secondary ID [1]
0
0
2006-005492-17
Query!
Secondary ID [2]
0
0
01-06-TL-322OPI-002
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus
0
0
Query!
Condition category
Condition code
Metabolic and Endocrine
0
0
0
0
Query!
Diabetes
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Alogliptin
Treatment: Drugs - Pioglitazone
Treatment: Drugs - Placebo
Experimental: Alogliptin 25 mg QD - Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Active comparator: Pioglitazone 30 mg QD - Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Experimental: Alogliptin 25 mg QD+ Pioglitazone 30 mg QD - Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Active comparator: Alogliptin 12.5 mg QD + Pioglitazone 30 mg QD - Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Treatment: Drugs: Alogliptin
Alogliptin tablets.
Treatment: Drugs: Pioglitazone
Pioglitazone tablets.
Treatment: Drugs: Placebo
Matching placebo tablets.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c)
Query!
Assessment method [1]
0
0
The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).
Query!
Timepoint [1]
0
0
Baseline and Week 26
Query!
Secondary outcome [1]
0
0
Change From Baseline in HbA1c Over Time
Query!
Assessment method [1]
0
0
The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at 4 week intervals during the study. Least Squares Means were from an Analysis of Covariance (ANCOVA) model with treatment and geographic region as class variables and baseline HbA1c as a covariate.
Query!
Timepoint [1]
0
0
Baseline and Weeks 4, 8, 12, 16 and 20.
Query!
Secondary outcome [2]
0
0
Change From Baseline in Fasting Plasma Glucose Over Time
Query!
Assessment method [2]
0
0
The change from Baseline in fasting plasma glucose was assessed at weeks 1, 2, 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline plasma glucose as a covariate.
Query!
Timepoint [2]
0
0
Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.
Query!
Secondary outcome [3]
0
0
Percentage of Participants With Marked Hyperglycemia
Query!
Assessment method [3]
0
0
Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL. Study week windows are defined to place hyperglycemia into visit categories.
Query!
Timepoint [3]
0
0
Weeks 1, 2, 4, 8, 12, 16, 20 and 26.
Query!
Secondary outcome [4]
0
0
Percentage of Participants Meeting Rescue Criteria
Query!
Assessment method [4]
0
0
Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days after the first sample and analyzed by the central laboratory:
1. After more than 4 weeks of treatment but prior to the Week 8 Visit: a single fasting plasma glucose =310 mg/dL (=17.5 mmol/L);
2. From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose =275 mg/dL (=15.27 mmol/L);
3. From the Week 12 Visit through the End-of-Treatment Visit: HbA1c =8.5% and =0.5% reduction in HbA1c as compared with the Baseline HbA1c.
Query!
Timepoint [4]
0
0
Weeks 4, 8, 12, 16, 20 and 26.
Query!
Secondary outcome [5]
0
0
Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5%
Query!
Assessment method [5]
0
0
Clinical response at Week 26 was assessed by the percentage of participants with HbA1c =6.5%.
Query!
Timepoint [5]
0
0
Week 26
Query!
Secondary outcome [6]
0
0
Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0%
Query!
Assessment method [6]
0
0
Clinical response at Week 26 was assessed by the percentage of participants with HbA1c = 7%.
Query!
Timepoint [6]
0
0
Week 26
Query!
Secondary outcome [7]
0
0
Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.5%
Query!
Assessment method [7]
0
0
Clinical response at Week 26 was assessed by the percentage of participants with HbA1c = 7.5%.
Query!
Timepoint [7]
0
0
Week 26
Query!
Secondary outcome [8]
0
0
Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 0.5%
Query!
Assessment method [8]
0
0
Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of = 0.5%.
Query!
Timepoint [8]
0
0
Baseline and Week 26
Query!
Secondary outcome [9]
0
0
Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.0%
Query!
Assessment method [9]
0
0
Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of = 1%.
Query!
Timepoint [9]
0
0
Baseline and Week 26
Query!
Secondary outcome [10]
0
0
Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.5%.
Query!
Assessment method [10]
0
0
Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of = 1.5%.
Query!
Timepoint [10]
0
0
Baseline and Week 26
Query!
Secondary outcome [11]
0
0
Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 2.0%
Query!
Assessment method [11]
0
0
Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of = 2.0%.
Query!
Timepoint [11]
0
0
Baseline and Week 26
Query!
Secondary outcome [12]
0
0
Change From Baseline in Fasting Proinsulin
Query!
Assessment method [12]
0
0
Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline proinsulin as a covariate.
Query!
Timepoint [12]
0
0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Query!
Secondary outcome [13]
0
0
Change From Baseline in Insulin
Query!
Assessment method [13]
0
0
The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline insulin as a covariate.
Query!
Timepoint [13]
0
0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Query!
Secondary outcome [14]
0
0
Change From Baseline in Proinsulin/Insulin Ratio
Query!
Assessment method [14]
0
0
The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (µIU/mL) at weeks 4, 8, 12, 16, 20 and 26 relative to the Baseline value. Least squares means were from an ANCOVA model with treatment and geographic region as class variables and Baseline proinsulin/insulin ratio as a covariate.
Query!
Timepoint [14]
0
0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Query!
Secondary outcome [15]
0
0
Change From Baseline in C-peptide Levels
Query!
Assessment method [15]
0
0
C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline C-peptide as a covariate.
Query!
Timepoint [15]
0
0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Query!
Secondary outcome [16]
0
0
Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance
Query!
Assessment method [16]
0
0
The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:
HOMA IR = fasting plasma insulin (µIU/mL) \* fasting plasma glucose (mmol/L) / 22.5
A higher number indicates a greater degree of insulin resistance. The change from Baseline in HOMA IR was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HOMA IR as a covariate.
Query!
Timepoint [16]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [17]
0
0
Change From Baseline in Homeostatic Model Assessment Beta Cell Function
Query!
Assessment method [17]
0
0
The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.
HOMA %B = 20 \* insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5
The change from Baseline in the homeostasis model assessment of beta cell function was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HOMA beta cell function as a covariate.
Query!
Timepoint [17]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [18]
0
0
Change From Baseline in Body Weight
Query!
Assessment method [18]
0
0
Change from Baseline in body weight was assessed at Weeks 8, 12, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and Baseline weight as a covariate.
Query!
Timepoint [18]
0
0
Baseline and Weeks 8, 12, 20 and 26.
Query!
Secondary outcome [19]
0
0
Change From Baseline in Total Cholesterol Level
Query!
Assessment method [19]
0
0
Change from Baseline in total cholesterol level was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline total cholesterol as a covariate.
Query!
Timepoint [19]
0
0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Query!
Secondary outcome [20]
0
0
Change From Baseline in Low-Density Lipoprotein Cholesterol
Query!
Assessment method [20]
0
0
Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline LDL cholesterol as a covariate.
Query!
Timepoint [20]
0
0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Query!
Secondary outcome [21]
0
0
Change From Baseline in High-Density Lipoprotein Cholesterol
Query!
Assessment method [21]
0
0
Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HDL cholesterol as a covariate.
Query!
Timepoint [21]
0
0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Query!
Secondary outcome [22]
0
0
Change From Baseline in Triglyceride Levels
Query!
Assessment method [22]
0
0
Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline triglycerides as a covariate.
Query!
Timepoint [22]
0
0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Query!
Secondary outcome [23]
0
0
Change From Baseline in Free Fatty Acids
Query!
Assessment method [23]
0
0
Change from Baseline in free fatty acids (FFA) was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline free fatty acid as a covariate.
Query!
Timepoint [23]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [24]
0
0
Change From Baseline in Plasminogen Activator Inhibitor-1
Query!
Assessment method [24]
0
0
Change from Baseline in plasminogen activator inhibitor-1 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline plasminogen activator inhibitor-1 as a covariate.
Query!
Timepoint [24]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [25]
0
0
Change From Baseline in High-sensitivity C-Reactive Protein
Query!
Assessment method [25]
0
0
Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline hsCRP as a covariate.
Query!
Timepoint [25]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [26]
0
0
Change From Baseline in Adiponectin
Query!
Assessment method [26]
0
0
Change from Baseline in adiponectin was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline adiponectin as a covariate.
Query!
Timepoint [26]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [27]
0
0
Change From Baseline in Apolipoprotein A1
Query!
Assessment method [27]
0
0
Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and Baseline apolipoprotein A1 as a covariate.
Query!
Timepoint [27]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [28]
0
0
Change From Baseline in Apolipoprotein A2
Query!
Assessment method [28]
0
0
Change from Baseline in apolipoprotein A2 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein A2 as a covariate.
Query!
Timepoint [28]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [29]
0
0
Change From Baseline in Apolipoprotein B
Query!
Assessment method [29]
0
0
Change from Baseline in apolipoprotein B was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein B as a covariate.
Query!
Timepoint [29]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [30]
0
0
Change From Baseline in Apolipoprotein C-III
Query!
Assessment method [30]
0
0
Change from Baseline in apolipoprotein C-III was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein C-III as a covariate.
Query!
Timepoint [30]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [31]
0
0
Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides
Query!
Assessment method [31]
0
0
Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline NMR total triglycerides as a covariate.
Query!
Timepoint [31]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [32]
0
0
Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles
Query!
Assessment method [32]
0
0
The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12 and 26.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL/chylomicron particles as a covariate.
Query!
Timepoint [32]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [33]
0
0
Change From Baseline in VLDL / Chylomicron Triglycerides
Query!
Assessment method [33]
0
0
The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12 and 26.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL/chylomicron triglycerides as a covariate.
Query!
Timepoint [33]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [34]
0
0
Change From Baseline in VLDL Particles
Query!
Assessment method [34]
0
0
The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12 and 26.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL particles as a covariate.
Query!
Timepoint [34]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [35]
0
0
Change From Baseline in Mean VLDL Particle Size
Query!
Assessment method [35]
0
0
Change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean VLDL particle size as a covariate.
Query!
Timepoint [35]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [36]
0
0
Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles
Query!
Assessment method [36]
0
0
The change from Baseline in levels of IDL particles was assessed by NMR fractionation at Weeks 12 and 26.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline IDL particles as a covariate.
Query!
Timepoint [36]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [37]
0
0
Change From Baseline in Low Density Lipoprotein (LDL) Particles
Query!
Assessment method [37]
0
0
The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12 and 26.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline LDL particles as a covariate.
Query!
Timepoint [37]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [38]
0
0
Change From Baseline in Mean LDL Particle Size
Query!
Assessment method [38]
0
0
Change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean LDL particle size as a covariate.
Query!
Timepoint [38]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [39]
0
0
Change From Baseline in High Density Lipoprotein (HDL) Particles
Query!
Assessment method [39]
0
0
The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12 and 26.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HDL particles as a covariate.
Query!
Timepoint [39]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [40]
0
0
Change From Baseline in Mean HDL Particle Size
Query!
Assessment method [40]
0
0
Change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean HDL particle size as a covariate.
Query!
Timepoint [40]
0
0
Baseline and Weeks 12 and 26.
Query!
Eligibility
Key inclusion criteria
Inclusion Criteria
* Historical diagnosis of type 2 diabetes.
* Failed treatment with diet and exercise for at least 2 months prior to Screening.
* Is experiencing inadequate glycemic control as defined as glycosylated hemoglobin concentration between 7.5-11%, inclusive.
* Has received any antidiabetic therapy for less than 7 days within 3 months prior to Screening.
* Has a body mass index greater than or equal to 23 kg/m2 and less than or equal to45 kg/m2.
* Fasting C-peptide greater than or equal to 0.8 ng per mL.
* Regular use of other, non-excluded medications is allowed if participant is on a stable dose for at least 4 weeks prior to Screening.
* Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
* Must be willing and able to monitor their blood concentrations with a home glucose monitor.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Exclusion Criteria
* Systolic blood pressure greater than or equal to 160 mmHg and diastolic blood pressure greater than or equal to 100 mmHg.
* Hemoglobin less than or equal to 12 g per dL for males and less than or equal to 10 g per dL for females.
* Alanine aminotransferase greater than or equal to 2.5times the upper limit of normal.
* Serum creatinine greater than 2.0 mg per dL.
* Thyroid stimulating hormone level greater than the upper limit of normal range.
* Major illness or debility that in the investigator's opinion prohibits the subject from completing the study.
* Urine albumin to creatinine ratio of greater than 1000 ug per mg at Screening. If elevated, the subject may be rescreened within 1 week.
* History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening
* History of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
* History of gastroparesis.
* Has New York Heart Association Class I to IV heart failure regardless of therapy.
* History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening.
* History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
* History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
* History of a psychiatric disorder that will affect participant's ability to participate in the study.
* History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
* Any alteration in angiotensin-II receptor inhibitors within 2 months prior to Randomization, if applicable.
* History of alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day) or substance abuse (defined as illicit drug use) within 2 years prior to Screening.
* Received any investigational drug within 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within 3 months prior to Screening.
* Previously participated in an investigational study of SYR-322.
* Glycosylated hemoglobin concentration between 7.5-11%, inclusive, and a fasting plasma glucose less than 310 mg per dL.
* At least 75% compliant with the single-blind placebo regimen during the run-in/stabilization period.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/11/2006
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/02/2008
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
655
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
- Kingswood
Query!
Recruitment hospital [2]
0
0
- Fitzroy
Query!
Recruitment hospital [3]
0
0
- Frankston
Query!
Recruitment postcode(s) [1]
0
0
- Kingswood
Query!
Recruitment postcode(s) [2]
0
0
- Fitzroy
Query!
Recruitment postcode(s) [3]
0
0
- Frankston
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Indiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Louisiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Maryland
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Massachusetts
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Michigan
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Mississippi
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Missouri
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Montana
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nevada
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New Jersey
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New York
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
North Carolina
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
North Dakota
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Ohio
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Oregon
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Pennsylvania
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
South Carolina
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Tennessee
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Texas
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Utah
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Virginia
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
West Virginia
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Wisconsin
Query!
Country [31]
0
0
Argentina
Query!
State/province [31]
0
0
Buenos Aires
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
Córdoba
Query!
Country [33]
0
0
Brazil
Query!
State/province [33]
0
0
CE
Query!
Country [34]
0
0
Brazil
Query!
State/province [34]
0
0
GO
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
PA
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
PR
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
RP
Query!
Country [38]
0
0
Brazil
Query!
State/province [38]
0
0
SP
Query!
Country [39]
0
0
Bulgaria
Query!
State/province [39]
0
0
Pleven
Query!
Country [40]
0
0
Chile
Query!
State/province [40]
0
0
Santiago
Query!
Country [41]
0
0
Croatia
Query!
State/province [41]
0
0
Slavonski Brod
Query!
Country [42]
0
0
Estonia
Query!
State/province [42]
0
0
Pärnu
Query!
Country [43]
0
0
Guatemala
Query!
State/province [43]
0
0
Guatemala
Query!
Country [44]
0
0
Hungary
Query!
State/province [44]
0
0
Budapest
Query!
Country [45]
0
0
Hungary
Query!
State/province [45]
0
0
Eger
Query!
Country [46]
0
0
Hungary
Query!
State/province [46]
0
0
Gyula
Query!
Country [47]
0
0
Hungary
Query!
State/province [47]
0
0
Mako
Query!
Country [48]
0
0
Hungary
Query!
State/province [48]
0
0
Nyiregyhaza
Query!
Country [49]
0
0
Hungary
Query!
State/province [49]
0
0
Pecs
Query!
Country [50]
0
0
India
Query!
State/province [50]
0
0
Andhra Pradesh
Query!
Country [51]
0
0
India
Query!
State/province [51]
0
0
Karnataka
Query!
Country [52]
0
0
India
Query!
State/province [52]
0
0
Maharashtra
Query!
Country [53]
0
0
India
Query!
State/province [53]
0
0
Tamil Nadu
Query!
Country [54]
0
0
Israel
Query!
State/province [54]
0
0
Hadera
Query!
Country [55]
0
0
Israel
Query!
State/province [55]
0
0
Haifa
Query!
Country [56]
0
0
Israel
Query!
State/province [56]
0
0
Holon
Query!
Country [57]
0
0
Israel
Query!
State/province [57]
0
0
Jaffa Tel Aviv
Query!
Country [58]
0
0
Israel
Query!
State/province [58]
0
0
Jerusalem
Query!
Country [59]
0
0
Israel
Query!
State/province [59]
0
0
Nahariya
Query!
Country [60]
0
0
Latvia
Query!
State/province [60]
0
0
Riga
Query!
Country [61]
0
0
Lithuania
Query!
State/province [61]
0
0
Kaunas
Query!
Country [62]
0
0
Lithuania
Query!
State/province [62]
0
0
Kedainiai
Query!
Country [63]
0
0
Mexico
Query!
State/province [63]
0
0
Aguascalientes
Query!
Country [64]
0
0
Mexico
Query!
State/province [64]
0
0
Mexico City
Query!
Country [65]
0
0
Mexico
Query!
State/province [65]
0
0
Monterrey
Query!
Country [66]
0
0
New Zealand
Query!
State/province [66]
0
0
Christchurch
Query!
Country [67]
0
0
New Zealand
Query!
State/province [67]
0
0
Hamilton
Query!
Country [68]
0
0
Poland
Query!
State/province [68]
0
0
Bialystok
Query!
Country [69]
0
0
Poland
Query!
State/province [69]
0
0
Bytom
Query!
Country [70]
0
0
Poland
Query!
State/province [70]
0
0
Gdansk
Query!
Country [71]
0
0
Poland
Query!
State/province [71]
0
0
Gniewkowo
Query!
Country [72]
0
0
Poland
Query!
State/province [72]
0
0
Kamieniec Zabkowicki
Query!
Country [73]
0
0
Poland
Query!
State/province [73]
0
0
Krakow
Query!
Country [74]
0
0
Poland
Query!
State/province [74]
0
0
Leczyca
Query!
Country [75]
0
0
Romania
Query!
State/province [75]
0
0
Brasov
Query!
Country [76]
0
0
Romania
Query!
State/province [76]
0
0
Bucharest
Query!
Country [77]
0
0
Romania
Query!
State/province [77]
0
0
Galati
Query!
Country [78]
0
0
Russian Federation
Query!
State/province [78]
0
0
Ekaterinburg
Query!
Country [79]
0
0
Russian Federation
Query!
State/province [79]
0
0
Kazan
Query!
Country [80]
0
0
Russian Federation
Query!
State/province [80]
0
0
Moscow
Query!
Country [81]
0
0
Serbia
Query!
State/province [81]
0
0
Belgrade
Query!
Country [82]
0
0
Serbia
Query!
State/province [82]
0
0
Kragujevac
Query!
Country [83]
0
0
Serbia
Query!
State/province [83]
0
0
Nis
Query!
Country [84]
0
0
Slovakia
Query!
State/province [84]
0
0
Nitra
Query!
Country [85]
0
0
Slovakia
Query!
State/province [85]
0
0
Banska Bysterica
Query!
Country [86]
0
0
Slovakia
Query!
State/province [86]
0
0
Lucenec
Query!
Country [87]
0
0
Slovakia
Query!
State/province [87]
0
0
Riverside
Query!
Country [88]
0
0
Slovakia
Query!
State/province [88]
0
0
Sahy
Query!
Country [89]
0
0
South Africa
Query!
State/province [89]
0
0
Eastern Cape
Query!
Country [90]
0
0
South Africa
Query!
State/province [90]
0
0
Gauteng
Query!
Country [91]
0
0
South Africa
Query!
State/province [91]
0
0
Kwa-Zulu Natal
Query!
Country [92]
0
0
South Africa
Query!
State/province [92]
0
0
Pretoria
Query!
Country [93]
0
0
South Africa
Query!
State/province [93]
0
0
Western Province
Query!
Country [94]
0
0
Ukraine
Query!
State/province [94]
0
0
Dnipropetrovsk
Query!
Country [95]
0
0
Ukraine
Query!
State/province [95]
0
0
Kharkiv
Query!
Country [96]
0
0
Ukraine
Query!
State/province [96]
0
0
Lviv
Query!
Country [97]
0
0
Ukraine
Query!
State/province [97]
0
0
Odesa
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Takeda
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to evaluate the combination of alogliptin, once daily (QD), and pioglitazone in patients with type 2 diabetes mellitus who are inadequately controlled with diet and exercise alone.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00395512
Query!
Trial related presentations / publications
Rosenstock J, Inzucchi SE, Seufert J, Fleck PR, Wilson CA, Mekki Q. Initial combination therapy with alogliptin and pioglitazone in drug-naive patients with type 2 diabetes. Diabetes Care. 2010 Nov;33(11):2406-8. doi: 10.2337/dc10-0159. Epub 2010 Aug 19.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
VP, Biological Sciences
Query!
Address
0
0
Takeda
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Rosenstock J, Inzucchi SE, Seufert J, Fleck PR, Wi...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT00395512
Download to PDF