Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01647542




Registration number
NCT01647542
Ethics application status
Date submitted
19/07/2012
Date registered
23/07/2012
Date last updated
11/11/2015

Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 and 50mg in Asia Pacific Adults With Type 2 Diabetes
Scientific title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24-week Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 and 50mg Compared With Placebo in Asia Pacific Subjects With Type 2 Diabetes
Secondary ID [1] 0 0
U1111-1129-7865
Secondary ID [2] 0 0
TAK-875_307
Universal Trial Number (UTN)
Trial acronym
GRAND-307
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TAK-875
Treatment: Drugs - TAK-875 Placebo

Experimental: TAK-875 25 mg - TAK-875 25 mg tablets, orally, once daily for up to 24 weeks.

Experimental: TAK-875 50 mg - TAK-875 50 mg tablets, orally, once daily for up to 24 weeks.

Placebo comparator: Placebo - TAK-875 placebo-matching tablets, orally, once daily for up to 24 weeks.


Treatment: Drugs: TAK-875
TAK-875 tablets

Treatment: Drugs: TAK-875 Placebo
TAK-875 placebo-matching tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in HbA1c at Week 24
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [1] 0 0
Percentage of Participants With HbA1c <7% at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Change in Fasting Plasma Glucose From Baseline to Week 24
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
Change From Baseline in 2-hour Postprandial Glucose (PPG) Following Oral Glucose Tolerance Test (OGTT) at Week 24
Timepoint [3] 0 0
Baseline and Week 24

Eligibility
Key inclusion criteria
1. In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements.
2. The patient or, when applicable, the patient's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
3. Male or female, aged at least 18 years or over the legal age of consent in countries where that is greater than 18 years, with a historical diagnosis of T2DM.
4. Has an HbA1c of 7.0% to 10.0%, inclusive at screening, and has been treated with diet and exercise for at least 3 months.
5. Has a body mass index (BMI) of =45 kg/m^2 at screening.
6. Patients regularly using, non-excluded medications, must be on a stable dose for at least 4 weeks prior to Screening. However, PRN (as needed) use of prescription or over-the-counter medication is allowed at the discretion of the investigator.
7. A female of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of the informed consent throughout the duration of the study and for 30 days after the last dose of study drug.
8. Is able and willing to monitor glucose with a home glucose monitor and consistently record his or her own blood glucose concentrations and complete subject diaries.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Is unable to understand the official language (verbal or written) of the country for which a certified translation of the approved informed consent is available.
2. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, or sibling; biological or legally adopted) or may consent under duress.
3. Has hemoglobin a level =12 g/dL (=120 g/L) (males) and =10 g/dL (=100 g/L) (females) at the Screening Visit.
4. Has a history of any hemoglobinopathy that may affect determination of HbA1c.
5. Donated or received any blood products within 12 weeks prior to Screening or is planning to donate blood during the study.
6. Has systolic blood pressure =160 mm Hg or diastolic pressure =95 mm Hg at Screening or Baseline (If the patient meets this exclusion criterion, the assessment may be repeated once at least 30 minutes after initial measurement and decision will be made based on the second measurement).
7. Had coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, unstable angina pectoris, clinically significant abnormal electrocardiogram, cerebrovascular accident or transient ischemic attack within 3 months prior or at Screening.
8. Has a serum creatinine level of =1.5 mg/dL (males) and =1.4 mg/dL (females) and/or estimated glomerular filtration rate (GFR) <60 mL/min/1.73m^2 at Screening.
9. Has uncontrolled thyroid disease.
10. Has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
11. Has a history or treatment for diabetic gastric paresis, gastric banding, or gastric bypass surgery.
12. Has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels >2.0x the upper limit of normal range (ULN) at Screening.
13. Has a total bilirubin level greater than the ULN at Screening. Exception: if a patient has documented Gilbert's Syndrome, they will be allowed with an elevated bilirubin level per the investigator's discretion.
14. Has a known history of infection with human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
15. If a patient has no known history of HBV infection, then a HBV Screening test panel should be done. If the test is positive and there is clinical manifestation of active infection per Investigator's diagnosis, then the patient should be excluded. In addition, if the patient is considered to need antiviral treatment, the patient should be excluded. (If the test results indicate only an hepatitis B surface antigen (HBsAg) carrier without any clinical manifestation of active infection, and no antiviral treatment is needed, then the patient could be enrolled provided all other criteria are met.)
16. Has a history of cancer that has been in remission for <5 years prior to Screening. A history of basal cell carcinoma or stage 1 squamous cell carcinoma of the skin is allowed.
17. Has received any investigational compound within 30 days prior to Screening or has received >7 days of any antidiabetic agent within 3 months prior to Screening.
18. Has received TAK-875 in a previous clinical study.
19. Has a history of hypersensitivity, allergies or has had an anaphylactic reaction(s) to any component of TAK-875.
20. Has a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within 2 years prior to Screening.
21. Received excluded medications prior to Screening or is expected to receive excluded medications.
22. If female, is pregnant (confirmed by laboratory testing, ie, serum/urine human chorionic gonadotropin (hCG), in females of childbearing potential) or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
23. If male, intends to donate sperm during the course of this study or for 30 days after final study medication dose.
24. Has any other physical or psychiatric disease or condition that in the judgment of the investigator may affect life expectancy or may make it difficult to successfully manage and follow the subject according to the protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2014
Sample size
Target
Accrual to date
Final
393
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
- Brookvale
Recruitment hospital [2] 0 0
- Maroubra
Recruitment hospital [3] 0 0
- Mosman
Recruitment hospital [4] 0 0
- Woy Woy
Recruitment hospital [5] 0 0
- Elizabeth Vale
Recruitment postcode(s) [1] 0 0
- Brookvale
Recruitment postcode(s) [2] 0 0
- Maroubra
Recruitment postcode(s) [3] 0 0
- Mosman
Recruitment postcode(s) [4] 0 0
- Woy Woy
Recruitment postcode(s) [5] 0 0
- Elizabeth Vale
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Anhui
Country [2] 0 0
China
State/province [2] 0 0
Beijing
Country [3] 0 0
China
State/province [3] 0 0
Chongqing
Country [4] 0 0
China
State/province [4] 0 0
Fujian
Country [5] 0 0
China
State/province [5] 0 0
Guangdong
Country [6] 0 0
China
State/province [6] 0 0
Guizhou
Country [7] 0 0
China
State/province [7] 0 0
Hebei
Country [8] 0 0
China
State/province [8] 0 0
Heilongjiang
Country [9] 0 0
China
State/province [9] 0 0
Hubei
Country [10] 0 0
China
State/province [10] 0 0
Hunan
Country [11] 0 0
China
State/province [11] 0 0
Jiangsu
Country [12] 0 0
China
State/province [12] 0 0
Jilin
Country [13] 0 0
China
State/province [13] 0 0
Shaanxi
Country [14] 0 0
China
State/province [14] 0 0
Shanghai
Country [15] 0 0
China
State/province [15] 0 0
Shanxi
Country [16] 0 0
China
State/province [16] 0 0
Sichuan
Country [17] 0 0
China
State/province [17] 0 0
Tianjin
Country [18] 0 0
China
State/province [18] 0 0
Guangzhou
Country [19] 0 0
China
State/province [19] 0 0
Guiyang
Country [20] 0 0
China
State/province [20] 0 0
Nanjing
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Gyeonggi-do
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Gyeonggi
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Incheon
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Seoul
Country [25] 0 0
New Zealand
State/province [25] 0 0
Auckland
Country [26] 0 0
New Zealand
State/province [26] 0 0
Hamilton
Country [27] 0 0
New Zealand
State/province [27] 0 0
Rotorua
Country [28] 0 0
New Zealand
State/province [28] 0 0
Tauranga
Country [29] 0 0
New Zealand
State/province [29] 0 0
Wellington
Country [30] 0 0
Taiwan
State/province [30] 0 0
Kaohsiung
Country [31] 0 0
Taiwan
State/province [31] 0 0
New Taipei City
Country [32] 0 0
Taiwan
State/province [32] 0 0
Taichung
Country [33] 0 0
Taiwan
State/province [33] 0 0
Tainan
Country [34] 0 0
Taiwan
State/province [34] 0 0
Taipei City
Country [35] 0 0
Taiwan
State/province [35] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01647542