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/NCT00328172




Registration number
NCT00328172
Ethics application status
Date submitted
18/05/2006
Date registered
19/05/2006
Date last updated
14/03/2014

Titles & IDs
Public title
Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients
Scientific title
A Randomized, Double-blind, Placebo-controlled, Five Parallel Group Study Investigating the Efficacy and Safety of BI 1356 BS (0.5 mg, 2.5 mg and 5.0 mg Administered Orally Once Daily) Over 12 Weeks in Drug Naive and Treated Patients With Type 2 Diabetes With Insufficient Glycemic Control (Study Includes an Open-label Metformin Treatment Arm)
Secondary ID [1] 0 0
1218.5
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 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 - Placebo
Treatment: Drugs - BI 1356 dose 3 once daily
Treatment: Drugs - BI 1356 dose 2 once daily
Treatment: Drugs - BI 1356 dose 1 once daily
Treatment: Drugs - Metformin

Placebo comparator: Placebo - Placebo tablets matching BI 1356

Experimental: BI 1356 0.5 mg - BI 1356 dose 1 once daily

Experimental: BI 1356 2.5 mg - BI 1356 dose 2 once daily

Experimental: BI 1356 5.0 mg - BI 1356 dose 3 once daily

Active comparator: Metformin - Metformin


Treatment: Drugs: Placebo
Placebo matching BI 1356

Treatment: Drugs: BI 1356 dose 3 once daily
BI 1356 dose 3 once daily

Treatment: Drugs: BI 1356 dose 2 once daily
BI 1356 dose 2 once daily

Treatment: Drugs: BI 1356 dose 1 once daily
BI 1356 dose 1 once daily

Treatment: Drugs: Metformin
Metformin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12
Timepoint [1] 0 0
Baseline, week 12
Secondary outcome [1] 0 0
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Timepoint [1] 0 0
Baseline, week 12
Secondary outcome [2] 0 0
Percentage of Patients With Absolute Efficacy Response (HbA1c <= 7.0%) at 12 Weeks
Timepoint [2] 0 0
Baseline, week 12

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Male and female patients with a diagnosis of Type 2 diabetes treated only with diet and exercise (drug naïve) or with one or two oral hypoglycemic agents (as single treatment or in combination) other than rosiglitazone or pioglitazone -treatment. Antidiabetic therapy has to be stable for at least 10 weeks prior to screening.
2. Diagnosis of Type 2 diabetes with duration of at least 3 months
3. Glycosylated haemoglobin A1 (HbA1c) of:

7.5-10.0% at screening for drug naïve patients (no wash-out needed) 7.0-9.0% at screening for patients treated with only one oral antidiabetic agent (wash-out required) 6.5-8.0% at screening for patients treated with two oral antidiabetic agents (wash-out required)
4. HbA1c of 7.5%-10.0% at Visit 3 (beginning of the 2-week placebo run-in period).
5. Age >=21 and <=75 years.
6. BMI (Body Mass Index) >=25.0 and <=40 kg/m2.
7. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
Minimum age
21 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Clinically relevant cardiovascular disease (e.g., myocardial infarction, stroke or transient ischemic attack within six months before enrollment)
2. Impaired hepatic function defined by serum levels of either alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase above 3-fold upper limit of normal
3. Renal insufficiency or impaired renal function defined by serum creatinine above upper limit of normal at screening
4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or clinically relevant neurologic disorders (including cerebrovascular but with the exception of polyneuropathy) that would interfere with participation in the trial
5. Chronic or clinically relevant acute infections (e.g., Human immunodeficiency virus, Hepatitis)
6. History of relevant allergy/hypersensitivity that would interfere with trial participation (including allergy to investigational product or its excipients)
7. Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
8. Treatment with insulin within 3 months prior to screening
9. Alcohol or drug abuse within the last 3 months that would interfere with trial participation)
10. Participation in another trial with an investigational drug within two months prior to administration or during the trial
11. Fasting plasma glucose >240 mg/dl (= 13.3 mmol/L) at Visit 2, 3 or 4 any visit and confirmed by a second measurement (not on the same day)
12. Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who:

1. are not surgically sterile,
2. or are nursing or pregnant;
3. or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra-uterine devices, oral, implantable or injectable contraceptives and vasectomised partner. No exception will be made.
13. Intolerance of metformin

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?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
302
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
1218.5.61001 Boehringer Ingelheim Investigational Site - Miranda
Recruitment hospital [2] 0 0
1218.5.61005 Boehringer Ingelheim Investigational Site - Box Hill
Recruitment hospital [3] 0 0
1218.5.61006 Boehringer Ingelheim Investigational Site - Dandenong
Recruitment hospital [4] 0 0
1218.5.61007 Boehringer Ingelheim Investigational Site - East Ringwood
Recruitment hospital [5] 0 0
1218.5.61004 Boehringer Ingelheim Investigational Site - Fremantle
Recruitment hospital [6] 0 0
1218.5.61002 Boehringer Ingelheim Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
- Miranda
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment postcode(s) [3] 0 0
- Dandenong
Recruitment postcode(s) [4] 0 0
- East Ringwood
Recruitment postcode(s) [5] 0 0
- Fremantle
Recruitment postcode(s) [6] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Montana
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Canada
State/province [19] 0 0
Alberta
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
Manitoba
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Prince Edward Island
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
Canada
State/province [25] 0 0
Saskatchewan
Country [26] 0 0
Czech Republic
State/province [26] 0 0
Olomouc 9
Country [27] 0 0
Czech Republic
State/province [27] 0 0
Praha 4
Country [28] 0 0
Czech Republic
State/province [28] 0 0
Praha 9
Country [29] 0 0
Czech Republic
State/province [29] 0 0
Sternberk
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Moscow
Country [31] 0 0
Russian Federation
State/province [31] 0 0
St. Petersburg
Country [32] 0 0
Ukraine
State/province [32] 0 0
Kharkov
Country [33] 0 0
Ukraine
State/province [33] 0 0
Kiev
Country [34] 0 0
Ukraine
State/province [34] 0 0
Lvov
Country [35] 0 0
Ukraine
State/province [35] 0 0
Vinnitsa

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
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/NCT00328172