Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00309608
First received: March 31, 2006
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1 356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metfor min in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In additi on, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for com parison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability a nd efficacy of BI 1356 BS will also be tested in this study.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Linagliptin Drug: Placebo Drug: Glimepiride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomised, Double-blind, Placebo-controlled, Five Parallel Groups Study Investigating the Efficacy and Safety of BI 1356 BS (1 mg, 5 mg and 10 mg Administered Orally Once Daily) Over 12 Weeks as add-on Therapy in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Metformin Therapy, Including an Open-label Glimepiride Treatment Arm. |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- HbA1c Change From Baseline at Week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the HbA1c percent baseline value. Means are treatment adjusted for baseline HbA1c.
Secondary Outcome Measures:
- Percentage of Patients With HbA1c<=7.0% at Week 12 [ Time Frame: week 12 ] [ Designated as safety issue: No ]Descriptive calculation of proportions on the basis of non-missing data
- Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
| Enrollment: | 333 |
| Study Start Date: | April 2006 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Linagliptin low dose
Patients receive Linagliptin low dose tablets once daily
|
Drug: Linagliptin
Linagliptin low dose tablet once daily
|
|
Experimental: Linagliptin medium dose
Patients receive Linagliptin medium dose tablets once daily
|
Drug: Linagliptin
Linagliptin medium dose tablet once daily
|
|
Experimental: Linagliptin high dose
Patients receive Linagliptin high dose tablets once daily
|
Drug: Linagliptin
Linagliptin high dose tablet once daily
|
|
Placebo Comparator: Placebo
Patients receive tablets identical to those containing Linagliptin low, medium and high dose
|
Drug: Placebo
Placebo tablets once daily
|
|
Active Comparator: Glimepiride
Patients receive Glimepiride tablets once daily
|
Drug: Glimepiride
Glimepiride tablets once daily
|
Eligibility| Ages Eligible for Study: | 21 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
Inclusion_Criteria:
- Male and female patients with a diagnosis of type 2 diabetes mellitus and previo usly treated with metformin alone or with metformin and one other oral antidiabetic d rug
- HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
- HbA1c 7.5 10.0% at screening for patients treated with metformin alone
- HbA1c 7.5 10.0% at beginning of the placebo run-in phase
- Age > 21 and < 75 years
- MI > 25 and < 40 kg/m2 (Body Mass Index)
Exclusion criteria:
Exclusion_Criteria:
- Clinically relevant cardiovascular disease
- Impaired hepatic function
- Renal insufficiency or impaired renal function
- Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
- Treatment with insulin within 3 months prior to screening
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309608
Show 48 Study Locations
Show 48 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
Related Info 
Related Info 
No publications provided
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00309608 History of Changes |
| Other Study ID Numbers: | 1218.6, 2005-004597-24 |
| Study First Received: | March 31, 2006 |
| Results First Received: | May 13, 2011 |
| Last Updated: | May 18, 2012 |
| Health Authority: | France: AFSSAPS Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte Great Britain: MHRA Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26 Sweden: Medical Products Agency Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine) |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glimepiride BI 1356 Metformin Hypoglycemic Agents Physiological Effects of Drugs |
Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013