A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00740051
First received: August 21, 2008
Last updated: July 10, 2012
Last verified: July 2012
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Purpose
Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride)
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Linagliptin Drug: Linagliptin Placebo Drug: Glimepiride |
Phase 3 |
| 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, db, Placebo-controlled, Parallel Group Efficacy and Safety Study of BI 1356 (5mg), Administered Orally Once Daily for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients With Insufficient Glycaemic Control for Whom Metformin Therapy is Inappropriate (Intolerability or Contraindication) |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- HbA1c Change From Baseline at Week 18 (Interim Analysis) [ Time Frame: Baseline and week 18 ] [ Designated as safety issue: No ]HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.
- HbA1c Change From Baseline at Week 18 (Final Analysis) [ Time Frame: Baseline and week 18 ] [ Designated as safety issue: No ]HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. The primary analysis was re-run at the completion of the study in the final study report.
Secondary Outcome Measures:
- Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 [ Time Frame: Baseline and week 18 ] [ Designated as safety issue: No ]This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG, baseline HbA1c, prior OADs and reason for metformin intolerance.
- Percentage of Patients With HbA1c<7.0 at Week 18 [ Time Frame: Week 18 ] [ Designated as safety issue: No ]Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.
- Percentage of Patients With HbA1c<6.5 at Week 18 [ Time Frame: Week 18 ] [ Designated as safety issue: No ]Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.
- Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 [ Time Frame: Week 18 ] [ Designated as safety issue: No ]Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.
| Enrollment: | 227 |
| Study Start Date: | August 2008 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Linagliptin
52 week treatment
|
Drug: Linagliptin
5mg once daily
|
|
Placebo Comparator: Placebo
First 18 weeks of treatment
|
Drug: Linagliptin Placebo
0 mg placebo comparator for part 1 of study (to 18 weeks)
|
|
Active Comparator: Glimepiride
Placebo patients switch to glimepiride week19-52
|
Drug: Glimepiride
1-4mg for part 2 of study (weeks 19-52)
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control (HbA1c 7% to 10%) for whom metformin therapy is inappropriate (intolerability or contraindication)
Exclusion criteria Myocardial infarction, stroke or Transient ischaemic attack in last 6 months Treatment with rosiglitazone or pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in past 3 months Impaired hepatic function Severe renal impairment current treatment with systemic steroids change in dosage of thyroid hormones hereditary galactose intolerance
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740051
Show 53 Study Locations
Show 53 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided by Boehringer Ingelheim Pharmaceuticals
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00740051 History of Changes |
| Other Study ID Numbers: | 1218.50, 2007-007485-38 |
| Study First Received: | August 21, 2008 |
| Results First Received: | August 3, 2011 |
| Last Updated: | July 10, 2012 |
| Health Authority: | Canada: Health Canada, Therapeutic Products Directorate Mexico: Federal Commission for Sanitary Risks Protection Philippines: Bureau of Food and Drug Romania: National Medicines Agency, Bucharest Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine) United States: Food and Drug Administration |
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 May 19, 2013