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:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00740051
First received: August 21, 2008
Last updated: June 17, 2014
Last verified: December 2013
  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:

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 (Interim Analysis) [ 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 (Interim Analysis).

  • Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis) [ 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 (Interim Analysis) [ 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 (Interim Analysis) [ Time Frame: Week 18 ] [ Designated as safety issue: No ]
    Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.

  • The Change in HbA1c From Baseline by Visit Over Time [ Time Frame: Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52 ] [ Designated as safety issue: No ]
    HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 HbA1c percent.

  • The Change in FPG From Baseline by Visit Over Time [ Time Frame: Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52 ] [ Designated as safety issue: No ]
    This change from baseline reflects the FPG (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 FPG.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740051

  Show 53 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

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: June 17, 2014
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 July 28, 2014