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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:
ClinicalTrials.gov Identifier:
NCT00740051
First Posted: August 22, 2008
Last Update Posted: June 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
  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
Intervention Model: Parallel Assignment
Masking: Double
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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740051


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

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 ( EudraCT Number: EudraCT )
First Submitted: August 21, 2008
First Posted: August 22, 2008
Results First Submitted: August 3, 2011
Results First Posted: October 26, 2011
Last Update Posted: June 27, 2014
Last Verified: December 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action