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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

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ClinicalTrials.gov Identifier: NCT00740051
Recruitment Status : Completed
First Posted : August 22, 2008
Results First Posted : October 26, 2011
Last Update Posted : June 27, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE August 21, 2008
First Posted Date  ICMJE August 22, 2008
Results First Submitted Date  ICMJE August 3, 2011
Results First Posted Date  ICMJE October 26, 2011
Last Update Posted Date June 27, 2014
Study Start Date  ICMJE August 2008
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2011)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 21, 2008)
The primary endpoint in this study is the change from baseline in HbA1c after 18 weeks of treatment. [ Time Frame: 18 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2008)
Key secondary endpoint is safety in this patient population with longer term (34 week) treatment in comparison to a sulfonylurea drug (glimepiride) [ Time Frame: 52 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
Brief Summary 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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Linagliptin
    5mg once daily
  • Drug: Linagliptin Placebo
    0 mg placebo comparator for part 1 of study (to 18 weeks)
  • Drug: Glimepiride
    1-4mg for part 2 of study (weeks 19-52)
Study Arms  ICMJE
  • Experimental: Linagliptin
    52 week treatment
    Intervention: Drug: Linagliptin
  • Placebo Comparator: Placebo
    First 18 weeks of treatment
    Intervention: Drug: Linagliptin Placebo
  • Active Comparator: Glimepiride
    Placebo patients switch to glimepiride week19-52
    Intervention: Drug: Glimepiride
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 17, 2010)
227
Original Estimated Enrollment  ICMJE
 (submitted: August 21, 2008)
225
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Mexico,   Philippines,   Romania,   Russian Federation,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00740051
Other Study ID Numbers  ICMJE 1218.50
2007-007485-38 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP