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NCT00740051 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00740051
Other study ID # 1218.50
Secondary ID 2007-007485-38
Status Completed
Phase Phase 3
First received August 21, 2008
Last updated June 17, 2014
Start date August 2008

Study information
Verified date December 2013
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada, Therapeutic Products DirectorateMexico: Federal Commission for Sanitary Risks ProtectionPhilippines: Bureau of Food and DrugRomania: National Medicines Agency, BucharestRussia: Ministry of Healthcare and Social Development of Russian Federation, MoscowUkraine: Ministry of Health Care of Ukraine (MoH of Ukraine)United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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)

Recruitment information / eligibility
Status Completed
Enrollment 227
Est. completion date
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Linagliptin
5mg once daily
• Linagliptin Placebo
0 mg placebo comparator for part 1 of study (to 18 weeks)
• Glimepiride
1-4mg for part 2 of study (weeks 19-52)

Locations
Country Name City State
Canada 1218.50.11001 Boehringer Ingelheim Investigational Site Edmonton Alberta
Canada 1218.50.11003 Boehringer Ingelheim Investigational Site Edmonton Alberta
Canada 1218.50.11002 Boehringer Ingelheim Investigational Site Montague Prince Edward Island
Canada 1218.50.11005 Boehringer Ingelheim Investigational Site Sarnia Ontario
Canada 1218.50.11004 Boehringer Ingelheim Investigational Site Saskatoon Saskatchewan
Mexico 1218.50.52007 Boehringer Ingelheim Investigational Site Aguascalientes
Mexico 1218.50.52010 Boehringer Ingelheim Investigational Site Guadalajara
Mexico 1218.50.52009 Boehringer Ingelheim Investigational Site León
Mexico 1218.50.52002 Boehringer Ingelheim Investigational Site Mexico
Mexico 1218.50.52008 Boehringer Ingelheim Investigational Site Mexico
Mexico 1218.50.52004 Boehringer Ingelheim Investigational Site México
Mexico 1218.50.52005 Boehringer Ingelheim Investigational Site México
Mexico 1218.50.52001 Boehringer Ingelheim Investigational Site Monterrey
Mexico 1218.50.52003 Boehringer Ingelheim Investigational Site Monterrey
Philippines 1218.50.63003 Boehringer Ingelheim Investigational Site Cebu
Philippines 1218.50.63005 Boehringer Ingelheim Investigational Site Cebu
Philippines 1218.50.63006 Boehringer Ingelheim Investigational Site Manila
Philippines 1218.50.63008 Boehringer Ingelheim Investigational Site Manila
Philippines 1218.50.63001 Boehringer Ingelheim Investigational Site Marikina
Philippines 1218.50.63004 Boehringer Ingelheim Investigational Site Marikina
Philippines 1218.50.63007 Boehringer Ingelheim Investigational Site Pasay
Philippines 1218.50.63002 Boehringer Ingelheim Investigational Site Pasig
Philippines 1218.50.63009 Boehringer Ingelheim Investigational Site Pasig
Romania 1218.50.40004 Boehringer Ingelheim Investigational Site Brasov
Romania 1218.50.40001 Boehringer Ingelheim Investigational Site Bucharest
Romania 1218.50.40002 Boehringer Ingelheim Investigational Site Bucharest
Romania 1218.50.40005 Boehringer Ingelheim Investigational Site Galati
Romania 1218.50.40003 Boehringer Ingelheim Investigational Site Sibiu
Russian Federation 1218.50.70001 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1218.50.70003 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1218.50.70002 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 1218.50.70004 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 1218.50.70005 Boehringer Ingelheim Investigational Site St. Petersburg
Ukraine 1218.50.38002 Boehringer Ingelheim Investigational Site Kharkiv
Ukraine 1218.50.38001 Boehringer Ingelheim Investigational Site Kiev
Ukraine 1218.50.38004 Boehringer Ingelheim Investigational Site Kiev
Ukraine 1218.50.38003 Boehringer Ingelheim Investigational Site Lvov
Ukraine 1218.50.38005 Boehringer Ingelheim Investigational Site Vinnitsa
United States 1218.50.10009 Boehringer Ingelheim Investigational Site Birmingham Alabama
United States 1218.50.10012 Boehringer Ingelheim Investigational Site Dallas Texas
United States 1218.50.10022 Boehringer Ingelheim Investigational Site Dallas Texas
United States 1218.50.10002 Boehringer Ingelheim Investigational Site Eugene Oregon
United States 1218.50.10013 Boehringer Ingelheim Investigational Site Greenbrae California
United States 1218.50.10015 Boehringer Ingelheim Investigational Site Greer South Carolina
United States 1218.50.10016 Boehringer Ingelheim Investigational Site Harbor City California
United States 1218.50.10017 Boehringer Ingelheim Investigational Site Huntington Park California
United States 1218.50.10005 Boehringer Ingelheim Investigational Site Kingsport Tennessee
United States 1218.50.10006 Boehringer Ingelheim Investigational Site Los Angeles California
United States 1218.50.10007 Boehringer Ingelheim Investigational Site Miami Florida
United States 1218.50.10011 Boehringer Ingelheim Investigational Site Peoria Arizona
United States 1218.50.10010 Boehringer Ingelheim Investigational Site San Antonio Texas
United States 1218.50.10018 Boehringer Ingelheim Investigational Site San Antonio Texas
United States 1218.50.10004 Boehringer Ingelheim Investigational Site Statesville North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Canada,  Mexico,  Philippines,  Romania,  Russian Federation,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c Change From Baseline at Week 18 (Interim Analysis) 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. Baseline and week 18 No
Primary HbA1c Change From Baseline at Week 18 (Final Analysis) 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. Baseline and week 18 No
Secondary Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis) 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). Baseline and week 18 No
Secondary Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis) Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. Week 18 No
Secondary Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis) Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. Week 18 No
Secondary Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis) Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. Week 18 No
Secondary The Change in HbA1c From Baseline by Visit Over Time 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. Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52 No
Secondary The Change in FPG From Baseline by Visit Over Time This change from baseline reflects the FPG (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 FPG. Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52 No
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