Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00819091
First received: January 7, 2009
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: BI 1356
Drug: Placebo
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 Randomized, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 18 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control (HbA1c 7.0-10%) Despite Background Therapy With a Sulfonylurea Drug.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18 [ Time Frame: Baseline, week 18 ] [ Designated as safety issue: No ]
    HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.


Secondary Outcome Measures:
  • Change From Baseline in Fasting Plasma Glucose at Week 18 [ Time Frame: Baseline, week 18 ] [ Designated as safety issue: No ]
    Change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.

  • Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18 [ Time Frame: week 18 ] [ Designated as safety issue: No ]
    An absolute efficacy response is defined as HbA1c < 7.0% at 18 weeks. A non-response is defined as HbA1c >= 7.0% at 18 weeks.

  • Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18 [ Time Frame: week 18 ] [ Designated as safety issue: No ]
    An absolute efficacy response is defined as HbA1c < 6.5% at 18 weeks. A non-response is defined as HbA1c >= 6.5% at 18 weeks.

  • Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18 [ Time Frame: Baseline, week 18 ] [ Designated as safety issue: No ]
    An efficacy response is defined as HbA1c lowered by 0.5% or more at 18 weeks. A non-response is defined as HbA1c not lowered by 0.5% or more at 18 weeks.

  • Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6 [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]
    HbA1c is measured as a percent. The change from baseline reflects the Week 6 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.

  • Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 12 [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]
    HbA1c is measured as a percent. The change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.

  • Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 18 [ Time Frame: Baseline, week 18 ] [ Designated as safety issue: No ]
    HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.

  • Change From Baseline in Fasting Plasma Glucose at Week 6 [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]
    Change from baseline reflects the Week 6 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.

  • Change From Baseline in Fasting Plasma Glucose at Week 12 [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]
    Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.


Enrollment: 245
Study Start Date: December 2008
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BI 1356
5 mg orally (po) once daily
Drug: BI 1356
5mg orally (po) tablet qd
Placebo Comparator: Placebo
one tablet once daily
Drug: Placebo
Placebo matching BI 1356 5mg one tablet daily

  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 [glycosylated hemoglobin (HbA1c 7% to 10%)] despite therapy with a sulfonylurea drug

Exclusion criteria:

Myocardial infarction,stroke or transient ischaemic attack in last 6 months Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in the past 3 months Impaired hepatic function Severe renal impairment Current treatment with systemic steroids Change in thyroid hormone dosage Hereditary galactose intolerance

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819091

  Hide Study Locations
Locations
United States, Alabama
1218.35.10002 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
United States, California
1218.35.10001 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1218.35.10016 Boehringer Ingelheim Investigational Site
National City, California, United States
United States, Florida
1218.35.10021 Boehringer Ingelheim Investigational Site
Ft. Lauderdale, Florida, United States
1218.35.10017 Boehringer Ingelheim Investigational Site
Ft. Lauderdale, Florida, United States
United States, Illinois
1218.35.10013 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
United States, Michigan
1218.35.10015 Boehringer Ingelheim Investigational Site
Flint, Michigan, United States
United States, North Carolina
1218.35.10018 Boehringer Ingelheim Investigational Site
Asheville, North Carolina, United States
United States, Ohio
1218.35.10004 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
United States, Oregon
1218.35.10005 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
United States, South Carolina
1218.35.10020 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
United States, Texas
1218.35.10009 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1218.35.10019 Boehringer Ingelheim Investigational Site
Sugar Land, Texas, United States
Argentina
1218.35.54003 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1218.35.54005 Boehringer Ingelheim Investigational Site
Corrientes, Argentina
1218.35.54001 Boehringer Ingelheim Investigational Site
Mar del Plata, Argentina
1218.35.54006 Boehringer Ingelheim Investigational Site
Parque Velez Sarfield, Argentina
Hungary
1218.35.36005 Boehringer Ingelheim Investigational Site
Budapest, Hungary
1218.35.36004 Boehringer Ingelheim Investigational Site
Budapest, Hungary
1218.35.36001 Boehringer Ingelheim Investigational Site
Budapest, Hungary
1218.35.36002 Boehringer Ingelheim Investigational Site
Budapest, Hungary
1218.35.36003 Boehringer Ingelheim Investigational Site
Debrecen, Hungary
India
1218.35.91003 Boehringer Ingelheim Investigational Site
Aligarh, Uttar Pradesh, India
1218.35.91007 Boehringer Ingelheim Investigational Site
Aminjikarai, Tamilnadu, India
1218.35.91004 Boehringer Ingelheim Investigational Site
Bangalore, Karnataka, India
1218.35.91001 Boehringer Ingelheim Investigational Site
Bangalore, Karnataka, India
1218.35.91002 Boehringer Ingelheim Investigational Site
Indore, India
1218.35.91008 Boehringer Ingelheim Investigational Site
Mumbai, Maharastra, India
1218.35.91005 Boehringer Ingelheim Investigational Site
Nagpur, Maharashtra, India
1218.35.91006 Boehringer Ingelheim Investigational Site
Pune, Maharastra, India
Japan
1218.35.81003 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
1218.35.81001 Boehringer Ingelheim Investigational Site
Shinjyuku-ku,Tokyo, Japan
1218.35.81002 Boehringer Ingelheim Investigational Site
Suita, Osaka,, Japan
Poland
1218.35.48002 Boehringer Ingelheim Investigational Site
Bialystok, Poland
1218.35.48004 Boehringer Ingelheim Investigational Site
Lublin, Poland
1218.35.48003 Boehringer Ingelheim Investigational Site
Poznan, Poland
1218.35.48001 Boehringer Ingelheim Investigational Site
Rzeszow, Poland
1218.35.48005 Boehringer Ingelheim Investigational Site
Wroclaw, Poland
Russian Federation
1218.35.70008 Boehringer Ingelheim Investigational Site
Arkhangelsk, Russian Federation
1218.35.70001 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1218.35.70003 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1218.35.70006 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1218.35.70009 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1218.35.70002 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1218.35.70007 Boehringer Ingelheim Investigational Site
Yaroslavl, Russian Federation
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: NCT00819091     History of Changes
Other Study ID Numbers: 1218.35, 2008-003118-86
Study First Received: January 7, 2009
Results First Received: May 13, 2011
Last Updated: December 11, 2013
Health Authority: Argentina: ANMAT (Food, Drug and Medical Technology National Administration)
Hungary: National Institute of Pharmacy
India: Drugs Controller General India
Japan: Ministry of Health, Labor and Welfare
Poland:
Russia: Pharmacological Committee, Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
BI 1356
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014