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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 Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00819091
First received: January 7, 2009
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
  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:

Drug Information available for: Linagliptin
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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

  Show 45 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided by Boehringer Ingelheim Pharmaceuticals

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: May 18, 2012
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 May 21, 2013