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: June 17, 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 45 Study Locations
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: June 17, 2014
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
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014