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 - Full Text View

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00819091

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 III

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

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

No publications provided

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:	July 1, 2011
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 February 12, 2012