Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes - Full Text View

Purpose

The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1 356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metfor min in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In additi on, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for com parison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability a nd efficacy of BI 1356 BS will also be tested in this study.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Linagliptin Drug: Placebo Drug: Glimepiride	Phase 2

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 Randomised, Double-blind, Placebo-controlled, Five Parallel Groups Study Investigating the Efficacy and Safety of BI 1356 BS (1 mg, 5 mg and 10 mg Administered Orally Once Daily) Over 12 Weeks as add-on Therapy in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Metformin Therapy, Including an Open-label Glimepiride Treatment Arm.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Glimepiride Linagliptin

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

HbA1c Change From Baseline at Week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the HbA1c percent baseline value. Means are treatment adjusted for baseline HbA1c.

Secondary Outcome Measures:

Percentage of Patients With HbA1c<=7.0% at Week 12 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
Descriptive calculation of proportions on the basis of non-missing data
Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.

Enrollment:	333
Study Start Date:	April 2006
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Linagliptin low dose Patients receive Linagliptin low dose tablets once daily	Drug: Linagliptin Linagliptin low dose tablet once daily
Experimental: Linagliptin medium dose Patients receive Linagliptin medium dose tablets once daily	Drug: Linagliptin Linagliptin medium dose tablet once daily
Experimental: Linagliptin high dose Patients receive Linagliptin high dose tablets once daily	Drug: Linagliptin Linagliptin high dose tablet once daily
Placebo Comparator: Placebo Patients receive tablets identical to those containing Linagliptin low, medium and high dose	Drug: Placebo Placebo tablets once daily
Active Comparator: Glimepiride Patients receive Glimepiride tablets once daily	Drug: Glimepiride Glimepiride tablets once daily

Eligibility

Ages Eligible for Study:	21 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Inclusion_Criteria:

Male and female patients with a diagnosis of type 2 diabetes mellitus and previo usly treated with metformin alone or with metformin and one other oral antidiabetic d rug
HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
HbA1c 7.5 10.0% at screening for patients treated with metformin alone
HbA1c 7.5 10.0% at beginning of the placebo run-in phase
Age > 21 and < 75 years
MI > 25 and < 40 kg/m2 (Body Mass Index)

Exclusion criteria:

Exclusion_Criteria:

Clinically relevant cardiovascular disease
Impaired hepatic function
Renal insufficiency or impaired renal function
Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
Treatment with insulin within 3 months prior to screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309608

Show 48 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:	NCT00309608 History of Changes
Other Study ID Numbers:	1218.6, 2005-004597-24
Study First Received:	March 31, 2006
Results First Received:	May 13, 2011
Last Updated:	May 18, 2012
Health Authority:	France: AFSSAPS Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte Great Britain: MHRA Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26 Sweden: Medical Products Agency Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
BI 1356
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs

Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013