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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00309608
First received: March 31, 2006
Last updated: June 24, 2014
Last verified: December 2013
  Purpose

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


Further study details as provided by Boehringer Ingelheim:

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 Patients with HbA1c <= 7.0% at Week 12.

  • 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
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: NCT00309608

  Show 48 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
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: June 24, 2014
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
Linagliptin
Glimepiride
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
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on October 01, 2014