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

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ClinicalTrials.gov Identifier: NCT00309608
Recruitment Status : Completed
First Posted : April 3, 2006
Results First Posted : June 15, 2011
Last Update Posted : July 8, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Linagliptin Drug: Placebo Drug: Glimepiride Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 333 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : April 2006
Actual Primary Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. HbA1c Change From Baseline at Week 12 [ Time Frame: Baseline and week 12 ]
    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 :
  1. Percentage of Patients With HbA1c<=7.0% at Week 12 [ Time Frame: week 12 ]
    Descriptive calculation of Patients with HbA1c <= 7.0% at Week 12.

  2. Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12 [ Time Frame: Baseline and week 12 ]
    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.



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309608


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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00309608     History of Changes
Other Study ID Numbers: 1218.6
2005-004597-24 ( EudraCT Number: EudraCT )
First Posted: April 3, 2006    Key Record Dates
Results First Posted: June 15, 2011
Last Update Posted: July 8, 2014
Last Verified: December 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action