BI 10773 add-on to Metformin in Patients With Type 2 Diabetes - Full Text View

Purpose

The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: BI 10773 Drug: placebo Drug: sitagliptin	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment
Official Title:	Randomised, Double-blind, Placebo-controlled Group Comparison Study Evaluating Safety and Efficacy of Different Dosages of BI 10773 in Comparison to Placebo Given for 12 Weeks as Add on Therapy to Ongoing Metformin or Sulfonylurea in Patients With Type 2 Diabetes Mellitus (Includes Sitagliptin Open-label Arm)

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

The primary endpoint is the HbA1c change from baseline after 12 weeks of treatment. [ Time Frame: 12 weeks ]

Secondary Outcome Measures:

Change in fasting plasma glucose Change in HbA1c over time The proportion of patients with HbA1c <=7.0%, HbA1c lowering >0.5% Change in fasting plasma insulin Change in HOMA indices Change in body weight Pharmacokinetics of BI 10773 [ Time Frame: 12 weeks ]

Enrollment:	495
Study Start Date:	August 2008
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
Stable metformin therapy of at least 1500 mg/day, or less if that is a maximum tolerated dose.
HbA1c at screening 6.5% to 9.0% for patients on metformin and one other antidiabetic drug, and HbA1c >7.0% to 10% for patients on metformin only
HbA1c >7.0% to 10.0% at Visit 2 (Start of Run-in)
Age >=18 and <80years
Body Mass Index (BMI) <=40 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
Impaired hepatic function
Renal insufficiency or impaired renal function
Diseases of the central nervous system or psychiatric disorders or clinically relevant neurological disorders that may interfere with participation in the trial
Chronic or clinically relevant acute infections
Current or chronic urogenital tract infection
History of clinically relevant allergy/hypersensitivity
Treatment with glitazones (e.g., rosiglitazone, pioglitazone), glucagon-like peptide (GLP-1) analogues, or insulin within 3 months prior to informed consent
Treatment with anti-obesity drugs within 3 months prior to informed consent
Treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent
Alcohol abuse or drug abuse
Treatment with an investigational drug within 2 months prior to informed consent
Women of child-bearing potential who are nursing or pregnant, or who are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to periodic pregnancy testing during participation in the trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749190

Show 116 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00749190 History of Changes
Other Study ID Numbers:	1245.10, EudraCT 2008-000641-54
Study First Received:	September 8, 2008
Last Updated:	November 24, 2009
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia (A.N.M.A.T) Austria: Federal Office for Safety in Health Care Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10 Estonia: State Agency of Medicines, EE-5041Tartu Finland: Finnish Medicines Agency France: French Health Products Safety Agency 143-147 boulevard Anatole France 93285 Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy (OGYI), H-1051 Budapest Latvia: State Agency of Medicines, LV-1003 Riga Norway: Norwegian Medicines Agency (Statens Legemiddelverk) Romania: National Medicines Agency, Bucharest Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26 Spain: Spanish Agency of Medicines Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine) United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Metformin

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013