Status:
COMPLETED
BI 10773 add-on to Metformin in Patients With Type 2 Diabetes
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
495 Patients enrolled
Trial Details
Trial ID
NCT00749190
Start Date
August 1 2008
Last Update
June 13 2014
Active Locations (116)
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1
1245.10.10026 Boehringer Ingelheim Investigational Site
Chula Vista, California, United States
2
1245.10.10001 Boehringer Ingelheim Investigational Site
Mission Viejo, California, United States
3
1245.10.10011 Boehringer Ingelheim Investigational Site
Pasadena, California, United States
4
1245.10.10028 Boehringer Ingelheim Investigational Site
Spring Valley, California, United States