Status:
COMPLETED
12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The objective is to investigate the efficacy, safety and pharmacokinetics of three different doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with ins...
Eligibility Criteria
Inclusion
- Male and female patients with a diagnosis of type 2 diabetes mellitus
- either treatment-naïve or on a maximum of 1 oral antidiabetic therapy on a stable dose for the10 weeks prior to screening
- HbA1c ≥6.5 to ≤9.0% and for treatment-naïve patients:HbA1c \>7.0 to ≤10.0%
- HbA1c \>7.0 to ≤10.0% at Visit 2 (start of run-in) for all patients
- Age between 18 and 80 years
- BMI less than 40 kg/m2
- Signed and dated informed consent prior to admission to the study in accordance with GCP and local legislation
Exclusion
- Myocardial infarction, stroke or TIA within 6 months prior to informed consent
- Impaired hepatic function
- Renal insufficiency or impaired renal function
- Disease of central nervous system, or psychiatric disorders or clinically relevant neurologic disorders that may interfere with trial participation
- Chronic or clinically relevant acute infections
- Current or chronic urogenital tract infection determined by medical history
- History of clinically relevant allergy/hypersensitivity
- Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to informed consent
- Treatment with anti obesity drugs
- Current treatment with systemic steroids
- Alcohol abuse
- Treatment with an investigational drug within 2 months prior to informed consent
- known intolerance to metformin
- Dehydration
- Unstable or acute CHF
- Acute or chronic acidosis
- Hereditary galactose intolerance
- Woman of child bearing potential who are nursing or pregnant or not practicing an acceptable method of birth control
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT00789035
Start Date
October 1 2008
Last Update
June 18 2014
Active Locations (74)
Enter a location and click search to find clinical trials sorted by distance.
1
1245.9.54001 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
2
1245.9.54002 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
3
1245.9.54007 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
4
1245.9.54008 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina