12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: BI 10773; Drug: placebo; Drug: metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00789035

EudraCT No 2008-000640-14

1245.9

Details and patient eligibility

About

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 insufficient glycemic control. In addition an open-label metformin arm will be assessed

Enrollment: 408 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

1. Myocardial infarction, stroke or TIA within 6 months prior to informed consent
2. Impaired hepatic function
3. Renal insufficiency or impaired renal function
4. Disease of central nervous system, or psychiatric disorders or clinically relevant neurologic disorders that may interfere with trial participation
5. Chronic or clinically relevant acute infections
6. Current or chronic urogenital tract infection determined by medical history
7. History of clinically relevant allergy/hypersensitivity
8. Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to informed consent
9. Treatment with anti obesity drugs
10. Current treatment with systemic steroids
11. Alcohol abuse
12. Treatment with an investigational drug within 2 months prior to informed consent
13. known intolerance to metformin
14. Dehydration
15. Unstable or acute CHF
16. Acute or chronic acidosis
17. Hereditary galactose intolerance
18. Woman of child bearing potential who are nursing or pregnant or not practicing an acceptable method of birth control