A Phase IIb, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (5 mg, 10 mg and 25 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo, as Monotherapy, With an Additional Open-label Metformin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control

Boehringer Ingelheim74 sites in 9 countries408 target enrollmentOctober 2008

ConditionsDiabetes Mellitus, Type 2

DrugsBI 10773 placebo metformin

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Enrollment: 408
Locations: 74
Primary Endpoint: Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

October 2009

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Eligibility Criteria

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

•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

Outcomes

Primary Outcomes

Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment

Time Frame: Baseline and 12 weeks

Change of HbA1c from baseline after 12 weeks of treatment. Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups.

Secondary Outcomes

Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)(Baseline and 12 weeks)
Change of Body Weight After 12 Weeks of Treatment(Baseline and 12 weeks)
Trough Concentrations of Empagliflozin in Plasma(Days 28, 56 and 84)
Change of HbA1c From Baseline Over Time(Baseline and weeks 4, 8 and 12)
Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment(12 weeks)
Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment(12 weeks)
Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)(Baseline and 12 weeks)
Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)(Baseline and 12 weeks)
Change of FPG From Baseline After 12 Weeks of Treatment(Baseline and 12 weeks)