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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00789035
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-13
• Study First Submitted QC: 2008-11-10
• Study First Posted: 2008-11-11
• Primary Completion: 2009-10
• Status Verified: 2014-05
• Results First Submitted: 2014-05-16
• Results First Submitted QC: 2014-05-16
• Last Update Submitted: 2014-05-16
• Results First Posted: 2014-06-18
• Last Update Posted: 2014-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 408

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment	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 Outcome Measures

Name	Time	Method
Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)	Baseline and 12 weeks	HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5). Results are based on ANCOVA.
Change of Body Weight After 12 Weeks of Treatment	Baseline and 12 weeks	Results for change of body weight after 12 weeks of treatment based on ANCOVA.
Trough Concentrations of Empagliflozin in Plasma	Days 28, 56 and 84	Pre-dose (within 30 minutes before dosing) trough concentrations of Empagliflozin in plasma
Change of HbA1c From Baseline Over Time	Baseline and weeks 4, 8 and 12	Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.
Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment	12 weeks	Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%).
Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment	12 weeks	Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%).
Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)	Baseline and 12 weeks	Results for change of FPI from baseline at week 12 based on ANCOVA.
Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)	Baseline and 12 weeks	HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.
Change of FPG From Baseline After 12 Weeks of Treatment	Baseline and 12 weeks	Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis.; 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.

Trial Locations

Locations (74)

1245.9.54001 Boehringer Ingelheim Investigational Site; 🇦🇷 Capital Federal, Argentina

1245.9.54002 Boehringer Ingelheim Investigational Site; 🇦🇷 Capital Federal, Argentina

1245.9.54007 Boehringer Ingelheim Investigational Site; 🇦🇷 Capital Federal, Argentina

1245.9.54008 Boehringer Ingelheim Investigational Site; 🇦🇷 Capital Federal, Argentina

1245.9.54009 Boehringer Ingelheim Investigational Site; 🇦🇷 Capital Federal, Argentina

1245.9.54010 Boehringer Ingelheim Investigational Site; 🇦🇷 Capital Federal, Argentina

1245.9.54004 Boehringer Ingelheim Investigational Site; 🇦🇷 Mar del Plata, Argentina

1245.9.54003 Boehringer Ingelheim Investigational Site; 🇦🇷 Mendoza, Argentina

1245.9.54005 Boehringer Ingelheim Investigational Site; 🇦🇷 Salta, Argentina

1245.9.54006 Boehringer Ingelheim Investigational Site; 🇦🇷 Salta, Argentina

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