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

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

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

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): 1245.9.49004 Boehringer Ingelheim Investigational Site
🇩🇪
Hamburg, Germany
1245.9.39004 Boehringer Ingelheim Investigational Site
🇮🇹
Siena, Italy
1245.9.54001 Boehringer Ingelheim Investigational Site
🇦🇷
Capital Federal, Argentina
1245.9.54008 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
1245.9.49003 Boehringer Ingelheim Investigational Site
🇩🇪
St. Ingbert/Oberwürzbach, Germany
1245.9.38501 Boehringer Ingelheim Investigational Site
🇭🇷
Zagreb, Croatia
1245.9.46004 Boehringer Ingelheim Investigational Site
🇸🇪
Härnösand, Sweden
1245.9.70007 Boehringer Ingelheim Investigational Site
🇷🇺
Yaroslavl, Russian Federation
1245.9.54010 Boehringer Ingelheim Investigational Site
🇦🇷
Capital Federal, Argentina
1245.9.82007 Boehringer Ingelheim Investigational Site
🇰🇷
Incheon, Korea, Republic of
1245.9.38504 Boehringer Ingelheim Investigational Site
🇭🇷
Karlovac, Croatia
1245.9.49001 Boehringer Ingelheim Investigational Site
🇩🇪
Erlangen, Germany
1245.9.39003 Boehringer Ingelheim Investigational Site
🇮🇹
Pisa, Italy
1245.9.39005 Boehringer Ingelheim Investigational Site
🇮🇹
Treviso, Italy
1245.9.38505 Boehringer Ingelheim Investigational Site
🇭🇷
Varazdin, Croatia
1245.9.49002 Boehringer Ingelheim Investigational Site
🇩🇪
Melsungen, Germany
1245.9.54005 Boehringer Ingelheim Investigational Site
🇦🇷
Salta, Argentina
1245.9.82009 Boehringer Ingelheim Investigational Site
🇰🇷
Suwon, Korea, Republic of
1245.9.82002 Boehringer Ingelheim Investigational Site
🇰🇷
Pucheon, Korea, Republic of
1245.9.54009 Boehringer Ingelheim Investigational Site
🇦🇷
Capital Federal, Argentina
1245.9.54004 Boehringer Ingelheim Investigational Site
🇦🇷
Mar del Plata, Argentina
1245.9.49006 Boehringer Ingelheim Investigational Site
🇩🇪
Sulzbach-Rosenberg, Germany
1245.9.39001 Boehringer Ingelheim Investigational Site
🇮🇹
Pisa, Italy
1245.9.49005 Boehringer Ingelheim Investigational Site
🇩🇪
Hamburg, Germany
1245.9.49008 Boehringer Ingelheim Investigational Site
🇩🇪
Nürnberg, Germany
1245.9.82006 Boehringer Ingelheim Investigational Site
🇰🇷
Goyang, Korea, Republic of
1245.9.54003 Boehringer Ingelheim Investigational Site
🇦🇷
Mendoza, Argentina
1245.9.54006 Boehringer Ingelheim Investigational Site
🇦🇷
Salta, Argentina
1245.9.38503 Boehringer Ingelheim Investigational Site
🇭🇷
Krapinske Toplice, Croatia
1245.9.37202 Boehringer Ingelheim Investigational Site
🇪🇪
Tallin, Estonia
1245.9.49007 Boehringer Ingelheim Investigational Site
🇩🇪
Aschaffenburg, Germany
1245.9.39006 Boehringer Ingelheim Investigational Site
🇮🇹
Genova, Italy
1245.9.82008 Boehringer Ingelheim Investigational Site
🇰🇷
Goyang, Korea, Republic of
1245.9.82004 Boehringer Ingelheim Investigational Site
🇰🇷
Seoul, Korea, Republic of
1245.9.82001 Boehringer Ingelheim Investigational Site
🇰🇷
Seoul, Korea, Republic of
1245.9.38004 Boehringer Ingelheim Investigational Site
🇺🇦
Kiev, Ukraine
1245.9.82005 Boehringer Ingelheim Investigational Site
🇰🇷
Seoul, Korea, Republic of
1245.9.82003 Boehringer Ingelheim Investigational Site
🇰🇷
Uijeongbu, Korea, Republic of
1245.9.37002 Boehringer Ingelheim Investigational Site
🇱🇹
Klaipeda, Lithuania
1245.9.37001 Boehringer Ingelheim Investigational Site
🇱🇹
Vilnius, Lithuania
1245.9.40003 Boehringer Ingelheim Investigational Site
🇷🇴
Brasov, Romania
1245.9.40002 Boehringer Ingelheim Investigational Site
🇷🇴
Bucharest, Romania
1245.9.40005 Boehringer Ingelheim Investigational Site
🇷🇴
Targu-Mures, Romania
1245.9.40004 Boehringer Ingelheim Investigational Site
🇷🇴
Galati, Romania
1245.9.70001 Boehringer Ingelheim Investigational Site
🇷🇺
Ekaterinburg, Russian Federation
1245.9.70002 Boehringer Ingelheim Investigational Site
🇷🇺
Kazan, Russian Federation
1245.9.70003 Boehringer Ingelheim Investigational Site
🇷🇺
Nizhniy Novgorod, Russian Federation
1245.9.70004 Boehringer Ingelheim Investigational Site
🇷🇺
Petrozavodsk, Russian Federation
1245.9.70006 Boehringer Ingelheim Investigational Site
🇷🇺
Yaroslavl, Russian Federation
1245.9.62002 Boehringer Ingelheim Investigational Site
🇸🇰
Bratislava, Slovakia
1245.9.62003 Boehringer Ingelheim Investigational Site
🇸🇰
Lucenec, Slovakia
1245.9.62001 Boehringer Ingelheim Investigational Site
🇸🇰
Prievidza, Slovakia
1245.9.62004 Boehringer Ingelheim Investigational Site
🇸🇰
Nove Mesto Nad Vahom, Slovakia
1245.9.46003 Boehringer Ingelheim Investigational Site
🇸🇪
Göteborg, Sweden
1245.9.46001 Boehringer Ingelheim Investigational Site
🇸🇪
Stockholm, Sweden
1245.9.46005 Boehringer Ingelheim Investigational Site
🇸🇪
Lund, Sweden
1245.9.88605 Boehringer Ingelheim Investigational Site
🇨🇳
Changhua, Taiwan
1245.9.46002 Boehringer Ingelheim Investigational Site
🇸🇪
Västerås, Sweden
1245.9.88607 Boehringer Ingelheim Investigational Site
🇨🇳
Kaohsiung, Taiwan
1245.9.88604 Boehringer Ingelheim Investigational Site
🇨🇳
Taichung, Taiwan
1245.9.88606 Boehringer Ingelheim Investigational Site
🇨🇳
Tainan, Taiwan
1245.9.88601 Boehringer Ingelheim Investigational Site
🇨🇳
Taipei, Taiwan
1245.9.88603 Boehringer Ingelheim Investigational Site
🇨🇳
Taipei, Taiwan
1245.9.88602 Boehringer Ingelheim Investigational Site
🇨🇳
Taoyuan, Taiwan
1245.9.38003 Boehringer Ingelheim Investigational Site
🇺🇦
Kharkov, Ukraine
1245.9.38002 Boehringer Ingelheim Investigational Site
🇺🇦
Odessa, Ukraine
1245.9.38001 Boehringer Ingelheim Investigational Site
🇺🇦
Vinnytsya, Ukraine
1245.9.38005 Boehringer Ingelheim Investigational Site
🇺🇦
Vinnytsya, Ukraine
1245.9.70005 Boehringer Ingelheim Investigational Site
🇷🇺
Smolensk, Russian Federation
1245.9.38506 Boehringer Ingelheim Investigational Site
🇭🇷
Osijek, Croatia
1245.9.37201 Boehringer Ingelheim Investigational Site
🇪🇪
Tallin, Estonia
1245.9.37203 Boehringer Ingelheim Investigational Site
🇪🇪
Tallin, Estonia