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NCT00749190 Clinical Trial

BI 10773 add-on to Metformin in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Phase II, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (1 mg, 5 mg, 10 mg, 25 mg, and 50 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo With an Additional Open-label Sitagliptin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control Despite Metformin Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00749190
Other study ID # 1245.10
Secondary ID EudraCT 2008-000
Status Completed
Phase Phase 2
First received September 8, 2008
Last updated May 16, 2014
Start date August 2008

Study information
Verified date May 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia (A.N.M.A.T)Austria: Federal Office for Safety in Health CareCzech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10Estonia: State Agency of Medicines, EE-5041TartuFinland: Finnish Medicines AgencyFrance: French Health Products Safety Agency 143-147 boulevard Anatole France 93285Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of Pharmacy (OGYI), H-1051 BudapestLatvia: State Agency of Medicines, LV-1003 RigaNorway: Norwegian Medicines Agency (Statens Legemiddelverk)Romania: National Medicines Agency, BucharestRussia: Ministry of Healthcare and Social Development of Russian Federation, MoscowSlovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26Spain: Spanish Agency of MedicinesUkraine: Ministry of Health Care of Ukraine (MoH of Ukraine)United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.

Recruitment information / eligibility
Status Completed
Enrollment 495
Est. completion date
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 79 Years
Eligibility Inclusion Criteria:

1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug

2. Stable metformin therapy of at least 1500 mg/day, or less if that is a maximum tolerated dose.

3. HbA1c at screening 6.5% to 9.0% for patients on metformin and one other antidiabetic drug, and HbA1c >7.0% to 10% for patients on metformin only

4. HbA1c >7.0% to 10.0% at Visit 2 (Start of Run-in)

5. Age >=18 and <80years

6. Body Mass Index (BMI) <=40 kg/m2

7. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent

2. Impaired hepatic function

3. Renal insufficiency or impaired renal function

4. Diseases of the central nervous system or psychiatric disorders or clinically relevant neurological disorders that may interfere with participation in the trial

5. Chronic or clinically relevant acute infections

6. Current or chronic urogenital tract infection

7. History of clinically relevant allergy/hypersensitivity

8. Treatment with glitazones (e.g., rosiglitazone, pioglitazone), glucagon-like peptide (GLP-1) analogues, or insulin within 3 months prior to informed consent

9. Treatment with anti-obesity drugs within 3 months prior to informed consent

10. Treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent

11. Alcohol abuse or drug abuse

12. Treatment with an investigational drug within 2 months prior to informed consent

13. Women of child-bearing potential who are nursing or pregnant, or who are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to periodic pregnancy testing during participation in the trial

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• BI 10773

• placebo

• sitagliptin

Locations
Country Name City State
Argentina 1245.10.54002 Boehringer Ingelheim Investigational Site Capital Federal
Argentina 1245.10.54004 Boehringer Ingelheim Investigational Site Capital Federal
Argentina 1245.10.54008 Boehringer Ingelheim Investigational Site Capital Federal
Argentina 1245.10.54006 Boehringer Ingelheim Investigational Site Mar del Plata
Argentina 1245.10.54005 Boehringer Ingelheim Investigational Site Mendoza
Austria 1245.10.43002 Boehringer Ingelheim Investigational Site Graz
Austria 1245.10.43004 Boehringer Ingelheim Investigational Site Innsbruck
Austria 1245.10.43001 Boehringer Ingelheim Investigational Site Wien
Austria 1245.10.43003 Boehringer Ingelheim Investigational Site Wien
Czech Republic 1245.10.42001 Boehringer Ingelheim Investigational Site Breclav
Czech Republic 1245.10.42003 Boehringer Ingelheim Investigational Site Brno
Czech Republic 1245.10.42005 Boehringer Ingelheim Investigational Site Brno
Czech Republic 1245.10.42002 Boehringer Ingelheim Investigational Site Hodonin
Estonia 1245.10.37201 Boehringer Ingelheim Investigational Site Tallin
Estonia 1245.10.37202 Boehringer Ingelheim Investigational Site Tartu
Finland 1245.10.58006 Boehringer Ingelheim Investigational Site Kerava
Finland 1245.10.58003 Boehringer Ingelheim Investigational Site Oulu
Finland 1245.10.58004 Boehringer Ingelheim Investigational Site Tampere
Finland 1245.10.58001 Boehringer Ingelheim Investigational Site Turku
France 1245.10.3302A Boehringer Ingelheim Investigational Site Bondy Cedex
France 1245.10.3302B Boehringer Ingelheim Investigational Site Bondy Cedex
France 1245.10.3310A Boehringer Ingelheim Investigational Site Caen Cedex 5
France 1245.10.3310B Boehringer Ingelheim Investigational Site Caen Cedex 5
France 1245.10.3310C Boehringer Ingelheim Investigational Site Caen Cedex 5
France 1245.10.3301A Boehringer Ingelheim Investigational Site Corbeil Essonnes
France 1245.10.3301B Boehringer Ingelheim Investigational Site Corbeil Essonnes
France 1245.10.3303A Boehringer Ingelheim Investigational Site La Rochelle Cedex 1
France 1245.10.3303B Boehringer Ingelheim Investigational Site La Rochelle Cedex 1
France 1245.10.3303C Boehringer Ingelheim Investigational Site La Rochelle Cedex 1
France 1245.10.3303D Boehringer Ingelheim Investigational Site La Rochelle Cedex 1
France 1245.10.3308A Boehringer Ingelheim Investigational Site Le Grau du Roi
France 1245.10.3308B Boehringer Ingelheim Investigational Site Le Grau du Roi
France 1245.10.3309A Boehringer Ingelheim Investigational Site Nanterre Cedex
France 1245.10.3306A Boehringer Ingelheim Investigational Site Narbonne Cedex
France 1245.10.3306B Boehringer Ingelheim Investigational Site Narbonne Cedex
France 1245.10.3307A Boehringer Ingelheim Investigational Site Quimper
France 1245.10.3304A Boehringer Ingelheim Investigational Site Reims Cedex
France 1245.10.3304B Boehringer Ingelheim Investigational Site Reims Cedex
France 1245.10.3304C Boehringer Ingelheim Investigational Site Reims Cedex
France 1245.10.3311A Boehringer Ingelheim Investigational Site Saint Mandé
France 1245.10.3311B Boehringer Ingelheim Investigational Site Saint Mandé
France 1245.10.3311C Boehringer Ingelheim Investigational Site Saint Mandé
France 1245.10.3311D Boehringer Ingelheim Investigational Site Saint Mandé
France 1245.10.3305A Boehringer Ingelheim Investigational Site Valenciennes
France 1245.10.3305B Boehringer Ingelheim Investigational Site Valenciennes
France 1245.10.3305C Boehringer Ingelheim Investigational Site Valenciennes
France 1245.10.3305D Boehringer Ingelheim Investigational Site Valenciennes
Germany 1245.10.49001 Boehringer Ingelheim Investigational Site Erlangen
Germany 1245.10.49003 Boehringer Ingelheim Investigational Site Frankfurt
Germany 1245.10.49002 Boehringer Ingelheim Investigational Site Hamburg
Germany 1245.10.49004 Boehringer Ingelheim Investigational Site Rehlingen-Siersburg
Hungary 1245.10.36001 Boehringer Ingelheim Investigational Site Budapest
Hungary 1245.10.36003 Boehringer Ingelheim Investigational Site Budapest
Hungary 1245.10.36004 Boehringer Ingelheim Investigational Site Budapest
Hungary 1245.10.36005 Boehringer Ingelheim Investigational Site Gyor
Hungary 1245.10.36002 Boehringer Ingelheim Investigational Site Szombathely
Latvia 1245.10.37101 Boehringer Ingelheim Investigational Site Daugavpils
Latvia 1245.10.37105 Boehringer Ingelheim Investigational Site Kuldiga
Latvia 1245.10.37106 Boehringer Ingelheim Investigational Site Ogre
Latvia 1245.10.37103 Boehringer Ingelheim Investigational Site Riga
Latvia 1245.10.37107 Boehringer Ingelheim Investigational Site Riga
Latvia 1245.10.37102 Boehringer Ingelheim Investigational Site Talsi
Latvia 1245.10.37104 Boehringer Ingelheim Investigational Site Valmiera
Norway 1245.10.47004 Boehringer Ingelheim Investigational Site Ålesund
Norway 1245.10.47003 Boehringer Ingelheim Investigational Site Hamar
Norway 1245.10.47005 Boehringer Ingelheim Investigational Site Oslo
Norway 1245.10.47001 Boehringer Ingelheim Investigational Site Stavanger
Romania 1245.10.40001 Boehringer Ingelheim Investigational Site Alba Iulia
Romania 1245.10.40005 Boehringer Ingelheim Investigational Site Baia Mare Maramures
Romania 1245.10.40003 Boehringer Ingelheim Investigational Site Brasov
Romania 1245.10.40002 Boehringer Ingelheim Investigational Site Bucharest
Romania 1245.10.40007 Boehringer Ingelheim Investigational Site Bucharest
Romania 1245.10.40004 Boehringer Ingelheim Investigational Site Galati
Romania 1245.10.40006 Boehringer Ingelheim Investigational Site Satu Mare
Russian Federation 1245.10.70001 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1245.10.70002 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1245.10.70003 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1245.10.70007 Boehringer Ingelheim Investigational Site Saratov
Russian Federation 1245.10.70004 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 1245.10.70005 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 1245.10.70006 Boehringer Ingelheim Investigational Site St. Petersburg
Slovakia 1245.10.62003 Boehringer Ingelheim Investigational Site Bratislava
Slovakia 1245.10.62001 Boehringer Ingelheim Investigational Site Nitra
Slovakia 1245.10.62002 Boehringer Ingelheim Investigational Site Nitra
Slovakia 1245.10.62004 Boehringer Ingelheim Investigational Site Presov
Spain 1245.10.34002 Boehringer Ingelheim Investigational Site Barcelona
Spain 1245.10.34001 Boehringer Ingelheim Investigational Site Girona
Spain 1245.10.34010 Boehringer Ingelheim Investigational Site L'Hospitalet de Llobregat (Barcelona)
Spain 1245.10.34004 Boehringer Ingelheim Investigational Site Málaga
Spain 1245.10.34005 Boehringer Ingelheim Investigational Site Palma (Mallorca)
Spain 1245.10.34006 Boehringer Ingelheim Investigational Site Palma de Mallorca
Spain 1245.10.34008 Boehringer Ingelheim Investigational Site Santander
Ukraine 1245.10.38002 Boehringer Ingelheim Investigational Site Dnepropetrovsk
Ukraine 1245.10.38005 Boehringer Ingelheim Investigational Site Kharkiv
Ukraine 1245.10.38004 Boehringer Ingelheim Investigational Site Kharkov
Ukraine 1245.10.38003 Boehringer Ingelheim Investigational Site Kiev
Ukraine 1245.10.38001 Boehringer Ingelheim Investigational Site Vinnitsa
United States 1245.10.10026 Boehringer Ingelheim Investigational Site Chula Vista California
United States 1245.10.10004 Boehringer Ingelheim Investigational Site Clearwarter Florida
United States 1245.10.10010 Boehringer Ingelheim Investigational Site Clemson South Carolina
United States 1245.10.10015 Boehringer Ingelheim Investigational Site Dallas Texas
United States 1245.10.10025 Boehringer Ingelheim Investigational Site Federal Way Washington
United States 1245.10.10021 Boehringer Ingelheim Investigational Site Melbourne Florida
United States 1245.10.10005 Boehringer Ingelheim Investigational Site Miami Florida
United States 1245.10.10019 Boehringer Ingelheim Investigational Site Miami Florida
United States 1245.10.10001 Boehringer Ingelheim Investigational Site Mission Viejo California
United States 1245.10.10023 Boehringer Ingelheim Investigational Site Norristown Pennsylvania
United States 1245.10.10011 Boehringer Ingelheim Investigational Site Pasadena California
United States 1245.10.10014 Boehringer Ingelheim Investigational Site Roswell Georgia
United States 1245.10.10009 Boehringer Ingelheim Investigational Site Shelby North Carolina
United States 1245.10.10028 Boehringer Ingelheim Investigational Site Spring Valley California
United States 1245.10.10024 Boehringer Ingelheim Investigational Site St. Cloud Florida
United States 1245.10.10016 Boehringer Ingelheim Investigational Site Staten Island New York
United States 1245.10.10012 Boehringer Ingelheim Investigational Site Temple Texas
United States 1245.10.10006 Boehringer Ingelheim Investigational Site Wadsworth Ohio
United States 1245.10.10027 Boehringer Ingelheim Investigational Site Walnut Creek California

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Czech Republic,  Estonia,  Finland,  France,  Germany,  Hungary,  Latvia,  Norway,  Romania,  Russian Federation,  Slovakia,  Spain,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline in HbA1c After 12 Weeks of Treatment Change from baseline in HbA1c after 12 weeks of treatment.
In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.		 Baseline and 12 weeks No
Secondary Change of FPG From Baseline After 12 Weeks of Treatment Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis.
In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.		 Baseline and 12 weeks No
Secondary Change of HbA1c From Baseline Over Time Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis. Baseline and weeks 4, 8 and 12 No
Secondary Proportion of Patients Who Achieve an HbA1c =7.0% After 12 Weeks of Treatment Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%) based on logistic regression Baseline and 12 weeks No
Secondary Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%) based on logistic regression Baseline and 12 weeks No
Secondary Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI) Results for change of FPI from baseline at week 12 based on ANCOVA Baseline and 12 weeks No
Secondary Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR) HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA. Baseline and 12 weeks No
Secondary Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B) HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5), FPG in mg/dl. Results are based on ANCOVA. Baseline and 12 weeks No
Secondary Change of Body Weight After 12 Weeks of Treatment Results for change of body weight after 12 weeks of treatment based on ANCOVA. Baseline and 12 weeks No
Secondary Trough Concentrations of Empagliflozin in Plasma (Pre-dose) trough concentrations of Empagliflozin in plasma, within 30 minutes of dosing. Days 28, 56 and 84 No
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