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NCT01167881 Clinical Trial

Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Phase III Randomised, Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 10773 Compared to Glimepiride Administered Orally During 104 Weeks With a 104 Week Extension Period in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Metformin Treatment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01167881
Other study ID # 1245.28
Secondary ID 2009-016244-39
Status Completed
Phase Phase 3
First received July 15, 2010
Last updated October 8, 2015
Start date August 2010
Est. completion date August 2015

Study information
Verified date October 2015
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia MedicaAustria: Medicines and Medical Devices AgencyCanada: Health CanadaColombia: Instituto Nacional de Vigilancia de Medicamentos y AlimentosCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyHong Kong: Department of HealthIndia: Drugs Controller General of IndiaItaly: Ethics CommitteeMalaysia: Ministry of HealthMexico: Federal Commission for Protection Against Health RisksNetherlands: Central Committee Research Involving Human SubjectsNorway: Norwegian Medicines AgencyPhilippines: Bureau of Food and DrugsPortugal: National Pharmacy and Medicines InstituteSouth Africa: Medicines Control CouncilSpain: Spanish Agency of MedicinesSweden: Medical Products AgencySwitzerland: SwissmedicTaiwan : Food and Drug AdministrationThailand: Ministry of Public HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.

Recruitment information / eligibility
Status Completed
Enrollment 1549
Est. completion date August 2015
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

- Diagnosis typ 2 diabetes mellitus

- Male and female on diet and exercise regimen, pre-treated with metformin 12 weeks prior to randomisation

- HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1

- 18 years or more

- BMI equal or less than 45Kg/m2

Exclusion criteria:

- Uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in

- Any other antidiabetic drug within 12 weeks prior to randomisation except metformin

- Acute coronary syndrome (non-STEMI, STEMI unstable angina pectoris), stroke or transient ischemic attack within 12 weeks of informed consent

- Indication of liver disease

- Moderate to severe renal impairment

- Bariatric surgery within past 2 years

- Medical history of cancer or treatment for cancer within last 5 years

- Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell

- Contraindications hypersensitivity to concomitant drugs

- Treatment with anti-obesity drugs

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• BI 10773
Medium dose once daily
• Glimepiride
1-4 mg once daily
• Placebo
Placebo matching BI 10773
• Placebo
Placebo matching Glimepiride

Locations
Country Name City State
Argentina 1245.28.54010 Boehringer Ingelheim Investigational Site Buenos Aires
Argentina 1245.28.54001 Boehringer Ingelheim Investigational Site Capital Federal
Argentina 1245.28.54002 Boehringer Ingelheim Investigational Site Córdoba
Argentina 1245.28.54003 Boehringer Ingelheim Investigational Site Córdoba
Austria 1245.28.43006 Boehringer Ingelheim Investigational Site Graz
Austria 1245.28.43005 Boehringer Ingelheim Investigational Site Salzburg
Austria 1245.28.43001 Boehringer Ingelheim Investigational Site Wien
Austria 1245.28.43002 Boehringer Ingelheim Investigational Site Wien
Austria 1245.28.43003 Boehringer Ingelheim Investigational Site Wien
Austria 1245.28.43004 Boehringer Ingelheim Investigational Site Wien
Canada 1245.28.20074 Boehringer Ingelheim Investigational Site Calgary Alberta
Canada 1245.28.20077 Boehringer Ingelheim Investigational Site Calgary Alberta
Canada 1245.28.20072 Boehringer Ingelheim Investigational Site Chicoutimi Quebec
Canada 1245.28.20081 Boehringer Ingelheim Investigational Site Chicoutimi Quebec
Canada 1245.28.20080 Boehringer Ingelheim Investigational Site Collingwood Ontario
Canada 1245.28.20075 Boehringer Ingelheim Investigational Site Edmonton Alberta
Canada 1245.28.20085 Boehringer Ingelheim Investigational Site Gatineau Quebec
Canada 1245.28.20082 Boehringer Ingelheim Investigational Site Grand Falls-Windsor Newfoundland and Labrador
Canada 1245.28.20071 Boehringer Ingelheim Investigational Site Halifax Nova Scotia
Canada 1245.28.20084 Boehringer Ingelheim Investigational Site Langley British Columbia
Canada 1245.28.20043 Boehringer Ingelheim Investigational Site Longueuil Quebec
Canada 1245.28.20070 Boehringer Ingelheim Investigational Site Montreal Quebec
Canada 1245.28.20016 Boehringer Ingelheim Investigational Site Mount Pearl Newfoundland and Labrador
Canada 1245.28.20076 Boehringer Ingelheim Investigational Site Quebec
Canada 1245.28.20073 Boehringer Ingelheim Investigational Site Sherbrooke Quebec
Canada 1245.28.20079 Boehringer Ingelheim Investigational Site St. John's Newfoundland and Labrador
Canada 1245.28.20078 Boehringer Ingelheim Investigational Site Stayner Ontario
Canada 1245.28.20005 Boehringer Ingelheim Investigational Site Strathroy Ontario
Canada 1245.28.20083 Boehringer Ingelheim Investigational Site Sudbury Ontario
Canada 1245.28.20021 Boehringer Ingelheim Investigational Site Trois Rivieres Quebec
Colombia 1245.28.57007 Boehringer Ingelheim Investigational Site Barranquilla
Colombia 1245.28.57005 Boehringer Ingelheim Investigational Site Bogota
Colombia 1245.28.57003 Boehringer Ingelheim Investigational Site Bogotá
Colombia 1245.28.57006 Boehringer Ingelheim Investigational Site Floridablanca
Czech Republic 1245.28.42003 Boehringer Ingelheim Investigational Site Brno
Czech Republic 1245.28.42005 Boehringer Ingelheim Investigational Site Holice
Czech Republic 1245.28.42002 Boehringer Ingelheim Investigational Site Mlada Boleslav
Czech Republic 1245.28.42008 Boehringer Ingelheim Investigational Site Praha 1
Czech Republic 1245.28.42001 Boehringer Ingelheim Investigational Site Slany
Czech Republic 1245.28.42007 Boehringer Ingelheim Investigational Site Slany
Czech Republic 1245.28.42004 Boehringer Ingelheim Investigational Site Uherske Hradiste
Czech Republic 1245.28.42006 Boehringer Ingelheim Investigational Site Zlin
Finland 1245.28.72001 Boehringer Ingelheim Investigational Site Helsinki
Finland 1245.28.72004 Boehringer Ingelheim Investigational Site Joensuu
Finland 1245.28.72003 Boehringer Ingelheim Investigational Site Oulu
Finland 1245.28.72002 Boehringer Ingelheim Investigational Site Pori
Hong Kong 1245.28.85201 Boehringer Ingelheim Investigational Site Hong Kong
Hong Kong 1245.28.85207 Boehringer Ingelheim Investigational Site Hong Kong
Hong Kong 1245.28.85202 Boehringer Ingelheim Investigational Site Kowloon
India 1245.28.91206 Boehringer Ingelheim Investigational Site Ahmedabad
India 1245.28.91202 Boehringer Ingelheim Investigational Site Bangalore
India 1245.28.91204 Boehringer Ingelheim Investigational Site Bangalore
India 1245.28.91205 Boehringer Ingelheim Investigational Site Bangalore
India 1245.28.91208 Boehringer Ingelheim Investigational Site Bangalore
India 1245.28.91201 Boehringer Ingelheim Investigational Site Chennai
India 1245.28.91213 Boehringer Ingelheim Investigational Site Chennai
India 1245.28.91203 Boehringer Ingelheim Investigational Site Hyderabad
India 1245.28.91211 Boehringer Ingelheim Investigational Site Kolkata
India 1245.28.91210 Boehringer Ingelheim Investigational Site Mangalore
India 1245.28.91212 Boehringer Ingelheim Investigational Site New Delhi
India 1245.28.91207 Boehringer Ingelheim Investigational Site Pune
India 1245.28.91209 Boehringer Ingelheim Investigational Site Uttar Pradesh
Italy 1245.28.39021 Boehringer Ingelheim Investigational Site Cagliari
Italy 1245.28.39022 Boehringer Ingelheim Investigational Site Chieri (to)
Italy 1245.28.39016 Boehringer Ingelheim Investigational Site Lucca
Italy 1245.28.39018 Boehringer Ingelheim Investigational Site Milano
Italy 1245.28.39019 Boehringer Ingelheim Investigational Site Milano
Italy 1245.28.39017 Boehringer Ingelheim Investigational Site Monserrato (ca)
Italy 1245.28.39023 Boehringer Ingelheim Investigational Site Rimini
Italy 1245.28.39020 Boehringer Ingelheim Investigational Site Salerno
Malaysia 1245.28.60003 Boehringer Ingelheim Investigational Site Johor Bahru
Malaysia 1245.28.60006 Boehringer Ingelheim Investigational Site Kelantan
Malaysia 1245.28.60005 Boehringer Ingelheim Investigational Site Kuala Lumpur
Malaysia 1245.28.60009 Boehringer Ingelheim Investigational Site Kuala Lumpur
Malaysia 1245.28.60004 Boehringer Ingelheim Investigational Site Pahang
Malaysia 1245.28.60007 Boehringer Ingelheim Investigational Site Perak
Malaysia 1245.28.60010 Boehringer Ingelheim Investigational Site Pulau Pinang
Malaysia 1245.28.60001 Boehringer Ingelheim Investigational Site Selangor Darul Ehsan
Mexico 1245.28.52006 Boehringer Ingelheim Investigational Site Aguascalientes
Mexico 1245.28.52008 Boehringer Ingelheim Investigational Site Cuautla
Mexico 1245.28.52009 Boehringer Ingelheim Investigational Site Guadalajara
Mexico 1245.28.52007 Boehringer Ingelheim Investigational Site Mexico
Netherlands 1245.28.31008 Boehringer Ingelheim Investigational Site 's HERTOGENBOSCH
Netherlands 1245.28.31020 Boehringer Ingelheim Investigational Site Losser
Netherlands 1245.28.31014 Boehringer Ingelheim Investigational Site Rotterdam
Norway 1245.28.47002 Boehringer Ingelheim Investigational Site Hønefoss
Norway 1245.28.47001 Boehringer Ingelheim Investigational Site Oslo
Norway 1245.28.47003 Boehringer Ingelheim Investigational Site Sandefjord
Philippines 1245.28.63016 Boehringer Ingelheim Investigational Site Cavite City
Philippines 1245.28.63013 Boehringer Ingelheim Investigational Site Cebu City
Philippines 1245.28.63020 Boehringer Ingelheim Investigational Site Jaro Iloilo City
Philippines 1245.28.63004 Boehringer Ingelheim Investigational Site Manila
Philippines 1245.28.63015 Boehringer Ingelheim Investigational Site Manila
Philippines 1245.28.63012 Boehringer Ingelheim Investigational Site Pasig City
Philippines 1245.28.63011 Boehringer Ingelheim Investigational Site Quezon City
Philippines 1245.28.63010 Boehringer Ingelheim Investigational Site Tacloban
Philippines 1245.28.63014 Boehringer Ingelheim Investigational Site Tagbilaran City, Bohol
Portugal 1245.28.35006 Boehringer Ingelheim Investigational Site Amadora
Portugal 1245.28.35002 Boehringer Ingelheim Investigational Site Lisboa
Portugal 1245.28.35012 Boehringer Ingelheim Investigational Site Porto
Portugal 1245.28.35016 Boehringer Ingelheim Investigational Site Vila Nova de Gaia
South Africa 1245.28.76019 Boehringer Ingelheim Investigational Site Boksburg North
South Africa 1245.28.76018 Boehringer Ingelheim Investigational Site Bryanston
South Africa 1245.28.76016 Boehringer Ingelheim Investigational Site Cape Town
South Africa 1245.28.76017 Boehringer Ingelheim Investigational Site Cape Town
South Africa 1245.28.76012 Boehringer Ingelheim Investigational Site Durban
South Africa 1245.28.76015 Boehringer Ingelheim Investigational Site Durban
South Africa 1245.28.76013 Boehringer Ingelheim Investigational Site Krugersdorp
South Africa 1245.28.76024 Boehringer Ingelheim Investigational Site Lenasia
South Africa 1245.28.76023 Boehringer Ingelheim Investigational Site Lenasia South
South Africa 1245.28.76014 Boehringer Ingelheim Investigational Site Pretoria
Spain 1245.28.34004 Boehringer Ingelheim Investigational Site Barcelona
Spain 1245.28.34011 Boehringer Ingelheim Investigational Site Barcelona
Spain 1245.28.34002 Boehringer Ingelheim Investigational Site Burjasot
Spain 1245.28.34003 Boehringer Ingelheim Investigational Site Centelles
Spain 1245.28.34009 Boehringer Ingelheim Investigational Site Granada
Spain 1245.28.34012 Boehringer Ingelheim Investigational Site Madrid
Spain 1245.28.34013 Boehringer Ingelheim Investigational Site Madrid
Spain 1245.28.34005 Boehringer Ingelheim Investigational Site Mataró
Spain 1245.28.34001 Boehringer Ingelheim Investigational Site Pineda de Mar
Spain 1245.28.34010 Boehringer Ingelheim Investigational Site San Sebastian de los Reyes
Spain 1245.28.34006 Boehringer Ingelheim Investigational Site Tarrega - Lleida
Sweden 1245.28.46009 Boehringer Ingelheim Investigational Site Borås
Sweden 1245.28.46008 Boehringer Ingelheim Investigational Site Lund
Sweden 1245.28.46001 Boehringer Ingelheim Investigational Site Malmö
Sweden 1245.28.46005 Boehringer Ingelheim Investigational Site Örebro
Sweden 1245.28.46002 Boehringer Ingelheim Investigational Site Stockholm
Sweden 1245.28.46006 Boehringer Ingelheim Investigational Site Stockholm
Sweden 1245.28.46007 Boehringer Ingelheim Investigational Site Stockholm
Sweden 1245.28.46004 Boehringer Ingelheim Investigational Site Uppsala
Switzerland 1245.28.41015 Boehringer Ingelheim Investigational Site Ascona
Switzerland 1245.28.41017 Inselspital Bern Bern
Taiwan 1245.28.88004 Boehringer Ingelheim Investigational Site Changhua
Taiwan 1245.28.88003 Boehringer Ingelheim Investigational Site Taichung
Taiwan 1245.28.88005 Boehringer Ingelheim Investigational Site Tainan Hsien
Taiwan 1245.28.88001 Boehringer Ingelheim Investigational Site Taipei
Taiwan 1245.28.88002 Boehringer Ingelheim Investigational Site Taipei Hsien
Thailand 1245.28.66006 Boehringer Ingelheim Investigational Site Bangkok
Thailand 1245.28.66007 Boehringer Ingelheim Investigational Site Bangkok
Thailand 1245.28.66004 Boehringer Ingelheim Investigational Site Muang District
Thailand 1245.28.66008 Boehringer Ingelheim Investigational Site Nakhonratchasima
United Kingdom 1245.28.44006 Boehringer Ingelheim Investigational Site Addlestone
United Kingdom 1245.28.44020 Boehringer Ingelheim Investigational Site Ashford
United Kingdom 1245.28.44008 Boehringer Ingelheim Investigational Site Balham
United Kingdom 1245.28.44035 Boehringer Ingelheim Investigational Site Barnstable
United Kingdom 1245.28.44016 Boehringer Ingelheim Investigational Site Blackpool
United Kingdom 1245.28.44021 Boehringer Ingelheim Investigational Site Bradford on Avon
United Kingdom 1245.28.44019 Boehringer Ingelheim Investigational Site Burbage
United Kingdom 1245.28.44027 Boehringer Ingelheim Investigational Site Chestfield, Whitstable
United Kingdom 1245.28.44011 Boehringer Ingelheim Investigational Site Chippenham
United Kingdom 1245.28.44022 Boehringer Ingelheim Investigational Site Chippenham
United Kingdom 1245.28.44043 Boehringer Ingelheim Investigational Site Coventry
United Kingdom 1245.28.44025 Boehringer Ingelheim Investigational Site Doncaster
United Kingdom 1245.28.44030 Boehringer Ingelheim Investigational Site Ely
United Kingdom 1245.28.44007 Boehringer Ingelheim Investigational Site Midsomer Norton
United Kingdom 1245.28.44023 Boehringer Ingelheim Investigational Site Nantwich
United Kingdom 1245.28.44017 Boehringer Ingelheim Investigational Site Whitstable
United States 1245.28.10033 Boehringer Ingelheim Investigational Site Blue Ridge Georgia
United States 1245.28.10026 Boehringer Ingelheim Investigational Site Boise Idaho
United States 1245.28.10009 Boehringer Ingelheim Investigational Site Bradednton Florida
United States 1245.28.10011 Boehringer Ingelheim Investigational Site Cincinnati Ohio
United States 1245.28.10019 Boehringer Ingelheim Investigational Site Cincinnati Ohio
United States 1245.28.10004 Boehringer Ingelheim Investigational Site Columbus Ohio
United States 1245.28.10031 Boehringer Ingelheim Investigational Site Dallas Texas
United States 1245.28.10030 Boehringer Ingelheim Investigational Site Draper Utah
United States 1245.28.10027 Boehringer Ingelheim Investigational Site Henderson Nevada
United States 1245.28.10016 Boehringer Ingelheim Investigational Site Hot Springs Arkansas
United States 1245.28.10013 Boehringer Ingelheim Investigational Site Kenosha Wisconsin
United States 1245.28.10032 Boehringer Ingelheim Investigational Site Longview Texas
United States 1245.28.10020 Boehringer Ingelheim Investigational Site Medford Oregon
United States 1245.28.10007 Boehringer Ingelheim Investigational Site Omaha Nebraska
United States 1245.28.10008 Boehringer Ingelheim Investigational Site Perrysburg Ohio
United States 1245.28.10005 Boehringer Ingelheim Investigational Site Phoenix Arizona
United States 1245.28.10012 Boehringer Ingelheim Investigational Site Phoenix Arizona
United States 1245.28.10017 Boehringer Ingelheim Investigational Site Portland Oregon
United States 1245.28.10014 Boehringer Ingelheim Investigational Site Rochester New York
United States 1245.28.10003 Boehringer Ingelheim Investigational Site Sacramento California
United States 1245.28.10023 Boehringer Ingelheim Investigational Site Salt Lake City Utah
United States 1245.28.10022 Boehringer Ingelheim Investigational Site San Antonio Texas
United States 1245.28.10006 Boehringer Ingelheim Investigational Site Shelby North Carolina
United States 1245.28.10015 Boehringer Ingelheim Investigational Site Tampa Florida
United States 1245.28.10021 Boehringer Ingelheim Investigational Site West Hills California

Sponsors (2)
Lead Sponsor Collaborator
Boehringer Ingelheim Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Canada,  Colombia,  Czech Republic,  Finland,  Hong Kong,  India,  Italy,  Malaysia,  Mexico,  Netherlands,  Norway,  Philippines,  Portugal,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment. Baseline and 104 weeks No
Secondary The Change in Body Weight From Baseline After 104 Weeks of Treatment. baseline and 104 weeks No
Secondary The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment. baseline and 104 weeks No
Secondary The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment. baseline and 104 weeks No
Secondary The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment. baseline and 104 weeks No
Secondary The Change From Baseline in HbA1c After 52 Weeks of Treatment. baseline and 52 weeks No
Secondary The Change in Body Weight From Baseline After 52 Weeks of Treatment. baseline and 52 weeks No
Secondary The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment. baseline and 52 weeks No
Secondary The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment. baseline and 52 weeks No
Secondary The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment. baseline and 52 weeks No
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