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

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

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