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NCT01649297 Clinical Trial

A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Randomised, Double Blind, Placebo Controlled, Parallel Group Efficacy and Safety Study of Oral Administration of Empagliflozin Twice Daily Versus Once Daily in Two Different Daily Doses Over 16 Weeks as add-on Therapy to a Twice Daily Dosing Regimen of Metformin in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01649297
Other study ID # 1276.10
Secondary ID 2012-000905-53
Status Completed
Phase Phase 2
First received July 23, 2012
Last updated June 26, 2015
Start date October 2012
Est. completion date December 2013

Study information
Verified date June 2015
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics CommitteeCanada: Health CanadaEstonia: The State Agency of MedicineFrance: Agence Nationale sécurité médicament et des produits santéGeorgia: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesGuatemala: Ministry of Public Health and Social AssistanceItaly: Ethics CommitteeLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthMexico: Federal Commission for Sanitary Risks ProtectionNew Zealand: Health and Disability Ethics CommitteesPoland: Registration Medicinal Product Medical Device Biocidal ProductRussia: Pharmacological Committee, Ministry of HealthSouth Africa: Medicines Control CouncilSpain: Spanish Agency of MedicinesUkraine: State Pharmacological Center - Ministry of HealthUnited States: Federal GovernmentUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.

Recruitment information / eligibility
Status Completed
Enrollment 983
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

1. confirmed diagnosis of T2DM

2. Glycated hemoglobin (HbA1c) >=7.0 and <=10/0% at Visit 1

3. Metformin therapy (at least 1500 mg/day, BID)

4. age>=18 at Visit 1

5. body mass index <=45 kg/m2

Exclusion criteria:

1. estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) screening and/or run-in

2. a confirmed glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in

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:
• Placebo
Patients receive placebo matching empagliflozin (low dose qd)
• Placebo
Patients receive placebo matching empagliflozin (low dose bid)
• Placebo
Patients receive placebo matching Empagliflozin (high dose qd)
• Placebo
Patients receive placebo matching Empagliflozin (high dose qd)
• Placebo
Patients receive placebo matching Empagliflozin (high dose qd)
• empagliflozin (low dose qd)
Patients receive Empagliflozin low dose once daily
• Placebo
Patients receive placebo matching empagliflozin (low dose qd)
• Placebo
Patients receive placebo matching empagliflozin (low dose bid)
• Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
• Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
• Placebo
Patients receive placebo matching empagliflozin (low dose qd)
• Placebo
Patients receive placebo matching empagliflozin (low dose bid)
• Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
• Placebo
Patients receive placebo matching empagliflozin (low dose qd)
• Placebo
Patients receive placebo matching empagliflozin (low dose bid)
• Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
• Empagliflozin (high dose qd)
Patients receive Empagliflozin high dose once daily
• empagliflozin (high dose bid)
Patients receive Empagliflozin high dose split twice daily
• Placebo
Patients receive placebo matching Empagliflozin (high dose qd)
• empagliflozin (low dose bid)
Patients receive Empagliflozin low dose split twice daily

Locations
Country Name City State
Australia 1276.10.61001 Boehringer Ingelheim Investigational Site Box Hill Victoria
Australia 1276.10.61002 Boehringer Ingelheim Investigational Site Wollongong New South Wales
Canada 1276.10.20002 Boehringer Ingelheim Investigational Site Bathurst New Brunswick
Canada 1276.10.20001 Boehringer Ingelheim Investigational Site Brampton Ontario
Canada 1276.10.20008 Boehringer Ingelheim Investigational Site Calgary Alberta
Canada 1276.10.20007 Boehringer Ingelheim Investigational Site Corunna Ontario
Canada 1276.10.20004 Boehringer Ingelheim Investigational Site Drummondville Quebec
Canada 1276.10.20003 Boehringer Ingelheim Investigational Site Point Claire Quebec
Canada 1276.10.20006 Boehringer Ingelheim Investigational Site Sarnia Ontario
Canada 1276.10.20005 Boehringer Ingelheim Investigational Site Surrey British Columbia
Canada 1276.10.20009 Boehringer Ingelheim Investigational Site Victoriaville Quebec
Canada 1276.10.20010 Boehringer Ingelheim Investigational Site Winnipeg Manitoba
Estonia 1276.10.37203 Boehringer Ingelheim Investigational Site Pärnu
Estonia 1276.10.37201 Boehringer Ingelheim Investigational Site Tallinn
Estonia 1276.10.37202 Boehringer Ingelheim Investigational Site Tallinn
Estonia 1276.10.37204 Boehringer Ingelheim Investigational Site Viljandi County
France 1276.10.33002 Boehringer Ingelheim Investigational Site Aire sur l'Adour
France 1276.10.33003 Boehringer Ingelheim Investigational Site Bischheim
France 1276.10.33009 Boehringer Ingelheim Investigational Site Bourg des Comptes
France 1276.10.33014 Boehringer Ingelheim Investigational Site Bourges
France 1276.10.33007 Boehringer Ingelheim Investigational Site Broglie
France 1276.10.33001 Boehringer Ingelheim Investigational Site Mont de Marsan
France 1276.10.33008 Boehringer Ingelheim Investigational Site Paris
France 1276.10.33006 Boehringer Ingelheim Investigational Site Saint Vinecnt de Tyrosse
France 1276.10.33011 Boehringer Ingelheim Investigational Site Segre
France 1276.10.33004 Boehringer Ingelheim Investigational Site Strasbourg
Georgia 1276.10.99501 Boehringer Ingelheim Investigational Site Tbilisi
Georgia 1276.10.99502 Boehringer Ingelheim Investigational Site Tbilisi
Georgia 1276.10.99503 Boehringer Ingelheim Investigational Site Tbilisi
Georgia 1276.10.99504 Boehringer Ingelheim Investigational Site Tbilisi
Georgia 1276.10.99505 Boehringer Ingelheim Investigational Site Tbilisi
Georgia 1276.10.99506 Boehringer Ingelheim Investigational Site Tbilisi
Germany 1276.10.49001 Boehringer Ingelheim Investigational Site Aschaffenburg
Germany 1276.10.49006 Boehringer Ingelheim Investigational Site Berlin
Germany 1276.10.49007 Boehringer Ingelheim Investigational Site Berlin
Germany 1276.10.49005 Boehringer Ingelheim Investigational Site Essen
Germany 1276.10.49004 Boehringer Ingelheim Investigational Site Frankfurt
Germany 1276.10.49002 Boehringer Ingelheim Investigational Site Nürnberg
Germany 1276.10.49003 Boehringer Ingelheim Investigational Site Rehlingen-Siersburg
Guatemala 1276.10.50201 Boehringer Ingelheim Investigational Site Guatemala Ciudad
Guatemala 1276.10.50203 Boehringer Ingelheim Investigational Site Guatemala Ciudad
Guatemala 1276.10.50204 Boehringer Ingelheim Investigational Site Guatemala Ciudad
Guatemala 1276.10.50205 Boehringer Ingelheim Investigational Site Guatemala Ciudad
Guatemala 1276.10.50202 Boehringer Ingelheim Investigational Site Quetzaltenango Ciudad
Italy 1276.10.39004 Boehringer Ingelheim Investigational Site Arenzano (GE)
Italy 1276.10.39003 Boehringer Ingelheim Investigational Site Bologna
Italy 1276.10.39007 Boehringer Ingelheim Investigational Site Catanzaro
Italy 1276.10.39009 Boehringer Ingelheim Investigational Site Catanzaro
Italy 1276.10.39002 Boehringer Ingelheim Investigational Site Napoli
Italy 1276.10.39006 Boehringer Ingelheim Investigational Site Palermo
Italy 1276.10.39001 Boehringer Ingelheim Investigational Site Roma
Italy 1276.10.39008 Boehringer Ingelheim Investigational Site Roma
Italy 1276.10.39005 Boehringer Ingelheim Investigational Site Torino
Latvia 1276.10.37102 Boehringer Ingelheim Investigational Site Daugavpils
Latvia 1276.10.37104 Boehringer Ingelheim Investigational Site Ogre
Latvia 1276.10.37101 Boehringer Ingelheim Investigational Site Riga
Latvia 1276.10.37103 Boehringer Ingelheim Investigational Site Tukums
Lithuania 1276.10.37003 Boehringer Ingelheim Investigational Site Kaunas
Lithuania 1276.10.37004 Boehringer Ingelheim Investigational Site Kaunas
Lithuania 1276.10.37002 Boehringer Ingelheim Investigational Site Klaipeda
Lithuania 1276.10.37001 Boehringer Ingelheim Investigational Site Vilnius
Mexico 1276.10.52001 Boehringer Ingelheim Investigational Site Ciudad de Mexico
Mexico 1276.10.52002 Boehringer Ingelheim Investigational Site Ciudad de Mexico
Mexico 1276.10.52003 Boehringer Ingelheim Investigational Site Durango
Mexico 1276.10.52005 Boehringer Ingelheim Investigational Site Pachuca
Mexico 1276.10.52004 Boehringer Ingelheim Investigational Site Tijuana
New Zealand 1276.10.64001 Boehringer Ingelheim Investigational Site Christchurch
New Zealand 1276.10.64002 Boehringer Ingelheim Investigational Site Greenlane East Auckland NZ
Poland 1276.10.48001 Boehringer Ingelheim Investigational Site Bialystok
Poland 1276.10.48002 Boehringer Ingelheim Investigational Site Bialystok
Poland 1276.10.48008 Boehringer Ingelheim Investigational Site Gizycko
Poland 1276.10.48005 Boehringer Ingelheim Investigational Site Katowice
Poland 1276.10.48006 Boehringer Ingelheim Investigational Site Katowice
Poland 1276.10.48004 Boehringer Ingelheim Investigational Site Krakow
Poland 1276.10.48003 Boehringer Ingelheim Investigational Site Warszawa
Russian Federation 1276.10.70001 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1276.10.70002 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1276.10.70003 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1276.10.70004 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1276.10.70005 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1276.10.70007 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1276.10.70008 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 1276.10.70009 Boehringer Ingelheim Investigational Site St. Petersburg
South Africa 1276.10.27004 Boehringer Ingelheim Investigational Site Paarl
South Africa 1276.10.27003 Boehringer Ingelheim Investigational Site Parow
South Africa 1276.10.27006 Boehringer Ingelheim Investigational Site Plumstead, Cape Town
South Africa 1276.10.27001 Boehringer Ingelheim Investigational Site Pretoria
South Africa 1276.10.27005 Boehringer Ingelheim Investigational Site Pretoria
South Africa 1276.10.27002 Boehringer Ingelheim Investigational Site Somerset West
Spain 1276.10.34005 Boehringer Ingelheim Investigational Site Barcelona
Spain 1276.10.34001 Boehringer Ingelheim Investigational Site L'Hospitalet de Llobregat
Spain 1276.10.34003 Boehringer Ingelheim Investigational Site L'Hospitalet de Llobregat
Spain 1276.10.34002 Boehringer Ingelheim Investigational Site Les Borges del Camp
Spain 1276.10.34004 Boehringer Ingelheim Investigational Site Sant Adria del Besos
Spain 1276.10.34006 Boehringer Ingelheim Investigational Site Vic
Ukraine 1276.10.38002 Boehringer Ingelheim Investigational Site Kharkiv
Ukraine 1276.10.38007 Boehringer Ingelheim Investigational Site Kharkiv
Ukraine 1276.10.38001 Boehringer Ingelheim Investigational Site Kiev
Ukraine 1276.10.38004 Boehringer Ingelheim Investigational Site Kiev
Ukraine 1276.10.38005 Boehringer Ingelheim Investigational Site Kyiv
United States 1276.10.11001 Boehringer Ingelheim Investigational Site Bangor Maine
United States 1276.10.11010 Boehringer Ingelheim Investigational Site Bradenton Florida
United States 1276.10.11011 Boehringer Ingelheim Investigational Site Brooklyn New York
United States 1276.10.11027 Boehringer Ingelheim Investigational Site Chicago Illinois
United States 1276.10.11018 Boehringer Ingelheim Investigational Site Cincinnati Ohio
United States 1276.10.11042 Boehringer Ingelheim Investigational Site Corpus Christi Texas
United States 1276.10.11013 Boehringer Ingelheim Investigational Site Dallas Texas
United States 1276.10.11005 Boehringer Ingelheim Investigational Site Davie Florida
United States 1276.10.11043 Boehringer Ingelheim Investigational Site Dayton Ohio
United States 1276.10.11030 Boehringer Ingelheim Investigational Site Dunwoody Georgia
United States 1276.10.11055 Boehringer Ingelheim Investigational Site Edison New Jersey
United States 1276.10.11020 Boehringer Ingelheim Investigational Site Elwood Indiana
United States 1276.10.11022 Boehringer Ingelheim Investigational Site Fleetwood Pennsylvania
United States 1276.10.11036 Boehringer Ingelheim Investigational Site Florence Alabama
United States 1276.10.11026 Boehringer Ingelheim Investigational Site Houston Texas
United States 1276.10.11031 Boehringer Ingelheim Investigational Site Houston Texas
United States 1276.10.11034 Boehringer Ingelheim Investigational Site Houston Texas
United States 1276.10.11058 Boehringer Ingelheim Investigational Site Jackson Mississippi
United States 1276.10.11004 Boehringer Ingelheim Investigational Site Jacksonville Florida
United States 1276.10.11003 Boehringer Ingelheim Investigational Site Johnson City Tennessee
United States 1276.10.11049 Boehringer Ingelheim Investigational Site Jonesboro Arkansas
United States 1276.10.11017 Boehringer Ingelheim Investigational Site Kettering Ohio
United States 1276.10.11040 Boehringer Ingelheim Investigational Site Lomita California
United States 1276.10.11033 Boehringer Ingelheim Investigational Site Los Angeles California
United States 1276.10.11051 Boehringer Ingelheim Investigational Site Miami Florida
United States 1276.10.11035 Boehringer Ingelheim Investigational Site North Myrtle Beach North Carolina
United States 1276.10.11012 Boehringer Ingelheim Investigational Site Norwalk Connecticut
United States 1276.10.11009 Boehringer Ingelheim Investigational Site Oakland Park Florida
United States 1276.10.11044 Boehringer Ingelheim Investigational Site Palm Harbor Florida
United States 1276.10.11028 Boehringer Ingelheim Investigational Site Pearland Texas
United States 1276.10.11016 Boehringer Ingelheim Investigational Site Port Orchard Washington
United States 1276.10.11002 Boehringer Ingelheim Investigational Site Rancho Cucamonga California
United States 1276.10.11050 Boehringer Ingelheim Investigational Site Sacramento California
United States 1276.10.11029 Boehringer Ingelheim Investigational Site San Antonio Texas
United States 1276.10.11024 Boehringer Ingelheim Investigational Site Spokane Washington
United States 1276.10.11048 Boehringer Ingelheim Investigational Site Sterling Heights Michigan
United States 1276.10.11047 Boehringer Ingelheim Investigational Site Waterbury Connecticut
United States 1276.10.11015 Boehringer Ingelheim Investigational Site West Hills California
United States 1276.10.11041 Boehringer Ingelheim Investigational Site Winston-Salem North Carolina

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

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Estonia,  France,  Georgia,  Germany,  Guatemala,  Italy,  Latvia,  Lithuania,  Mexico,  New Zealand,  Poland,  Russian Federation,  South Africa,  Spain,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16 Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.
Means provided are the adjusted means.		 Baseline and 16 weeks No
Secondary Fasting Plasma Glucose (FPG) Change From Baseline at Week 16 Change from baseline in FPG (mg/dL) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.
Means provided are the adjusted means.		 Baseline and 16 weeks No
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External Links