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NCT01719003 Clinical Trial

Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A 24-week Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Oral Administration of Empagliflozin + Metformin Compared With the Individual Components of Empagliflozin or Metformin in Drug Naive Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01719003
Other study ID # 1276.1
Secondary ID 2010-021375-92
Status Completed
Phase Phase 3
First received October 30, 2012
Last updated January 22, 2016
Start date October 2012
Est. completion date December 2014

Study information
Verified date January 2016
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of HealthCanada: Health CanadaCzech Republic: State Institute for Drug ControlEgypt: Ministry of Health, Drug Policy and Planning CenterFrance: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesGuatemala: Ministry of Public Health and Social AssistanceLebanon: Institutional Review BoardMalaysia: Ministry of HealthMexico: Ministry of HealthPeru: General Directorate of Pharmaceuticals, Devices, and DrugsPhilippines: Bureau of Food and DrugsRussia: Pharmacological Committee, Ministry of HealthSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSouth Korea: Ministry of Food and Drug Safety (MFDS)Spain: Spanish Agency of MedicinesTaiwan: Department of HealthThailand: Food and Drug AdministrationTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.

Recruitment information / eligibility
Status Completed
Enrollment 1413
Est. completion date December 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

1. Diagnosis of type 2 diabetes mellitus prior to informed consent

2. Male and female patients on diet and exercise regimen who are drug-naive, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomization

3. HbA1c >=7.5% and <= 12% (>=58.5 mmol/mol and <=107.7 mmol/mol)

4. Body Mass Index (BMI) <= 45 kg/m2 at screening

Exclusion criteria:

1. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second laboratory measurement (not on the same day)

2. Any antidiabetic drug within 12 weeks prior to randomization

3. Impaired renal function, defined as estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) as determined during screening and/or run-in period

4. Contraindications to metformin according to the local label

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:
• Metformin 500 mg bid
Metformin 500 mg twice daily
• Metformin 1000 mg bid
Metformin 1000 mg twice daily
• Empagliflozin low dose qd
Empagliflozin low dose once daily
• Empagliflozin high dose qd
Empagliflozin high dose once daily
• Empagliflozin low dose bid
Empagliflozin low dose split twice daily
• Metformin 500 mg bid
Metformin 500 mg twice daily
• Empagliflozin high dose bid
Empagliflozin high dose split twice daily
• Empagliflozin low dose bid
Empagliflozin low dose split twice daily
• Metformin 1000 mg bid
Metformin 1000 mg twice daily
• Metformin 500 mg bid
Metformin 500 mg twice daily
• Metformin 1000 mg bid
Metformin 1000 mg twice daily
• Empagliflozin high dose bid
Empagliflozin high dose split twice daily
• Metformin 1000 mg bid
Metformin 1000 mg twice daily
• Empagliflozin high dose bid
Empagliflozin high dose split twice daily

Locations
Country Name City State
Brazil 1276.1.55008 Boehringer Ingelheim Investigational Site Belém
Brazil 1276.1.55003 Boehringer Ingelheim Investigational Site Brasilia
Brazil 1276.1.55006 Boehringer Ingelheim Investigational Site Fortaleza
Brazil 1276.1.55007 Boehringer Ingelheim Investigational Site Fortaleza
Brazil 1276.1.55009 Boehringer Ingelheim Investigational Site Fortaleza
Brazil 1276.1.55004 Boehringer Ingelheim Investigational Site Goiania
Brazil 1276.1.55002 Boehringer Ingelheim Investigational Site Porto Alegre
Brazil 1276.1.55001 Boehringer Ingelheim Investigational Site Sao Paulo
Canada 1276.1.20004 Boehringer Ingelheim Investigational Site Antigonish Nova Scotia
Canada 1276.1.20003 Boehringer Ingelheim Investigational Site Coquitlam British Columbia
Canada 1276.1.20012 Boehringer Ingelheim Investigational Site Coquitlam British Columbia
Canada 1276.1.20005 Boehringer Ingelheim Investigational Site Hawkesbury Ontario
Canada 1276.1.20007 Boehringer Ingelheim Investigational Site Mirabel Quebec
Canada 1276.1.20002 Boehringer Ingelheim Investigational Site Quebec
Canada 1276.1.20013 Boehringer Ingelheim Investigational Site Sarnia Ontario
Canada 1276.1.20001 Boehringer Ingelheim Investigational Site Saskatoon Saskatchewan
Canada 1276.1.20010 Boehringer Ingelheim Investigational Site Strathroy Ontario
Canada 1276.1.20006 Boehringer Ingelheim Investigational Site Thornhill Ontario
Canada 1276.1.20008 Boehringer Ingelheim Investigational Site Victoria British Columbia
Czech Republic 1276.1.42002 Boehringer Ingelheim Investigational Site Benatky nad Jizerou
Czech Republic 1276.1.42008 Boehringer Ingelheim Investigational Site Olomouc
Czech Republic 1276.1.42007 Boehringer Ingelheim Investigational Site Ostrava
Czech Republic 1276.1.42009 Boehringer Ingelheim Investigational Site Plzen
Czech Republic 1276.1.42010 Boehringer Ingelheim Investigational Site Praha 1
Czech Republic 1276.1.42004 Boehringer Ingelheim Investigational Site Praha 10
Czech Republic 1276.1.42003 Boehringer Ingelheim Investigational Site Praha 3
Egypt 1276.1.95001 Boehringer Ingelheim Investigational Site Abbasia Cairo, Egypt
Egypt 1276.1.95003 Boehringer Ingelheim Investigational Site Al Manial, Cairo, Egypt
Egypt 1276.1.95004 Boehringer Ingelheim Investigational Site Alexandria
Egypt 1276.1.95002 Boehringer Ingelheim Investigational Site El Darasa Cairo Egypt
France 1276.1.33004 Boehringer Ingelheim Investigational Site Behren Les Forbach
France 1276.1.33012 Boehringer Ingelheim Investigational Site Bersée
France 1276.1.33005 Boehringer Ingelheim Investigational Site Cournonterral
France 1276.1.33007 Boehringer Ingelheim Investigational Site Hautmont
France 1276.1.33013 Boehringer Ingelheim Investigational Site Paris
France 1276.1.33001 Boehringer Ingelheim Investigational Site Poitiers
France 1276.1.33003 Boehringer Ingelheim Investigational Site Savonnières
France 1276.1.33006 Boehringer Ingelheim Investigational Site St Genis des Fontaines
France 1276.1.33002 Boehringer Ingelheim Investigational Site Thouars
France 1276.1.33011 Boehringer Ingelheim Investigational Site Thun St amand
France 1276.1.33010 Boehringer Ingelheim Investigational Site Tours
France 1276.1.33009 Boehringer Ingelheim Investigational Site Vandome
France 1276.1.33008 Boehringer Ingelheim Investigational Site Vieux Condé
Germany 1276.1.49005 Boehringer Ingelheim Investigational Site Berlin
Germany 1276.1.49008 Boehringer Ingelheim Investigational Site Celle
Germany 1276.1.49006 Boehringer Ingelheim Investigational Site Dortmund
Germany 1276.1.49011 Boehringer Ingelheim Investigational Site Dresden
Germany 1276.1.49003 Boehringer Ingelheim Investigational Site Essen
Germany 1276.1.49007 Boehringer Ingelheim Investigational Site Ingelheim
Germany 1276.1.49014 Boehringer Ingelheim Investigational Site Neuwied
Germany 1276.1.49004 Boehringer Ingelheim Investigational Site Offenbach
Germany 1276.1.49002 Boehringer Ingelheim Investigational Site Stuhr-Brinkum
Germany 1276.1.49012 Boehringer Ingelheim Investigational Site Teuchern
Guatemala 1276.1.50002 Boehringer Ingelheim Investigational Site Barbena Santa Rosa
Guatemala 1276.1.50003 Boehringer Ingelheim Investigational Site Guatemala
Guatemala 1276.1.50005 Boehringer Ingelheim Investigational Site Guatemala
Guatemala 1276.1.50006 Boehringer Ingelheim Investigational Site Guatemala
Guatemala 1276.1.50001 Boehringer Ingelheim Investigational Site Quetzaltenango
Korea, Republic of 1276.1.82006 Boehringer Ingelheim Investigational Site Deagu
Korea, Republic of 1276.1.82010 Boehringer Ingelheim Investigational Site Goyang
Korea, Republic of 1276.1.82001 Boehringer Ingelheim Investigational Site Incheon
Korea, Republic of 1276.1.82009 Boehringer Ingelheim Investigational Site Pusan
Korea, Republic of 1276.1.82002 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1276.1.82004 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1276.1.82005 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1276.1.82007 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1276.1.82008 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1276.1.82003 Boehringer Ingelheim Investigational Site Wonju
Lebanon 1276.1.96001 Boehringer Ingelheim Investigational Site Beirut
Lebanon 1276.1.96002 Boehringer Ingelheim Investigational Site El Chouf
Lebanon 1276.1.96003 Boehringer Ingelheim Investigational Site Saida
Lebanon 1276.1.96004 Boehringer Ingelheim Investigational Site Saida
Malaysia 1276.1.60002 Boehringer Ingelheim Investigational Site Ipoh, Perak
Malaysia 1276.1.60001 Boehringer Ingelheim Investigational Site Johor Bahru
Malaysia 1276.1.60003 Boehringer Ingelheim Investigational Site Kubang Kerian
Mexico 1276.1.52004 Boehringer Ingelheim Investigational Site Aguascalientes
Mexico 1276.1.52007 Boehringer Ingelheim Investigational Site Aguascalientes
Mexico 1276.1.52002 Boehringer Ingelheim Investigational Site Ciudad de Mexico
Mexico 1276.1.52003 Boehringer Ingelheim Investigational Site Guadalajara
Mexico 1276.1.52001 Boehringer Ingelheim Investigational Site Monterrey
Mexico 1276.1.52006 Boehringer Ingelheim Investigational Site San Lucas tepetlcalco
Mexico 1276.1.52005 Boehringer Ingelheim Investigational Site Zapopan
Peru 1276.1.51001 Boehringer Ingelheim Investigational Site Lima
Peru 1276.1.51002 Boehringer Ingelheim Investigational Site Lima
Peru 1276.1.51003 Boehringer Ingelheim Investigational Site Lima
Peru 1276.1.51004 Boehringer Ingelheim Investigational Site Lima
Peru 1276.1.51005 Boehringer Ingelheim Investigational Site Lima
Philippines 1276.1.63009 Boehringer Ingelheim Investigational Site Cebu City, Cebu
Philippines 1276.1.63002 Boehringer Ingelheim Investigational Site Cebu City, Philippines
Philippines 1276.1.63004 Boehringer Ingelheim Investigational Site Davao City
Philippines 1276.1.63003 Boehringer Ingelheim Investigational Site Iloilo City
Philippines 1276.1.63006 Boehringer Ingelheim Investigational Site Manila
Philippines 1276.1.63001 Boehringer Ingelheim Investigational Site Marikina City
Philippines 1276.1.63005 Boehringer Ingelheim Investigational Site Maybunga, Pasig City
Philippines 1276.1.63007 Boehringer Ingelheim Investigational Site San Juan City
Philippines 1276.1.63008 Boehringer Ingelheim Investigational Site Tarlac
Russian Federation 1276.1.70012 Boehringer Ingelheim Investigational Site Barnaul
Russian Federation 1276.1.70011 Boehringer Ingelheim Investigational Site Kemerovo
Russian Federation 1276.1.70015 Boehringer Ingelheim Investigational Site Novosibirsk
Russian Federation 1276.1.70016 Boehringer Ingelheim Investigational Site Novosibirsk
Russian Federation 1276.1.70018 Boehringer Ingelheim Investigational Site Novosibirsk
Russian Federation 1276.1.70007 Boehringer Ingelheim Investigational Site Petrozavodsk
Russian Federation 1276.1.70009 Boehringer Ingelheim Investigational Site Saratov
Russian Federation 1276.1.70010 Boehringer Ingelheim Investigational Site Smolensk
Russian Federation 1276.1.70005 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 1276.1.70006 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 1276.1.70017 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 1276.1.70013 Boehringer Ingelheim Investigational Site Yaroslavl
Serbia 1276.1.38104 Boehringer Ingelheim Investigational Site Belgrade
Serbia 1276.1.38105 Boehringer Ingelheim Investigational Site Belgrade
Serbia 1276.1.38106 Boehringer Ingelheim Investigational Site Belgrade
Serbia 1276.1.38107 Boehringer Ingelheim Investigational Site Belgrade
Serbia 1276.1.38103 Boehringer Ingelheim Investigational Site Kragujevac
Serbia 1276.1.38101 Boehringer Ingelheim Investigational Site Nis
Serbia 1276.1.38108 Boehringer Ingelheim Investigational Site Novi Sad
Serbia 1276.1.38102 Boehringer Ingelheim Investigational Site Zajecar
Spain 1276.1.34048 Boehringer Ingelheim Investigational Site Alicante
Spain 1276.1.34050 Boehringer Ingelheim Investigational Site Alzira
Spain 1276.1.34028 Boehringer Ingelheim Investigational Site Madrid
Spain 1276.1.34045 Boehringer Ingelheim Investigational Site pozuelo de Alarcon
Spain 1276.1.34034 Boehringer Ingelheim Investigational Site Sabadell (Barcelona)
Spain 1276.1.34027 Boehringer Ingelheim Investigational Site Salamanca
Spain 1276.1.34052 Boehringer Ingelheim Investigational Site Tarragona
Spain 1276.1.34051 Boehringer Ingelheim Investigational Site Zaragoza
Taiwan 1276.1.88005 Boehringer Ingelheim Investigational Site Kaohsiung City,
Taiwan 1276.1.88002 Boehringer Ingelheim Investigational Site New Taipei City
Taiwan 1276.1.88001 Boehringer Ingelheim Investigational Site Taichung
Taiwan 1276.1.88003 Boehringer Ingelheim Investigational Site Taichung
Taiwan 1276.1.88004 Boehringer Ingelheim Investigational Site Taichung
Taiwan 1276.1.88006 Boehringer Ingelheim Investigational Site Taipei
Thailand 1276.1.66001 Boehringer Ingelheim Investigational Site Bangkok, Thailand
Thailand 1276.1.66003 Boehringer Ingelheim Investigational Site Bangkok, Thailand
Thailand 1276.1.66002 Boehringer Ingelheim Investigational Site Nakhon Ratchasima
Turkey 1276.1.90003 Boehringer Ingelheim Investigational Site Ankara
Turkey 1276.1.90004 Boehringer Ingelheim Investigational Site Antalya
Turkey 1276.1.90006 Boehringer Ingelheim Investigational Site Denizli
Turkey 1276.1.90002 Boehringer Ingelheim Investigational Site Erzurum
Turkey 1276.1.90005 Boehringer Ingelheim Investigational Site Istanbul
Turkey 1276.1.90001 Boehringer Ingelheim Investigational Site Izmir
United Kingdom 1276.1.44002 Boehringer Ingelheim Investigational Site Bolton
United Kingdom 1276.1.44001 Boehringer Ingelheim Investigational Site Bradford on Avon
United Kingdom 1276.1.44005 Boehringer Ingelheim Investigational Site Chippenham
United Kingdom 1276.1.44006 Boehringer Ingelheim Investigational Site Dagenham
United Kingdom 1276.1.44004 Boehringer Ingelheim Investigational Site Doncaster
United Kingdom 1276.1.44008 Boehringer Ingelheim Investigational Site Glasgow
United Kingdom 1276.1.44003 Boehringer Ingelheim Investigational Site Leeds
United Kingdom 1276.1.44007 Boehringer Ingelheim Investigational Site Manchester
United Kingdom 1276.1.44011 Boehringer Ingelheim Investigational Site Mortimer
United Kingdom 1276.1.44009 Boehringer Ingelheim Investigational Site Sandbach
United States 1276.1.10033 Boehringer Ingelheim Investigational Site Asheboro North Carolina
United States 1276.1.10014 Boehringer Ingelheim Investigational Site Birmingham Alabama
United States 1276.1.10019 Boehringer Ingelheim Investigational Site Birmingham Alabama
United States 1276.1.10036 Boehringer Ingelheim Investigational Site Bridgman Michigan
United States 1276.1.10022 Boehringer Ingelheim Investigational Site Burlington North Carolina
United States 1276.1.10046 Boehringer Ingelheim Investigational Site Chula Vista California
United States 1276.1.10005 Boehringer Ingelheim Investigational Site Cincinnati Ohio
United States 1276.1.10042 Boehringer Ingelheim Investigational Site Colorado Springs Colorado
United States 1276.1.10030 Boehringer Ingelheim Investigational Site Columbia South Carolina
United States 1276.1.10001 Boehringer Ingelheim Investigational Site Denver Colorado
United States 1276.1.10034 Boehringer Ingelheim Investigational Site Evansville Indiana
United States 1276.1.10032 Boehringer Ingelheim Investigational Site Fall River Massachusetts
United States 1276.1.10026 Boehringer Ingelheim Investigational Site Fort Lauderdale Florida
United States 1276.1.10011 Boehringer Ingelheim Investigational Site Gallipolis Ohio
United States 1276.1.10010 Boehringer Ingelheim Investigational Site Glendale Arizona
United States 1276.1.10008 Boehringer Ingelheim Investigational Site Greer South Carolina
United States 1276.1.10037 Boehringer Ingelheim Investigational Site Hazelwood Missouri
United States 1276.1.10013 Boehringer Ingelheim Investigational Site Hodges South Carolina
United States 1276.1.10044 Boehringer Ingelheim Investigational Site Hot Springs Alaska
United States 1276.1.10018 Boehringer Ingelheim Investigational Site Houston Texas
United States 1276.1.10025 Boehringer Ingelheim Investigational Site Houston Texas
United States 1276.1.10028 Boehringer Ingelheim Investigational Site Houston Texas
United States 1276.1.10017 Boehringer Ingelheim Investigational Site Humboldt Tennessee
United States 1276.1.10006 Boehringer Ingelheim Investigational Site Huntington Beach California
United States 1276.1.10016 Boehringer Ingelheim Investigational Site Kingwood Texas
United States 1276.1.10043 Boehringer Ingelheim Investigational Site La Mesa California
United States 1276.1.10007 Boehringer Ingelheim Investigational Site Las Vegas Nevada
United States 1276.1.10002 Boehringer Ingelheim Investigational Site Lenoir North Carolina
United States 1276.1.10009 Boehringer Ingelheim Investigational Site Los Angeles California
United States 1276.1.10040 Boehringer Ingelheim Investigational Site Los Angeles California
United States 1276.1.10004 Boehringer Ingelheim Investigational Site Manassas Virginia
United States 1276.1.10023 Boehringer Ingelheim Investigational Site Marietta Georgia
United States 1276.1.10003 Boehringer Ingelheim Investigational Site Northglenn Colorado
United States 1276.1.10045 Boehringer Ingelheim Investigational Site Oceanside California
United States 1276.1.10024 Boehringer Ingelheim Investigational Site Oldsmar Florida
United States 1276.1.10027 Boehringer Ingelheim Investigational Site Port Orange Florida
United States 1276.1.10021 Boehringer Ingelheim Investigational Site San Antonio Texas
United States 1276.1.10041 Boehringer Ingelheim Investigational Site San Antonio Texas
United States 1276.1.10035 Boehringer Ingelheim Investigational Site Searcy Arkansas
United States 1276.1.10015 Boehringer Ingelheim Investigational Site Union New Jersey
United States 1276.1.10012 Boehringer Ingelheim Investigational Site Wenatchee Washington

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

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Czech Republic,  Egypt,  France,  Germany,  Guatemala,  Korea, Republic of,  Lebanon,  Malaysia,  Mexico,  Peru,  Philippines,  Russian Federation,  Serbia,  Spain,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24 Change from baseline in HbA1c (%) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means baseline and 24 weeks No
Secondary FPG (Fasting Plasma Glucose) Change From Baseline at Week 24 Change from baseline in FPG (mg/dL) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means. baseline and 24 weeks No
Secondary Body Weight Change From Baseline at Week 24 Change from baseline in body weight (kg) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment. medication. Means presented are the adjusted means. baseline and 24 weeks No
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