Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289990
• Other study ID #: 1245.31
• Secondary ID: 2010-022718-17
• Status: Completed
• Phase: Phase 3
• First received: January 31, 2011
• Last updated: July 14, 2014
• Start date: February 2011
• Est. completion date: May 2013

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal and Health ProductsCanada: Health CanadaChina: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesGreece: Ethics CommitteeIndia: Drugs Controller General of IndiaIreland: Irish Medicines BoardJapan: Ministry of Health, Labor and WelfareMexico: Federal Commission for Sanitary Risks ProtectionPhilippines: Department of HealthSlovakia: State Institute for Drug ControlSlovenia: Agency for Medicinal Products - Ministry of HealthSouth Korea: Ministry of Food and Drug Safety (MFDS)Switzerland: SwissmedicTaiwan:Turkey: Ministry of HealthUkraine: State Pharmacological Center - Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2705
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Patients completing the entire treatment period of the preceding double-blind trial 1245.19, 1245.20 or 1245.23 with or without rescue therapy.

2. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice and local legislation.

Exclusion criteria:

1. Patient who meet one or more of the withdrawal criteria of the treatment period of the previous trial 1245.19, 1245.20 or 1245.23.

2. Indication of liver disease, defined by serum levels of either alanine aminotransferase , aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during last visit of preceding trial.

3. Impaired renal function defined as glomerular filtration rate<30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) as determined during last visit of preceding trial.

4. Contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to local label, which started during trial participation in 1245.19, 1245.20 or 1245.23

5. Pre-menopausal women (last menstruation < or = 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential and 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 submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner.

6. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake.

7. Participation in another trial with an investigational drug within 30 days prior to informed consent (except 1245.19, 1245.20 and 1245.23).

8. Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial.

Study Design

Allocation: Non-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
BI 10773 tablets once daily
• Placebo
Placebo matching BI 10773 low dose
• Placebo
Placebo matching BI 10773 high dose
• Placebo
Placebo matching Sitagliptin
• Placebo
Placebo matching BI 10773 high dose
• Placebo
Placebo matching BI 10773 high dose
• BI 10773
BI 10773 tablets once daily
• Placebo
Placebo matching BI 10773 low dose
• Placebo
Placebo matching BI 10773 low dose
• BI 10773
BI 10773 tablets once daily
• Placebo
Placebo matching BI 10773 low dose
• Placebo
Placebo matching BI 10773 high dose
• Placebo
Placebo matching Sitagliptin
• BI 10773
BI 10773 tablets once daily
• BI 10773
BI 10773 tablets once daily
• BI 10773
BI 10773 tablets once daily
• Placebo
Placebo matching BI 10773 high dose
• BI 10773
BI 10773 tablets once daily
• Placebo
Placebo matching BI 10773 low dose
• Placebo
Placebo matching BI 10773 high dose
• Placebo
Placebo matching Sitagliptin
• Sitagliptin 100mg
Sitagliptin once daily
• BI 10773
BI 10773 tablets once daily
• Placebo
Placebo matching BI 10773 low dose
• Placebo
Placebo matching BI 10773 low dose
• Placebo
Placebo matching BI 10773 low dose
• Placebo
Placebo matching BI 10773 high dose
• Placebo
Placebo matching BI 10773 low dose
• Placebo
Placebo matching BI 10773 high dose
• Placebo
Placebo matching BI 10773 high dose

Locations

Country	Name	City	State
Belgium	1245.31.32008 Boehringer Ingelheim Investigational Site	Bruxelles
Belgium	1245.31.32023 Boehringer Ingelheim Investigational Site	Bruxelles
Belgium	1245.31.32003 Boehringer Ingelheim Investigational Site	De Pinte
Belgium	1245.31.32015 Boehringer Ingelheim Investigational Site	Deurne
Belgium	1245.31.32016 Boehringer Ingelheim Investigational Site	Deurne
Belgium	1245.31.32025 Boehringer Ingelheim Investigational Site	Gozée
Belgium	1245.31.32019 Boehringer Ingelheim Investigational Site	Leopoldsburg
Belgium	1245.31.32024 Boehringer Ingelheim Investigational Site	Linkebeek
Belgium	1245.31.32021 Boehringer Ingelheim Investigational Site	Mouscron
Belgium	1245.31.32020 Boehringer Ingelheim Investigational Site	Sint-Gillis-Waas
Belgium	1245.31.32018 Boehringer Ingelheim Investigational Site	Tielt
Belgium	1245.31.32026 Boehringer Ingelheim Investigational Site	Tremelo
Canada	1245.31.20022 Boehringer Ingelheim Investigational Site	Brampton	Ontario
Canada	1245.31.20057 Boehringer Ingelheim Investigational Site	Brampton	Ontario
Canada	1245.31.20032 Boehringer Ingelheim Investigational Site	Calgary	Alberta
Canada	1245.31.20011 Boehringer Ingelheim Investigational Site	Chilliwack	British Columbia
Canada	1245.31.20035 Boehringer Ingelheim Investigational Site	Corunna	Ontario
Canada	1245.31.20023 Boehringer Ingelheim Investigational Site	Edmonton	Alberta
Canada	1245.31.20030 Boehringer Ingelheim Investigational Site	Etobicoke	Ontario
Canada	1245.31.20026 Boehringer Ingelheim Investigational Site	Halifax	Nova Scotia
Canada	1245.31.20019 Boehringer Ingelheim Investigational Site	Hamilton	Ontario
Canada	1245.31.20027 Boehringer Ingelheim Investigational Site	Laval	Quebec
Canada	1245.31.20017 Boehringer Ingelheim Investigational Site	London	Ontario
Canada	1245.31.20029 Boehringer Ingelheim Investigational Site	London	Ontario
Canada	1245.31.20060 Boehringer Ingelheim Investigational Site	London	Ontario
Canada	1245.31.20003 Boehringer Ingelheim Investigational Site	Markham	Ontario
Canada	1245.31.20012 Boehringer Ingelheim Investigational Site	Moncton	New Brunswick
Canada	1245.31.20007 Boehringer Ingelheim Investigational Site	Montague	Prince Edward Island
Canada	1245.31.20025 Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	1245.31.20016 Boehringer Ingelheim Investigational Site	Mount Pearl	Newfoundland and Labrador
Canada	1245.31.20009 Boehringer Ingelheim Investigational Site	Newmarket	Ontario
Canada	1245.31.20040 Boehringer Ingelheim Investigational Site	Oakville	Ontario
Canada	1245.31.20024 Boehringer Ingelheim Investigational Site	Paradise	Newfoundland and Labrador
Canada	1245.31.20034 Boehringer Ingelheim Investigational Site	Sarnia	Ontario
Canada	1245.31.20041 Boehringer Ingelheim Investigational Site	Saskatoon	Saskatchewan
Canada	1245.31.20036 Boehringer Ingelheim Investigational Site	Sherbrooke	Quebec
Canada	1245.31.20058 Boehringer Ingelheim Investigational Site	St-Romuald	Quebec
Canada	1245.31.20008 Boehringer Ingelheim Investigational Site	St. John's	Newfoundland and Labrador
Canada	1245.31.20005 Boehringer Ingelheim Investigational Site	Strathroy	Ontario
Canada	1245.31.20002 Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	1245.31.20006 Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	1245.31.20021 Boehringer Ingelheim Investigational Site	Trois Rivieres	Quebec
Canada	1245.31.20028 Boehringer Ingelheim Investigational Site	Vancouver	British Columbia
Canada	1245.31.20018 Boehringer Ingelheim Investigational Site	Victoria	British Columbia
Canada	1245.31.20033 Boehringer Ingelheim Investigational Site	Victoria	British Columbia
Canada	1245.31.20038 Boehringer Ingelheim Investigational Site	Ville Saint-Laurent	Quebec
Canada	1245.31.20015 Boehringer Ingelheim Investigational Site	Winnipeg	Manitoba
China	1245.31.86007 Boehringer Ingelheim Investigational Site	Beijing
China	1245.31.86008 Boehringer Ingelheim Investigational Site	Beijing
China	1245.31.86031 Boehringer Ingelheim Investigational Site	Beijing
China	1245.31.86032 Boehringer Ingelheim Investigational Site	Beijing
China	1245.31.86033 Boehringer Ingelheim Investigational Site	Beijing
China	1245.31.86034 Boehringer Ingelheim Investigational Site	Beijing
China	1245.31.86035 Boehringer Ingelheim Investigational Site	Beijing
China	1245.31.86058 Boehringer Ingelheim Investigational Site	Chongqing
China	1245.31.86038 Boehringer Ingelheim Investigational Site	Dalian
China	1245.31.86001 Boehringer Ingelheim Investigational Site	Guangzhou
China	1245.31.86003 Boehringer Ingelheim Investigational Site	Guangzhou
China	1245.31.86052 Boehringer Ingelheim Investigational Site	Guangzhou
China	1245.31.86012 Boehringer Ingelheim Investigational Site	Guiyang
China	1245.31.86037 Boehringer Ingelheim Investigational Site	Haerbin
China	1245.31.86020 Boehringer Ingelheim Investigational Site	Hangzhou
China	1245.31.86049 Boehringer Ingelheim Investigational Site	Jinan
China	1245.31.86053 Boehringer Ingelheim Investigational Site	Jinan
China	1245.31.86018 Boehringer Ingelheim Investigational Site	Jingzhou
China	1245.31.86055 Boehringer Ingelheim Investigational Site	Nan Ning
China	1245.31.86056 Boehringer Ingelheim Investigational Site	Nan Ning
China	1245.31.86019 Boehringer Ingelheim Investigational Site	Nanchang
China	1245.31.86042 Boehringer Ingelheim Investigational Site	Nanjing
China	1245.31.86043 Boehringer Ingelheim Investigational Site	Nanjing
China	1245.31.86016 Boehringer Ingelheim Investigational Site	QingDao
China	1245.31.86039 Boehringer Ingelheim Investigational Site	Shanghai
China	1245.31.86054 Boehringer Ingelheim Investigational Site	Shantou
China	1245.31.86057 Boehringer Ingelheim Investigational Site	Shenyang
China	1245.31.86045 Boehringer Ingelheim Investigational Site	Shijiazhuang
China	1245.31.86017 Boehringer Ingelheim Investigational Site	Shiyan
China	1245.31.86013 Boehringer Ingelheim Investigational Site	Suzhou
China	1245.31.86015 Boehringer Ingelheim Investigational Site	Taiyuan
China	1245.31.86036 Boehringer Ingelheim Investigational Site	Tianjin
China	1245.31.86011 Boehringer Ingelheim Investigational Site	Xi'An
China	1245.31.86041 Boehringer Ingelheim Investigational Site	Xi'An
China	1245.31.86014 Boehringer Ingelheim Investigational Site	Xiamen
France	1245.31.33008 Boehringer Ingelheim Investigational Site	Bersée
France	1245.31.33020 Boehringer Ingelheim Investigational Site	Bischheim
France	1245.31.33002 Boehringer Ingelheim Investigational Site	Bondy Cedex
France	1245.31.33016 Boehringer Ingelheim Investigational Site	Bruay La Buissiere
France	1245.31.33001 Boehringer Ingelheim Investigational Site	Corbeil Essonnes
France	1245.31.33010 Boehringer Ingelheim Investigational Site	Croix
France	1245.31.33009 Boehringer Ingelheim Investigational Site	Hautmont
France	1245.31.33003 Boehringer Ingelheim Investigational Site	La Rochelle Cedex 1
France	1245.31.33045 Boehringer Ingelheim Investigational Site	Marseille
France	1245.31.33004 Boehringer Ingelheim Investigational Site	Narbonne Cedex
France	1245.31.33012 Boehringer Ingelheim Investigational Site	Schiltigheim
France	1245.31.33013 Boehringer Ingelheim Investigational Site	Strasbourg
France	1245.31.33019 Boehringer Ingelheim Investigational Site	Strasbourg
France	1245.31.33007 Boehringer Ingelheim Investigational Site	Vieux Condé
France	1245.31.33018 Boehringer Ingelheim Investigational Site	Wattrelos
Germany	1245.31.49001 Boehringer Ingelheim Investigational Site	Dormagen
Germany	1245.31.49013 Boehringer Ingelheim Investigational Site	Dresden
Germany	1245.31.49016 Boehringer Ingelheim Investigational Site	Düsseldorf
Germany	1245.31.49009 Boehringer Ingelheim Investigational Site	Flörsheim
Germany	1245.31.49015 Boehringer Ingelheim Investigational Site	Frankfurt
Germany	1245.31.49019 Boehringer Ingelheim Investigational Site	Haag
Germany	1245.31.49004 Boehringer Ingelheim Investigational Site	Hatten
Germany	1245.31.49020 Boehringer Ingelheim Investigational Site	Hohenmölsen
Germany	1245.31.49007 Boehringer Ingelheim Investigational Site	Künzing
Germany	1245.31.49002 Boehringer Ingelheim Investigational Site	Neuwied
Germany	1245.31.49008 Boehringer Ingelheim Investigational Site	Nürnberg
Germany	1245.31.49010 Boehringer Ingelheim Investigational Site	Rednitzhembach
Germany	1245.31.49006 Boehringer Ingelheim Investigational Site	Rehburg-Loccum
Germany	1245.31.49011 Boehringer Ingelheim Investigational Site	Rehlingen-Siersburg
Germany	1245.31.49005 Boehringer Ingelheim Investigational Site	Saarbrücken
Germany	1245.31.49022 Boehringer Ingelheim Investigational Site	Schauenburg
Germany	1245.31.49017 Boehringer Ingelheim Investigational Site	St. Ingbert/Oberwürzbach
Germany	1245.31.49003 Boehringer Ingelheim Investigational Site	Unterschneidheim
Greece	1245.31.30004 Boehringer Ingelheim Investigational Site	Thessaloniki
India	1245.31.91005 Boehringer Ingelheim Investigational Site	Bangalore
India	1245.31.91006 Boehringer Ingelheim Investigational Site	Bangalore
India	1245.31.91008 Boehringer Ingelheim Investigational Site	Bangalore
India	1245.31.91003 Boehringer Ingelheim Investigational Site	Belgaum
India	1245.31.91004 Boehringer Ingelheim Investigational Site	Chennai
India	1245.31.91009 Boehringer Ingelheim Investigational Site	Chennai
India	1245.31.91001 Boehringer Ingelheim Investigational Site	Coimbatore
India	1245.31.91101 Boehringer Ingelheim Investigational Site	Coimbatore
India	1245.31.91015 Boehringer Ingelheim Investigational Site	Gulbarga
India	1245.31.91104 Boehringer Ingelheim Investigational Site	Indore
India	1245.31.91103 Boehringer Ingelheim Investigational Site	Maharashtra
India	1245.31.91002 Boehringer Ingelheim Investigational Site	Mumbai
India	1245.31.91007 Boehringer Ingelheim Investigational Site	Mumbai, Maharastra
India	1245.31.91010 Boehringer Ingelheim Investigational Site	Nagpur
India	1245.31.91012 Boehringer Ingelheim Investigational Site	New Delhi
India	1245.31.91014 Boehringer Ingelheim Investigational Site	Pune
India	1245.31.91105 Boehringer Ingelheim Investigational Site	Pune
Ireland	1245.31.35304 Boehringer Ingelheim Investigational Site	Birr, Co. Offaly
Ireland	1245.31.35302 Boehringer Ingelheim Investigational Site	Co. Cork
Ireland	1245.31.35305 Boehringer Ingelheim Investigational Site	Co. Galway
Ireland	1245.31.35303 Boehringer Ingelheim Investigational Site	Co. Wexford
Ireland	1245.31.35306 Boehringer Ingelheim Investigational Site	Co. Wexford
Japan	1245.31.81007 Boehringer Ingelheim Investigational Site	Chiyoda-ku, Tokyo
Japan	1245.31.81001 Boehringer Ingelheim Investigational Site	Chuo-ku, Tokyo
Japan	1245.31.81002 Boehringer Ingelheim Investigational Site	Chuo-ku, Tokyo
Japan	1245.31.81005 Boehringer Ingelheim Investigational Site	Ebetsu, Hokkaido
Japan	1245.31.81004 Boehringer Ingelheim Investigational Site	Kamakura, Kanagawa
Japan	1245.31.81003 Boehringer Ingelheim Investigational Site	Minato-ku, Tokyo
Japan	1245.31.81006 Boehringer Ingelheim Investigational Site	Shinjuku-ku, Tokyo
Japan	1245.31.81008 Boehringer Ingelheim Investigational Site	Shinjuku-ku, Tokyo
Japan	1245.31.81009 Boehringer Ingelheim Investigational Site	Suita, Osaka
Japan	1245.31.81010 Boehringer Ingelheim Investigational Site	Ube, Yamaguchi
Japan	1245.31.81012 Boehringer Ingelheim Investigational Site	Urasoe, Okinawa
Japan	1245.31.81013 Boehringer Ingelheim Investigational Site	Urasoe, Okinawa
Korea, Republic of	1245.31.82012 Boehringer Ingelheim Investigational Site	Anyang
Korea, Republic of	1245.31.82011 Boehringer Ingelheim Investigational Site	Goyang
Korea, Republic of	1245.31.82009 Boehringer Ingelheim Investigational Site	Ilsan
Korea, Republic of	1245.31.82001 Boehringer Ingelheim Investigational Site	Incheon
Korea, Republic of	1245.31.82006 Boehringer Ingelheim Investigational Site	Jeonju
Korea, Republic of	1245.31.82004 Boehringer Ingelheim Investigational Site	Pusan
Korea, Republic of	1245.31.82005 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1245.31.82007 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1245.31.82008 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1245.31.82010 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1245.31.82014 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1245.31.82002 Boehringer Ingelheim Investigational Site	Suwon
Korea, Republic of	1245.31.82003 Boehringer Ingelheim Investigational Site	Wonju
Mexico	1245.31.52003 Boehringer Ingelheim Investigational Site	Guadalajara
Mexico	1245.31.52004 Boehringer Ingelheim Investigational Site	Guadalajara
Mexico	1245.31.52001 Boehringer Ingelheim Investigational Site	Monterrey
Mexico	1245.31.52002 Boehringer Ingelheim Investigational Site	Monterrey
Philippines	1245.31.63002 Boehringer Ingelheim Investigational Site	Cebu
Philippines	1245.31.63003 Boehringer Ingelheim Investigational Site	Davao City
Philippines	1245.31.63001 Boehringer Ingelheim Investigational Site	Manila
Philippines	1245.31.63004 Boehringer Ingelheim Investigational Site	Manila
Philippines	1245.31.63005 Boehringer Ingelheim Investigational Site	Manila
Slovakia	1245.31.74005 Boehringer Ingelheim Investigational Site	Bratislava
Slovakia	1245.31.74002 Boehringer Ingelheim Investigational Site	Lucenec
Slovakia	1245.31.74006 Boehringer Ingelheim Investigational Site	Nitra
Slovakia	1245.31.74014 Boehringer Ingelheim Investigational Site	Nove Zamky
Slovakia	1245.31.74001 Boehringer Ingelheim Investigational Site	Povazska Bystrica
Slovakia	1245.31.74004 Boehringer Ingelheim Investigational Site	Presov
Slovakia	1245.31.74003 Boehringer Ingelheim Investigational Site	Trebisov
Slovenia	1245.31.38003 Boehringer Ingelheim Investigational Site	Celje
Slovenia	1245.31.38002 Boehringer Ingelheim Investigational Site	Koper
Slovenia	1245.31.38001 Boehringer Ingelheim Investigational Site	Maribor
Switzerland	1245.31.41004 Boehringer Ingelheim Investigational Site	Lugano
Switzerland	1245.31.41003 Boehringer Ingelheim Investigational Site	Rorschach
Taiwan	1245.31.88010 Boehringer Ingelheim Investigational Site	Kaohsiung
Taiwan	1245.31.88011 Boehringer Ingelheim Investigational Site	Kaohsiung
Taiwan	1245.31.88012 Boehringer Ingelheim Investigational Site	Kaohsiung
Taiwan	1245.31.88013 Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	1245.31.88009 Boehringer Ingelheim Investigational Site	Taichung
Taiwan	1245.31.88014 Boehringer Ingelheim Investigational Site	Tainan
Taiwan	1245.31.88006 Boehringer Ingelheim Investigational Site	Taipei
Taiwan	1245.31.88021 Boehringer Ingelheim Investigational Site	Taipei
Taiwan	1245.31.88008 Boehringer Ingelheim Investigational Site	Taoyuan County
Turkey	1245.31.90003 Boehringer Ingelheim Investigational Site	Erzurum
Turkey	1245.31.90001 Boehringer Ingelheim Investigational Site	Gaziantep
Turkey	1245.31.90002 Boehringer Ingelheim Investigational Site	Istanbul
Turkey	1245.31.90006 Boehringer Ingelheim Investigational Site	Istanbul
Turkey	1245.31.90004 Boehringer Ingelheim Investigational Site	Izmir
Ukraine	1245.31.75002 Boehringer Ingelheim Investigational Site	Dnepropetrovsk
Ukraine	1245.31.75001 Boehringer Ingelheim Investigational Site	Kharkiv
Ukraine	1245.31.75006 Boehringer Ingelheim Investigational Site	Lviv
Ukraine	1245.31.75004 Boehringer Ingelheim Investigational Site	Vinnitsa
Ukraine	1245.31.75003 Boehringer Ingelheim Investigational Site	Vinnytsya
United States	1245.31.10117 Boehringer Ingelheim Investigational Site	Arkansas City	Kansas
United States	1245.31.10071 Boehringer Ingelheim Investigational Site	Asheboro	North Carolina
United States	1245.31.10145 Boehringer Ingelheim Investigational Site	Birmingham	Alabama
United States	1245.31.10129 Boehringer Ingelheim Investigational Site	Carlisle	Ohio
United States	1245.31.10033 Boehringer Ingelheim Investigational Site	Chattanooga	Tennessee
United States	1245.31.10001 Boehringer Ingelheim Investigational Site	Chicago	Illinois
United States	1245.31.10154 Boehringer Ingelheim Investigational Site	Chino	California
United States	1245.31.10045 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio
United States	1245.31.10119 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio
United States	1245.31.10137 Boehringer Ingelheim Investigational Site	Clearwater	Florida
United States	1245.31.10003 Boehringer Ingelheim Investigational Site	Dearborn	Michigan
United States	1245.31.10080 Boehringer Ingelheim Investigational Site	Decatur	Georgia
United States	1245.31.10159 Boehringer Ingelheim Investigational Site	Des Moines	Iowa
United States	1245.31.10014 Boehringer Ingelheim Investigational Site	Dubuque	Iowa
United States	1245.31.10130 Boehringer Ingelheim Investigational Site	Gallipolis	Ohio
United States	1245.31.10162 Boehringer Ingelheim Investigational Site	Glendale	Arizona
United States	1245.31.10156 Boehringer Ingelheim Investigational Site	Houston	Texas
United States	1245.31.10151 Boehringer Ingelheim Investigational Site	Hurst	Texas
United States	1245.31.10133 Boehringer Ingelheim Investigational Site	Jupiter	Florida
United States	1245.31.10143 Boehringer Ingelheim Investigational Site	Killeen	Texas
United States	1245.31.10146 Boehringer Ingelheim Investigational Site	Louisville	Kentucky
United States	1245.31.10112 Boehringer Ingelheim Investigational Site	Memphis	Tennessee
United States	1245.31.10124 Boehringer Ingelheim Investigational Site	Mesa	Arizona
United States	1245.31.10006 Boehringer Ingelheim Investigational Site	Miami	Florida
United States	1245.31.10158 Boehringer Ingelheim Investigational Site	Mount Pleasant	South Carolina
United States	1245.31.10059 Boehringer Ingelheim Investigational Site	New Hyde Park	New York
United States	1245.31.10157 Boehringer Ingelheim Investigational Site	Newton	Kansas
United States	1245.31.10038 Boehringer Ingelheim Investigational Site	Northglenn	Colorado
United States	1245.31.10077 Boehringer Ingelheim Investigational Site	Perry	Georgia
United States	1245.31.10108 Boehringer Ingelheim Investigational Site	Phoenix	Arizona
United States	1245.31.10085 Boehringer Ingelheim Investigational Site	Plantation	Florida
United States	1245.31.10149 Boehringer Ingelheim Investigational Site	Rancho Cucamonga	California
United States	1245.31.10034 Boehringer Ingelheim Investigational Site	Rochester	New York
United States	1245.31.10086 Boehringer Ingelheim Investigational Site	Salisbury	North Carolina
United States	1245.31.10155 Boehringer Ingelheim Investigational Site	San Antonio	Texas
United States	1245.31.10015 Boehringer Ingelheim Investigational Site	Simpsonville	South Carolina
United States	1245.31.10123 Boehringer Ingelheim Investigational Site	Smithtown	New York
United States	1245.31.10046 Boehringer Ingelheim Investigational Site	Tempe	Arizona
United States	1245.31.10127 Boehringer Ingelheim Investigational Site	Waterbury	Connecticut
United States	1245.31.10131 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,  Belgium,  Canada,  China,  France,  Germany,  Greece,  India,  Ireland,  Japan,  Korea, Republic of,  Mexico,  Philippines,  Slovakia,  Slovenia,  Switzerland,  Taiwan,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment	Change from baseline in HbA1c after 52 weeks	Baseline and 52 weeks	No
Primary	Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment	Change from baseline in HbA1c after 76 weeks	Baseline and 76 weeks	No
Secondary	HbA1c (%) Changes From Baseline After 76 Weeks of Treatment	Change from baseline in HbA1c (%) after 76 weeks using MMRM approach	Baseline and 76 weeks	No
Secondary	Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment	Systolic blood pressure - change from baseline after 52 weeks of treatment	Baseline and 52 weeks	No
Secondary	Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment	Systolic blood pressure - change from baseline after 76 weeks of treatment	Baseline and 76 weeks	No
Secondary	Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment	Diastolic blood pressure - change from baseline after 52 weeks of treatment	Baseline and 52 weeks	No
Secondary	Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment	Diastolic blood pressure - change from baseline after 76 weeks of treatment	Baseline and 76 weeks	No
Secondary	Body Weight (kg) Change From Baseline After 52 Weeks of Treatment	Body Weight (kg) - Change From Baseline After 52 Weeks of Treatment	Baseline and 52 weeks	No
Secondary	Body Weight (kg) Change From Baseline After 76 Weeks of Treatment	Body Weight (kg) - Change From Baseline After 76 Weeks of Treatment	Baseline and 76 weeks	No
Secondary	Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment	Waist circumference (cm) - change from baseline after 52 weeks of treatment	Baseline and 52 weeks	No
Secondary	Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment	Waist circumference (cm) - change from baseline after 76 weeks of treatment	Baseline and 76 weeks	No
Secondary	Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment	Fasting plasma glucose - change from baseline after 52 weeks of treatment	Baseline and 52 weeks	No
Secondary	Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment	Fasting plasma glucose - change from baseline after 76 weeks of treatment	Baseline and 76 weeks	No