Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01289990
First received: January 31, 2011
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: BI 10773
Drug: Placebo
Drug: Sitagliptin 100mg
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Change from baseline in HbA1c after 52 weeks

  • Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment [ Time Frame: Baseline and 76 weeks ] [ Designated as safety issue: No ]
    Change from baseline in HbA1c after 76 weeks


Secondary Outcome Measures:
  • HbA1c (%) Changes From Baseline After 76 Weeks of Treatment [ Time Frame: Baseline and 76 weeks ] [ Designated as safety issue: No ]
    Change from baseline in HbA1c (%) after 76 weeks using MMRM approach

  • Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Systolic blood pressure - change from baseline after 52 weeks of treatment

  • Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment [ Time Frame: Baseline and 76 weeks ] [ Designated as safety issue: No ]
    Systolic blood pressure - change from baseline after 76 weeks of treatment

  • Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Diastolic blood pressure - change from baseline after 52 weeks of treatment

  • Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment [ Time Frame: Baseline and 76 weeks ] [ Designated as safety issue: No ]
    Diastolic blood pressure - change from baseline after 76 weeks of treatment

  • Body Weight (kg) Change From Baseline After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Body Weight (kg) - Change From Baseline After 52 Weeks of Treatment

  • Body Weight (kg) Change From Baseline After 76 Weeks of Treatment [ Time Frame: Baseline and 76 weeks ] [ Designated as safety issue: No ]
    Body Weight (kg) - Change From Baseline After 76 Weeks of Treatment

  • Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Waist circumference (cm) - change from baseline after 52 weeks of treatment

  • Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment [ Time Frame: Baseline and 76 weeks ] [ Designated as safety issue: No ]
    Waist circumference (cm) - change from baseline after 76 weeks of treatment

  • Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Fasting plasma glucose - change from baseline after 52 weeks of treatment

  • Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment [ Time Frame: Baseline and 76 weeks ] [ Designated as safety issue: No ]
    Fasting plasma glucose - change from baseline after 76 weeks of treatment


Enrollment: 2705
Study Start Date: February 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 10773 low (drug naive)
BI 10773 tablets once daily
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo matching Sitagliptin
Drug: Placebo
Placebo matching BI 10773 high dose
Experimental: BI 10773 high (drug naive)
BI 10773 tablets once daily
Drug: Placebo
Placebo matching Sitagliptin
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo matching BI 10773 low dose
Placebo Comparator: Placebo (drug naive)
Placebo tablets matching BI 10773 / Sitagliptin once daily
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: Placebo
Placebo matching Sitagliptin
Drug: Placebo
Placebo matching BI 10773 high dose
Active Comparator: Sitagliptin 100mg (drug naive)
Sitagliptin once daily
Drug: Placebo
Placebo matching BI 10773 high dose
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: Sitagliptin 100mg
Sitagliptin once daily
Experimental: BI 10773 low (pioglitazone)
BI 10773 tablets once daily
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo matching BI 10773 high dose
Experimental: BI 10773 high (pioglitazone)
BI 10773 tablets once daily
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo matching BI 10773 low dose
Placebo Comparator: Placebo (pioglitazone)
Placebo tablets matching BI 10773 once daily
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: Placebo
Placebo matching BI 10773 high dose
Experimental: BI 10773 low (metformin)
BI 10773 tablets once daily
Drug: Placebo
Placebo matching BI 10773 high dose
Drug: BI 10773
BI 10773 tablets once daily
Experimental: BI 10773 high (metformin)
BI 10773 tablets once daily
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo matching BI 10773 low dose
Placebo Comparator: Placebo (metformin)
Placebo tablets matching BI 10773 once daily
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: Placebo
Placebo matching BI 10773 high dose
Experimental: BI 10773 low (metformin+sulfonylurea)
BI 10773 tablets once daily
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo matching BI 10773 high dose
Experimental: BI 10773 high (metformin+sulfonylurea)
BI 10773 tablets once daily
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo matching BI 10773 low dose
Placebo Comparator: Placebo (metformin+sulfonylurea)
Placebo tablets matching BI 10773
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: Placebo
Placebo matching BI 10773 high dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289990

  Hide Study Locations
Locations
United States, Alabama
1245.31.10145 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
United States, Arizona
1245.31.10162 Boehringer Ingelheim Investigational Site
Glendale, Arizona, United States
1245.31.10124 Boehringer Ingelheim Investigational Site
Mesa, Arizona, United States
1245.31.10108 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
1245.31.10046 Boehringer Ingelheim Investigational Site
Tempe, Arizona, United States
United States, California
1245.31.10154 Boehringer Ingelheim Investigational Site
Chino, California, United States
1245.31.10149 Boehringer Ingelheim Investigational Site
Rancho Cucamonga, California, United States
1245.31.10131 Boehringer Ingelheim Investigational Site
West Hills, California, United States
United States, Colorado
1245.31.10038 Boehringer Ingelheim Investigational Site
Northglenn, Colorado, United States
United States, Connecticut
1245.31.10127 Boehringer Ingelheim Investigational Site
Waterbury, Connecticut, United States
United States, Florida
1245.31.10137 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
1245.31.10133 Boehringer Ingelheim Investigational Site
Jupiter, Florida, United States
1245.31.10006 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1245.31.10085 Boehringer Ingelheim Investigational Site
Plantation, Florida, United States
United States, Georgia
1245.31.10080 Boehringer Ingelheim Investigational Site
Decatur, Georgia, United States
1245.31.10077 Boehringer Ingelheim Investigational Site
Perry, Georgia, United States
United States, Illinois
1245.31.10001 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
United States, Iowa
1245.31.10159 Boehringer Ingelheim Investigational Site
Des Moines, Iowa, United States
1245.31.10014 Boehringer Ingelheim Investigational Site
Dubuque, Iowa, United States
United States, Kansas
1245.31.10117 Boehringer Ingelheim Investigational Site
Arkansas City, Kansas, United States
1245.31.10157 Boehringer Ingelheim Investigational Site
Newton, Kansas, United States
United States, Kentucky
1245.31.10146 Boehringer Ingelheim Investigational Site
Louisville, Kentucky, United States
United States, Michigan
1245.31.10003 Boehringer Ingelheim Investigational Site
Dearborn, Michigan, United States
United States, New York
1245.31.10059 Boehringer Ingelheim Investigational Site
New Hyde Park, New York, United States
1245.31.10034 Boehringer Ingelheim Investigational Site
Rochester, New York, United States
1245.31.10123 Boehringer Ingelheim Investigational Site
Smithtown, New York, United States
United States, North Carolina
1245.31.10071 Boehringer Ingelheim Investigational Site
Asheboro, North Carolina, United States
1245.31.10086 Boehringer Ingelheim Investigational Site
Salisbury, North Carolina, United States
United States, Ohio
1245.31.10129 Boehringer Ingelheim Investigational Site
Carlisle, Ohio, United States
1245.31.10045 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
1245.31.10119 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
1245.31.10130 Boehringer Ingelheim Investigational Site
Gallipolis, Ohio, United States
United States, South Carolina
1245.31.10158 Boehringer Ingelheim Investigational Site
Mount Pleasant, South Carolina, United States
1245.31.10015 Boehringer Ingelheim Investigational Site
Simpsonville, South Carolina, United States
United States, Tennessee
1245.31.10033 Boehringer Ingelheim Investigational Site
Chattanooga, Tennessee, United States
1245.31.10112 Boehringer Ingelheim Investigational Site
Memphis, Tennessee, United States
United States, Texas
1245.31.10156 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1245.31.10151 Boehringer Ingelheim Investigational Site
Hurst, Texas, United States
1245.31.10143 Boehringer Ingelheim Investigational Site
Killeen, Texas, United States
1245.31.10155 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
Belgium
1245.31.32023 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1245.31.32008 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, Belgium
Canada, Alberta
1245.31.20032 Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
1245.31.20023 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
Canada, British Columbia
1245.31.20011 Boehringer Ingelheim Investigational Site
Chilliwack, British Columbia, 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
Canada, Manitoba
1245.31.20015 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba, Canada
Canada, New Brunswick
1245.31.20012 Boehringer Ingelheim Investigational Site
Moncton, New Brunswick, Canada
Canada, Newfoundland and Labrador
1245.31.20016 Boehringer Ingelheim Investigational Site
Mount Pearl, Newfoundland and Labrador, Canada
1245.31.20024 Boehringer Ingelheim Investigational Site
Paradise, Newfoundland and Labrador, Canada
1245.31.20008 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador, Canada
Canada, Nova Scotia
1245.31.20026 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia, Canada
Canada, Ontario
1245.31.20022 Boehringer Ingelheim Investigational Site
Brampton, Ontario, Canada
1245.31.20057 Boehringer Ingelheim Investigational Site
Brampton, Ontario, Canada
1245.31.20035 Boehringer Ingelheim Investigational Site
Corunna, Ontario, Canada
1245.31.20030 Boehringer Ingelheim Investigational Site
Etobicoke, Ontario, Canada
1245.31.20019 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, 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
1245.31.20009 Boehringer Ingelheim Investigational Site
Newmarket, Ontario, Canada
1245.31.20040 Boehringer Ingelheim Investigational Site
Oakville, Ontario, Canada
1245.31.20034 Boehringer Ingelheim Investigational Site
Sarnia, Ontario, 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
Canada, Prince Edward Island
1245.31.20007 Boehringer Ingelheim Investigational Site
Montague, Prince Edward Island, Canada
Canada, Quebec
1245.31.20027 Boehringer Ingelheim Investigational Site
Laval, Quebec, Canada
1245.31.20025 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1245.31.20036 Boehringer Ingelheim Investigational Site
Sherbrooke, Quebec, Canada
1245.31.20058 Boehringer Ingelheim Investigational Site
St-Romuald, Quebec, Canada
1245.31.20021 Boehringer Ingelheim Investigational Site
Trois Rivieres, Quebec, Canada
1245.31.20038 Boehringer Ingelheim Investigational Site
Ville Saint-Laurent, Quebec, Canada
Canada, Saskatchewan
1245.31.20041 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada
China
1245.31.86031 Boehringer Ingelheim Investigational Site
Beijing, China
1245.31.86008 Boehringer Ingelheim Investigational Site
Beijing, China
1245.31.86034 Boehringer Ingelheim Investigational Site
Beijing, China
1245.31.86032 Boehringer Ingelheim Investigational Site
Beijing, China
1245.31.86033 Boehringer Ingelheim Investigational Site
Beijing, China
1245.31.86007 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
1245.31.86052 Boehringer Ingelheim Investigational Site
Guangzhou, China
1245.31.86003 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, China
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
1245.31.33019 Boehringer Ingelheim Investigational Site
Strasbourg, France
1245.31.33013 Boehringer Ingelheim Investigational Site
Strasbourg, France
1245.31.33007 Boehringer Ingelheim Investigational Site
Vieux Condé, France
1245.31.33018 Boehringer Ingelheim Investigational Site
Wattrelos, France
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, Germany
Greece
1245.31.30004 Boehringer Ingelheim Investigational Site
Thessaloniki, Greece
India
1245.31.91008 Boehringer Ingelheim Investigational Site
Bangalore, India
1245.31.91006 Boehringer Ingelheim Investigational Site
Bangalore, India
1245.31.91005 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
1245.31.91101 Boehringer Ingelheim Investigational Site
Coimbatore, India
1245.31.91001 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, India
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, Ireland
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, Japan
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
1245.31.82014 Boehringer Ingelheim Investigational Site
Seoul, 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
1245.31.82002 Boehringer Ingelheim Investigational Site
Suwon, Korea, Republic of
1245.31.82003 Boehringer Ingelheim Investigational Site
Wonju, Korea, Republic of
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, Mexico
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, Philippines
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, Slovakia
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, Slovenia
Switzerland
1245.31.41004 Boehringer Ingelheim Investigational Site
Lugano, Switzerland
1245.31.41003 Boehringer Ingelheim Investigational Site
Rorschach, Switzerland
Taiwan
1245.31.88013 Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, 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
1245.31.88009 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, Taiwan
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, Turkey
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, Ukraine
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01289990     History of Changes
Other Study ID Numbers: 1245.31, 2010-022718-17
Study First Received: January 31, 2011
Results First Received: May 16, 2014
Last Updated: July 14, 2014
Health Authority: Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
China: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
India: Drugs Controller General of India
Ireland: Irish Medicines Board
Japan: Ministry of Health, Labor and Welfare
Mexico: Federal Commission for Sanitary Risks Protection
Philippines: Department of Health
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
South Korea: Ministry of Food and Drug Safety (MFDS)
Switzerland: Swissmedic
Taiwan:
Turkey: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014