Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes

A Phase III Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 10773 and Sitagliptin Administered Orally Over 24 Weeks, in Drug naïve Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Diet and Exercise

Sponsors

Lead Sponsor: Boehringer Ingelheim

Collaborator: Eli Lilly and Company

Source Boehringer Ingelheim
Brief Summary

The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773 compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM with very poor glycaemic control.

Overall Status Completed
Start Date 2010-07-01
Primary Completion Date 2012-03-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks Baseline and day 169
Secondary Outcome
Measure Time Frame
Change From Baseline to Week 24 in Body Weight Baseline and day 169
Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP) Baseline and week 24
Enrollment 986
Condition
Intervention

Intervention Type: Drug

Intervention Name: Placebo identical to BI10773 high dose

Description: placebo tablets once daily

Arm Group Label: BI 10773 low dose

Intervention Type: Drug

Intervention Name: BI 10773

Description: BI 10773 low dose tablet once daily

Arm Group Label: BI 10773 low dose

Intervention Type: Drug

Intervention Name: BI 10773 open label

Description: Patients receive BI 10773 high dose tablets open label once daily

Arm Group Label: BI 10773 high dose open label

Intervention Type: Drug

Intervention Name: Placebo identical to BI10773 low dose

Description: placebo tablets once daily

Arm Group Label: BI 10773 high dose

Intervention Type: Drug

Intervention Name: Placebo identical to BI10773 low dose

Description: placebo tablets once daily

Arm Group Label: Placebo

Intervention Type: Drug

Intervention Name: Placebo identical to BI10773 high dose

Description: placebo tablets once daily

Arm Group Label: Sitagliptin 100 mg

Intervention Type: Drug

Intervention Name: Placebo identical to Sitagliptin 100mg

Description: placebo tablets once daily

Arm Group Label: Placebo

Intervention Type: Drug

Intervention Name: Placebo identical to Sitagliptin 100mg

Description: placebo tablets once daily

Arm Group Label: BI 10773 low dose

Intervention Type: Drug

Intervention Name: BI10773

Description: BI 10773 high dose tablets once daily

Arm Group Label: BI 10773 high dose

Intervention Type: Drug

Intervention Name: Sitagliptin

Description: Sitagliptin tablets 100 mg once daily

Arm Group Label: Sitagliptin 100 mg

Intervention Type: Drug

Intervention Name: Placebo identical to Sitagliptin 100mg

Description: placebo tablets once daily

Arm Group Label: BI 10773 high dose

Intervention Type: Drug

Intervention Name: Placebo identical to BI10773 low dose

Description: placebo tablets once daily

Arm Group Label: Sitagliptin 100 mg

Intervention Type: Drug

Intervention Name: Placebo identical to BI10773 high dose

Description: placebo tablets once daily

Arm Group Label: Placebo

Eligibility

Criteria:

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-naïve; 3. HbA1c >= 7.0% and <= 10.0% at Visit 1 (screening) for randomised treatment; HbA1c > 10.0% at visit 1 (screening) for the open-label BI 10773 arm; 4. Age >= 20 (Japan); Age >= 18 (countries other than Japan); 5. BMI <= 45 kg/m2 at Visit 1 (screening); 6. Signed and dated written informed consent by date of Visit 1 Exclusion criteria: 1. Uncontrolled hyperglycaemia; 2. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent; 3. Indication of liver disease, either ALT, AST, or alkaline phosphatase above 3 x ULN; 4. Impaired renal function (eGFR<50 ml/min); 5. Bariatric surgery within the past two years or other GI surgeries; 6. Medical history of cancer; 7. Contraindications to sitagliptin; 8. Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell; 9. Treatment with any anti-diabetes drug within 12 weeks prior to randomisation; 10. Treatment with anti-obesity drugs or any other treatment leading to unstable body weight; 11. Current treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM; 12. Pre-menopausal women who are nursing or pregnant or are of child-bearing potential and not practicing an acceptable method of birth control; 13. Alcohol or drug abuse; 14. Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial; 15. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Boehringer Ingelheim Study Chair Boehringer Ingelheim
Location
Facility:
1245.20.10124 Boehringer Ingelheim Investigational Site | Mesa, Arizona, United States
1245.20.10108 Boehringer Ingelheim Investigational Site | Phoenix, Arizona, United States
1245.20.10150 Boehringer Ingelheim Investigational Site | Hot Springs, Arkansas, United States
1245.20.10154 Boehringer Ingelheim Investigational Site | Chino, California, United States
1245.20.10009 Boehringer Ingelheim Investigational Site | Santa Ana, California, United States
1245.20.10131 Boehringer Ingelheim Investigational Site | West Hills, California, United States
1245.20.10038 Boehringer Ingelheim Investigational Site | Northglenn, Colorado, United States
1245.20.10137 Boehringer Ingelheim Investigational Site | Clearwater, Florida, United States
1245.20.10006 Boehringer Ingelheim Investigational Site | Miami, Florida, United States
1245.20.10085 Boehringer Ingelheim Investigational Site | Plantation, Florida, United States
1245.20.10078 Boehringer Ingelheim Investigational Site | Tampa, Florida, United States
1245.20.10080 Boehringer Ingelheim Investigational Site | Decatur, Georgia, United States
1245.20.10128 Boehringer Ingelheim Investigational Site | Avon, Indiana, United States
1245.20.10060 Boehringer Ingelheim Investigational Site | Fishers, Indiana, United States
1245.20.10065 Boehringer Ingelheim Investigational Site | Indianapolis, Indiana, United States
1245.20.10117 Boehringer Ingelheim Investigational Site | Arkansas City, Kansas, United States
1245.20.10039 Boehringer Ingelheim Investigational Site | Wichita, Kansas, United States
1245.20.10146 Boehringer Ingelheim Investigational Site | Louisville, Kentucky, United States
1245.20.10144 Boehringer Ingelheim Investigational Site | Watertown, Massachusetts, United States
1245.20.10115 Boehringer Ingelheim Investigational Site | Brick, New Jersey, United States
1245.20.10129 Boehringer Ingelheim Investigational Site | Carlisle, Ohio, United States
1245.20.10045 Boehringer Ingelheim Investigational Site | Cincinnati, Ohio, United States
1245.20.10119 Boehringer Ingelheim Investigational Site | Cincinnati, Ohio, United States
1245.20.10130 Boehringer Ingelheim Investigational Site | Gallipolis, Ohio, United States
1245.20.10089 Boehringer Ingelheim Investigational Site | Houston, Texas, United States
1245.20.10151 Boehringer Ingelheim Investigational Site | Hurst, Texas, United States
1245.20.10155 Boehringer Ingelheim Investigational Site | San Antonio, Texas, United States
1245.20.32008 Boehringer Ingelheim Investigational Site | Bruxelles, Belgium
1245.20.32011 Boehringer Ingelheim Investigational Site | Bruxelles, Belgium
1245.20.32023 Boehringer Ingelheim Investigational Site | Bruxelles, Belgium
1245.20.32003 Boehringer Ingelheim Investigational Site | De Pinte, Belgium
1245.20.32015 Boehringer Ingelheim Investigational Site | Deurne, Belgium
1245.20.32016 Boehringer Ingelheim Investigational Site | Deurne, Belgium
1245.20.32025 Boehringer Ingelheim Investigational Site | Gozée, Belgium
1245.20.32022 Boehringer Ingelheim Investigational Site | Landen, Belgium
1245.20.32019 Boehringer Ingelheim Investigational Site | Leopoldsburg, Belgium
1245.20.32024 Boehringer Ingelheim Investigational Site | Linkebeek, Belgium
1245.20.32021 Boehringer Ingelheim Investigational Site | Mouscron, Belgium
1245.20.32027 Boehringer Ingelheim Investigational Site | Retie, Belgium
1245.20.32020 Boehringer Ingelheim Investigational Site | Sint-Gillis-Waas, Belgium
1245.20.32018 Boehringer Ingelheim Investigational Site | Tielt, Belgium
1245.20.32026 Boehringer Ingelheim Investigational Site | Tremelo, Belgium
1245.20.20011 Boehringer Ingelheim Investigational Site | Chilliwack, British Columbia, Canada
1245.20.20018 Boehringer Ingelheim Investigational Site | Victoria, British Columbia, Canada
1245.20.20015 Boehringer Ingelheim Investigational Site | Winnipeg, Manitoba, Canada
1245.20.20012 Boehringer Ingelheim Investigational Site | Moncton, New Brunswick, Canada
1245.20.20016 Boehringer Ingelheim Investigational Site | Mount Pearl, Newfoundland and Labrador, Canada
1245.20.20008 Boehringer Ingelheim Investigational Site | St. John's, Newfoundland and Labrador, Canada
1245.20.20001 Boehringer Ingelheim Investigational Site | Barrie, Ontario, Canada
1245.20.20019 Boehringer Ingelheim Investigational Site | Hamilton, Ontario, Canada
1245.20.20010 Boehringer Ingelheim Investigational Site | London, Ontario, Canada
1245.20.20017 Boehringer Ingelheim Investigational Site | London, Ontario, Canada
1245.20.20003 Boehringer Ingelheim Investigational Site | Markham, Ontario, Canada
1245.20.20009 Boehringer Ingelheim Investigational Site | Newmarket, Ontario, Canada
1245.20.20013 Boehringer Ingelheim Investigational Site | Ottawa, Ontario, Canada
1245.20.20005 Boehringer Ingelheim Investigational Site | Strathroy, Ontario, Canada
1245.20.20002 Boehringer Ingelheim Investigational Site | Toronto, Ontario, Canada
1245.20.20006 Boehringer Ingelheim Investigational Site | Toronto, Ontario, Canada
1245.20.20014 Boehringer Ingelheim Investigational Site | Charlottetown, Prince Edward Island, Canada
1245.20.20007 Boehringer Ingelheim Investigational Site | Montague, Prince Edward Island, Canada
1245.20.20021 Boehringer Ingelheim Investigational Site | Trois Rivieres, Quebec, Canada
1245.20.86007 Boehringer Ingelheim Investigational Site | Beijing, China
1245.20.86008 Boehringer Ingelheim Investigational Site | Beijing, China
1245.20.86001 Boehringer Ingelheim Investigational Site | Guangzhou, China
1245.20.86002 Boehringer Ingelheim Investigational Site | Guangzhou, China
1245.20.86003 Boehringer Ingelheim Investigational Site | Guangzhou, China
1245.20.86012 Boehringer Ingelheim Investigational Site | Guiyang, China
1245.20.86020 Boehringer Ingelheim Investigational Site | Hangzhou, China
1245.20.86049 Boehringer Ingelheim Investigational Site | Jinan, China
1245.20.86018 Boehringer Ingelheim Investigational Site | Jingzhou, China
1245.20.86019 Boehringer Ingelheim Investigational Site | Nanchang, China
1245.20.86010 Boehringer Ingelheim Investigational Site | Nanjing, China
1245.20.86043 Boehringer Ingelheim Investigational Site | Nanjing, China
1245.20.86016 Boehringer Ingelheim Investigational Site | QingDao, China
1245.20.86004 Boehringer Ingelheim Investigational Site | Shanghai, China
1245.20.86005 Boehringer Ingelheim Investigational Site | Shanghai, China
1245.20.86006 Boehringer Ingelheim Investigational Site | Shanghai, China
1245.20.86057 Boehringer Ingelheim Investigational Site | Shenyang, China
1245.20.86017 Boehringer Ingelheim Investigational Site | Shiyan, China
1245.20.86013 Boehringer Ingelheim Investigational Site | Suzhou, China
1245.20.86015 Boehringer Ingelheim Investigational Site | Taiyuan, China
1245.20.86009 Boehringer Ingelheim Investigational Site | Wuhan, China
1245.20.86011 Boehringer Ingelheim Investigational Site | Xi'An, China
1245.20.86014 Boehringer Ingelheim Investigational Site | Xiamen, China
1245.20.49013 Boehringer Ingelheim Investigational Site | Dresden, Germany
1245.20.49016 Boehringer Ingelheim Investigational Site | Düsseldorf, Germany
1245.20.49015 Boehringer Ingelheim Investigational Site | Frankfurt, Germany
1245.20.49019 Boehringer Ingelheim Investigational Site | Haag, Germany
1245.20.49020 Boehringer Ingelheim Investigational Site | Hohenmölsen, Germany
1245.20.49014 Boehringer Ingelheim Investigational Site | Köthen, Germany
1245.20.49002 Boehringer Ingelheim Investigational Site | Neuwied, Germany
1245.20.49008 Boehringer Ingelheim Investigational Site | Nürnberg, Germany
1245.20.49022 Boehringer Ingelheim Investigational Site | Schauenburg, Germany
1245.20.49017 Boehringer Ingelheim Investigational Site | St. Ingbert/Oberwürzbach, Germany
1245.20.49003 Boehringer Ingelheim Investigational Site | Unterschneidheim, Germany
1245.20.91005 Boehringer Ingelheim Investigational Site | Bangalore, India
1245.20.91006 Boehringer Ingelheim Investigational Site | Bangalore, India
1245.20.91008 Boehringer Ingelheim Investigational Site | Bangalore, India
1245.20.91003 Boehringer Ingelheim Investigational Site | Belgaum, India
1245.20.91004 Boehringer Ingelheim Investigational Site | Chennai, India
1245.20.91009 Boehringer Ingelheim Investigational Site | Chennai, India
1245.20.91007 Boehringer Ingelheim Investigational Site | Mumbai, Maharastra, India
1245.20.91002 Boehringer Ingelheim Investigational Site | Mumbai, India
1245.20.91010 Boehringer Ingelheim Investigational Site | Nagpur, India
1245.20.91001 Boehringer Ingelheim Investigational Site | Tamil Nadu, India
1245.20.35302 Boehringer Ingelheim Investigational Site | Co. Cork, Ireland
1245.20.35305 Boehringer Ingelheim Investigational Site | Co. Galway, Ireland
1245.20.35303 Boehringer Ingelheim Investigational Site | Co. Wexford, Ireland
1245.20.35304 Boehringer Ingelheim Investigational Site | Offaly, Ireland
1245.20.35306 Boehringer Ingelheim Investigational Site | Wexford, Ireland
1245.20.81007 Boehringer Ingelheim Investigational Site | Chiyoda-ku, Tokyo, Japan
1245.20.81001 Boehringer Ingelheim Investigational Site | Chuo-ku, Tokyo, Japan
1245.20.81002 Boehringer Ingelheim Investigational Site | Chuo-ku, Tokyo, Japan
1245.20.81005 Boehringer Ingelheim Investigational Site | Ebetsu, Hokkaido, Japan
1245.20.81004 Boehringer Ingelheim Investigational Site | Kamakura, Kanagawa, Japan
1245.20.81003 Boehringer Ingelheim Investigational Site | Minato-ku, Tokyo, Japan
1245.20.81006 Boehringer Ingelheim Investigational Site | Shinjuku-ku, Tokyo, Japan
1245.20.81008 Boehringer Ingelheim Investigational Site | Shinjuku-ku, Tokyo, Japan
1245.20.81009 Boehringer Ingelheim Investigational Site | Suita, Osaka, Japan
1245.20.81010 Boehringer Ingelheim Investigational Site | Ube, Yamaguchi, Japan
1245.20.81012 Boehringer Ingelheim Investigational Site | Urasoe, Okinawa, Japan
1245.20.81013 Boehringer Ingelheim Investigational Site | Urasoe, Okinawa, Japan
1245.20.41004 Boehringer Ingelheim Investigational Site | Lugano, Switzerland
1245.20.41003 Boehringer Ingelheim Investigational Site | Rorschach, Switzerland
Location Countries

Belgium

Canada

China

Germany

India

Ireland

Japan

Switzerland

United States

Verification Date

2014-05-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Label: BI 10773 low dose

Type: Experimental

Description: Patients receive BI 10773 low dose tablets once daily

Label: BI 10773 high dose

Type: Experimental

Description: Patients receive BI 10773 high dose tablets once daily

Label: Placebo

Type: Placebo Comparator

Description: Patients receive tablets identical to those containing BI 10773 low dose and high dose and to Sitagliptin

Label: Sitagliptin 100 mg

Type: Active Comparator

Description: Patients receive Sitagliptin 100 mg tablets once daily

Label: BI 10773 high dose open label

Type: Experimental

Description: Patients receive BI 10773 high dose tablets open label once daily

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double

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