Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 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:
NCT01177813
First received: July 29, 2010
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo identical to BI10773 high dose
Drug: BI 10773
Drug: BI 10773 open label
Drug: Placebo identical to BI10773 low dose
Drug: Placebo identical to Sitagliptin 100mg
Drug: BI10773
Drug: Sitagliptin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks [ Time Frame: Baseline and day 169 ] [ Designated as safety issue: No ]

    The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).

    In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.



Secondary Outcome Measures:
  • Change From Baseline to Week 24 in Body Weight [ Time Frame: Baseline and day 169 ] [ Designated as safety issue: No ]

    The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).

    In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.


  • Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP) [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]

    The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).

    In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.

    For blood pressure, data following changes in antihypertensive therapy is censored, in the same way that data following initiation of rescue medication is censored.



Other Outcome Measures:
  • Confirmed Hypoglycaemic Adverse Events [ Time Frame: From first drug intake until 7 days after last medication intake, up to 219 days ] [ Designated as safety issue: No ]

    Confirmed hypoglycaemic events refer to all hypoglycaemic events, that had a glucose value <= 70 ml/dL or where assistance was required.

    Symptomatic hypoglycaemic events were to be reported as adverse events. Patients can be counted in more than one category.



Enrollment: 986
Study Start Date: July 2010
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 10773 low dose
Patients receive BI 10773 low dose tablets once daily
Drug: Placebo identical to BI10773 high dose
placebo tablets once daily
Drug: BI 10773
BI 10773 low dose tablet once daily
Drug: Placebo identical to Sitagliptin 100mg
placebo tablets once daily
Experimental: BI 10773 high dose
Patients receive BI 10773 high dose tablets once daily
Drug: Placebo identical to BI10773 low dose
placebo tablets once daily
Drug: BI10773
BI 10773 high dose tablets once daily
Drug: Placebo identical to Sitagliptin 100mg
placebo tablets once daily
Placebo Comparator: Placebo
Patients receive tablets identical to those containing BI 10773 low dose and high dose and to Sitagliptin
Drug: Placebo identical to BI10773 low dose
placebo tablets once daily
Drug: Placebo identical to Sitagliptin 100mg
placebo tablets once daily
Drug: Placebo identical to BI10773 high dose
placebo tablets once daily
Active Comparator: Sitagliptin 100 mg
Patients receive Sitagliptin 100 mg tablets once daily
Drug: Placebo identical to BI10773 high dose
placebo tablets once daily
Drug: Sitagliptin
Sitagliptin tablets 100 mg once daily
Drug: Placebo identical to BI10773 low dose
placebo tablets once daily
Experimental: BI 10773 high dose open label
Patients receive BI 10773 high dose tablets open label once daily
Drug: BI 10773 open label
Patients receive BI 10773 high dose tablets open label once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01177813

  Hide Study Locations
Locations
United States, Arizona
1245.20.10124 Boehringer Ingelheim Investigational Site
Mesa, Arizona, United States
1245.20.10108 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
United States, Arkansas
1245.20.10150 Boehringer Ingelheim Investigational Site
Hot Springs, Arkansas, United States
United States, California
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
United States, Colorado
1245.20.10038 Boehringer Ingelheim Investigational Site
Northglenn, Colorado, United States
United States, Florida
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
United States, Georgia
1245.20.10080 Boehringer Ingelheim Investigational Site
Decatur, Georgia, United States
United States, Indiana
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
United States, Kansas
1245.20.10117 Boehringer Ingelheim Investigational Site
Arkansas City, Kansas, United States
1245.20.10039 Boehringer Ingelheim Investigational Site
Wichita, Kansas, United States
United States, Kentucky
1245.20.10146 Boehringer Ingelheim Investigational Site
Louisville, Kentucky, United States
United States, Massachusetts
1245.20.10144 Boehringer Ingelheim Investigational Site
Watertown, Massachusetts, United States
United States, New Jersey
1245.20.10115 Boehringer Ingelheim Investigational Site
Brick, New Jersey, United States
United States, Ohio
1245.20.10129 Boehringer Ingelheim Investigational Site
Carlisle, Ohio, United States
1245.20.10119 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
1245.20.10045 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
1245.20.10130 Boehringer Ingelheim Investigational Site
Gallipolis, Ohio, United States
United States, Texas
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
Belgium
1245.20.32008 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1245.20.32023 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1245.20.32011 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1245.20.32003 Boehringer Ingelheim Investigational Site
De Pinte, Belgium
1245.20.32016 Boehringer Ingelheim Investigational Site
Deurne, Belgium
1245.20.32015 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
Canada, British Columbia
1245.20.20011 Boehringer Ingelheim Investigational Site
Chilliwack, British Columbia, Canada
1245.20.20018 Boehringer Ingelheim Investigational Site
Victoria, British Columbia, Canada
Canada, Manitoba
1245.20.20015 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba, Canada
Canada, New Brunswick
1245.20.20012 Boehringer Ingelheim Investigational Site
Moncton, New Brunswick, Canada
Canada, Newfoundland and Labrador
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
Canada, Ontario
1245.20.20001 Boehringer Ingelheim Investigational Site
Barrie, Ontario, Canada
1245.20.20019 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1245.20.20017 Boehringer Ingelheim Investigational Site
London, Ontario, Canada
1245.20.20010 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
1245.20.20006 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1245.20.20002 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Canada, Prince Edward Island
1245.20.20014 Boehringer Ingelheim Investigational Site
Charlottetown, Prince Edward Island, Canada
1245.20.20007 Boehringer Ingelheim Investigational Site
Montague, Prince Edward Island, Canada
Canada, Quebec
1245.20.20021 Boehringer Ingelheim Investigational Site
Trois Rivieres, Quebec, Canada
China
1245.20.86008 Boehringer Ingelheim Investigational Site
Beijing, China
1245.20.86007 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
1245.20.86005 Boehringer Ingelheim Investigational Site
Shanghai, China
1245.20.86006 Boehringer Ingelheim Investigational Site
Shanghai, China
1245.20.86004 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
Germany
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
India
1245.20.91008 Boehringer Ingelheim Investigational Site
Bangalore, India
1245.20.91006 Boehringer Ingelheim Investigational Site
Bangalore, India
1245.20.91005 Boehringer Ingelheim Investigational Site
Bangalore, India
1245.20.91003 Boehringer Ingelheim Investigational Site
Belgaum, India
1245.20.91009 Boehringer Ingelheim Investigational Site
Chennai, India
1245.20.91004 Boehringer Ingelheim Investigational Site
Chennai, India
1245.20.91002 Boehringer Ingelheim Investigational Site
Mumbai, India
1245.20.91007 Boehringer Ingelheim Investigational Site
Mumbai, Maharastra, India
1245.20.91010 Boehringer Ingelheim Investigational Site
Nagpur, India
1245.20.91001 Boehringer Ingelheim Investigational Site
Tamil Nadu, India
Ireland
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
Japan
1245.20.81007 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo, Japan
1245.20.81002 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo, Japan
1245.20.81001 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
Switzerland
1245.20.41004 Boehringer Ingelheim Investigational Site
Lugano, Switzerland
1245.20.41003 Boehringer Ingelheim Investigational Site
Rorschach, Switzerland
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01177813     History of Changes
Other Study ID Numbers: 1245.20, 2009-016243-20
Study First Received: July 29, 2010
Results First Received: May 16, 2014
Last Updated: May 16, 2014
Health Authority: Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
China: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
India: Drugs Controller General of India
Ireland: Irish Medicines Board
Japan: Ministry of Health, Labor and Welfare
Switzerland: Swissmedic
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 20, 2014