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: September 26, 2012
Last verified: September 2012
  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 HbA1c after 24 weeks of treatment (%). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body weight: Change from baseline to week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Systolic and diastolic blood pressure (SBP and DBP): Change from baseline to week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177813

  Show 124 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

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
Last Updated: September 26, 2012
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 April 17, 2014