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

  Show 124 Study Locations
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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014