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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

July 29, 2010
May 16, 2014
July 2010
March 2012   (final data collection date for primary outcome measure)
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.

The primary endpoint in this study is the change from baseline in HbA1c after 24 weeks of treatment (%). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01177813 on ClinicalTrials.gov Archive Site
  • 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.

The key secondary endpoints are: - Body weight: Change from baseline to week 24 - Systolic and diastolic blood pressure (SBP and DBP): Change from baseline to week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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.

Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Placebo identical to BI10773 high dose
    placebo tablets once daily
  • Drug: BI 10773
    BI 10773 low dose tablet once daily
  • Drug: BI 10773 open label
    Patients receive BI 10773 high dose tablets open label once daily
  • Drug: Placebo identical to BI10773 low dose
    placebo tablets once daily
  • Drug: Placebo identical to Sitagliptin 100mg
    placebo tablets once daily
  • Drug: BI10773
    BI 10773 high dose tablets once daily
  • Drug: Sitagliptin
    Sitagliptin tablets 100 mg once daily
  • Experimental: BI 10773 low dose
    Patients receive BI 10773 low dose tablets once daily
    Interventions:
    • Drug: Placebo identical to BI10773 high dose
    • Drug: BI 10773
    • Drug: Placebo identical to Sitagliptin 100mg
  • Experimental: BI 10773 high dose
    Patients receive BI 10773 high dose tablets once daily
    Interventions:
    • Drug: Placebo identical to BI10773 low dose
    • Drug: BI10773
    • Drug: Placebo identical to Sitagliptin 100mg
  • Placebo Comparator: Placebo
    Patients receive tablets identical to those containing BI 10773 low dose and high dose and to Sitagliptin
    Interventions:
    • Drug: Placebo identical to BI10773 low dose
    • Drug: Placebo identical to Sitagliptin 100mg
    • Drug: Placebo identical to BI10773 high dose
  • Active Comparator: Sitagliptin 100 mg
    Patients receive Sitagliptin 100 mg tablets once daily
    Interventions:
    • Drug: Placebo identical to BI10773 high dose
    • Drug: Sitagliptin
    • Drug: Placebo identical to BI10773 low dose
  • Experimental: BI 10773 high dose open label
    Patients receive BI 10773 high dose tablets open label once daily
    Intervention: Drug: BI 10773 open label
Roden M, Weng J, Eilbracht J, Delafont B, Kim G, Woerle HJ, Broedl UC; EMPA-REG MONO trial investigators. Empagliflozin monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2013 Nov;1(3):208-19. doi: 10.1016/S2213-8587(13)70084-6. Epub 2013 Sep 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
986
Not Provided
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   China,   Germany,   India,   Ireland,   Japan,   Switzerland
 
NCT01177813
1245.20, 2009-016243-20
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP