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Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01159600
Recruitment Status : Completed
First Posted : July 9, 2010
Results First Posted : June 17, 2014
Last Update Posted : June 17, 2014
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE July 8, 2010
First Posted Date  ICMJE July 9, 2010
Results First Submitted Date  ICMJE May 16, 2014
Results First Posted Date  ICMJE June 17, 2014
Last Update Posted Date June 17, 2014
Study Start Date  ICMJE July 2010
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2014)
HbA1c Change From Baseline [ Time Frame: Baseline and 24 weeks ]
Change from baseline in HbA1c after 24 weeks. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2010)
The change from baseline in HbA1c after 24 weeks. [ Time Frame: 24 weeks ]
Change History Complete list of historical versions of study NCT01159600 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2014)
  • Body Weight Change From Baseline [ Time Frame: Baseline and 24 weeks ]
    Body weight change from baseline after 24 weeks. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
  • Mean Daily Plasma Glucose (MDG) Change From Baseline [ Time Frame: Baseline and 24 weeks ]
    Change from baseline in mean daily glucose (MDG) using the 8-point blood glucose profile, after 24 weeks of treatment. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2010)
  • The body weight (kg) change from baseline after 24 weeks. [ Time Frame: 24 weeks ]
  • The mean daily plasma glucose (MDG) change from baseline after 24 weeks of treatment. [ Time Frame: 24 weeks ]
  • Occurrence of a treat to target response, (i.e. an HbA1c under treatment of < 7.0%) [ Time Frame: 24 weeks ]
  • Occurrence of relative efficacy response (HbA1c lowering by at least 0.5%) [ Time Frame: 24 weeks ]
  • The change in HbA1c and FPG by visit over time [ Time Frame: 24 weeks ]
  • The change in fasting plasma glucose (FPG), waist and systolic and diastolic blood pressure from baseline to week 24 [ Time Frame: 24 weeks ]
  • The composite endpoint of the following conditions at week 24: HbA1c lowering by a least 0.5%, lowering of systolic blood pressure by at least 3 mm Hg and decrease in body weight by more than 2%. [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: May 16, 2014)
Confirmed Hypoglycaemic Adverse Events [ Time Frame: From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days ]
Number of patients with confirmed hypoglycaemic events, as reported as adverse events.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes
Official Title  ICMJE A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea
Brief Summary The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Placebo identical to BI 10773 high dose
    Placebo tablets matching BI 10773 high dose
  • Drug: Placebo identical to BI 10773 low dose
    Placebo tablets matching BI 10773 low dose
  • Drug: BI 10773
    BI 10773 tablets once daily high dose open label
  • Drug: BI 10773
    BI 10773 tablets once daily high dose
  • Drug: BI 10773
    BI 10773 tablets once daily low dose
Study Arms  ICMJE
  • Experimental: BI 10773 Arm 2
    BI 10773 once daily high dose
    Interventions:
    • Drug: BI 10773
    • Drug: Placebo identical to BI 10773 low dose
  • Placebo Comparator: Placebo
    Placebo matching BI 10773
    Interventions:
    • Drug: Placebo identical to BI 10773 low dose
    • Drug: Placebo identical to BI 10773 high dose
  • Experimental: BI 10773 open-label
    BI 10773 once daily high dose open label
    Intervention: Drug: BI 10773
  • Experimental: BI 10773 Arm 1
    BI 10773 once daily low dose
    Interventions:
    • Drug: Placebo identical to BI 10773 high dose
    • Drug: BI 10773
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2012)
1504
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2010)
1390
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Diagnosis of type 2 diabetes mellitus prior to informed consent
  2. Male and female patients on a diet and exercise regimen who are pre-treated with immediate release metformin or immediate release metformin plus sulfonylurea (see below for minimum doses). The treatment regimen has to be unchanged for 12 weeks prior to randomisation.

    Minimum dose for metformin: > or = 1500 mg/day or maximum tolerated dose or maximum dose according to local label Minimum dose for sulfonylurea: > or = half of the maximal recommended dose or maximum tolerated dose or maximum dose according to local label

  3. HbA1c of > or = 7.0% and < or = 11% at Visit 1 (screening) in order to be eligible for randomised treatment HbA1c of > 11% at Visit 1 (screening) in order to be eligible for the open-label treatment arm (25 mg BI 10773)
  4. Age> or = 18
  5. Body Mass Index (BM)I < or = 45 kg/m2 (Body Mass Index) at Visit 1 (Screening)
  6. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion criteria:

  1. Uncontrolled hyperglycaemia with a glucose level > 240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day)
  2. Any other antidiabetic drug within 12 weeks prior to randomisation except those mentioned in inclusion criterion 2
  3. Myocardial infarction, stroke or transient ischemic attack (TIA) within 3 months prior to informed consent
  4. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run-in phase
  5. Impaired renal function, defined as eGFR<30 ml/min (severe renal impairment) as determined during screening and/or run-in phase
  6. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
  7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
  8. Contraindications to metformin and/or sulfonylurea according to the local label for those patients that enter the study with the respective background therapy
  9. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia)
  10. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
  11. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except Typ 2 Diabetes
  12. Pre-menopausal women (last menstruation ¿ 1 year prior to informed consent) who:

    • are nursing or pregnant or
    • are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner
  13. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
  14. Participation in another trial with an investigational drug within 30 days prior to informed consent
  15. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   China,   France,   Germany,   India,   Korea, Republic of,   Mexico,   Slovakia,   Slovenia,   Taiwan,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01159600
Other Study ID Numbers  ICMJE 1245.23
2009-016258-41 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date May 2014

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