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Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01306214
Recruitment Status : Completed
First Posted : March 1, 2011
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 February 28, 2011
First Posted Date  ICMJE March 1, 2011
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 February 2011
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2014)
Change From Baseline in HbA1c After 18 Weeks of Treatment [ Time Frame: Baseline and 18 weeks ]
The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: February 28, 2011)
Change From Baseline in HbA1c After 18 Weeks of Treatment [ Time Frame: 18 weeks ]
Change History Complete list of historical versions of study NCT01306214 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2014)
  • Change From Baseline in Insulin Dose After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ]
    The secondary endpoint is change from baseline in insulin dose after 52 weeks of treatment
  • Change From Baseline in Body Weight After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ]
    The secondary endpoint was the change from baseline in body weight after 52 weeks of treatment
  • Change From Baseline in HbA1c After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ]
    The secondary endpoint was the change from baseline in HbA1c after 52 weeks of treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2011)
  • Change From Baseline in Insulin Dose After 52 Weeks of Treatment [ Time Frame: 52 weeks ]
  • Change from baseline in body weigh after 52 weeks of treatment [ Time Frame: 52 weeks ]
  • Change From Baseline in HbA1c After 52 Weeks of Treatment [ Time Frame: 52 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus
Official Title  ICMJE A Phase III, Randomized, Double-blind, Placebo-controlled, Parallel Group Safety and Efficacy Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) During 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycemic Control on MDI Insulin Regimen Alone or With Metformin
Brief Summary This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.
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
  • Obesity
Intervention  ICMJE
  • Drug: Placebo
    Placebo matching BI 10773 low dose
  • Drug: Placebo
    Placebo matching BI 10773 high dose
  • Drug: BI 10773
    BI 10773 low dose once daily
  • Drug: BI 10773
    BI 10773 high dose once daily
Study Arms  ICMJE
  • Experimental: BI 10773 low dose
    BI 10773 low dose once daily
    Interventions:
    • Drug: Placebo
    • Drug: BI 10773
  • Experimental: BI 10773 high dose
    BI 10733 high dose once daily
    Interventions:
    • Drug: Placebo
    • Drug: BI 10773
  • Placebo Comparator: Placebo
    Placebo tablets matching BI 10773
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
Publications * Rosenstock J, Jelaska A, Frappin G, Salsali A, Kim G, Woerle HJ, Broedl UC; EMPA-REG MDI Trial Investigators. Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes. Diabetes Care. 2014 Jul;37(7):1815-23. doi: 10.2337/dc13-3055. Epub 2014 Jun 14.

*   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: May 29, 2013)
566
Original Estimated Enrollment  ICMJE
 (submitted: February 28, 2011)
555
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Diagnosis of T2DM prior to informed consent
  2. Male and female patients on diet and exercise regimen who are pre-treated with multiple daily injections (MDI) of insulin alone or in combination with immediate or extended release metformin
  3. Stable metformin therapy: daily dose >=1500 mg/day or maximum tolerated dose
  4. HbA1c >=7.5% and <=10% at screening

Exclusion criteria:

  1. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in
  2. Any contraindications to metformin according to the local label
  3. Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent
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 Belgium,   Bulgaria,   Colombia,   Czech Republic,   Finland,   France,   Germany,   Guatemala,   Mexico,   Peru,   Russian Federation,   Spain,   Ukraine,   United States
Removed Location Countries El Salvador,   India
 
Administrative Information
NCT Number  ICMJE NCT01306214
Other Study ID Numbers  ICMJE 1245.49
2010-019968-37 ( 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