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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01306214
First received: February 28, 2011
Last updated: May 16, 2014
Last verified: May 2014

February 28, 2011
May 16, 2014
February 2011
April 2013   (final data collection date for primary outcome measure)
Change From Baseline in HbA1c After 18 Weeks of Treatment [ Time Frame: Baseline and 18 weeks ] [ Designated as safety issue: No ]
The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment.
Change from baseline in HbA1c after 18 weeks of treatment [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01306214 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Insulin Dose After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The secondary endpoint was the change from baseline in HbA1c after 52 weeks of treatment
  • Change from baseline in insulin dose after 52 weeks of treatment [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in body weigh after 52 weeks of treatment [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in HbA1c after 52 weeks of treatment [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus
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

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.

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
  • Obesity
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
566
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Bulgaria,   Colombia,   Czech Republic,   Finland,   France,   Germany,   Guatemala,   Mexico,   Peru,   Russian Federation,   Spain,   Ukraine
 
NCT01306214
1245.49, 2010-019968-37
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