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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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Obesity
Drug: Placebo
Drug: BI 10773
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, 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 566
Study Start Date: February 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 10773 low dose
BI 10773 low dose once daily
Drug: Placebo
Placebo matching BI 10773 high dose
Drug: BI 10773
BI 10773 low dose once daily
Experimental: BI 10773 high dose
BI 10733 high dose once daily
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: BI 10773
BI 10773 high dose once daily
Placebo Comparator: Placebo
Placebo tablets matching BI 10773
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: Placebo
Placebo matching BI 10773 high dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01306214

  Show 103 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: NCT01306214     History of Changes
Other Study ID Numbers: 1245.49, 2010-019968-37
Study First Received: February 28, 2011
Results First Received: May 16, 2014
Last Updated: May 16, 2014
Health Authority: Belgium: Federal Agency for Medicinal and Health Products
Bulgaria: Bulgarian Drug Agency
Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Guatemala:
Mexico: Federal Commission for Protection Against Health Risks
Peru: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Spain: Spanish Agency of Medicines
Ukraine: State Pharmacological Center - Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 24, 2014