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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 Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01306214
First received: February 28, 2011
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in HbA1c after 18 weeks of treatment [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 565
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306214

  Show 103 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01306214     History of Changes
Other Study ID Numbers: 1245.49, 2010-019968-37
Study First Received: February 28, 2011
Last Updated: May 15, 2013
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
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013