Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01011868
First received: November 10, 2009
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: BI 10773 placebo
Drug: BI 10773 low dose
Drug: BI 10773 high dose
Phase 2

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 IIb Randomised, Double-blind, Placebo-controlled, Parallel Group Efficacy and Safety Study of BI 10773 Administered Orally Once Daily for 78 Weeks in Type 2 Diabetic Patients in Combination With Basal Insulin Therapy

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change from baseline in Glycosylated haemoglobin A1c (HbA1c) [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treat to target and relative efficacy response of reduction in HbA1c of at least 0.5% [ Time Frame: 18, 54, 78 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline and percent change from baseline in fasting plasma glucose (FPG) [ Time Frame: 18, 54, 78 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in dose of basal insulin therapy [ Time Frame: 54 and 78 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: 54, 78 and 82 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Glycosylated haemoglobin A1c (HbA1c) [ Time Frame: 54 and 78 weeks ] [ Designated as safety issue: No ]

Enrollment: 494
Study Start Date: November 2009
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 10773 low dose
Patients receive BI 10773 low dose daily
Drug: BI 10773 low dose
BI 10773 low dose
Experimental: BI 10773 high dose
Patients receive BI 10773 high dose daily
Drug: BI 10773 placebo
BI 10773 placebo
Drug: BI 10773 high dose
BI 10773 high dose
Placebo Comparator: placebo
Patients receive placebo to match BI 10773 daily
Drug: BI 10773 placebo
BI 10773 placebo

  Eligibility

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

Inclusion criteria:

  1. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation
  2. Male and female patients with a diagnosis of Type 2 Diabetes Mellitus treated with a stable dose of basal insulin with or without concomitant metformin and / or sulfonylurea.
  3. Glycosylated hemoglobin A1c (Type A, subtype 1c) of >7.0% and < or = 10% at Visit 1 (screening)
  4. Suitability for trial participation according to investigator's judgment (evaluating all alternative treatment options and in consideration of the patient completing the study)
  5. Age > or =18 years at Visit 1 (screening)
  6. BMI < or = 45 kg/m2 (Body Mass Index) at Visit 1 (screening)

Exclusion criteria:

  1. Patients with poorly controlled hyperglycemia
  2. Frequent (at the discretion of the investigator) episodes of hypoglycemic events on basal insulin therapy
  3. MI, stroke, or TIA within 3 months prior to obtaining informed consent
  4. Impaired hepatic or renal function; gastric surgery; cancer within the last 5 years; blood dyscrasias

6. Treatment with other anti-diabetics, anti-obesity medications, steroids or thyroid hormones, participation in another trial with an investigational drug 7. Pre-menopausal women on insufficient birth control 8. Alcohol or drug abuse

  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: NCT01011868

  Show 99 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01011868     History of Changes
Other Study ID Numbers: 1245.33, 2009-013668-38
Study First Received: November 10, 2009
Last Updated: October 17, 2012
Health Authority: Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Ireland: Irish Medicines Board
Portugal: National Pharmacy and Medicines Institute
South Korea: Korea Food and Drug Administration (KFDA)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 24, 2014