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: September 24, 2014
Last verified: September 2014
  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, Randomized, Double-blind, Placebo-controlled, Parallel Group, Safety and Efficacy Study of BI 10773 (10 mg and 25 mg) Administered Orally, Once Daily Over 78 Weeks in Type 2 Diabetic Patients Receiving Treatment With Basal Insulin (Glargine, Detemir, or NPH Insulin Only) With or Without Concomitant Metformin and/or Sulfonylurea Therapy and Insufficient Glycemic Control

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment [ Time Frame: Baseline and 18 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment


Secondary Outcome Measures:
  • Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5%) After 18, 54 and 78 Weeks of Treatment [ Time Frame: Baseline and 18, 54 and 78 weeks ] [ Designated as safety issue: No ]
    Patients that had a reduction in HbA1c of at least 0.5% from baseline to 18, 54 and 78 weeks of treatment

  • Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment [ Time Frame: Baseline, 18, 54 and 78 weeks ] [ Designated as safety issue: No ]
    Change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment

  • Percent Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment [ Time Frame: Baseline, 18, 54 and 78 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment

  • Change From Baseline in Basal Insulin Dose/Day After 54 and 78 Weeks of Treatment [ Time Frame: Baseline, 54 and 78 weeks ] [ Designated as safety issue: No ]
    Change from baseline in basal insulin dose/day after 54 and 78 weeks of treatment

  • Change From Baseline in Body Weight After 18, 54 and 78 Weeks of Treatment [ Time Frame: Baseline, 18, 54, 78 weeks ] [ Designated as safety issue: No ]
    Change from baseline in body weight after 18, 54 and 78 weeks of treatment

  • Change From Baseline in Body Weight at Follow-up [ Time Frame: Baseline and 82 weeks ] [ Designated as safety issue: No ]
    Change from baseline in body weight at follow up (82 weeks)

  • Change From Baseline in HbA1c After 54 and 78 Weeks of Treatment [ Time Frame: Baseline, 54 and 78 weeks ] [ Designated as safety issue: No ]
    Change from baseline in HbA1c after 54 and 78 weeks of treatment

  • The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 18, 54, and 78 Weeks of Treatment [ Time Frame: Baseline, 18, 54 and 78 weeks ] [ Designated as safety issue: No ]
    The occurrence of treat to target efficacy response, that is an HbA1c under treatment of <7.0% After 18, 54, and 78 weeks of treatment


Other Outcome Measures:
  • Confirmed Hypoglycemic Events [ Time Frame: During the course of the study (82 weeks) ] [ Designated as safety issue: No ]
    Confirmed hypoglycemic events refer to all hypoglycemic events that had a glucose value ≤70 ml/dL or where assistance was required. Symptomatic hypoglycemic events were to be reported as adverse events. Investigator-defined hypoglycaemia adverse events include all events that investigator marked as 'Hypoglycaemic event' in CRFs, regardless of the reported term or blood glucose value. It may include hypoglycemia itself as reported term or any other symptoms that that investigator may have attributed to hypoglycemia (e.g. dizziness, hyperhidrosis, and asthenia).


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

Additional 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
Results First Received: May 16, 2014
Last Updated: September 24, 2014
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 22, 2014