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Completed

NCT Number: NCT01306214

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1245.49.32010 Boehringer Ingelheim Investigational Site, Bonheiden, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of T2DM prior to informed consent
  • 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
  • Stable metformin therapy: daily dose >=1500 mg/day or maximum tolerated dose
  • HbA1c >=7.5% and <=10% at screening

Exclusion criteria

  • Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in
  • Any contraindications to metformin according to the local label
  • Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent

Treatment and study plan

Placebo

Drug

Placebo matching BI 10773 low dose

BI 10773

Drug

BI 10773 low dose once daily

Primary outcomes

  1. Change From Baseline in HbA1c After 18 Weeks of Treatment

    Time frame: Baseline and 18 weeks

    The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment.

Secondary outcomes

  1. Change From Baseline in Insulin Dose After 52 Weeks of Treatment

    Time frame: Baseline and 52 weeks

    The secondary endpoint is change from baseline in insulin dose after 52 weeks of treatment

  2. Change From Baseline in Body Weight After 52 Weeks of Treatment

    Time frame: Baseline and 52 weeks

    The secondary endpoint was the change from baseline in body weight after 52 weeks of treatment

  3. Change From Baseline in HbA1c After 52 Weeks of Treatment

    Time frame: Baseline and 52 weeks

    The secondary endpoint was the change from baseline in HbA1c after 52 weeks of treatment

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 1, 2011
Registry last updated
Jun 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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