Skip to main content
OpenTrials
Completed

NCT Number: NCT01011868

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1245.33.45006 Boehringer Ingelheim Investigational Site, Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation
  • 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.
  • Glycosylated hemoglobin A1c (Type A, subtype 1c) of >7.0% and < or = 10% at Visit 1 (screening)
  • Suitability for trial participation according to investigator's judgment (evaluating all alternative treatment options and in consideration of the patient completing the study)
  • Age > or =18 years at Visit 1 (screening)
  • BMI < or = 45 kg/m2 (Body Mass Index) at Visit 1 (screening)

Exclusion criteria

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

Treatment and study plan

BI 10773 Placebo

Drug

BI 10773 placebo

BI 10773 low dose

Drug

BI 10773 low dose

BI 10773 high dose

Drug

BI 10773 high dose

Primary outcomes

  1. Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment

    Time frame: Baseline and 18 weeks

    Change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment

Secondary outcomes

  1. 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

    Patients that had a reduction in HbA1c of at least 0.5% from baseline to 18, 54 and 78 weeks of treatment

  2. Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment

    Time frame: Baseline, 18, 54 and 78 weeks

    Change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment

  3. 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

    Percent change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment

  4. Change From Baseline in Basal Insulin Dose/Day After 54 and 78 Weeks of Treatment

    Time frame: Baseline, 54 and 78 weeks

    Change from baseline in basal insulin dose/day after 54 and 78 weeks of treatment

  5. Change From Baseline in Body Weight After 18, 54 and 78 Weeks of Treatment

    Time frame: Baseline, 18, 54, 78 weeks

    Change from baseline in body weight after 18, 54 and 78 weeks of treatment

  6. Change From Baseline in Body Weight at Follow-up

    Time frame: Baseline and 82 weeks

    Change from baseline in body weight at follow up (82 weeks)

  7. Change From Baseline in HbA1c After 54 and 78 Weeks of Treatment

    Time frame: Baseline, 54 and 78 weeks

    Change from baseline in HbA1c after 54 and 78 weeks of treatment

  8. 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

    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 outcomes

  1. Confirmed Hypoglycemic Events

    Time frame: During the course of the study (82 weeks)

    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).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
First posted
Nov 11, 2009
Registry last updated
Sep 30, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.