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Completed

NCT Number: NCT00749190

BI 10773 add-on to Metformin in Patients With Type 2 Diabetes

The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.

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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–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1245.10.54002 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
  • Stable metformin therapy of at least 1500 mg/day, or less if that is a maximum tolerated dose.
  • HbA1c at screening 6.5% to 9.0% for patients on metformin and one other antidiabetic drug, and HbA1c >7.0% to 10% for patients on metformin only
  • HbA1c >7.0% to 10.0% at Visit 2 (Start of Run-in)
  • Age >=18 and <80years
  • Body Mass Index (BMI) <=40 kg/m2
  • Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion criteria

  • Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
  • Impaired hepatic function
  • Renal insufficiency or impaired renal function
  • Diseases of the central nervous system or psychiatric disorders or clinically relevant neurological disorders that may interfere with participation in the trial
  • Chronic or clinically relevant acute infections
  • Current or chronic urogenital tract infection
  • History of clinically relevant allergy/hypersensitivity
  • Treatment with glitazones (e.g., rosiglitazone, pioglitazone), glucagon-like peptide (GLP-1) analogues, or insulin within 3 months prior to informed consent
  • Treatment with anti-obesity drugs within 3 months prior to informed consent
  • Treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent
  • Alcohol abuse or drug abuse
  • Treatment with an investigational drug within 2 months prior to informed consent
  • Women of child-bearing potential who are nursing or pregnant, or who are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to periodic pregnancy testing during participation in the trial

Treatment and study plan

BI 10773

Drug

Placebo

Drug

Sitagliptin

Drug

Primary outcomes

  1. Change From Baseline in HbA1c After 12 Weeks of Treatment

    Time frame: Baseline and 12 weeks

    Change from baseline in HbA1c after 12 weeks of treatment.

    In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.

Secondary outcomes

  1. Change of FPG From Baseline After 12 Weeks of Treatment

    Time frame: Baseline and 12 weeks

    Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis.

    In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.

  2. Change of HbA1c From Baseline Over Time

    Time frame: Baseline and weeks 4, 8 and 12

    Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.

  3. Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment

    Time frame: Baseline and 12 weeks

    Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%) based on logistic regression

  4. Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment

    Time frame: Baseline and 12 weeks

    Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%) based on logistic regression

  5. Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)

    Time frame: Baseline and 12 weeks

    Results for change of FPI from baseline at week 12 based on ANCOVA

  6. Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)

    Time frame: Baseline and 12 weeks

    HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.

  7. Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)

    Time frame: Baseline and 12 weeks

    HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5), FPG in mg/dl. Results are based on ANCOVA.

  8. Change of Body Weight After 12 Weeks of Treatment

    Time frame: Baseline and 12 weeks

    Results for change of body weight after 12 weeks of treatment based on ANCOVA.

  9. Trough Concentrations of Empagliflozin in Plasma

    Time frame: Days 28, 56 and 84

    (Pre-dose) trough concentrations of Empagliflozin in plasma, within 30 minutes of dosing.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Phase II, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (1 mg, 5 mg, 10 mg, 25 mg, and 50 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo With an Additional Open-label Sitagliptin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control Despite Metformin Therapy

Important dates

Study start
2008
Primary completion
2009
First posted
Sep 9, 2008
Registry last updated
Jun 13, 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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