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OpenTrials
Completed

NCT Number: NCT00789035

12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients

The objective is to investigate the efficacy, safety and pharmacokinetics of three different doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control. In addition an open-label metformin arm will be assessed

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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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1245.9.54001 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
  • either treatment-naïve or on a maximum of 1 oral antidiabetic therapy on a stable dose for the10 weeks prior to screening
  • HbA1c ≥6.5 to ≤9.0% and for treatment-naïve patients:HbA1c >7.0 to ≤10.0%
  • HbA1c >7.0 to ≤10.0% at Visit 2 (start of run-in) for all patients
  • Age between 18 and 80 years
  • BMI less than 40 kg/m2
  • Signed and dated informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria

  • Myocardial infarction, stroke or TIA within 6 months prior to informed consent
  • Impaired hepatic function
  • Renal insufficiency or impaired renal function
  • Disease of central nervous system, or psychiatric disorders or clinically relevant neurologic disorders that may interfere with trial participation
  • Chronic or clinically relevant acute infections
  • Current or chronic urogenital tract infection determined by medical history
  • History of clinically relevant allergy/hypersensitivity
  • Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to informed consent
  • Treatment with anti obesity drugs
  • Current treatment with systemic steroids
  • Alcohol abuse
  • Treatment with an investigational drug within 2 months prior to informed consent
  • known intolerance to metformin
  • Dehydration
  • Unstable or acute CHF
  • Acute or chronic acidosis
  • Hereditary galactose intolerance
  • Woman of child bearing potential who are nursing or pregnant or not practicing an acceptable method of birth control

Treatment and study plan

BI 10773

Drug

Placebo

Drug

metformin

Drug

Primary outcomes

  1. Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment

    Time frame: Baseline and 12 weeks

    Change of HbA1c from baseline after 12 weeks of treatment.

    Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups.

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.

    Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups.

  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: 12 weeks

    Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%).

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

    Time frame: 12 weeks

    Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%).

  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). 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 (within 30 minutes before dosing) trough concentrations of Empagliflozin in plasma

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
First posted
Nov 11, 2008
Registry last updated
Jun 18, 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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