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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00749190
First received: September 8, 2008
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: BI 10773
Drug: placebo
Drug: sitagliptin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in HbA1c After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Change of FPG From Baseline After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

    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.


  • Change of HbA1c From Baseline Over Time [ Time Frame: Baseline and weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
    Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.

  • Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%) based on logistic regression

  • Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%) based on logistic regression

  • Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Results for change of FPI from baseline at week 12 based on ANCOVA

  • Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.

  • Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Change of Body Weight After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Results for change of body weight after 12 weeks of treatment based on ANCOVA.

  • Trough Concentrations of Empagliflozin in Plasma [ Time Frame: Days 28, 56 and 84 ] [ Designated as safety issue: No ]
    (Pre-dose) trough concentrations of Empagliflozin in plasma, within 30 minutes of dosing.


Enrollment: 495
Study Start Date: August 2008
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Stable metformin therapy of at least 1500 mg/day, or less if that is a maximum tolerated dose.
  3. 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
  4. HbA1c >7.0% to 10.0% at Visit 2 (Start of Run-in)
  5. Age >=18 and <80years
  6. Body Mass Index (BMI) <=40 kg/m2
  7. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

  1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
  2. Impaired hepatic function
  3. Renal insufficiency or impaired renal function
  4. Diseases of the central nervous system or psychiatric disorders or clinically relevant neurological disorders that may interfere with participation in the trial
  5. Chronic or clinically relevant acute infections
  6. Current or chronic urogenital tract infection
  7. History of clinically relevant allergy/hypersensitivity
  8. Treatment with glitazones (e.g., rosiglitazone, pioglitazone), glucagon-like peptide (GLP-1) analogues, or insulin within 3 months prior to informed consent
  9. Treatment with anti-obesity drugs within 3 months prior to informed consent
  10. Treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent
  11. Alcohol abuse or drug abuse
  12. Treatment with an investigational drug within 2 months prior to informed consent
  13. 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
  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: NCT00749190

  Show 116 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00749190     History of Changes
Other Study ID Numbers: 1245.10, EudraCT 2008-000641-54
Study First Received: September 8, 2008
Results First Received: May 16, 2014
Last Updated: May 16, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia (A.N.M.A.T)
Austria: Federal Office for Safety in Health Care
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Estonia: State Agency of Medicines, EE-5041Tartu
Finland: Finnish Medicines Agency
France: French Health Products Safety Agency 143-147 boulevard Anatole France 93285
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy (OGYI), H-1051 Budapest
Latvia: State Agency of Medicines, LV-1003 Riga
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Romania: National Medicines Agency, Bucharest
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
Spain: Spanish Agency of Medicines
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on October 20, 2014