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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00789035
First received: October 13, 2008
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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


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

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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

    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 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.

    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.


  • 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: 12 weeks ] [ Designated as safety issue: No ]
    Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%).

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

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


Enrollment: 408
Study Start Date: October 2008
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  1. Myocardial infarction, stroke or TIA within 6 months prior to informed consent
  2. Impaired hepatic function
  3. Renal insufficiency or impaired renal function
  4. Disease of central nervous system, or psychiatric disorders or clinically relevant neurologic disorders that may interfere with trial participation
  5. Chronic or clinically relevant acute infections
  6. Current or chronic urogenital tract infection determined by medical history
  7. History of clinically relevant allergy/hypersensitivity
  8. Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to informed consent
  9. Treatment with anti obesity drugs
  10. Current treatment with systemic steroids
  11. Alcohol abuse
  12. Treatment with an investigational drug within 2 months prior to informed consent
  13. known intolerance to metformin
  14. Dehydration
  15. Unstable or acute CHF
  16. Acute or chronic acidosis
  17. Hereditary galactose intolerance
  18. Woman of child bearing potential who are nursing or pregnant or not practicing an acceptable method of birth control
  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: NCT00789035

  Show 74 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: NCT00789035     History of Changes
Other Study ID Numbers: 1245.9, EudraCT No 2008-000640-14
Study First Received: October 13, 2008
Results First Received: May 16, 2014
Last Updated: May 16, 2014
Health Authority: Argentina: A.N.M.A.T. (National Administration of Medications, Food and Medical Technology)
Croatia: Croatian Institute for Medicines Control, HR-10000 Zagreb
Estonia: State Agency of Medicines, EE-5041Tartu
Germany: Federal Institute for Drugs and Medical Devices
Italy: Comitato per la Sperimentazione Clinica dei Medicinali Azienda Ospedaliero-Universitaria Pisana
Korea, Republic of: Korea Food and Drug Administration (KFDA)
Lithuania: State Medicines Control Agency, LT-01132 Vilnius
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
Sweden: Medical Products Agency, Box 26, 751 03 Uppsala, Sweden Regional Ethical Review Board of Stockholm, PO Box 289, SE-171 77 Stockholm, Sweden.
Taiwan: Department of Health, Executive Yuan, Taiwan
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014