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Efficacy and Safety of Empagliflozin (BI 10773) in Type 2 Diabetes Patients on a Background of Pioglitazone Alone or With Metformin

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ClinicalTrials.gov Identifier: NCT01210001
Recruitment Status : Completed
First Posted : September 28, 2010
Results First Posted : June 17, 2014
Last Update Posted : June 17, 2014
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
This study will investigate the efficacy and safety of BI 10773 in type 2 diabetic patients in order to provide these data for approval for BI 10773 by regulatory authorities as an antidiabetic agent as add-on therapy to pioglitazone alone or in combination with metformin.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Placebo Drug: BI 10773 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 499 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Trial of BI 10773 (10 and 25 mg Administered Orally Once Daily) Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite a Background Therapy of Pioglitazone Alone or in Combination With Metformin
Study Start Date : September 2010
Actual Primary Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BI 10773 low dose
BI 10773 tablets once daily
Drug: BI 10773
BI 10773 tablets once daily

Drug: Placebo
Placebo tablets matching BI 10773 high dose

Experimental: BI 10773 high dose
BI 10773 tablets once daily
Drug: Placebo
Placebo tablets matching BI 10773 high dose

Drug: BI 10773
BI 10773 tablets once daily

Placebo Comparator: Placebo
Placebo tablets matching BI 10773
Drug: Placebo
Placebo tablets matching BI 10773 low dose

Drug: Placebo
Placebo tablets matching BI 10773 high dose




Primary Outcome Measures :
  1. HbA1c Change From Baseline [ Time Frame: Baseline and 24 weeks ]

    Change From Baseline in HbA1c after 24 weeks.

    Note that adjusted means are provided.


  2. HbA1c Change From Baseline for Pio and Met Background Medication Patients [ Time Frame: Baseline and 24 weeks ]

    Change From Baseline in HbA1c after 24 weeks for patients with pioglitazone (pio) and metformin (met) background medication only.

    Note that adjusted means are provided.



Secondary Outcome Measures :
  1. Fasting Plasma Glucose (FPG) Change From Baseline [ Time Frame: Baseline and 24 weeks ]

    Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment.

    Note that adjusted means are provided.


  2. Body Weight Change From Baseline [ Time Frame: Baseline and 24 weeks ]

    Change from baseline in body weight after 24 weeks.

    Note that adjusted means are provided.



Other Outcome Measures:
  1. Hypoglycaemic Events [ Time Frame: From first drug administration until 7 days after last intake of study drug, up to 256 days ]
    Number of patients with hypoglycaemic events, as reported as adverse events.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Diagnosis of type 2 diabetes mellitus prior to informed consent.
  2. Male and female patients on diet and exercise regimen who are pre-treated with pioglitazone alone or in combination with metformin. The treatment regimen should be unchanged for 12 weeks prior to randomisation.
  3. HbA1c of >/= 7.0% and </= 10.0% at Visit 1 (screening).
  4. Age >/= 18.
  5. BMI </= 45 kg/m2 (Body Mass Index) at Visit 1 (screening).
  6. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation.

Exclusion criteria:

  1. Uncontrolled hyperglycaemia with a glucose level > 240 mg/dl (> 13.3 mmol/l) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
  2. Any other antidiabetic medication within 12 weeks prior to randomisation, except those defined as the permitted background therapy via inclusion criteria no. 2.
  3. Myocardial infarction, stroke or transient ischaemic attack (TIA) within 3 months prior to informed consent.
  4. Indication of liver disease, defined by serum levels of either alanine transaminase (ALT/SGPT), aspartate transaminase (AST/SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening or during the placebo run-in period (i.e. at a visit prior to the randomisation visit, Visit 3).
  5. Impaired renal function, defined as eGFR (estimated Glomerular Filtration Rate) < 30 ml/min (severe renal impairment, MDRD [Modification of Diet in Renal Disease] formula) as determined during screening or during the placebo run-in period (i.e. at a visit prior to the randomisation visit, Visit 3).
  6. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption.
  7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years .
  8. Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells (e.g. malaria, babesiosis, haemolytic anaemia).
  9. Contraindications to pioglitazone according to the local label.
  10. Contraindication to pioglitazone and/or metformin (relevant only for those patients who enter the study with both these background therapies) according to the local labels.
  11. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen etc.) leading to unstable body weight.
  12. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2D.
  13. Pre-menopausal women (last menstruation </= 1 year prior to informed consent) who:

    • are nursing or pregnant or
    • are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the trial and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if acceptable to local authorities), double barrier method and vasectomised partner.
  14. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake.
  15. Participation in another trial with an investigational drug within 30 days prior to informed consent.
  16. Any other clinical condition that would jeopardise patient safety while participating in this clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210001


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Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01210001     History of Changes
Other Study ID Numbers: 1245.19
2009-016154-40 ( EudraCT Number: EudraCT )
First Posted: September 28, 2010    Key Record Dates
Results First Posted: June 17, 2014
Last Update Posted: June 17, 2014
Last Verified: May 2014

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