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A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy

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ClinicalTrials.gov Identifier: NCT01649297
Recruitment Status : Completed
First Posted : July 25, 2012
Results First Posted : July 23, 2015
Last Update Posted : July 23, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Placebo Drug: empagliflozin (low dose qd) Drug: Empagliflozin (high dose qd) Drug: empagliflozin (high dose bid) Drug: empagliflozin (low dose bid) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 983 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 Study of Oral Administration of Empagliflozin Twice Daily Versus Once Daily in Two Different Daily Doses Over 16 Weeks as add-on Therapy to a Twice Daily Dosing Regimen of Metformin in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control
Study Start Date : October 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: empagliflozin (high dose qd)
Patients receive Empagliflozin high dose once daily
 Drug: Placebo
Patients receive placebo matching empagliflozin (low dose qd)

Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)

Drug: Placebo
Patients receive placebo matching empagliflozin (low dose bid)

Drug: Empagliflozin (high dose qd)
Patients receive Empagliflozin high dose once daily
Experimental: empagliflozin (high dose bid)
Patients receive Empagliflozin high dose split twice daily
 Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)

Drug: Placebo
Patients receive placebo matching empagliflozin (low dose qd)

Drug: Placebo
Patients receive placebo matching empagliflozin (low dose bid)

Drug: empagliflozin (high dose bid)
Patients receive Empagliflozin high dose split twice daily
Experimental: empagliflozin (low dose qd)
Patients receive Empagliflozin low dose once daily
 Drug: empagliflozin (low dose qd)
Patients receive Empagliflozin low dose once daily

Drug: Placebo
Patients receive placebo matching empagliflozin (low dose bid)

Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)

Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)
Experimental: empagliflozin (low dose bid)
Patients receive Empagliflozin low dose split twice daily
 Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)

Drug: Placebo
Patients receive placebo matching empagliflozin (low dose qd)

Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)

Drug: empagliflozin (low dose bid)
Patients receive Empagliflozin low dose split twice daily
Placebo Comparator: Placebo
Patients receive placebo matching Empagliflozin
 Drug: Placebo
Patients receive placebo matching empagliflozin (low dose bid)

Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)

Drug: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)

Drug: Placebo
Patients receive placebo matching empagliflozin (low dose qd)


Outcome Measures
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Primary Outcome Measures :
  1. HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16 [ Time Frame: Baseline and 16 weeks ]

    Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.

    Means provided are the adjusted means.



Secondary Outcome Measures :
  1. Fasting Plasma Glucose (FPG) Change From Baseline at Week 16 [ Time Frame: Baseline and 16 weeks ]

    Change from baseline in FPG (mg/dL) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.

    Means provided are the adjusted means.



Eligibility Criteria
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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. confirmed diagnosis of T2DM
  2. Glycated hemoglobin (HbA1c) >=7.0 and <=10/0% at Visit 1
  3. Metformin therapy (at least 1500 mg/day, BID)
  4. age>=18 at Visit 1
  5. body mass index <=45 kg/m2

Exclusion criteria:

  1. estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) screening and/or run-in
  2. a confirmed glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in
Contacts and Locations
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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): NCT01649297


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01649297    
Other Study ID Numbers: 1276.10
2012-000905-53 ( EudraCT Number: EudraCT )
First Posted: July 25, 2012    Key Record Dates
Results First Posted: July 23, 2015
Last Update Posted: July 23, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Empagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs