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Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01167881
Recruitment Status : Completed
First Posted : July 22, 2010
Results First Posted : August 8, 2014
Last Update Posted : September 2, 2016
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1549 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase III Randomised, Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 10773 Compared to Glimepiride Administered Orally During 104 Weeks With a 104 Week Extension Period in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Metformin Treatment
Study Start Date : August 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BI 10773 dose plus metformin
Patients receive one BI10773 tablet and one placebo Glimepiride capsule once daily
 Drug: BI 10773
Medium dose once daily

Drug: Placebo
Placebo matching Glimepiride
Active Comparator: Glimepiride 1-4 mg plus metformin
Patients receive one glimepiride capsule and one placebo tablet Bi 10773 once daily.
 Drug: Glimepiride
1-4 mg once daily

Drug: Placebo
Placebo matching BI 10773


Outcome Measures
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Primary Outcome Measures :
  1. The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment. [ Time Frame: Baseline and 104 weeks ]

Secondary Outcome Measures :
  1. The Change in Body Weight From Baseline After 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ]
  2. The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ]
  3. The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ]
  4. The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ]
  5. The Change From Baseline in HbA1c After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ]
  6. The Change in Body Weight From Baseline After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ]
  7. The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ]
  8. The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ]
  9. The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ]

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:

  • Diagnosis typ 2 diabetes mellitus
  • Male and female on diet and exercise regimen, pre-treated with metformin 12 weeks prior to randomisation
  • HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1
  • 18 years or more
  • BMI equal or less than 45Kg/m2

Exclusion criteria:

  • Uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in
  • Any other antidiabetic drug within 12 weeks prior to randomisation except metformin
  • Acute coronary syndrome (non-STEMI, STEMI unstable angina pectoris), stroke or transient ischemic attack within 12 weeks of informed consent
  • Indication of liver disease
  • Moderate to severe renal impairment
  • Bariatric surgery within past 2 years
  • Medical history of cancer or treatment for cancer within last 5 years
  • Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell
  • Contraindications hypersensitivity to concomitant drugs
  • Treatment with anti-obesity drugs
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): NCT01167881


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Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01167881     History of Changes
Other Study ID Numbers: 1245.28
2009-016244-39 ( EudraCT Number: EudraCT )
First Posted: July 22, 2010    Key Record Dates
Results First Posted: August 8, 2014
Last Update Posted: September 2, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Empagliflozin
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors