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

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
|
- The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment. [ Time Frame: Baseline and 104 weeks ]
- The Change in Body Weight From Baseline After 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ]
- The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ]
- The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ]
- The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ]
- The Change From Baseline in HbA1c After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ]
- The Change in Body Weight From Baseline After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ]
- The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ]
- The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ]
- The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ]

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

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

Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Additional Information:
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 |