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

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

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, Senior)
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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  Show 182 Study Locations

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 

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

Ridderstråle M, Andersen KR, Zeller C, Kim G, Woerle HJ, Broedl UC; EMPA-REG H2H-SU trial investigators. Comparison of empagliflozin and glimepiride as add-on to metformin in patients with type 2 diabetes: a 104-week randomised, active-controlled, double-blind, phase 3 trial. Lancet Diabetes Endocrinol. 2014 Sep;2(9):691-700. doi: 10.1016/S2213-8587(14)70120-2. Epub 2014 Jun 16. Erratum in: Lancet Diabetes Endocrinol. 2015 Sept;3(9):e7.

Ridderstråle M, Svaerd R, Zeller C, Kim G, Woerle HJ, Broedl UC; EMPA-REG H2H-SU trial investigators. Rationale, design and baseline characteristics of a 4-year (208-week) phase III trial of empagliflozin, an SGLT2 inhibitor, versus glimepiride as add-on to metformin in patients with type 2 diabetes mellitus with insufficient glycemic control. Cardiovasc Diabetol. 2013 Sep 5;12:129. doi: 10.1186/1475-2840-12-129.

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
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