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

Purpose

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	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: BI 10773 Drug: Glimepiride Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Drug Information available for: Metformin Metformin hydrochloride Glimepiride Empagliflozin

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]


Enrollment:	1549
Study Start Date:	August 2010
Study Completion Date:	August 2015
Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01167881

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Sponsors and Collaborators

Boehringer Ingelheim

Eli Lilly and Company

Investigators


Study Chair:	Boehringer Ingelheim	Boehringer Ingelheim

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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 )
Study First Received:	July 15, 2010
Results First Received:	July 17, 2014
Last Updated:	July 28, 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

ClinicalTrials.gov processed this record on September 21, 2017