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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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:

MedlinePlus related topics: Diabetes Type 2

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The Change in Body Weight From Baseline After 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ] [ Designated as safety issue: No ]
The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ] [ Designated as safety issue: No ]
The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ] [ Designated as safety issue: No ]
The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment. [ Time Frame: baseline and 104 weeks ] [ Designated as safety issue: No ]
The Change From Baseline in HbA1c After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
The Change in Body Weight From Baseline After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment. [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]


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)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Show 182 Study Locations

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
Study First Received:	July 15, 2010
Results First Received:	July 17, 2014
Last Updated:	July 28, 2016
Health Authority:	Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica Austria: Medicines and Medical Devices Agency Canada: Health Canada Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos Czech Republic: State Institute for Drug Control Finland: Finnish Medicines Agency Hong Kong: Department of Health India: Drugs Controller General of India Italy: Ethics Committee Malaysia: Ministry of Health Mexico: Federal Commission for Protection Against Health Risks Netherlands: Central Committee Research Involving Human Subjects Norway: Norwegian Medicines Agency Philippines: Bureau of Food and Drugs Portugal: National Pharmacy and Medicines Institute South Africa: Medicines Control Council Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Switzerland: Swissmedic Taiwan : Food and Drug Administration Thailand: Ministry of Public Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration

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 23, 2016