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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01167881
First received: July 15, 2010
Last updated: July 17, 2014
Last verified: July 2014

July 15, 2010
July 17, 2014
August 2010
August 2013   (final data collection date for primary outcome measure)
The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment. [ Time Frame: Baseline and 104 weeks ] [ Designated as safety issue: No ]
  • The change from baseline in HbA1c 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 ]
Complete list of historical versions of study NCT01167881 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 symptomatic hypoglycaemic events during 52 weeks of treatment. [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
  • The change in blood pressure (SBP and DBP ) from baseline after 52 weeks of treatment. [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
  • The change in body weight from baseline after 104 weeks of treatment. [ Time Frame: baseline and 104weeks ] [ Designated as safety issue: No ]
  • The occurrence of confirmed symptomatic hypoglycaemic events during 104 weeks of treatment. [ Time Frame: baseline and 104 weeks ] [ Designated as safety issue: No ]
  • The change in blood pressure (SBP and DBP ) from baseline after 104 weeks of treatment. [ Time Frame: baseline and 104 weeks ] [ Designated as safety issue: No ]
  • Incidence of Adverse events [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of Adverse events [ Time Frame: baseline and 104 weeks ] [ Designated as safety issue: Yes ]
  • Occurrence of adverse events of protocol specific significant AEs [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Occurrence of adverse events of protocol specific significant AEs [ Time Frame: 104weeks ] [ Designated as safety issue: Yes ]
  • Occurrence of Hypoglycaemic events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Occurrence of Hypoglycaemic events [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]
  • Occurrence of Cardiovascular events (Clinical Event Committee adjudication results) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Occurrence of Cardiovascular events (Clinical Event Committee adjudication results) [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: BI 10773
    Medium dose once daily
  • Drug: Glimepiride
    1-4 mg once daily
  • Drug: Placebo
    Placebo matching BI 10773
  • Drug: Placebo
    Placebo matching Glimepiride
  • Experimental: BI 10773 dose plus metformin
    Patients receive one BI10773 tablet and one placebo Glimepiride capsule once daily
    Interventions:
    • Drug: BI 10773
    • Drug: Placebo
  • Active Comparator: Glimepiride 1-4 mg plus metformin
    Patients receive one glimepiride capsule and one placebo tablet Bi 10773 once daily.
    Interventions:
    • Drug: Glimepiride
    • Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1549
August 2015
August 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

1) Diagnosis typ 2 diabetes mellitus, 2) male and female on diet and exercise regimen, pre-treated with metformin 12 weeks prior to randomisation, 3)HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1, 4) 18 years or more, 5) BMI equal or less than 45Kg/m2.

Exclusion criteria:

1) uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in, 2) any other antidiabetic drug within 12 weeks prior to randomisation except metformin,3) acute coronary syndrome (non-STEMI, STEMI unstable angina pectoris), stroke or transient ischemic attack within 12 weeks of informed consent,4) indication liver disease, 5) moderate to severe renal impairment, 6) bariatric surgery within past 2 years, 7) medical history of cancer or treatment for cancer within last 5 years, 8) blood dyscrasias or any disorders causing haemolysis or unstable red blood cell, 9) contraindications hypersensitivity to concomitant drugs,10) treatment with anti-obesity drugs

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Netherlands,   Spain,   Portugal,   Italy,   Switzerland,   Czech Republic,   Austria,   United Kingdom,   Sweden,   Norway,   Mexico,   Argentina,   Colombia,   Malaysia,   Philippines,   Thailand,   Finland,   South Africa,   Hong Kong,   Taiwan,   India
 
NCT01167881
1245.28, 2009-016244-39
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP