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Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2, Hyperglycemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Metformin 500 mg bid
Metformin 1000 mg bid
Empagliflozin low dose qd
Empagliflozin high dose qd
Empagliflozin low dose bid
Metformin 500 mg bid
Empagliflozin high dose bid
Empagliflozin low dose bid
Metformin 1000 mg bid
Metformin 500 mg bid
Metformin 1000 mg bid
Empagliflozin high dose bid
Metformin 1000 mg bid
Empagliflozin high dose bid
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Diagnosis of type 2 diabetes mellitus prior to informed consent
  2. Male and female patients on diet and exercise regimen who are drug-naive, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomization
  3. HbA1c >=7.5% and <= 12% (>=58.5 mmol/mol and <=107.7 mmol/mol)
  4. Body Mass Index (BMI) <= 45 kg/m2 at screening

Exclusion criteria:

  1. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second laboratory measurement (not on the same day)
  2. Any antidiabetic drug within 12 weeks prior to randomization
  3. Impaired renal function, defined as estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) as determined during screening and/or run-in period
  4. Contraindications to metformin according to the local label

Sites / Locations

  • 1276.1.10014 Boehringer Ingelheim Investigational Site
  • 1276.1.10019 Boehringer Ingelheim Investigational Site
  • 1276.1.10044 Boehringer Ingelheim Investigational Site
  • 1276.1.10010 Boehringer Ingelheim Investigational Site
  • 1276.1.10035 Boehringer Ingelheim Investigational Site
  • 1276.1.10046 Boehringer Ingelheim Investigational Site
  • 1276.1.10006 Boehringer Ingelheim Investigational Site
  • 1276.1.10043 Boehringer Ingelheim Investigational Site
  • 1276.1.10009 Boehringer Ingelheim Investigational Site
  • 1276.1.10040 Boehringer Ingelheim Investigational Site
  • 1276.1.10045 Boehringer Ingelheim Investigational Site
  • 1276.1.10042 Boehringer Ingelheim Investigational Site
  • 1276.1.10001 Boehringer Ingelheim Investigational Site
  • 1276.1.10003 Boehringer Ingelheim Investigational Site
  • 1276.1.10026 Boehringer Ingelheim Investigational Site
  • 1276.1.10024 Boehringer Ingelheim Investigational Site
  • 1276.1.10027 Boehringer Ingelheim Investigational Site
  • 1276.1.10023 Boehringer Ingelheim Investigational Site
  • 1276.1.10034 Boehringer Ingelheim Investigational Site
  • 1276.1.10032 Boehringer Ingelheim Investigational Site
  • 1276.1.10036 Boehringer Ingelheim Investigational Site
  • 1276.1.10037 Boehringer Ingelheim Investigational Site
  • 1276.1.10007 Boehringer Ingelheim Investigational Site
  • 1276.1.10015 Boehringer Ingelheim Investigational Site
  • 1276.1.10033 Boehringer Ingelheim Investigational Site
  • 1276.1.10022 Boehringer Ingelheim Investigational Site
  • 1276.1.10002 Boehringer Ingelheim Investigational Site
  • 1276.1.10005 Boehringer Ingelheim Investigational Site
  • 1276.1.10011 Boehringer Ingelheim Investigational Site
  • 1276.1.10030 Boehringer Ingelheim Investigational Site
  • 1276.1.10008 Boehringer Ingelheim Investigational Site
  • 1276.1.10013 Boehringer Ingelheim Investigational Site
  • 1276.1.10017 Boehringer Ingelheim Investigational Site
  • 1276.1.10018 Boehringer Ingelheim Investigational Site
  • 1276.1.10025 Boehringer Ingelheim Investigational Site
  • 1276.1.10028 Boehringer Ingelheim Investigational Site
  • 1276.1.10016 Boehringer Ingelheim Investigational Site
  • 1276.1.10021 Boehringer Ingelheim Investigational Site
  • 1276.1.10041 Boehringer Ingelheim Investigational Site
  • 1276.1.10004 Boehringer Ingelheim Investigational Site
  • 1276.1.10012 Boehringer Ingelheim Investigational Site
  • 1276.1.55008 Boehringer Ingelheim Investigational Site
  • 1276.1.55003 Boehringer Ingelheim Investigational Site
  • 1276.1.55006 Boehringer Ingelheim Investigational Site
  • 1276.1.55007 Boehringer Ingelheim Investigational Site
  • 1276.1.55009 Boehringer Ingelheim Investigational Site
  • 1276.1.55004 Boehringer Ingelheim Investigational Site
  • 1276.1.55002 Boehringer Ingelheim Investigational Site
  • 1276.1.55001 Boehringer Ingelheim Investigational Site
  • 1276.1.20003 Boehringer Ingelheim Investigational Site
  • 1276.1.20012 Boehringer Ingelheim Investigational Site
  • 1276.1.20008 Boehringer Ingelheim Investigational Site
  • 1276.1.20004 Boehringer Ingelheim Investigational Site
  • 1276.1.20005 Boehringer Ingelheim Investigational Site
  • 1276.1.20013 Boehringer Ingelheim Investigational Site
  • 1276.1.20010 Boehringer Ingelheim Investigational Site
  • 1276.1.20006 Boehringer Ingelheim Investigational Site
  • 1276.1.20007 Boehringer Ingelheim Investigational Site
  • 1276.1.20001 Boehringer Ingelheim Investigational Site
  • 1276.1.20002 Boehringer Ingelheim Investigational Site
  • 1276.1.42002 Boehringer Ingelheim Investigational Site
  • 1276.1.42008 Boehringer Ingelheim Investigational Site
  • 1276.1.42007 Boehringer Ingelheim Investigational Site
  • 1276.1.42009 Boehringer Ingelheim Investigational Site
  • 1276.1.42004 Boehringer Ingelheim Investigational Site
  • 1276.1.42010 Boehringer Ingelheim Investigational Site
  • 1276.1.42003 Boehringer Ingelheim Investigational Site
  • 1276.1.95001 Boehringer Ingelheim Investigational Site
  • 1276.1.95003 Boehringer Ingelheim Investigational Site
  • 1276.1.95004 Boehringer Ingelheim Investigational Site
  • 1276.1.95002 Boehringer Ingelheim Investigational Site
  • 1276.1.33004 Boehringer Ingelheim Investigational Site
  • 1276.1.33012 Boehringer Ingelheim Investigational Site
  • 1276.1.33005 Boehringer Ingelheim Investigational Site
  • 1276.1.33007 Boehringer Ingelheim Investigational Site
  • 1276.1.33013 Boehringer Ingelheim Investigational Site
  • 1276.1.33001 Boehringer Ingelheim Investigational Site
  • 1276.1.33003 Boehringer Ingelheim Investigational Site
  • 1276.1.33006 Boehringer Ingelheim Investigational Site
  • 1276.1.33002 Boehringer Ingelheim Investigational Site
  • 1276.1.33011 Boehringer Ingelheim Investigational Site
  • 1276.1.33010 Boehringer Ingelheim Investigational Site
  • 1276.1.33009 Boehringer Ingelheim Investigational Site
  • 1276.1.33008 Boehringer Ingelheim Investigational Site
  • 1276.1.49005 Boehringer Ingelheim Investigational Site
  • 1276.1.49008 Boehringer Ingelheim Investigational Site
  • 1276.1.49006 Boehringer Ingelheim Investigational Site
  • 1276.1.49011 Boehringer Ingelheim Investigational Site
  • 1276.1.49003 Boehringer Ingelheim Investigational Site
  • 1276.1.49007 Boehringer Ingelheim Investigational Site
  • 1276.1.49014 Boehringer Ingelheim Investigational Site
  • 1276.1.49004 Boehringer Ingelheim Investigational Site
  • 1276.1.49002 Boehringer Ingelheim Investigational Site
  • 1276.1.49012 Boehringer Ingelheim Investigational Site
  • 1276.1.50002 Boehringer Ingelheim Investigational Site
  • 1276.1.50003 Boehringer Ingelheim Investigational Site
  • 1276.1.50005 Boehringer Ingelheim Investigational Site
  • 1276.1.50006 Boehringer Ingelheim Investigational Site
  • 1276.1.50001 Boehringer Ingelheim Investigational Site
  • 1276.1.82006 Boehringer Ingelheim Investigational Site
  • 1276.1.82010 Boehringer Ingelheim Investigational Site
  • 1276.1.82001 Boehringer Ingelheim Investigational Site
  • 1276.1.82009 Boehringer Ingelheim Investigational Site
  • 1276.1.82002 Boehringer Ingelheim Investigational Site
  • 1276.1.82004 Boehringer Ingelheim Investigational Site
  • 1276.1.82005 Boehringer Ingelheim Investigational Site
  • 1276.1.82007 Boehringer Ingelheim Investigational Site
  • 1276.1.82008 Boehringer Ingelheim Investigational Site
  • 1276.1.82003 Boehringer Ingelheim Investigational Site
  • 1276.1.96001 Boehringer Ingelheim Investigational Site
  • 1276.1.96002 Boehringer Ingelheim Investigational Site
  • 1276.1.96003 Boehringer Ingelheim Investigational Site
  • 1276.1.96004 Boehringer Ingelheim Investigational Site
  • 1276.1.60002 Boehringer Ingelheim Investigational Site
  • 1276.1.60001 Boehringer Ingelheim Investigational Site
  • 1276.1.60003 Boehringer Ingelheim Investigational Site
  • 1276.1.52004 Boehringer Ingelheim Investigational Site
  • 1276.1.52007 Boehringer Ingelheim Investigational Site
  • 1276.1.52002 Boehringer Ingelheim Investigational Site
  • 1276.1.52003 Boehringer Ingelheim Investigational Site
  • 1276.1.52001 Boehringer Ingelheim Investigational Site
  • 1276.1.52006 Boehringer Ingelheim Investigational Site
  • 1276.1.52005 Boehringer Ingelheim Investigational Site
  • 1276.1.51001 Boehringer Ingelheim Investigational Site
  • 1276.1.51002 Boehringer Ingelheim Investigational Site
  • 1276.1.51003 Boehringer Ingelheim Investigational Site
  • 1276.1.51004 Boehringer Ingelheim Investigational Site
  • 1276.1.51005 Boehringer Ingelheim Investigational Site
  • 1276.1.63009 Boehringer Ingelheim Investigational Site
  • 1276.1.63002 Boehringer Ingelheim Investigational Site
  • 1276.1.63004 Boehringer Ingelheim Investigational Site
  • 1276.1.63003 Boehringer Ingelheim Investigational Site
  • 1276.1.63006 Boehringer Ingelheim Investigational Site
  • 1276.1.63001 Boehringer Ingelheim Investigational Site
  • 1276.1.63005 Boehringer Ingelheim Investigational Site
  • 1276.1.63007 Boehringer Ingelheim Investigational Site
  • 1276.1.63008 Boehringer Ingelheim Investigational Site
  • 1276.1.70012 Boehringer Ingelheim Investigational Site
  • 1276.1.70011 Boehringer Ingelheim Investigational Site
  • 1276.1.70015 Boehringer Ingelheim Investigational Site
  • 1276.1.70016 Boehringer Ingelheim Investigational Site
  • 1276.1.70018 Boehringer Ingelheim Investigational Site
  • 1276.1.70007 Boehringer Ingelheim Investigational Site
  • 1276.1.70009 Boehringer Ingelheim Investigational Site
  • 1276.1.70010 Boehringer Ingelheim Investigational Site
  • 1276.1.70005 Boehringer Ingelheim Investigational Site
  • 1276.1.70006 Boehringer Ingelheim Investigational Site
  • 1276.1.70017 Boehringer Ingelheim Investigational Site
  • 1276.1.70013 Boehringer Ingelheim Investigational Site
  • 1276.1.38104 Boehringer Ingelheim Investigational Site
  • 1276.1.38105 Boehringer Ingelheim Investigational Site
  • 1276.1.38106 Boehringer Ingelheim Investigational Site
  • 1276.1.38107 Boehringer Ingelheim Investigational Site
  • 1276.1.38103 Boehringer Ingelheim Investigational Site
  • 1276.1.38101 Boehringer Ingelheim Investigational Site
  • 1276.1.38108 Boehringer Ingelheim Investigational Site
  • 1276.1.38102 Boehringer Ingelheim Investigational Site
  • 1276.1.34048 Boehringer Ingelheim Investigational Site
  • 1276.1.34050 Boehringer Ingelheim Investigational Site
  • 1276.1.34028 Boehringer Ingelheim Investigational Site
  • 1276.1.34045 Boehringer Ingelheim Investigational Site
  • 1276.1.34034 Boehringer Ingelheim Investigational Site
  • 1276.1.34027 Boehringer Ingelheim Investigational Site
  • 1276.1.34052 Boehringer Ingelheim Investigational Site
  • 1276.1.34051 Boehringer Ingelheim Investigational Site
  • 1276.1.88005 Boehringer Ingelheim Investigational Site
  • 1276.1.88002 Boehringer Ingelheim Investigational Site
  • 1276.1.88001 Boehringer Ingelheim Investigational Site
  • 1276.1.88003 Boehringer Ingelheim Investigational Site
  • 1276.1.88004 Boehringer Ingelheim Investigational Site
  • 1276.1.88006 Boehringer Ingelheim Investigational Site
  • 1276.1.66001 Boehringer Ingelheim Investigational Site
  • 1276.1.66003 Boehringer Ingelheim Investigational Site
  • 1276.1.66002 Boehringer Ingelheim Investigational Site
  • 1276.1.90003 Boehringer Ingelheim Investigational Site
  • 1276.1.90004 Boehringer Ingelheim Investigational Site
  • 1276.1.90006 Boehringer Ingelheim Investigational Site
  • 1276.1.90002 Boehringer Ingelheim Investigational Site
  • 1276.1.90005 Boehringer Ingelheim Investigational Site
  • 1276.1.90001 Boehringer Ingelheim Investigational Site
  • 1276.1.44002 Boehringer Ingelheim Investigational Site
  • 1276.1.44001 Boehringer Ingelheim Investigational Site
  • 1276.1.44005 Boehringer Ingelheim Investigational Site
  • 1276.1.44006 Boehringer Ingelheim Investigational Site
  • 1276.1.44004 Boehringer Ingelheim Investigational Site
  • 1276.1.44008 Boehringer Ingelheim Investigational Site
  • 1276.1.44003 Boehringer Ingelheim Investigational Site
  • 1276.1.44007 Boehringer Ingelheim Investigational Site
  • 1276.1.44011 Boehringer Ingelheim Investigational Site
  • 1276.1.44009 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Empagliflozin low dose qd

Empagliflozin high dose qd

OL empa high dose + met 1000 mg bid

Empagliflozin low dose + met 500 mg bid

Empagliflozin low dose + met 1000 mg bid

Empagliflozin high dose + met 500 mg bid

Empagliflozin high dose + met 1000mg bid

Metformin 500 mg bid

Metformin 1000 mg bid

Arm Description

Empagliflozin low dose once daily

Empagliflozin high dose once daily

Open label empagliflozin high dose split twice daily + metformin 1000 mg twice daily - Patients are no longer enrolled into this arm because of change in the inclusion criteria in protocol version 2.0 all patients are now enrolled into remaining double-blind arms. Patients already enrolled in the open-label arm according to protocol version 1.0 can complete the study.

Empagliflozin low dose split twice daily + metformin 500 mg twice daily

Empagliflozin low dose split twice daily + metformin 1000 mg twice daily

Empagliflozin high dose split twice daily + metformin 500 mg twice daily

Empagliflozin high dose split twice daily + metformin 1000 mg twice daily

Metformin 500 mg twice daily

Metformin 1000 mg twice daily

Outcomes

Primary Outcome Measures

HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24
Change from baseline in HbA1c (%) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means

Secondary Outcome Measures

FPG (Fasting Plasma Glucose) Change From Baseline at Week 24
Change from baseline in FPG (mg/dL) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means.
Body Weight Change From Baseline at Week 24
Change from baseline in body weight (kg) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment. medication. Means presented are the adjusted means.

Full Information

First Posted
October 30, 2012
Last Updated
January 22, 2016
Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01719003
Brief Title
Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes
Official Title
A 24-week Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Oral Administration of Empagliflozin + Metformin Compared With the Individual Components of Empagliflozin or Metformin in Drug Naive Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Hyperglycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1413 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Empagliflozin low dose qd
Arm Type
Experimental
Arm Description
Empagliflozin low dose once daily
Arm Title
Empagliflozin high dose qd
Arm Type
Experimental
Arm Description
Empagliflozin high dose once daily
Arm Title
OL empa high dose + met 1000 mg bid
Arm Type
Experimental
Arm Description
Open label empagliflozin high dose split twice daily + metformin 1000 mg twice daily - Patients are no longer enrolled into this arm because of change in the inclusion criteria in protocol version 2.0 all patients are now enrolled into remaining double-blind arms. Patients already enrolled in the open-label arm according to protocol version 1.0 can complete the study.
Arm Title
Empagliflozin low dose + met 500 mg bid
Arm Type
Experimental
Arm Description
Empagliflozin low dose split twice daily + metformin 500 mg twice daily
Arm Title
Empagliflozin low dose + met 1000 mg bid
Arm Type
Experimental
Arm Description
Empagliflozin low dose split twice daily + metformin 1000 mg twice daily
Arm Title
Empagliflozin high dose + met 500 mg bid
Arm Type
Experimental
Arm Description
Empagliflozin high dose split twice daily + metformin 500 mg twice daily
Arm Title
Empagliflozin high dose + met 1000mg bid
Arm Type
Experimental
Arm Description
Empagliflozin high dose split twice daily + metformin 1000 mg twice daily
Arm Title
Metformin 500 mg bid
Arm Type
Experimental
Arm Description
Metformin 500 mg twice daily
Arm Title
Metformin 1000 mg bid
Arm Type
Experimental
Arm Description
Metformin 1000 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Metformin 500 mg bid
Intervention Description
Metformin 500 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Metformin 1000 mg bid
Intervention Description
Metformin 1000 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Empagliflozin low dose qd
Intervention Description
Empagliflozin low dose once daily
Intervention Type
Drug
Intervention Name(s)
Empagliflozin high dose qd
Intervention Description
Empagliflozin high dose once daily
Intervention Type
Drug
Intervention Name(s)
Empagliflozin low dose bid
Intervention Description
Empagliflozin low dose split twice daily
Intervention Type
Drug
Intervention Name(s)
Metformin 500 mg bid
Intervention Description
Metformin 500 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Empagliflozin high dose bid
Intervention Description
Empagliflozin high dose split twice daily
Intervention Type
Drug
Intervention Name(s)
Empagliflozin low dose bid
Intervention Description
Empagliflozin low dose split twice daily
Intervention Type
Drug
Intervention Name(s)
Metformin 1000 mg bid
Intervention Description
Metformin 1000 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Metformin 500 mg bid
Intervention Description
Metformin 500 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Metformin 1000 mg bid
Intervention Description
Metformin 1000 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Empagliflozin high dose bid
Intervention Description
Empagliflozin high dose split twice daily
Intervention Type
Drug
Intervention Name(s)
Metformin 1000 mg bid
Intervention Description
Metformin 1000 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Empagliflozin high dose bid
Intervention Description
Empagliflozin high dose split twice daily
Primary Outcome Measure Information:
Title
HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24
Description
Change from baseline in HbA1c (%) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means
Time Frame
baseline and 24 weeks
Secondary Outcome Measure Information:
Title
FPG (Fasting Plasma Glucose) Change From Baseline at Week 24
Description
Change from baseline in FPG (mg/dL) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means.
Time Frame
baseline and 24 weeks
Title
Body Weight Change From Baseline at Week 24
Description
Change from baseline in body weight (kg) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment. medication. Means presented are the adjusted means.
Time Frame
baseline and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Diagnosis of type 2 diabetes mellitus prior to informed consent Male and female patients on diet and exercise regimen who are drug-naive, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomization HbA1c >=7.5% and <= 12% (>=58.5 mmol/mol and <=107.7 mmol/mol) Body Mass Index (BMI) <= 45 kg/m2 at screening Exclusion criteria: Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second laboratory measurement (not on the same day) Any antidiabetic drug within 12 weeks prior to randomization Impaired renal function, defined as estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) as determined during screening and/or run-in period Contraindications to metformin according to the local label
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1276.1.10014 Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
1276.1.10019 Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
1276.1.10044 Boehringer Ingelheim Investigational Site
City
Hot Springs
State/Province
Alaska
Country
United States
Facility Name
1276.1.10010 Boehringer Ingelheim Investigational Site
City
Glendale
State/Province
Arizona
Country
United States
Facility Name
1276.1.10035 Boehringer Ingelheim Investigational Site
City
Searcy
State/Province
Arkansas
Country
United States
Facility Name
1276.1.10046 Boehringer Ingelheim Investigational Site
City
Chula Vista
State/Province
California
Country
United States
Facility Name
1276.1.10006 Boehringer Ingelheim Investigational Site
City
Huntington Beach
State/Province
California
Country
United States
Facility Name
1276.1.10043 Boehringer Ingelheim Investigational Site
City
La Mesa
State/Province
California
Country
United States
Facility Name
1276.1.10009 Boehringer Ingelheim Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1276.1.10040 Boehringer Ingelheim Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1276.1.10045 Boehringer Ingelheim Investigational Site
City
Oceanside
State/Province
California
Country
United States
Facility Name
1276.1.10042 Boehringer Ingelheim Investigational Site
City
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
1276.1.10001 Boehringer Ingelheim Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
1276.1.10003 Boehringer Ingelheim Investigational Site
City
Northglenn
State/Province
Colorado
Country
United States
Facility Name
1276.1.10026 Boehringer Ingelheim Investigational Site
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
1276.1.10024 Boehringer Ingelheim Investigational Site
City
Oldsmar
State/Province
Florida
Country
United States
Facility Name
1276.1.10027 Boehringer Ingelheim Investigational Site
City
Port Orange
State/Province
Florida
Country
United States
Facility Name
1276.1.10023 Boehringer Ingelheim Investigational Site
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
1276.1.10034 Boehringer Ingelheim Investigational Site
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
1276.1.10032 Boehringer Ingelheim Investigational Site
City
Fall River
State/Province
Massachusetts
Country
United States
Facility Name
1276.1.10036 Boehringer Ingelheim Investigational Site
City
Bridgman
State/Province
Michigan
Country
United States
Facility Name
1276.1.10037 Boehringer Ingelheim Investigational Site
City
Hazelwood
State/Province
Missouri
Country
United States
Facility Name
1276.1.10007 Boehringer Ingelheim Investigational Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
1276.1.10015 Boehringer Ingelheim Investigational Site
City
Union
State/Province
New Jersey
Country
United States
Facility Name
1276.1.10033 Boehringer Ingelheim Investigational Site
City
Asheboro
State/Province
North Carolina
Country
United States
Facility Name
1276.1.10022 Boehringer Ingelheim Investigational Site
City
Burlington
State/Province
North Carolina
Country
United States
Facility Name
1276.1.10002 Boehringer Ingelheim Investigational Site
City
Lenoir
State/Province
North Carolina
Country
United States
Facility Name
1276.1.10005 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
1276.1.10011 Boehringer Ingelheim Investigational Site
City
Gallipolis
State/Province
Ohio
Country
United States
Facility Name
1276.1.10030 Boehringer Ingelheim Investigational Site
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
1276.1.10008 Boehringer Ingelheim Investigational Site
City
Greer
State/Province
South Carolina
Country
United States
Facility Name
1276.1.10013 Boehringer Ingelheim Investigational Site
City
Hodges
State/Province
South Carolina
Country
United States
Facility Name
1276.1.10017 Boehringer Ingelheim Investigational Site
City
Humboldt
State/Province
Tennessee
Country
United States
Facility Name
1276.1.10018 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1276.1.10025 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1276.1.10028 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1276.1.10016 Boehringer Ingelheim Investigational Site
City
Kingwood
State/Province
Texas
Country
United States
Facility Name
1276.1.10021 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1276.1.10041 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1276.1.10004 Boehringer Ingelheim Investigational Site
City
Manassas
State/Province
Virginia
Country
United States
Facility Name
1276.1.10012 Boehringer Ingelheim Investigational Site
City
Wenatchee
State/Province
Washington
Country
United States
Facility Name
1276.1.55008 Boehringer Ingelheim Investigational Site
City
Belém
Country
Brazil
Facility Name
1276.1.55003 Boehringer Ingelheim Investigational Site
City
Brasilia
Country
Brazil
Facility Name
1276.1.55006 Boehringer Ingelheim Investigational Site
City
Fortaleza
Country
Brazil
Facility Name
1276.1.55007 Boehringer Ingelheim Investigational Site
City
Fortaleza
Country
Brazil
Facility Name
1276.1.55009 Boehringer Ingelheim Investigational Site
City
Fortaleza
Country
Brazil
Facility Name
1276.1.55004 Boehringer Ingelheim Investigational Site
City
Goiania
Country
Brazil
Facility Name
1276.1.55002 Boehringer Ingelheim Investigational Site
City
Porto Alegre
Country
Brazil
Facility Name
1276.1.55001 Boehringer Ingelheim Investigational Site
City
Sao Paulo
Country
Brazil
Facility Name
1276.1.20003 Boehringer Ingelheim Investigational Site
City
Coquitlam
State/Province
British Columbia
Country
Canada
Facility Name
1276.1.20012 Boehringer Ingelheim Investigational Site
City
Coquitlam
State/Province
British Columbia
Country
Canada
Facility Name
1276.1.20008 Boehringer Ingelheim Investigational Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
1276.1.20004 Boehringer Ingelheim Investigational Site
City
Antigonish
State/Province
Nova Scotia
Country
Canada
Facility Name
1276.1.20005 Boehringer Ingelheim Investigational Site
City
Hawkesbury
State/Province
Ontario
Country
Canada
Facility Name
1276.1.20013 Boehringer Ingelheim Investigational Site
City
Sarnia
State/Province
Ontario
Country
Canada
Facility Name
1276.1.20010 Boehringer Ingelheim Investigational Site
City
Strathroy
State/Province
Ontario
Country
Canada
Facility Name
1276.1.20006 Boehringer Ingelheim Investigational Site
City
Thornhill
State/Province
Ontario
Country
Canada
Facility Name
1276.1.20007 Boehringer Ingelheim Investigational Site
City
Mirabel
State/Province
Quebec
Country
Canada
Facility Name
1276.1.20001 Boehringer Ingelheim Investigational Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
1276.1.20002 Boehringer Ingelheim Investigational Site
City
Quebec
Country
Canada
Facility Name
1276.1.42002 Boehringer Ingelheim Investigational Site
City
Benatky nad Jizerou
Country
Czech Republic
Facility Name
1276.1.42008 Boehringer Ingelheim Investigational Site
City
Olomouc
Country
Czech Republic
Facility Name
1276.1.42007 Boehringer Ingelheim Investigational Site
City
Ostrava
Country
Czech Republic
Facility Name
1276.1.42009 Boehringer Ingelheim Investigational Site
City
Plzen
Country
Czech Republic
Facility Name
1276.1.42004 Boehringer Ingelheim Investigational Site
City
Praha 10
Country
Czech Republic
Facility Name
1276.1.42010 Boehringer Ingelheim Investigational Site
City
Praha 1
Country
Czech Republic
Facility Name
1276.1.42003 Boehringer Ingelheim Investigational Site
City
Praha 3
Country
Czech Republic
Facility Name
1276.1.95001 Boehringer Ingelheim Investigational Site
City
Abbasia Cairo, Egypt
Country
Egypt
Facility Name
1276.1.95003 Boehringer Ingelheim Investigational Site
City
Al Manial, Cairo, Egypt
Country
Egypt
Facility Name
1276.1.95004 Boehringer Ingelheim Investigational Site
City
Alexandria
Country
Egypt
Facility Name
1276.1.95002 Boehringer Ingelheim Investigational Site
City
El Darasa Cairo Egypt
Country
Egypt
Facility Name
1276.1.33004 Boehringer Ingelheim Investigational Site
City
Behren Les Forbach
Country
France
Facility Name
1276.1.33012 Boehringer Ingelheim Investigational Site
City
Bersée
Country
France
Facility Name
1276.1.33005 Boehringer Ingelheim Investigational Site
City
Cournonterral
Country
France
Facility Name
1276.1.33007 Boehringer Ingelheim Investigational Site
City
Hautmont
Country
France
Facility Name
1276.1.33013 Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
1276.1.33001 Boehringer Ingelheim Investigational Site
City
Poitiers
Country
France
Facility Name
1276.1.33003 Boehringer Ingelheim Investigational Site
City
Savonnières
Country
France
Facility Name
1276.1.33006 Boehringer Ingelheim Investigational Site
City
St Genis des Fontaines
Country
France
Facility Name
1276.1.33002 Boehringer Ingelheim Investigational Site
City
Thouars
Country
France
Facility Name
1276.1.33011 Boehringer Ingelheim Investigational Site
City
Thun St amand
Country
France
Facility Name
1276.1.33010 Boehringer Ingelheim Investigational Site
City
Tours
Country
France
Facility Name
1276.1.33009 Boehringer Ingelheim Investigational Site
City
Vandome
Country
France
Facility Name
1276.1.33008 Boehringer Ingelheim Investigational Site
City
Vieux Condé
Country
France
Facility Name
1276.1.49005 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1276.1.49008 Boehringer Ingelheim Investigational Site
City
Celle
Country
Germany
Facility Name
1276.1.49006 Boehringer Ingelheim Investigational Site
City
Dortmund
Country
Germany
Facility Name
1276.1.49011 Boehringer Ingelheim Investigational Site
City
Dresden
Country
Germany
Facility Name
1276.1.49003 Boehringer Ingelheim Investigational Site
City
Essen
Country
Germany
Facility Name
1276.1.49007 Boehringer Ingelheim Investigational Site
City
Ingelheim
Country
Germany
Facility Name
1276.1.49014 Boehringer Ingelheim Investigational Site
City
Neuwied
Country
Germany
Facility Name
1276.1.49004 Boehringer Ingelheim Investigational Site
City
Offenbach
Country
Germany
Facility Name
1276.1.49002 Boehringer Ingelheim Investigational Site
City
Stuhr-Brinkum
Country
Germany
Facility Name
1276.1.49012 Boehringer Ingelheim Investigational Site
City
Teuchern
Country
Germany
Facility Name
1276.1.50002 Boehringer Ingelheim Investigational Site
City
Barbena Santa Rosa
Country
Guatemala
Facility Name
1276.1.50003 Boehringer Ingelheim Investigational Site
City
Guatemala
Country
Guatemala
Facility Name
1276.1.50005 Boehringer Ingelheim Investigational Site
City
Guatemala
Country
Guatemala
Facility Name
1276.1.50006 Boehringer Ingelheim Investigational Site
City
Guatemala
Country
Guatemala
Facility Name
1276.1.50001 Boehringer Ingelheim Investigational Site
City
Quetzaltenango
Country
Guatemala
Facility Name
1276.1.82006 Boehringer Ingelheim Investigational Site
City
Deagu
Country
Korea, Republic of
Facility Name
1276.1.82010 Boehringer Ingelheim Investigational Site
City
Goyang
Country
Korea, Republic of
Facility Name
1276.1.82001 Boehringer Ingelheim Investigational Site
City
Incheon
Country
Korea, Republic of
Facility Name
1276.1.82009 Boehringer Ingelheim Investigational Site
City
Pusan
Country
Korea, Republic of
Facility Name
1276.1.82002 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1276.1.82004 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1276.1.82005 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1276.1.82007 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1276.1.82008 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1276.1.82003 Boehringer Ingelheim Investigational Site
City
Wonju
Country
Korea, Republic of
Facility Name
1276.1.96001 Boehringer Ingelheim Investigational Site
City
Beirut
Country
Lebanon
Facility Name
1276.1.96002 Boehringer Ingelheim Investigational Site
City
El Chouf
Country
Lebanon
Facility Name
1276.1.96003 Boehringer Ingelheim Investigational Site
City
Saida
Country
Lebanon
Facility Name
1276.1.96004 Boehringer Ingelheim Investigational Site
City
Saida
Country
Lebanon
Facility Name
1276.1.60002 Boehringer Ingelheim Investigational Site
City
Ipoh, Perak
Country
Malaysia
Facility Name
1276.1.60001 Boehringer Ingelheim Investigational Site
City
Johor Bahru
Country
Malaysia
Facility Name
1276.1.60003 Boehringer Ingelheim Investigational Site
City
Kubang Kerian
Country
Malaysia
Facility Name
1276.1.52004 Boehringer Ingelheim Investigational Site
City
Aguascalientes
Country
Mexico
Facility Name
1276.1.52007 Boehringer Ingelheim Investigational Site
City
Aguascalientes
Country
Mexico
Facility Name
1276.1.52002 Boehringer Ingelheim Investigational Site
City
Ciudad de Mexico
Country
Mexico
Facility Name
1276.1.52003 Boehringer Ingelheim Investigational Site
City
Guadalajara
Country
Mexico
Facility Name
1276.1.52001 Boehringer Ingelheim Investigational Site
City
Monterrey
Country
Mexico
Facility Name
1276.1.52006 Boehringer Ingelheim Investigational Site
City
San Lucas tepetlcalco
Country
Mexico
Facility Name
1276.1.52005 Boehringer Ingelheim Investigational Site
City
Zapopan
Country
Mexico
Facility Name
1276.1.51001 Boehringer Ingelheim Investigational Site
City
Lima
Country
Peru
Facility Name
1276.1.51002 Boehringer Ingelheim Investigational Site
City
Lima
Country
Peru
Facility Name
1276.1.51003 Boehringer Ingelheim Investigational Site
City
Lima
Country
Peru
Facility Name
1276.1.51004 Boehringer Ingelheim Investigational Site
City
Lima
Country
Peru
Facility Name
1276.1.51005 Boehringer Ingelheim Investigational Site
City
Lima
Country
Peru
Facility Name
1276.1.63009 Boehringer Ingelheim Investigational Site
City
Cebu City, Cebu
Country
Philippines
Facility Name
1276.1.63002 Boehringer Ingelheim Investigational Site
City
Cebu City, Philippines
Country
Philippines
Facility Name
1276.1.63004 Boehringer Ingelheim Investigational Site
City
Davao City
Country
Philippines
Facility Name
1276.1.63003 Boehringer Ingelheim Investigational Site
City
Iloilo City
Country
Philippines
Facility Name
1276.1.63006 Boehringer Ingelheim Investigational Site
City
Manila
Country
Philippines
Facility Name
1276.1.63001 Boehringer Ingelheim Investigational Site
City
Marikina City
Country
Philippines
Facility Name
1276.1.63005 Boehringer Ingelheim Investigational Site
City
Maybunga, Pasig City
Country
Philippines
Facility Name
1276.1.63007 Boehringer Ingelheim Investigational Site
City
San Juan City
Country
Philippines
Facility Name
1276.1.63008 Boehringer Ingelheim Investigational Site
City
Tarlac
Country
Philippines
Facility Name
1276.1.70012 Boehringer Ingelheim Investigational Site
City
Barnaul
Country
Russian Federation
Facility Name
1276.1.70011 Boehringer Ingelheim Investigational Site
City
Kemerovo
Country
Russian Federation
Facility Name
1276.1.70015 Boehringer Ingelheim Investigational Site
City
Novosibirsk
Country
Russian Federation
Facility Name
1276.1.70016 Boehringer Ingelheim Investigational Site
City
Novosibirsk
Country
Russian Federation
Facility Name
1276.1.70018 Boehringer Ingelheim Investigational Site
City
Novosibirsk
Country
Russian Federation
Facility Name
1276.1.70007 Boehringer Ingelheim Investigational Site
City
Petrozavodsk
Country
Russian Federation
Facility Name
1276.1.70009 Boehringer Ingelheim Investigational Site
City
Saratov
Country
Russian Federation
Facility Name
1276.1.70010 Boehringer Ingelheim Investigational Site
City
Smolensk
Country
Russian Federation
Facility Name
1276.1.70005 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1276.1.70006 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1276.1.70017 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1276.1.70013 Boehringer Ingelheim Investigational Site
City
Yaroslavl
Country
Russian Federation
Facility Name
1276.1.38104 Boehringer Ingelheim Investigational Site
City
Belgrade
Country
Serbia
Facility Name
1276.1.38105 Boehringer Ingelheim Investigational Site
City
Belgrade
Country
Serbia
Facility Name
1276.1.38106 Boehringer Ingelheim Investigational Site
City
Belgrade
Country
Serbia
Facility Name
1276.1.38107 Boehringer Ingelheim Investigational Site
City
Belgrade
Country
Serbia
Facility Name
1276.1.38103 Boehringer Ingelheim Investigational Site
City
Kragujevac
Country
Serbia
Facility Name
1276.1.38101 Boehringer Ingelheim Investigational Site
City
Nis
Country
Serbia
Facility Name
1276.1.38108 Boehringer Ingelheim Investigational Site
City
Novi Sad
Country
Serbia
Facility Name
1276.1.38102 Boehringer Ingelheim Investigational Site
City
Zajecar
Country
Serbia
Facility Name
1276.1.34048 Boehringer Ingelheim Investigational Site
City
Alicante
Country
Spain
Facility Name
1276.1.34050 Boehringer Ingelheim Investigational Site
City
Alzira
Country
Spain
Facility Name
1276.1.34028 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1276.1.34045 Boehringer Ingelheim Investigational Site
City
pozuelo de Alarcon
Country
Spain
Facility Name
1276.1.34034 Boehringer Ingelheim Investigational Site
City
Sabadell (Barcelona)
Country
Spain
Facility Name
1276.1.34027 Boehringer Ingelheim Investigational Site
City
Salamanca
Country
Spain
Facility Name
1276.1.34052 Boehringer Ingelheim Investigational Site
City
Tarragona
Country
Spain
Facility Name
1276.1.34051 Boehringer Ingelheim Investigational Site
City
Zaragoza
Country
Spain
Facility Name
1276.1.88005 Boehringer Ingelheim Investigational Site
City
Kaohsiung City,
Country
Taiwan
Facility Name
1276.1.88002 Boehringer Ingelheim Investigational Site
City
New Taipei City
Country
Taiwan
Facility Name
1276.1.88001 Boehringer Ingelheim Investigational Site
City
Taichung
Country
Taiwan
Facility Name
1276.1.88003 Boehringer Ingelheim Investigational Site
City
Taichung
Country
Taiwan
Facility Name
1276.1.88004 Boehringer Ingelheim Investigational Site
City
Taichung
Country
Taiwan
Facility Name
1276.1.88006 Boehringer Ingelheim Investigational Site
City
Taipei
Country
Taiwan
Facility Name
1276.1.66001 Boehringer Ingelheim Investigational Site
City
Bangkok, Thailand
Country
Thailand
Facility Name
1276.1.66003 Boehringer Ingelheim Investigational Site
City
Bangkok, Thailand
Country
Thailand
Facility Name
1276.1.66002 Boehringer Ingelheim Investigational Site
City
Nakhon Ratchasima
Country
Thailand
Facility Name
1276.1.90003 Boehringer Ingelheim Investigational Site
City
Ankara
Country
Turkey
Facility Name
1276.1.90004 Boehringer Ingelheim Investigational Site
City
Antalya
Country
Turkey
Facility Name
1276.1.90006 Boehringer Ingelheim Investigational Site
City
Denizli
Country
Turkey
Facility Name
1276.1.90002 Boehringer Ingelheim Investigational Site
City
Erzurum
Country
Turkey
Facility Name
1276.1.90005 Boehringer Ingelheim Investigational Site
City
Istanbul
Country
Turkey
Facility Name
1276.1.90001 Boehringer Ingelheim Investigational Site
City
Izmir
Country
Turkey
Facility Name
1276.1.44002 Boehringer Ingelheim Investigational Site
City
Bolton
Country
United Kingdom
Facility Name
1276.1.44001 Boehringer Ingelheim Investigational Site
City
Bradford on Avon
Country
United Kingdom
Facility Name
1276.1.44005 Boehringer Ingelheim Investigational Site
City
Chippenham
Country
United Kingdom
Facility Name
1276.1.44006 Boehringer Ingelheim Investigational Site
City
Dagenham
Country
United Kingdom
Facility Name
1276.1.44004 Boehringer Ingelheim Investigational Site
City
Doncaster
Country
United Kingdom
Facility Name
1276.1.44008 Boehringer Ingelheim Investigational Site
City
Glasgow
Country
United Kingdom
Facility Name
1276.1.44003 Boehringer Ingelheim Investigational Site
City
Leeds
Country
United Kingdom
Facility Name
1276.1.44007 Boehringer Ingelheim Investigational Site
City
Manchester
Country
United Kingdom
Facility Name
1276.1.44011 Boehringer Ingelheim Investigational Site
City
Mortimer
Country
United Kingdom
Facility Name
1276.1.44009 Boehringer Ingelheim Investigational Site
City
Sandbach
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27493136
Citation
Hadjadj S, Rosenstock J, Meinicke T, Woerle HJ, Broedl UC. Initial Combination of Empagliflozin and Metformin in Patients With Type 2 Diabetes. Diabetes Care. 2016 Oct;39(10):1718-28. doi: 10.2337/dc16-0522. Epub 2016 Aug 4.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info

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Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes

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