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Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
high dose FDC
BI 10773 high dose
high dose FDC placebo
low dose FDC placebo
high dose FDC placebo
high dose FDC placebo
low dose FDC placebo
low dose FDC placebo
high dose BI 10773 placebo
low dose FDC
high dose FDC placebo
BI 10773 low dose
high dose BI 10773 placebo
high dose BI 10773 placebo
linagliptin
low dose FDC placebo
linagliptin placebo
BI 10773 low dose placebo
linagliptin placebo
low dose BI 10773 placebo
linagliptin placebo
high dose BI 10773 placebo
BI 10773 low dose placebo
low dose BI 10773 placebo
linagliptin placebo
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-naïve (defined as absence of any oral antidiabetic therapy, glucagon like peptide-1 analog or insulin for 12 weeks prior to randomization) or pre-treated with metformin (=1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
  3. Glycosylated hemoglobin (HbA1c) = 7.0% and = 10.5% (= 53.0 mmol/mol and = 91.3 mmol/mol) at Visit 1 (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 measurement (not on the same day).
  2. Any other antidiabetic drug within 12 weeks prior to randomization (except metformin background therapy as defined via inclusion criterion 2)
  3. Acute coronary syndrome (non-ST elevation myocardial infarction, ST elevation myocardial infarction and unstable angina pectoris), stroke or (transient ischemic attack) TIA within 3 months prior to informed consent

Sites / Locations

  • 1275.1.01103 Boehringer Ingelheim Investigational Site
  • 1275.1.01107 Boehringer Ingelheim Investigational Site
  • 1275.1.01043 Boehringer Ingelheim Investigational Site
  • 1275.1.01066 Boehringer Ingelheim Investigational Site
  • 1275.1.01047 Boehringer Ingelheim Investigational Site
  • 1275.1.01089 Boehringer Ingelheim Investigational Site
  • 1275.1.01064 Boehringer Ingelheim Investigational Site
  • 1275.1.01028 Boehringer Ingelheim Investigational Site
  • 1275.1.01086 Boehringer Ingelheim Investigational Site
  • 1275.1.01067 Boehringer Ingelheim Investigational Site
  • 1275.1.01109 Boehringer Ingelheim Investigational Site
  • 1275.1.01012 Boehringer Ingelheim Investigational Site
  • 1275.1.01050 Boehringer Ingelheim Investigational Site
  • 1275.1.01056 Boehringer Ingelheim Investigational Site
  • 1275.1.01021 Boehringer Ingelheim Investigational Site
  • 1275.1.01024 Boehringer Ingelheim Investigational Site
  • 1275.1.01112 Boehringer Ingelheim Investigational Site
  • 1275.1.01083 Boehringer Ingelheim Investigational Site
  • 1275.1.01071 Boehringer Ingelheim Investigational Site
  • 1275.1.01044 Boehringer Ingelheim Investigational Site
  • 1275.1.01078 Boehringer Ingelheim Investigational Site
  • 1275.1.01124 Boehringer Ingelheim Investigational Site
  • 1275.1.01010 Boehringer Ingelheim Investigational Site
  • 1275.1.01048 Boehringer Ingelheim Investigational Site
  • 1275.1.01073 Boehringer Ingelheim Investigational Site
  • 1275.1.01063 Boehringer Ingelheim Investigational Site
  • 1275.1.01077 Boehringer Ingelheim Investigational Site
  • 1275.1.01090 Boehringer Ingelheim Investigational Site
  • 1275.1.01054 Boehringer Ingelheim Investigational Site
  • 1275.1.01092 Boehringer Ingelheim Investigational Site
  • 1275.1.01040 Boehringer Ingelheim Investigational Site
  • 1275.1.01025 Boehringer Ingelheim Investigational Site
  • 1275.1.01065 Boehringer Ingelheim Investigational Site
  • 1275.1.01110 Boehringer Ingelheim Investigational Site
  • 1275.1.01094 Boehringer Ingelheim Investigational Site
  • 1275.1.01068 Boehringer Ingelheim Investigational Site
  • 1275.1.01051 Boehringer Ingelheim Investigational Site
  • 1275.1.01079 Boehringer Ingelheim Investigational Site
  • 1275.1.01117 Boehringer Ingelheim Investigational Site
  • 1275.1.01039 Boehringer Ingelheim Investigational Site
  • 1275.1.01007 Boehringer Ingelheim Investigational Site
  • 1275.1.01111 Boehringer Ingelheim Investigational Site
  • 1275.1.01076 Boehringer Ingelheim Investigational Site
  • 1275.1.01100 Boehringer Ingelheim Investigational Site
  • 1275.1.01042 Boehringer Ingelheim Investigational Site
  • 1275.1.01059 Boehringer Ingelheim Investigational Site
  • 1275.1.01003 Boehringer Ingelheim Investigational Site
  • 1275.1.01125 Boehringer Ingelheim Investigational Site
  • 1275.1.01081 Boehringer Ingelheim Investigational Site
  • 1275.1.01085 Boehringer Ingelheim Investigational Site
  • 1275.1.01035 Boehringer Ingelheim Investigational Site
  • 1275.1.01023 Boehringer Ingelheim Investigational Site
  • 1275.1.01027 Boehringer Ingelheim Investigational Site
  • 1275.1.01033 Boehringer Ingelheim Investigational Site
  • 1275.1.01099 Boehringer Ingelheim Investigational Site
  • 1275.1.01101 Boehringer Ingelheim Investigational Site
  • 1275.1.01114 Boehringer Ingelheim Investigational Site
  • 1275.1.01123 Boehringer Ingelheim Investigational Site
  • 1275.1.01013 Boehringer Ingelheim Investigational Site
  • 1275.1.01057 Boehringer Ingelheim Investigational Site
  • 1275.1.01002 Boehringer Ingelheim Investigational Site
  • 1275.1.01020 Boehringer Ingelheim Investigational Site
  • 1275.1.01095 Boehringer Ingelheim Investigational Site
  • 1275.1.01062 Boehringer Ingelheim Investigational Site
  • 1275.1.01006 Boehringer Ingelheim Investigational Site
  • 1275.1.01011 Boehringer Ingelheim Investigational Site
  • 1275.1.01052 Boehringer Ingelheim Investigational Site
  • 1275.1.01045 Boehringer Ingelheim Investigational Site
  • 1275.1.01001 Boehringer Ingelheim Investigational Site
  • 1275.1.01032 Boehringer Ingelheim Investigational Site
  • 1275.1.01061 Boehringer Ingelheim Investigational Site
  • 1275.1.01116 Boehringer Ingelheim Investigational Site
  • 1275.1.01016 Boehringer Ingelheim Investigational Site
  • 1275.1.01102 Boehringer Ingelheim Investigational Site
  • 1275.1.01017 Boehringer Ingelheim Investigational Site
  • 1275.1.01036 Boehringer Ingelheim Investigational Site
  • 1275.1.01030 Boehringer Ingelheim Investigational Site
  • 1275.1.01055 Boehringer Ingelheim Investigational Site
  • 1275.1.01075 Boehringer Ingelheim Investigational Site
  • 1275.1.01034 Boehringer Ingelheim Investigational Site
  • 1275.1.01082 Boehringer Ingelheim Investigational Site
  • 1275.1.01084 Boehringer Ingelheim Investigational Site
  • 1275.1.01038 Boehringer Ingelheim Investigational Site
  • 1275.1.01019 Boehringer Ingelheim Investigational Site
  • 1275.1.01072 Boehringer Ingelheim Investigational Site
  • 1275.1.01088 Boehringer Ingelheim Investigational Site
  • 1275.1.01014 Boehringer Ingelheim Investigational Site
  • 1275.1.01060 Boehringer Ingelheim Investigational Site
  • 1275.1.01093 Boehringer Ingelheim Investigational Site
  • 1275.1.01122 Boehringer Ingelheim Investigational Site
  • 1275.1.01005 Boehringer Ingelheim Investigational Site
  • 1275.1.01015 Boehringer Ingelheim Investigational Site
  • 1275.1.01031 Boehringer Ingelheim Investigational Site
  • 1275.1.01121 Boehringer Ingelheim Investigational Site
  • 1275.1.01069 Boehringer Ingelheim Investigational Site
  • 1275.1.01049 Boehringer Ingelheim Investigational Site
  • 1275.1.01080 Boehringer Ingelheim Investigational Site
  • 1275.1.01029 Boehringer Ingelheim Investigational Site
  • 1275.1.01053 Boehringer Ingelheim Investigational Site
  • 1275.1.01106 Boehringer Ingelheim Investigational Site
  • 1275.1.01018 Boehringer Ingelheim Investigational Site
  • 1275.1.01096 Boehringer Ingelheim Investigational Site
  • 1275.1.01113 Boehringer Ingelheim Investigational Site
  • 1275.1.01120 Boehringer Ingelheim Investigational Site
  • 1275.1.01105 Boehringer Ingelheim Investigational Site
  • 1275.1.01037 Boehringer Ingelheim Investigational Site
  • 1275.1.01008 Boehringer Ingelheim Investigational Site
  • 1275.1.01022 Boehringer Ingelheim Investigational Site
  • 1275.1.01091 Boehringer Ingelheim Investigational Site
  • 1275.1.01118 Boehringer Ingelheim Investigational Site
  • 1275.1.01087 Boehringer Ingelheim Investigational Site
  • 1275.1.01119 Boehringer Ingelheim Investigational Site
  • 1275.1.54001 Boehringer Ingelheim Investigational Site
  • 1275.1.54005 Boehringer Ingelheim Investigational Site
  • 1275.1.54003 Boehringer Ingelheim Investigational Site
  • 1275.1.54004 Boehringer Ingelheim Investigational Site
  • 1275.1.54002 Boehringer Ingelheim Investigational Site
  • 1275.1.61003 Boehringer Ingelheim Investigational Site
  • 1275.1.61002 Boehringer Ingelheim Investigational Site
  • 1275.1.55002 Boehringer Ingelheim Investigational Site
  • 1275.1.55001 Boehringer Ingelheim Investigational Site
  • 1275.1.55005 Boehringer Ingelheim Investigational Site
  • 1275.1.59003 Boehringer Ingelheim Investigational Site
  • 1275.1.59006 Boehringer Ingelheim Investigational Site
  • 1275.1.59004 Boehringer Ingelheim Investigational Site
  • 1275.1.20008 Boehringer Ingelheim Investigational Site
  • 1275.1.20007 Boehringer Ingelheim Investigational Site
  • 1275.1.20006 Boehringer Ingelheim Investigational Site
  • 1275.1.20004 Boehringer Ingelheim Investigational Site
  • 1275.1.20001 Boehringer Ingelheim Investigational Site
  • 1275.1.20005 Boehringer Ingelheim Investigational Site
  • 1275.1.20003 Boehringer Ingelheim Investigational Site
  • 1275.1.20002 Boehringer Ingelheim Investigational Site
  • 1275.1.57004 Boehringer Ingelheim Investigational Site
  • 1275.1.57005 Boehringer Ingelheim Investigational Site
  • 1275.1.57002 Boehringer Ingelheim Investigational Site
  • 1275.1.57003 Boehringer Ingelheim Investigational Site
  • 1275.1.45004 Boehringer Ingelheim Investigational Site
  • 1275.1.45003 Boehringer Ingelheim Investigational Site
  • 1275.1.45002 Boehringer Ingelheim Investigational Site
  • 1275.1.37206 Boehringer Ingelheim Investigational Site
  • 1275.1.37202 Boehringer Ingelheim Investigational Site
  • 1275.1.37201 Boehringer Ingelheim Investigational Site
  • 1275.1.37204 Boehringer Ingelheim Investigational Site
  • 1275.1.37203 Boehringer Ingelheim Investigational Site
  • 1275.1.36002 Boehringer Ingelheim Investigational Site
  • 1275.1.36003 Boehringer Ingelheim Investigational Site
  • 1275.1.36001 Boehringer Ingelheim Investigational Site
  • 1275.1.39003 Boehringer Ingelheim Investigational Site
  • 1275.1.39002 Boehringer Ingelheim Investigational Site
  • 1275.1.39001 Boehringer Ingelheim Investigational Site
  • 1275.1.39004 Boehringer Ingelheim Investigational Site
  • 1275.1.96004 Boehringer Ingelheim Investigational Site
  • 1275.1.96002 Boehringer Ingelheim Investigational Site
  • 1275.1.96003 Boehringer Ingelheim Investigational Site
  • 1275.1.96006 Boehringer Ingelheim Investigational Site
  • 1275.1.96008 Boehringer Ingelheim Investigational Site
  • 1275.1.96007 Boehringer Ingelheim Investigational Site
  • 1275.1.60001 Boehringer Ingelheim Investigational Site
  • 1275.1.60002 Boehringer Ingelheim Investigational Site
  • 1275.1.52002 Boehringer Ingelheim Investigational Site
  • 1275.1.52005 Boehringer Ingelheim Investigational Site
  • 1275.1.52003 Boehringer Ingelheim Investigational Site
  • 1275.1.52001 Boehringer Ingelheim Investigational Site
  • 1275.1.52004 Boehringer Ingelheim Investigational Site
  • 1275.1.51001 Boehringer Ingelheim Investigational Site
  • 1275.1.51003 Boehringer Ingelheim Investigational Site
  • 1275.1.51002 Boehringer Ingelheim Investigational Site
  • 1275.1.51004 Boehringer Ingelheim Investigational Site
  • 1275.1.51005 Boehringer Ingelheim Investigational Site
  • 1275.1.63002 Boehringer Ingelheim Investigational Site
  • 1275.1.63001 Boehringer Ingelheim Investigational Site
  • 1275.1.63004 Boehringer Ingelheim Investigational Site
  • 1275.1.63006 Boehringer Ingelheim Investigational Site
  • 1275.1.63003 Boehringer Ingelheim Investigational Site
  • 1275.1.63005 Boehringer Ingelheim Investigational Site
  • 1275.1.48002 Boehringer Ingelheim Investigational Site
  • 1275.1.48004 Boehringer Ingelheim Investigational Site
  • 1275.1.48001 Boehringer Ingelheim Investigational Site
  • 1275.1.48003 Boehringer Ingelheim Investigational Site
  • 1275.1.40001 Boehringer Ingelheim Investigational Site
  • 1275.1.40005 Boehringer Ingelheim Investigational Site
  • 1275.1.40004 Boehringer Ingelheim Investigational Site
  • 1275.1.40008 Boehringer Ingelheim Investigational Site
  • 1275.1.40009 Boehringer Ingelheim Investigational Site
  • 1275.1.40006 Boehringer Ingelheim Investigational Site
  • 1275.1.40007 Boehringer Ingelheim Investigational Site
  • 1275.1.40002 Boehringer Ingelheim Investigational Site
  • 1275.1.40010 Boehringer Ingelheim Investigational Site
  • 1275.1.40003 Boehringer Ingelheim Investigational Site
  • 1275.1.70006 Boehringer Ingelheim Investigational Site
  • 1275.1.70001 Boehringer Ingelheim Investigational Site
  • 1275.1.70004 Boehringer Ingelheim Investigational Site
  • 1275.1.70002 Boehringer Ingelheim Investigational Site
  • 1275.1.70003 Boehringer Ingelheim Investigational Site
  • 1275.1.70005 Boehringer Ingelheim Investigational Site
  • 1275.1.34004 Boehringer Ingelheim Investigational Site
  • 1275.1.34005 Boehringer Ingelheim Investigational Site
  • 1275.1.34002 Boehringer Ingelheim Investigational Site
  • 1275.1.34003 Boehringer Ingelheim Investigational Site
  • 1275.1.34006 Boehringer Ingelheim Investigational Site
  • 1275.1.46003 Boehringer Ingelheim Investigational Site
  • 1275.1.46004 Boehringer Ingelheim Investigational Site
  • 1275.1.46002 Boehringer Ingelheim Investigational Site
  • 1275.1.88006 Chang Gung Memorial Hospital-CY
  • 1275.1.88007 E-Da Hospital
  • 1275.1.88001 Cardinal Tien Hospital
  • 1275.1.88004 Taichung Veterans General Hospital
  • 1275.1.88008 Chi Mei Medical Center
  • 1275.1.88002 Far Eastern Memorial Hospital
  • 1275.1.88003 Taipei Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

BI 10773/linagliptin FDC (high dose)

BI 10773/linagliptin FDC (low dose)

BI 10773 (high dose)

BI 10773 (low dose)

Linagliptin

Arm Description

Patients receive BI 10773/linagliptin FDC (high dose) once daily

Patients receive BI 10773/linagliptin FDC (low dose) once daily

Patients receive BI 10773 (high dose) once daily

Patients receive BI 10773 (low dose) once daily

Patients receive linagliptin once daily

Outcomes

Primary Outcome Measures

Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients
Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients
Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.

Secondary Outcome Measures

Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients
Change from baseline in fasting plasma glucose at week 24 for Metformin Background patients.
Change From Baseline in Fasting Plasma Glucose at Week 24 for Treatment Naive Patients
Change from baseline in fasting plasma glucose at week 24 for Treatment Naive patients.
Change From Baseline in Body Weight for Metformin Background Patients
Change from baseline in body weight for Metformin Background patients.
Change From Baseline in Body Weight for Treatment Naive Patients
Change from baseline in body weight for Treatment Naive patients.
Occurrence of Treat to Target Efficacy Response for Metformin Background Patients
Occurrence of the treat-to-target efficacy response for Metformin Background patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline.
Occurrence of Treat to Target Efficacy Response for Treatment Naive Patients
Occurrence of the treat-to-target efficacy response for Treatment Naive patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline.

Full Information

First Posted
August 23, 2011
Last Updated
April 1, 2015
Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01422876
Brief Title
Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients
Official Title
A Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Once Daily Oral Administration of BI 10773 25 mg/Linagliptin 5 mg and BI 10773 10 mg/Linagliptin 5 mg Fixed Dose Combination Tablets Compared With the Individual Components (BI 10773 25 mg, BI 10773 10 mg, and Linagliptin 5 mg) for 52 Weeks in Treatment naïve and Metformin Treated Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (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 trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1405 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 10773/linagliptin FDC (high dose)
Arm Type
Experimental
Arm Description
Patients receive BI 10773/linagliptin FDC (high dose) once daily
Arm Title
BI 10773/linagliptin FDC (low dose)
Arm Type
Experimental
Arm Description
Patients receive BI 10773/linagliptin FDC (low dose) once daily
Arm Title
BI 10773 (high dose)
Arm Type
Active Comparator
Arm Description
Patients receive BI 10773 (high dose) once daily
Arm Title
BI 10773 (low dose)
Arm Type
Active Comparator
Arm Description
Patients receive BI 10773 (low dose) once daily
Arm Title
Linagliptin
Arm Type
Active Comparator
Arm Description
Patients receive linagliptin once daily
Intervention Type
Drug
Intervention Name(s)
high dose FDC
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
BI 10773 high dose
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
high dose FDC placebo
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
low dose FDC placebo
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
high dose FDC placebo
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
high dose FDC placebo
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
low dose FDC placebo
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
low dose FDC placebo
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
high dose BI 10773 placebo
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
low dose FDC
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
high dose FDC placebo
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
BI 10773 low dose
Intervention Description
low dose once daily
Intervention Type
Drug
Intervention Name(s)
high dose BI 10773 placebo
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
high dose BI 10773 placebo
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
linagliptin
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
low dose FDC placebo
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
linagliptin placebo
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
BI 10773 low dose placebo
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
linagliptin placebo
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
low dose BI 10773 placebo
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
linagliptin placebo
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
high dose BI 10773 placebo
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
BI 10773 low dose placebo
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
low dose BI 10773 placebo
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
linagliptin placebo
Intervention Description
once daily
Primary Outcome Measure Information:
Title
Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients
Description
Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.
Time Frame
Baseline and 24 weeks
Title
Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients
Description
Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.
Time Frame
Baseline and 24 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients
Description
Change from baseline in fasting plasma glucose at week 24 for Metformin Background patients.
Time Frame
Baseline and 24 Weeks
Title
Change From Baseline in Fasting Plasma Glucose at Week 24 for Treatment Naive Patients
Description
Change from baseline in fasting plasma glucose at week 24 for Treatment Naive patients.
Time Frame
Baseline and 24 Weeks
Title
Change From Baseline in Body Weight for Metformin Background Patients
Description
Change from baseline in body weight for Metformin Background patients.
Time Frame
Baseline and 24 Weeks
Title
Change From Baseline in Body Weight for Treatment Naive Patients
Description
Change from baseline in body weight for Treatment Naive patients.
Time Frame
Baseline and 24 Weeks
Title
Occurrence of Treat to Target Efficacy Response for Metformin Background Patients
Description
Occurrence of the treat-to-target efficacy response for Metformin Background patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline.
Time Frame
24 Weeks
Title
Occurrence of Treat to Target Efficacy Response for Treatment Naive Patients
Description
Occurrence of the treat-to-target efficacy response for Treatment Naive patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline.
Time Frame
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-naïve (defined as absence of any oral antidiabetic therapy, glucagon like peptide-1 analog or insulin for 12 weeks prior to randomization) or pre-treated with metformin (=1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Glycosylated hemoglobin (HbA1c) = 7.0% and = 10.5% (= 53.0 mmol/mol and = 91.3 mmol/mol) at Visit 1 (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 measurement (not on the same day). Any other antidiabetic drug within 12 weeks prior to randomization (except metformin background therapy as defined via inclusion criterion 2) Acute coronary syndrome (non-ST elevation myocardial infarction, ST elevation myocardial infarction and unstable angina pectoris), stroke or (transient ischemic attack) TIA within 3 months prior to informed consent
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
1275.1.01103 Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
1275.1.01107 Boehringer Ingelheim Investigational Site
City
Foley
State/Province
Alabama
Country
United States
Facility Name
1275.1.01043 Boehringer Ingelheim Investigational Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
1275.1.01066 Boehringer Ingelheim Investigational Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
1275.1.01047 Boehringer Ingelheim Investigational Site
City
Pell City
State/Province
Alabama
Country
United States
Facility Name
1275.1.01089 Boehringer Ingelheim Investigational Site
City
Mesa
State/Province
Arizona
Country
United States
Facility Name
1275.1.01064 Boehringer Ingelheim Investigational Site
City
Tempe
State/Province
Arizona
Country
United States
Facility Name
1275.1.01028 Boehringer Ingelheim Investigational Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
1275.1.01086 Boehringer Ingelheim Investigational Site
City
Cerritos
State/Province
California
Country
United States
Facility Name
1275.1.01067 Boehringer Ingelheim Investigational Site
City
Chula Vista
State/Province
California
Country
United States
Facility Name
1275.1.01109 Boehringer Ingelheim Investigational Site
City
Encino
State/Province
California
Country
United States
Facility Name
1275.1.01012 Boehringer Ingelheim Investigational Site
City
Fresno
State/Province
California
Country
United States
Facility Name
1275.1.01050 Boehringer Ingelheim Investigational Site
City
Harbor City
State/Province
California
Country
United States
Facility Name
1275.1.01056 Boehringer Ingelheim Investigational Site
City
Huntington Park
State/Province
California
Country
United States
Facility Name
1275.1.01021 Boehringer Ingelheim Investigational Site
City
Long Beach
State/Province
California
Country
United States
Facility Name
1275.1.01024 Boehringer Ingelheim Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1275.1.01112 Boehringer Ingelheim Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1275.1.01083 Boehringer Ingelheim Investigational Site
City
Oceanside
State/Province
California
Country
United States
Facility Name
1275.1.01071 Boehringer Ingelheim Investigational Site
City
San Dimas
State/Province
California
Country
United States
Facility Name
1275.1.01044 Boehringer Ingelheim Investigational Site
City
Tustin
State/Province
California
Country
United States
Facility Name
1275.1.01078 Boehringer Ingelheim Investigational Site
City
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
1275.1.01124 Boehringer Ingelheim Investigational Site
City
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
1275.1.01010 Boehringer Ingelheim Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
1275.1.01048 Boehringer Ingelheim Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
1275.1.01073 Boehringer Ingelheim Investigational Site
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
1275.1.01063 Boehringer Ingelheim Investigational Site
City
Hialeah
State/Province
Florida
Country
United States
Facility Name
1275.1.01077 Boehringer Ingelheim Investigational Site
City
Hialeah
State/Province
Florida
Country
United States
Facility Name
1275.1.01090 Boehringer Ingelheim Investigational Site
City
Inverness
State/Province
Florida
Country
United States
Facility Name
1275.1.01054 Boehringer Ingelheim Investigational Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
1275.1.01092 Boehringer Ingelheim Investigational Site
City
Maitland
State/Province
Florida
Country
United States
Facility Name
1275.1.01040 Boehringer Ingelheim Investigational Site
City
Miami Beach
State/Province
Florida
Country
United States
Facility Name
1275.1.01025 Boehringer Ingelheim Investigational Site
City
Miami Lakes
State/Province
Florida
Country
United States
Facility Name
1275.1.01065 Boehringer Ingelheim Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
1275.1.01110 Boehringer Ingelheim Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
1275.1.01094 Boehringer Ingelheim Investigational Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
1275.1.01068 Boehringer Ingelheim Investigational Site
City
Ormond Beach
State/Province
Florida
Country
United States
Facility Name
1275.1.01051 Boehringer Ingelheim Investigational Site
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
1275.1.01079 Boehringer Ingelheim Investigational Site
City
Port Orange
State/Province
Florida
Country
United States
Facility Name
1275.1.01117 Boehringer Ingelheim Investigational Site
City
St. Petersburg
State/Province
Florida
Country
United States
Facility Name
1275.1.01039 Boehringer Ingelheim Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
1275.1.01007 Boehringer Ingelheim Investigational Site
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
1275.1.01111 Boehringer Ingelheim Investigational Site
City
Norcross
State/Province
Georgia
Country
United States
Facility Name
1275.1.01076 Boehringer Ingelheim Investigational Site
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
1275.1.01100 Boehringer Ingelheim Investigational Site
City
Addison
State/Province
Illinois
Country
United States
Facility Name
1275.1.01042 Boehringer Ingelheim Investigational Site
City
Des Moines
State/Province
Iowa
Country
United States
Facility Name
1275.1.01059 Boehringer Ingelheim Investigational Site
City
Paducah
State/Province
Kentucky
Country
United States
Facility Name
1275.1.01003 Boehringer Ingelheim Investigational Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
1275.1.01125 Boehringer Ingelheim Investigational Site
City
Hyattsville
State/Province
Maryland
Country
United States
Facility Name
1275.1.01081 Boehringer Ingelheim Investigational Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
1275.1.01085 Boehringer Ingelheim Investigational Site
City
Rochester
State/Province
Michigan
Country
United States
Facility Name
1275.1.01035 Boehringer Ingelheim Investigational Site
City
Southfield
State/Province
Michigan
Country
United States
Facility Name
1275.1.01023 Boehringer Ingelheim Investigational Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
1275.1.01027 Boehringer Ingelheim Investigational Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
1275.1.01033 Boehringer Ingelheim Investigational Site
City
Great Falls
State/Province
Montana
Country
United States
Facility Name
1275.1.01099 Boehringer Ingelheim Investigational Site
City
Henderson
State/Province
Nevada
Country
United States
Facility Name
1275.1.01101 Boehringer Ingelheim Investigational Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
1275.1.01114 Boehringer Ingelheim Investigational Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
1275.1.01123 Boehringer Ingelheim Investigational Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
1275.1.01013 Boehringer Ingelheim Investigational Site
City
Elizabeth
State/Province
New Jersey
Country
United States
Facility Name
1275.1.01057 Boehringer Ingelheim Investigational Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
1275.1.01002 Boehringer Ingelheim Investigational Site
City
Binghamton
State/Province
New York
Country
United States
Facility Name
1275.1.01020 Boehringer Ingelheim Investigational Site
City
Endwell
State/Province
New York
Country
United States
Facility Name
1275.1.01095 Boehringer Ingelheim Investigational Site
City
Flushing
State/Province
New York
Country
United States
Facility Name
1275.1.01062 Boehringer Ingelheim Investigational Site
City
Glens Falls
State/Province
New York
Country
United States
Facility Name
1275.1.01006 Boehringer Ingelheim Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
1275.1.01011 Boehringer Ingelheim Investigational Site
City
Asheboro
State/Province
North Carolina
Country
United States
Facility Name
1275.1.01052 Boehringer Ingelheim Investigational Site
City
Burlington
State/Province
North Carolina
Country
United States
Facility Name
1275.1.01045 Boehringer Ingelheim Investigational Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
1275.1.01001 Boehringer Ingelheim Investigational Site
City
Akron
State/Province
Ohio
Country
United States
Facility Name
1275.1.01032 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
1275.1.01061 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
1275.1.01116 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
1275.1.01016 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
1275.1.01102 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
1275.1.01017 Boehringer Ingelheim Investigational Site
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
1275.1.01036 Boehringer Ingelheim Investigational Site
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
1275.1.01030 Boehringer Ingelheim Investigational Site
City
Delaware
State/Province
Ohio
Country
United States
Facility Name
1275.1.01055 Boehringer Ingelheim Investigational Site
City
Groveport
State/Province
Ohio
Country
United States
Facility Name
1275.1.01075 Boehringer Ingelheim Investigational Site
City
Wadsworth
State/Province
Ohio
Country
United States
Facility Name
1275.1.01034 Boehringer Ingelheim Investigational Site
City
Norman
State/Province
Oklahoma
Country
United States
Facility Name
1275.1.01082 Boehringer Ingelheim Investigational Site
City
Corvallis
State/Province
Oregon
Country
United States
Facility Name
1275.1.01084 Boehringer Ingelheim Investigational Site
City
Altoona
State/Province
Pennsylvania
Country
United States
Facility Name
1275.1.01038 Boehringer Ingelheim Investigational Site
City
Fleetwood
State/Province
Pennsylvania
Country
United States
Facility Name
1275.1.01019 Boehringer Ingelheim Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
1275.1.01072 Boehringer Ingelheim Investigational Site
City
Scottdale
State/Province
Pennsylvania
Country
United States
Facility Name
1275.1.01088 Boehringer Ingelheim Investigational Site
City
Tipton
State/Province
Pennsylvania
Country
United States
Facility Name
1275.1.01014 Boehringer Ingelheim Investigational Site
City
Uniontown
State/Province
Pennsylvania
Country
United States
Facility Name
1275.1.01060 Boehringer Ingelheim Investigational Site
City
Uniontown
State/Province
Pennsylvania
Country
United States
Facility Name
1275.1.01093 Boehringer Ingelheim Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
1275.1.01122 Boehringer Ingelheim Investigational Site
City
Florence
State/Province
South Carolina
Country
United States
Facility Name
1275.1.01005 Boehringer Ingelheim Investigational Site
City
Hodges
State/Province
South Carolina
Country
United States
Facility Name
1275.1.01015 Boehringer Ingelheim Investigational Site
City
Brentwood
State/Province
Tennessee
Country
United States
Facility Name
1275.1.01031 Boehringer Ingelheim Investigational Site
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
1275.1.01121 Boehringer Ingelheim Investigational Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
1275.1.01069 Boehringer Ingelheim Investigational Site
City
Spring Hill
State/Province
Tennessee
Country
United States
Facility Name
1275.1.01049 Boehringer Ingelheim Investigational Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
1275.1.01080 Boehringer Ingelheim Investigational Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
1275.1.01029 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1275.1.01053 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1275.1.01106 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1275.1.01018 Boehringer Ingelheim Investigational Site
City
Pearland
State/Province
Texas
Country
United States
Facility Name
1275.1.01096 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1275.1.01113 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1275.1.01120 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1275.1.01105 Boehringer Ingelheim Investigational Site
City
Spring
State/Province
Texas
Country
United States
Facility Name
1275.1.01037 Boehringer Ingelheim Investigational Site
City
Waco
State/Province
Texas
Country
United States
Facility Name
1275.1.01008 Boehringer Ingelheim Investigational Site
City
Bountiful
State/Province
Utah
Country
United States
Facility Name
1275.1.01022 Boehringer Ingelheim Investigational Site
City
West Jordan
State/Province
Utah
Country
United States
Facility Name
1275.1.01091 Boehringer Ingelheim Investigational Site
City
South Chesterfield
State/Province
Virginia
Country
United States
Facility Name
1275.1.01118 Boehringer Ingelheim Investigational Site
City
Selah
State/Province
Washington
Country
United States
Facility Name
1275.1.01087 Boehringer Ingelheim Investigational Site
City
Shoreline
State/Province
Washington
Country
United States
Facility Name
1275.1.01119 Boehringer Ingelheim Investigational Site
City
Spokane
State/Province
Washington
Country
United States
Facility Name
1275.1.54001 Boehringer Ingelheim Investigational Site
City
Caba
Country
Argentina
Facility Name
1275.1.54005 Boehringer Ingelheim Investigational Site
City
Capital Federal
Country
Argentina
Facility Name
1275.1.54003 Boehringer Ingelheim Investigational Site
City
Cordoba
Country
Argentina
Facility Name
1275.1.54004 Boehringer Ingelheim Investigational Site
City
Mar del Plata
Country
Argentina
Facility Name
1275.1.54002 Boehringer Ingelheim Investigational Site
City
Mendoza
Country
Argentina
Facility Name
1275.1.61003 Boehringer Ingelheim Investigational Site
City
Wollongong
State/Province
New South Wales
Country
Australia
Facility Name
1275.1.61002 Boehringer Ingelheim Investigational Site
City
East Ringwood
State/Province
Victoria
Country
Australia
Facility Name
1275.1.55002 Boehringer Ingelheim Investigational Site
City
Joaquim Távora
Country
Brazil
Facility Name
1275.1.55001 Boehringer Ingelheim Investigational Site
City
Rio de Janeiro - RJ
Country
Brazil
Facility Name
1275.1.55005 Boehringer Ingelheim Investigational Site
City
Sao Paulo
Country
Brazil
Facility Name
1275.1.59003 Boehringer Ingelheim Investigational Site
City
Plovdiv
Country
Bulgaria
Facility Name
1275.1.59006 Boehringer Ingelheim Investigational Site
City
Ruse
Country
Bulgaria
Facility Name
1275.1.59004 Boehringer Ingelheim Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
1275.1.20008 Boehringer Ingelheim Investigational Site
City
Bathurst
State/Province
New Brunswick
Country
Canada
Facility Name
1275.1.20007 Boehringer Ingelheim Investigational Site
City
Bay Roberts
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
1275.1.20006 Boehringer Ingelheim Investigational Site
City
Mount Pearl
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
1275.1.20004 Boehringer Ingelheim Investigational Site
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
1275.1.20001 Boehringer Ingelheim Investigational Site
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
1275.1.20005 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1275.1.20003 Boehringer Ingelheim Investigational Site
City
Drummondville
State/Province
Quebec
Country
Canada
Facility Name
1275.1.20002 Boehringer Ingelheim Investigational Site
City
Pointe Claire
State/Province
Quebec
Country
Canada
Facility Name
1275.1.57004 Boehringer Ingelheim Investigational Site
City
Barranquilla
Country
Colombia
Facility Name
1275.1.57005 Boehringer Ingelheim Investigational Site
City
Bogota
Country
Colombia
Facility Name
1275.1.57002 Boehringer Ingelheim Investigational Site
City
Bogotá
Country
Colombia
Facility Name
1275.1.57003 Boehringer Ingelheim Investigational Site
City
Tolima
Country
Colombia
Facility Name
1275.1.45004 Boehringer Ingelheim Investigational Site
City
Aalborg
Country
Denmark
Facility Name
1275.1.45003 Boehringer Ingelheim Investigational Site
City
Aarhus C
Country
Denmark
Facility Name
1275.1.45002 Boehringer Ingelheim Investigational Site
City
København NV
Country
Denmark
Facility Name
1275.1.37206 Boehringer Ingelheim Investigational Site
City
Kivioli
Country
Estonia
Facility Name
1275.1.37202 Boehringer Ingelheim Investigational Site
City
Pärnu
Country
Estonia
Facility Name
1275.1.37201 Boehringer Ingelheim Investigational Site
City
Tallinn
Country
Estonia
Facility Name
1275.1.37204 Boehringer Ingelheim Investigational Site
City
Tallinn
Country
Estonia
Facility Name
1275.1.37203 Boehringer Ingelheim Investigational Site
City
Viljandi County
Country
Estonia
Facility Name
1275.1.36002 Boehringer Ingelheim Investigational Site
City
Budapest
Country
Hungary
Facility Name
1275.1.36003 Boehringer Ingelheim Investigational Site
City
Budapest
Country
Hungary
Facility Name
1275.1.36001 Boehringer Ingelheim Investigational Site
City
Gyongyos
Country
Hungary
Facility Name
1275.1.39003 Boehringer Ingelheim Investigational Site
City
Bassano del Grappa (VI)
Country
Italy
Facility Name
1275.1.39002 Boehringer Ingelheim Investigational Site
City
Fermo
Country
Italy
Facility Name
1275.1.39001 Boehringer Ingelheim Investigational Site
City
Milan
Country
Italy
Facility Name
1275.1.39004 Boehringer Ingelheim Investigational Site
City
Roma
Country
Italy
Facility Name
1275.1.96004 Boehringer Ingelheim Investigational Site
City
Baabda
Country
Lebanon
Facility Name
1275.1.96002 Boehringer Ingelheim Investigational Site
City
Beirut
Country
Lebanon
Facility Name
1275.1.96003 Boehringer Ingelheim Investigational Site
City
Beirut
Country
Lebanon
Facility Name
1275.1.96006 Boehringer Ingelheim Investigational Site
City
Beirut
Country
Lebanon
Facility Name
1275.1.96008 Boehringer Ingelheim Investigational Site
City
Beirut
Country
Lebanon
Facility Name
1275.1.96007 Boehringer Ingelheim Investigational Site
City
Saida
Country
Lebanon
Facility Name
1275.1.60001 Boehringer Ingelheim Investigational Site
City
Kedah
Country
Malaysia
Facility Name
1275.1.60002 Boehringer Ingelheim Investigational Site
City
Perak
Country
Malaysia
Facility Name
1275.1.52002 Boehringer Ingelheim Investigational Site
City
Mexico
Country
Mexico
Facility Name
1275.1.52005 Boehringer Ingelheim Investigational Site
City
Mexico
Country
Mexico
Facility Name
1275.1.52003 Boehringer Ingelheim Investigational Site
City
Monterrey
Country
Mexico
Facility Name
1275.1.52001 Boehringer Ingelheim Investigational Site
City
Pachuca
Country
Mexico
Facility Name
1275.1.52004 Boehringer Ingelheim Investigational Site
City
San Luis Potosí
Country
Mexico
Facility Name
1275.1.51001 Boehringer Ingelheim Investigational Site
City
Arequipa
Country
Peru
Facility Name
1275.1.51003 Boehringer Ingelheim Investigational Site
City
Ica
Country
Peru
Facility Name
1275.1.51002 Boehringer Ingelheim Investigational Site
City
Lima
Country
Peru
Facility Name
1275.1.51004 Boehringer Ingelheim Investigational Site
City
Lima
Country
Peru
Facility Name
1275.1.51005 Boehringer Ingelheim Investigational Site
City
Lima
Country
Peru
Facility Name
1275.1.63002 Boehringer Ingelheim Investigational Site
City
Davao
Country
Philippines
Facility Name
1275.1.63001 Boehringer Ingelheim Investigational Site
City
Greenhills, San Juan
Country
Philippines
Facility Name
1275.1.63004 Boehringer Ingelheim Investigational Site
City
Manila
Country
Philippines
Facility Name
1275.1.63006 Boehringer Ingelheim Investigational Site
City
Marikina city
Country
Philippines
Facility Name
1275.1.63003 Boehringer Ingelheim Investigational Site
City
Pasay City
Country
Philippines
Facility Name
1275.1.63005 Boehringer Ingelheim Investigational Site
City
Pasig
Country
Philippines
Facility Name
1275.1.48002 Boehringer Ingelheim Investigational Site
City
Lodz
Country
Poland
Facility Name
1275.1.48004 Boehringer Ingelheim Investigational Site
City
Poznan
Country
Poland
Facility Name
1275.1.48001 Boehringer Ingelheim Investigational Site
City
Warsaw
Country
Poland
Facility Name
1275.1.48003 Boehringer Ingelheim Investigational Site
City
Warsaw
Country
Poland
Facility Name
1275.1.40001 Boehringer Ingelheim Investigational Site
City
Alba Iulia
Country
Romania
Facility Name
1275.1.40005 Boehringer Ingelheim Investigational Site
City
Baia Mare Maramures
Country
Romania
Facility Name
1275.1.40004 Boehringer Ingelheim Investigational Site
City
Brasov
Country
Romania
Facility Name
1275.1.40008 Boehringer Ingelheim Investigational Site
City
Bucharest
Country
Romania
Facility Name
1275.1.40009 Boehringer Ingelheim Investigational Site
City
Bucharest
Country
Romania
Facility Name
1275.1.40006 Boehringer Ingelheim Investigational Site
City
Cluj-Napoca
Country
Romania
Facility Name
1275.1.40007 Boehringer Ingelheim Investigational Site
City
Galati
Country
Romania
Facility Name
1275.1.40002 Boehringer Ingelheim Investigational Site
City
Oradea
Country
Romania
Facility Name
1275.1.40010 Boehringer Ingelheim Investigational Site
City
Sibiu
Country
Romania
Facility Name
1275.1.40003 Boehringer Ingelheim Investigational Site
City
Targu-Mures
Country
Romania
Facility Name
1275.1.70006 Boehringer Ingelheim Investigational Site
City
Arkhangelsk
Country
Russian Federation
Facility Name
1275.1.70001 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1275.1.70004 Boehringer Ingelheim Investigational Site
City
Samara
Country
Russian Federation
Facility Name
1275.1.70002 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1275.1.70003 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1275.1.70005 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1275.1.34004 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1275.1.34005 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1275.1.34002 Boehringer Ingelheim Investigational Site
City
Hospitalet de Llobegrat
Country
Spain
Facility Name
1275.1.34003 Boehringer Ingelheim Investigational Site
City
Palma de Mallorca
Country
Spain
Facility Name
1275.1.34006 Boehringer Ingelheim Investigational Site
City
Tarragona
Country
Spain
Facility Name
1275.1.46003 Boehringer Ingelheim Investigational Site
City
Järfälla
Country
Sweden
Facility Name
1275.1.46004 Boehringer Ingelheim Investigational Site
City
Rättvik
Country
Sweden
Facility Name
1275.1.46002 Boehringer Ingelheim Investigational Site
City
Skene
Country
Sweden
Facility Name
1275.1.88006 Chang Gung Memorial Hospital-CY
City
Chiayi
Country
Taiwan
Facility Name
1275.1.88007 E-Da Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
1275.1.88001 Cardinal Tien Hospital
City
New Taipei
Country
Taiwan
Facility Name
1275.1.88004 Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
1275.1.88008 Chi Mei Medical Center
City
Tainan
Country
Taiwan
Facility Name
1275.1.88002 Far Eastern Memorial Hospital
City
Taipei
Country
Taiwan
Facility Name
1275.1.88003 Taipei Chang Gung Memorial Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
29949041
Citation
DeFronzo RA, Lee C, Kohler S. Safety and Tolerability of Combinations of Empagliflozin and Linagliptin in Patients with Type 2 Diabetes: Pooled Data from Two Randomized Controlled Trials. Adv Ther. 2018 Jul;35(7):1009-1022. doi: 10.1007/s12325-018-0724-y. Epub 2018 Jun 15.
Results Reference
derived
PubMed Identifier
25633662
Citation
Lewin A, DeFronzo RA, Patel S, Liu D, Kaste R, Woerle HJ, Broedl UC. Initial combination of empagliflozin and linagliptin in subjects with type 2 diabetes. Diabetes Care. 2015 Mar;38(3):394-402. doi: 10.2337/dc14-2365. Epub 2015 Jan 29. Erratum In: Diabetes Care. 2015 Jun;38(6):1173.
Results Reference
derived
PubMed Identifier
25583754
Citation
DeFronzo RA, Lewin A, Patel S, Liu D, Kaste R, Woerle HJ, Broedl UC. Combination of empagliflozin and linagliptin as second-line therapy in subjects with type 2 diabetes inadequately controlled on metformin. Diabetes Care. 2015 Mar;38(3):384-93. doi: 10.2337/dc14-2364. Epub 2015 Jan 12. Erratum In: Diabetes Care. 2015 Jun;38(6):1173.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Boehringer Ingelheim Global Clinical Trials Website

Learn more about this trial

Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients

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