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Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BI 10773
Placebo
Placebo
Placebo
Placebo
Placebo
BI 10773
Placebo
Placebo
BI 10773
Placebo
Placebo
Placebo
BI 10773
BI 10773
BI 10773
Placebo
BI 10773
Placebo
Placebo
Placebo
Sitagliptin 100mg
BI 10773
Placebo
Placebo
Placebo
Placebo
Placebo
Placebo
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. Patients completing the entire treatment period of the preceding double-blind trial 1245.19, 1245.20 or 1245.23 with or without rescue therapy.
  2. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice and local legislation.

Exclusion criteria:

  1. Patient who meet one or more of the withdrawal criteria of the treatment period of the previous trial 1245.19, 1245.20 or 1245.23.
  2. Indication of liver disease, defined by serum levels of either alanine aminotransferase , aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during last visit of preceding trial.
  3. Impaired renal function defined as glomerular filtration rate<30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) as determined during last visit of preceding trial.
  4. Contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to local label, which started during trial participation in 1245.19, 1245.20 or 1245.23
  5. Pre-menopausal women (last menstruation < or = 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner.
  6. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake.
  7. Participation in another trial with an investigational drug within 30 days prior to informed consent (except 1245.19, 1245.20 and 1245.23).
  8. Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial.

Sites / Locations

  • 1245.31.10145 Boehringer Ingelheim Investigational Site
  • 1245.31.10162 Boehringer Ingelheim Investigational Site
  • 1245.31.10124 Boehringer Ingelheim Investigational Site
  • 1245.31.10108 Boehringer Ingelheim Investigational Site
  • 1245.31.10046 Boehringer Ingelheim Investigational Site
  • 1245.31.10154 Boehringer Ingelheim Investigational Site
  • 1245.31.10149 Boehringer Ingelheim Investigational Site
  • 1245.31.10131 Boehringer Ingelheim Investigational Site
  • 1245.31.10038 Boehringer Ingelheim Investigational Site
  • 1245.31.10127 Boehringer Ingelheim Investigational Site
  • 1245.31.10137 Boehringer Ingelheim Investigational Site
  • 1245.31.10133 Boehringer Ingelheim Investigational Site
  • 1245.31.10006 Boehringer Ingelheim Investigational Site
  • 1245.31.10085 Boehringer Ingelheim Investigational Site
  • 1245.31.10080 Boehringer Ingelheim Investigational Site
  • 1245.31.10077 Boehringer Ingelheim Investigational Site
  • 1245.31.10001 Boehringer Ingelheim Investigational Site
  • 1245.31.10159 Boehringer Ingelheim Investigational Site
  • 1245.31.10014 Boehringer Ingelheim Investigational Site
  • 1245.31.10117 Boehringer Ingelheim Investigational Site
  • 1245.31.10157 Boehringer Ingelheim Investigational Site
  • 1245.31.10146 Boehringer Ingelheim Investigational Site
  • 1245.31.10003 Boehringer Ingelheim Investigational Site
  • 1245.31.10059 Boehringer Ingelheim Investigational Site
  • 1245.31.10034 Boehringer Ingelheim Investigational Site
  • 1245.31.10123 Boehringer Ingelheim Investigational Site
  • 1245.31.10071 Boehringer Ingelheim Investigational Site
  • 1245.31.10086 Boehringer Ingelheim Investigational Site
  • 1245.31.10129 Boehringer Ingelheim Investigational Site
  • 1245.31.10045 Boehringer Ingelheim Investigational Site
  • 1245.31.10119 Boehringer Ingelheim Investigational Site
  • 1245.31.10130 Boehringer Ingelheim Investigational Site
  • 1245.31.10158 Boehringer Ingelheim Investigational Site
  • 1245.31.10015 Boehringer Ingelheim Investigational Site
  • 1245.31.10033 Boehringer Ingelheim Investigational Site
  • 1245.31.10112 Boehringer Ingelheim Investigational Site
  • 1245.31.10156 Boehringer Ingelheim Investigational Site
  • 1245.31.10151 Boehringer Ingelheim Investigational Site
  • 1245.31.10143 Boehringer Ingelheim Investigational Site
  • 1245.31.10155 Boehringer Ingelheim Investigational Site
  • 1245.31.32008 Boehringer Ingelheim Investigational Site
  • 1245.31.32023 Boehringer Ingelheim Investigational Site
  • 1245.31.32003 Boehringer Ingelheim Investigational Site
  • 1245.31.32015 Boehringer Ingelheim Investigational Site
  • 1245.31.32016 Boehringer Ingelheim Investigational Site
  • 1245.31.32025 Boehringer Ingelheim Investigational Site
  • 1245.31.32019 Boehringer Ingelheim Investigational Site
  • 1245.31.32024 Boehringer Ingelheim Investigational Site
  • 1245.31.32021 Boehringer Ingelheim Investigational Site
  • 1245.31.32020 Boehringer Ingelheim Investigational Site
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  • 1245.31.32026 Boehringer Ingelheim Investigational Site
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  • 1245.31.20028 Boehringer Ingelheim Investigational Site
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  • 1245.31.20015 Boehringer Ingelheim Investigational Site
  • 1245.31.20012 Boehringer Ingelheim Investigational Site
  • 1245.31.20016 Boehringer Ingelheim Investigational Site
  • 1245.31.20024 Boehringer Ingelheim Investigational Site
  • 1245.31.20008 Boehringer Ingelheim Investigational Site
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  • 1245.31.20022 Boehringer Ingelheim Investigational Site
  • 1245.31.20057 Boehringer Ingelheim Investigational Site
  • 1245.31.20035 Boehringer Ingelheim Investigational Site
  • 1245.31.20030 Boehringer Ingelheim Investigational Site
  • 1245.31.20019 Boehringer Ingelheim Investigational Site
  • 1245.31.20017 Boehringer Ingelheim Investigational Site
  • 1245.31.20029 Boehringer Ingelheim Investigational Site
  • 1245.31.20060 Boehringer Ingelheim Investigational Site
  • 1245.31.20003 Boehringer Ingelheim Investigational Site
  • 1245.31.20009 Boehringer Ingelheim Investigational Site
  • 1245.31.20040 Boehringer Ingelheim Investigational Site
  • 1245.31.20034 Boehringer Ingelheim Investigational Site
  • 1245.31.20005 Boehringer Ingelheim Investigational Site
  • 1245.31.20002 Boehringer Ingelheim Investigational Site
  • 1245.31.20006 Boehringer Ingelheim Investigational Site
  • 1245.31.20007 Boehringer Ingelheim Investigational Site
  • 1245.31.20027 Boehringer Ingelheim Investigational Site
  • 1245.31.20025 Boehringer Ingelheim Investigational Site
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  • 1245.31.20021 Boehringer Ingelheim Investigational Site
  • 1245.31.20038 Boehringer Ingelheim Investigational Site
  • 1245.31.20041 Boehringer Ingelheim Investigational Site
  • 1245.31.86007 Boehringer Ingelheim Investigational Site
  • 1245.31.86008 Boehringer Ingelheim Investigational Site
  • 1245.31.86031 Boehringer Ingelheim Investigational Site
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  • 1245.31.86058 Boehringer Ingelheim Investigational Site
  • 1245.31.86038 Boehringer Ingelheim Investigational Site
  • 1245.31.86001 Boehringer Ingelheim Investigational Site
  • 1245.31.86003 Boehringer Ingelheim Investigational Site
  • 1245.31.86052 Boehringer Ingelheim Investigational Site
  • 1245.31.86012 Boehringer Ingelheim Investigational Site
  • 1245.31.86037 Boehringer Ingelheim Investigational Site
  • 1245.31.86020 Boehringer Ingelheim Investigational Site
  • 1245.31.86049 Boehringer Ingelheim Investigational Site
  • 1245.31.86053 Boehringer Ingelheim Investigational Site
  • 1245.31.86018 Boehringer Ingelheim Investigational Site
  • 1245.31.86055 Boehringer Ingelheim Investigational Site
  • 1245.31.86056 Boehringer Ingelheim Investigational Site
  • 1245.31.86019 Boehringer Ingelheim Investigational Site
  • 1245.31.86042 Boehringer Ingelheim Investigational Site
  • 1245.31.86043 Boehringer Ingelheim Investigational Site
  • 1245.31.86016 Boehringer Ingelheim Investigational Site
  • 1245.31.86039 Boehringer Ingelheim Investigational Site
  • 1245.31.86054 Boehringer Ingelheim Investigational Site
  • 1245.31.86057 Boehringer Ingelheim Investigational Site
  • 1245.31.86045 Boehringer Ingelheim Investigational Site
  • 1245.31.86017 Boehringer Ingelheim Investigational Site
  • 1245.31.86013 Boehringer Ingelheim Investigational Site
  • 1245.31.86015 Boehringer Ingelheim Investigational Site
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  • 1245.31.33045 Boehringer Ingelheim Investigational Site
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  • 1245.31.33013 Boehringer Ingelheim Investigational Site
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  • 1245.31.91005 Boehringer Ingelheim Investigational Site
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  • 1245.31.91008 Boehringer Ingelheim Investigational Site
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  • 1245.31.91004 Boehringer Ingelheim Investigational Site
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  • 1245.31.81007 Boehringer Ingelheim Investigational Site
  • 1245.31.81001 Boehringer Ingelheim Investigational Site
  • 1245.31.81002 Boehringer Ingelheim Investigational Site
  • 1245.31.81005 Boehringer Ingelheim Investigational Site
  • 1245.31.81004 Boehringer Ingelheim Investigational Site
  • 1245.31.81003 Boehringer Ingelheim Investigational Site
  • 1245.31.81006 Boehringer Ingelheim Investigational Site
  • 1245.31.81008 Boehringer Ingelheim Investigational Site
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  • 1245.31.81013 Boehringer Ingelheim Investigational Site
  • 1245.31.82012 Boehringer Ingelheim Investigational Site
  • 1245.31.82011 Boehringer Ingelheim Investigational Site
  • 1245.31.82009 Boehringer Ingelheim Investigational Site
  • 1245.31.82001 Boehringer Ingelheim Investigational Site
  • 1245.31.82006 Boehringer Ingelheim Investigational Site
  • 1245.31.82004 Boehringer Ingelheim Investigational Site
  • 1245.31.82005 Boehringer Ingelheim Investigational Site
  • 1245.31.82007 Boehringer Ingelheim Investigational Site
  • 1245.31.82008 Boehringer Ingelheim Investigational Site
  • 1245.31.82010 Boehringer Ingelheim Investigational Site
  • 1245.31.82014 Boehringer Ingelheim Investigational Site
  • 1245.31.82002 Boehringer Ingelheim Investigational Site
  • 1245.31.82003 Boehringer Ingelheim Investigational Site
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  • 1245.31.52004 Boehringer Ingelheim Investigational Site
  • 1245.31.52001 Boehringer Ingelheim Investigational Site
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  • 1245.31.63002 Boehringer Ingelheim Investigational Site
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  • 1245.31.63004 Boehringer Ingelheim Investigational Site
  • 1245.31.63005 Boehringer Ingelheim Investigational Site
  • 1245.31.74005 Boehringer Ingelheim Investigational Site
  • 1245.31.74002 Boehringer Ingelheim Investigational Site
  • 1245.31.74006 Boehringer Ingelheim Investigational Site
  • 1245.31.74014 Boehringer Ingelheim Investigational Site
  • 1245.31.74001 Boehringer Ingelheim Investigational Site
  • 1245.31.74004 Boehringer Ingelheim Investigational Site
  • 1245.31.74003 Boehringer Ingelheim Investigational Site
  • 1245.31.38003 Boehringer Ingelheim Investigational Site
  • 1245.31.38002 Boehringer Ingelheim Investigational Site
  • 1245.31.38001 Boehringer Ingelheim Investigational Site
  • 1245.31.41004 Boehringer Ingelheim Investigational Site
  • 1245.31.41003 Boehringer Ingelheim Investigational Site
  • 1245.31.88010 Boehringer Ingelheim Investigational Site
  • 1245.31.88011 Boehringer Ingelheim Investigational Site
  • 1245.31.88012 Boehringer Ingelheim Investigational Site
  • 1245.31.88013 Kaohsiung Medical University Chung-Ho Memorial Hospital
  • 1245.31.88009 Boehringer Ingelheim Investigational Site
  • 1245.31.88014 Boehringer Ingelheim Investigational Site
  • 1245.31.88006 Boehringer Ingelheim Investigational Site
  • 1245.31.88021 Boehringer Ingelheim Investigational Site
  • 1245.31.88008 Boehringer Ingelheim Investigational Site
  • 1245.31.90003 Boehringer Ingelheim Investigational Site
  • 1245.31.90001 Boehringer Ingelheim Investigational Site
  • 1245.31.90002 Boehringer Ingelheim Investigational Site
  • 1245.31.90006 Boehringer Ingelheim Investigational Site
  • 1245.31.90004 Boehringer Ingelheim Investigational Site
  • 1245.31.75002 Boehringer Ingelheim Investigational Site
  • 1245.31.75001 Boehringer Ingelheim Investigational Site
  • 1245.31.75006 Boehringer Ingelheim Investigational Site
  • 1245.31.75004 Boehringer Ingelheim Investigational Site
  • 1245.31.75003 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 10

Arm 11

Arm 12

Arm 13

Arm Type

Experimental

Experimental

Placebo Comparator

Active Comparator

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Arm Label

BI 10773 low (drug naive)

BI 10773 high (drug naive)

Placebo (drug naive)

Sitagliptin 100mg (drug naive)

BI 10773 low (pioglitazone)

BI 10773 high (pioglitazone)

Placebo (pioglitazone)

BI 10773 low (metformin)

BI 10773 high (metformin)

Placebo (metformin)

BI 10773 low (metformin+sulfonylurea)

BI 10773 high (metformin+sulfonylurea)

Placebo (metformin+sulfonylurea)

Arm Description

BI 10773 tablets once daily

BI 10773 tablets once daily

Placebo tablets matching BI 10773 / Sitagliptin once daily

Sitagliptin once daily

BI 10773 tablets once daily

BI 10773 tablets once daily

Placebo tablets matching BI 10773 once daily

BI 10773 tablets once daily

BI 10773 tablets once daily

Placebo tablets matching BI 10773 once daily

BI 10773 tablets once daily

BI 10773 tablets once daily

Placebo tablets matching BI 10773

Outcomes

Primary Outcome Measures

Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
Change from baseline in HbA1c after 52 weeks
Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
Change from baseline in HbA1c after 76 weeks

Secondary Outcome Measures

HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
Change from baseline in HbA1c (%) after 76 weeks using MMRM approach
Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Systolic blood pressure - change from baseline after 52 weeks of treatment
Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Systolic blood pressure - change from baseline after 76 weeks of treatment
Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Diastolic blood pressure - change from baseline after 52 weeks of treatment
Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Diastolic blood pressure - change from baseline after 76 weeks of treatment
Body Weight (kg) Change From Baseline After 52 Weeks of Treatment
Body Weight (kg) - Change From Baseline After 52 Weeks of Treatment
Body Weight (kg) Change From Baseline After 76 Weeks of Treatment
Body Weight (kg) - Change From Baseline After 76 Weeks of Treatment
Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment
Waist circumference (cm) - change from baseline after 52 weeks of treatment
Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment
Waist circumference (cm) - change from baseline after 76 weeks of treatment
Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment
Fasting plasma glucose - change from baseline after 52 weeks of treatment
Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment
Fasting plasma glucose - change from baseline after 76 weeks of treatment

Full Information

First Posted
January 31, 2011
Last Updated
July 14, 2014
Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT01289990
Brief Title
Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes
Official Title
A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 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 study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.

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
Non-Randomized
Enrollment
2705 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 10773 low (drug naive)
Arm Type
Experimental
Arm Description
BI 10773 tablets once daily
Arm Title
BI 10773 high (drug naive)
Arm Type
Experimental
Arm Description
BI 10773 tablets once daily
Arm Title
Placebo (drug naive)
Arm Type
Placebo Comparator
Arm Description
Placebo tablets matching BI 10773 / Sitagliptin once daily
Arm Title
Sitagliptin 100mg (drug naive)
Arm Type
Active Comparator
Arm Description
Sitagliptin once daily
Arm Title
BI 10773 low (pioglitazone)
Arm Type
Experimental
Arm Description
BI 10773 tablets once daily
Arm Title
BI 10773 high (pioglitazone)
Arm Type
Experimental
Arm Description
BI 10773 tablets once daily
Arm Title
Placebo (pioglitazone)
Arm Type
Placebo Comparator
Arm Description
Placebo tablets matching BI 10773 once daily
Arm Title
BI 10773 low (metformin)
Arm Type
Experimental
Arm Description
BI 10773 tablets once daily
Arm Title
BI 10773 high (metformin)
Arm Type
Experimental
Arm Description
BI 10773 tablets once daily
Arm Title
Placebo (metformin)
Arm Type
Placebo Comparator
Arm Description
Placebo tablets matching BI 10773 once daily
Arm Title
BI 10773 low (metformin+sulfonylurea)
Arm Type
Experimental
Arm Description
BI 10773 tablets once daily
Arm Title
BI 10773 high (metformin+sulfonylurea)
Arm Type
Experimental
Arm Description
BI 10773 tablets once daily
Arm Title
Placebo (metformin+sulfonylurea)
Arm Type
Placebo Comparator
Arm Description
Placebo tablets matching BI 10773
Intervention Type
Drug
Intervention Name(s)
BI 10773
Intervention Description
BI 10773 tablets once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 low dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 high dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching Sitagliptin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 high dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 high dose
Intervention Type
Drug
Intervention Name(s)
BI 10773
Intervention Description
BI 10773 tablets once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 low dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 low dose
Intervention Type
Drug
Intervention Name(s)
BI 10773
Intervention Description
BI 10773 tablets once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 low dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 high dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching Sitagliptin
Intervention Type
Drug
Intervention Name(s)
BI 10773
Intervention Description
BI 10773 tablets once daily
Intervention Type
Drug
Intervention Name(s)
BI 10773
Intervention Description
BI 10773 tablets once daily
Intervention Type
Drug
Intervention Name(s)
BI 10773
Intervention Description
BI 10773 tablets once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 high dose
Intervention Type
Drug
Intervention Name(s)
BI 10773
Intervention Description
BI 10773 tablets once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 low dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 high dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching Sitagliptin
Intervention Type
Drug
Intervention Name(s)
Sitagliptin 100mg
Intervention Description
Sitagliptin once daily
Intervention Type
Drug
Intervention Name(s)
BI 10773
Intervention Description
BI 10773 tablets once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 low dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 low dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 low dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 high dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 low dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 high dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 10773 high dose
Primary Outcome Measure Information:
Title
Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
Description
Change from baseline in HbA1c after 52 weeks
Time Frame
Baseline and 52 weeks
Title
Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
Description
Change from baseline in HbA1c after 76 weeks
Time Frame
Baseline and 76 weeks
Secondary Outcome Measure Information:
Title
HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
Description
Change from baseline in HbA1c (%) after 76 weeks using MMRM approach
Time Frame
Baseline and 76 weeks
Title
Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Description
Systolic blood pressure - change from baseline after 52 weeks of treatment
Time Frame
Baseline and 52 weeks
Title
Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Description
Systolic blood pressure - change from baseline after 76 weeks of treatment
Time Frame
Baseline and 76 weeks
Title
Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Description
Diastolic blood pressure - change from baseline after 52 weeks of treatment
Time Frame
Baseline and 52 weeks
Title
Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Description
Diastolic blood pressure - change from baseline after 76 weeks of treatment
Time Frame
Baseline and 76 weeks
Title
Body Weight (kg) Change From Baseline After 52 Weeks of Treatment
Description
Body Weight (kg) - Change From Baseline After 52 Weeks of Treatment
Time Frame
Baseline and 52 weeks
Title
Body Weight (kg) Change From Baseline After 76 Weeks of Treatment
Description
Body Weight (kg) - Change From Baseline After 76 Weeks of Treatment
Time Frame
Baseline and 76 weeks
Title
Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment
Description
Waist circumference (cm) - change from baseline after 52 weeks of treatment
Time Frame
Baseline and 52 weeks
Title
Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment
Description
Waist circumference (cm) - change from baseline after 76 weeks of treatment
Time Frame
Baseline and 76 weeks
Title
Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment
Description
Fasting plasma glucose - change from baseline after 52 weeks of treatment
Time Frame
Baseline and 52 weeks
Title
Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment
Description
Fasting plasma glucose - change from baseline after 76 weeks of treatment
Time Frame
Baseline and 76 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients completing the entire treatment period of the preceding double-blind trial 1245.19, 1245.20 or 1245.23 with or without rescue therapy. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice and local legislation. Exclusion criteria: Patient who meet one or more of the withdrawal criteria of the treatment period of the previous trial 1245.19, 1245.20 or 1245.23. Indication of liver disease, defined by serum levels of either alanine aminotransferase , aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during last visit of preceding trial. Impaired renal function defined as glomerular filtration rate<30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) as determined during last visit of preceding trial. Contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to local label, which started during trial participation in 1245.19, 1245.20 or 1245.23 Pre-menopausal women (last menstruation < or = 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake. Participation in another trial with an investigational drug within 30 days prior to informed consent (except 1245.19, 1245.20 and 1245.23). Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial.
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
1245.31.10145 Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
1245.31.10162 Boehringer Ingelheim Investigational Site
City
Glendale
State/Province
Arizona
Country
United States
Facility Name
1245.31.10124 Boehringer Ingelheim Investigational Site
City
Mesa
State/Province
Arizona
Country
United States
Facility Name
1245.31.10108 Boehringer Ingelheim Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
1245.31.10046 Boehringer Ingelheim Investigational Site
City
Tempe
State/Province
Arizona
Country
United States
Facility Name
1245.31.10154 Boehringer Ingelheim Investigational Site
City
Chino
State/Province
California
Country
United States
Facility Name
1245.31.10149 Boehringer Ingelheim Investigational Site
City
Rancho Cucamonga
State/Province
California
Country
United States
Facility Name
1245.31.10131 Boehringer Ingelheim Investigational Site
City
West Hills
State/Province
California
Country
United States
Facility Name
1245.31.10038 Boehringer Ingelheim Investigational Site
City
Northglenn
State/Province
Colorado
Country
United States
Facility Name
1245.31.10127 Boehringer Ingelheim Investigational Site
City
Waterbury
State/Province
Connecticut
Country
United States
Facility Name
1245.31.10137 Boehringer Ingelheim Investigational Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
1245.31.10133 Boehringer Ingelheim Investigational Site
City
Jupiter
State/Province
Florida
Country
United States
Facility Name
1245.31.10006 Boehringer Ingelheim Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
1245.31.10085 Boehringer Ingelheim Investigational Site
City
Plantation
State/Province
Florida
Country
United States
Facility Name
1245.31.10080 Boehringer Ingelheim Investigational Site
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
1245.31.10077 Boehringer Ingelheim Investigational Site
City
Perry
State/Province
Georgia
Country
United States
Facility Name
1245.31.10001 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
1245.31.10159 Boehringer Ingelheim Investigational Site
City
Des Moines
State/Province
Iowa
Country
United States
Facility Name
1245.31.10014 Boehringer Ingelheim Investigational Site
City
Dubuque
State/Province
Iowa
Country
United States
Facility Name
1245.31.10117 Boehringer Ingelheim Investigational Site
City
Arkansas City
State/Province
Kansas
Country
United States
Facility Name
1245.31.10157 Boehringer Ingelheim Investigational Site
City
Newton
State/Province
Kansas
Country
United States
Facility Name
1245.31.10146 Boehringer Ingelheim Investigational Site
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
1245.31.10003 Boehringer Ingelheim Investigational Site
City
Dearborn
State/Province
Michigan
Country
United States
Facility Name
1245.31.10059 Boehringer Ingelheim Investigational Site
City
New Hyde Park
State/Province
New York
Country
United States
Facility Name
1245.31.10034 Boehringer Ingelheim Investigational Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
1245.31.10123 Boehringer Ingelheim Investigational Site
City
Smithtown
State/Province
New York
Country
United States
Facility Name
1245.31.10071 Boehringer Ingelheim Investigational Site
City
Asheboro
State/Province
North Carolina
Country
United States
Facility Name
1245.31.10086 Boehringer Ingelheim Investigational Site
City
Salisbury
State/Province
North Carolina
Country
United States
Facility Name
1245.31.10129 Boehringer Ingelheim Investigational Site
City
Carlisle
State/Province
Ohio
Country
United States
Facility Name
1245.31.10045 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
1245.31.10119 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
1245.31.10130 Boehringer Ingelheim Investigational Site
City
Gallipolis
State/Province
Ohio
Country
United States
Facility Name
1245.31.10158 Boehringer Ingelheim Investigational Site
City
Mount Pleasant
State/Province
South Carolina
Country
United States
Facility Name
1245.31.10015 Boehringer Ingelheim Investigational Site
City
Simpsonville
State/Province
South Carolina
Country
United States
Facility Name
1245.31.10033 Boehringer Ingelheim Investigational Site
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
1245.31.10112 Boehringer Ingelheim Investigational Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
1245.31.10156 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1245.31.10151 Boehringer Ingelheim Investigational Site
City
Hurst
State/Province
Texas
Country
United States
Facility Name
1245.31.10143 Boehringer Ingelheim Investigational Site
City
Killeen
State/Province
Texas
Country
United States
Facility Name
1245.31.10155 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1245.31.32008 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
1245.31.32023 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
1245.31.32003 Boehringer Ingelheim Investigational Site
City
De Pinte
Country
Belgium
Facility Name
1245.31.32015 Boehringer Ingelheim Investigational Site
City
Deurne
Country
Belgium
Facility Name
1245.31.32016 Boehringer Ingelheim Investigational Site
City
Deurne
Country
Belgium
Facility Name
1245.31.32025 Boehringer Ingelheim Investigational Site
City
Gozée
Country
Belgium
Facility Name
1245.31.32019 Boehringer Ingelheim Investigational Site
City
Leopoldsburg
Country
Belgium
Facility Name
1245.31.32024 Boehringer Ingelheim Investigational Site
City
Linkebeek
Country
Belgium
Facility Name
1245.31.32021 Boehringer Ingelheim Investigational Site
City
Mouscron
Country
Belgium
Facility Name
1245.31.32020 Boehringer Ingelheim Investigational Site
City
Sint-Gillis-Waas
Country
Belgium
Facility Name
1245.31.32018 Boehringer Ingelheim Investigational Site
City
Tielt
Country
Belgium
Facility Name
1245.31.32026 Boehringer Ingelheim Investigational Site
City
Tremelo
Country
Belgium
Facility Name
1245.31.20032 Boehringer Ingelheim Investigational Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
1245.31.20023 Boehringer Ingelheim Investigational Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
1245.31.20011 Boehringer Ingelheim Investigational Site
City
Chilliwack
State/Province
British Columbia
Country
Canada
Facility Name
1245.31.20028 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1245.31.20018 Boehringer Ingelheim Investigational Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
1245.31.20033 Boehringer Ingelheim Investigational Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
1245.31.20015 Boehringer Ingelheim Investigational Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
1245.31.20012 Boehringer Ingelheim Investigational Site
City
Moncton
State/Province
New Brunswick
Country
Canada
Facility Name
1245.31.20016 Boehringer Ingelheim Investigational Site
City
Mount Pearl
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
1245.31.20024 Boehringer Ingelheim Investigational Site
City
Paradise
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
1245.31.20008 Boehringer Ingelheim Investigational Site
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
1245.31.20026 Boehringer Ingelheim Investigational Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
1245.31.20022 Boehringer Ingelheim Investigational Site
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
1245.31.20057 Boehringer Ingelheim Investigational Site
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
1245.31.20035 Boehringer Ingelheim Investigational Site
City
Corunna
State/Province
Ontario
Country
Canada
Facility Name
1245.31.20030 Boehringer Ingelheim Investigational Site
City
Etobicoke
State/Province
Ontario
Country
Canada
Facility Name
1245.31.20019 Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1245.31.20017 Boehringer Ingelheim Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
1245.31.20029 Boehringer Ingelheim Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
1245.31.20060 Boehringer Ingelheim Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
1245.31.20003 Boehringer Ingelheim Investigational Site
City
Markham
State/Province
Ontario
Country
Canada
Facility Name
1245.31.20009 Boehringer Ingelheim Investigational Site
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
1245.31.20040 Boehringer Ingelheim Investigational Site
City
Oakville
State/Province
Ontario
Country
Canada
Facility Name
1245.31.20034 Boehringer Ingelheim Investigational Site
City
Sarnia
State/Province
Ontario
Country
Canada
Facility Name
1245.31.20005 Boehringer Ingelheim Investigational Site
City
Strathroy
State/Province
Ontario
Country
Canada
Facility Name
1245.31.20002 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1245.31.20006 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1245.31.20007 Boehringer Ingelheim Investigational Site
City
Montague
State/Province
Prince Edward Island
Country
Canada
Facility Name
1245.31.20027 Boehringer Ingelheim Investigational Site
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
1245.31.20025 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1245.31.20036 Boehringer Ingelheim Investigational Site
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
1245.31.20058 Boehringer Ingelheim Investigational Site
City
St-Romuald
State/Province
Quebec
Country
Canada
Facility Name
1245.31.20021 Boehringer Ingelheim Investigational Site
City
Trois Rivieres
State/Province
Quebec
Country
Canada
Facility Name
1245.31.20038 Boehringer Ingelheim Investigational Site
City
Ville Saint-Laurent
State/Province
Quebec
Country
Canada
Facility Name
1245.31.20041 Boehringer Ingelheim Investigational Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
1245.31.86007 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1245.31.86008 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1245.31.86031 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1245.31.86032 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1245.31.86033 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1245.31.86034 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1245.31.86035 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1245.31.86058 Boehringer Ingelheim Investigational Site
City
Chongqing
Country
China
Facility Name
1245.31.86038 Boehringer Ingelheim Investigational Site
City
Dalian
Country
China
Facility Name
1245.31.86001 Boehringer Ingelheim Investigational Site
City
Guangzhou
Country
China
Facility Name
1245.31.86003 Boehringer Ingelheim Investigational Site
City
Guangzhou
Country
China
Facility Name
1245.31.86052 Boehringer Ingelheim Investigational Site
City
Guangzhou
Country
China
Facility Name
1245.31.86012 Boehringer Ingelheim Investigational Site
City
Guiyang
Country
China
Facility Name
1245.31.86037 Boehringer Ingelheim Investigational Site
City
Haerbin
Country
China
Facility Name
1245.31.86020 Boehringer Ingelheim Investigational Site
City
Hangzhou
Country
China
Facility Name
1245.31.86049 Boehringer Ingelheim Investigational Site
City
Jinan
Country
China
Facility Name
1245.31.86053 Boehringer Ingelheim Investigational Site
City
Jinan
Country
China
Facility Name
1245.31.86018 Boehringer Ingelheim Investigational Site
City
Jingzhou
Country
China
Facility Name
1245.31.86055 Boehringer Ingelheim Investigational Site
City
Nan Ning
Country
China
Facility Name
1245.31.86056 Boehringer Ingelheim Investigational Site
City
Nan Ning
Country
China
Facility Name
1245.31.86019 Boehringer Ingelheim Investigational Site
City
Nanchang
Country
China
Facility Name
1245.31.86042 Boehringer Ingelheim Investigational Site
City
Nanjing
Country
China
Facility Name
1245.31.86043 Boehringer Ingelheim Investigational Site
City
Nanjing
Country
China
Facility Name
1245.31.86016 Boehringer Ingelheim Investigational Site
City
QingDao
Country
China
Facility Name
1245.31.86039 Boehringer Ingelheim Investigational Site
City
Shanghai
Country
China
Facility Name
1245.31.86054 Boehringer Ingelheim Investigational Site
City
Shantou
Country
China
Facility Name
1245.31.86057 Boehringer Ingelheim Investigational Site
City
Shenyang
Country
China
Facility Name
1245.31.86045 Boehringer Ingelheim Investigational Site
City
Shijiazhuang
Country
China
Facility Name
1245.31.86017 Boehringer Ingelheim Investigational Site
City
Shiyan
Country
China
Facility Name
1245.31.86013 Boehringer Ingelheim Investigational Site
City
Suzhou
Country
China
Facility Name
1245.31.86015 Boehringer Ingelheim Investigational Site
City
Taiyuan
Country
China
Facility Name
1245.31.86036 Boehringer Ingelheim Investigational Site
City
Tianjin
Country
China
Facility Name
1245.31.86011 Boehringer Ingelheim Investigational Site
City
Xi'An
Country
China
Facility Name
1245.31.86041 Boehringer Ingelheim Investigational Site
City
Xi'An
Country
China
Facility Name
1245.31.86014 Boehringer Ingelheim Investigational Site
City
Xiamen
Country
China
Facility Name
1245.31.33008 Boehringer Ingelheim Investigational Site
City
Bersée
Country
France
Facility Name
1245.31.33020 Boehringer Ingelheim Investigational Site
City
Bischheim
Country
France
Facility Name
1245.31.33002 Boehringer Ingelheim Investigational Site
City
Bondy Cedex
Country
France
Facility Name
1245.31.33016 Boehringer Ingelheim Investigational Site
City
Bruay La Buissiere
Country
France
Facility Name
1245.31.33001 Boehringer Ingelheim Investigational Site
City
Corbeil Essonnes
Country
France
Facility Name
1245.31.33010 Boehringer Ingelheim Investigational Site
City
Croix
Country
France
Facility Name
1245.31.33009 Boehringer Ingelheim Investigational Site
City
Hautmont
Country
France
Facility Name
1245.31.33003 Boehringer Ingelheim Investigational Site
City
La Rochelle Cedex 1
Country
France
Facility Name
1245.31.33045 Boehringer Ingelheim Investigational Site
City
Marseille
Country
France
Facility Name
1245.31.33004 Boehringer Ingelheim Investigational Site
City
Narbonne Cedex
Country
France
Facility Name
1245.31.33012 Boehringer Ingelheim Investigational Site
City
Schiltigheim
Country
France
Facility Name
1245.31.33013 Boehringer Ingelheim Investigational Site
City
Strasbourg
Country
France
Facility Name
1245.31.33019 Boehringer Ingelheim Investigational Site
City
Strasbourg
Country
France
Facility Name
1245.31.33007 Boehringer Ingelheim Investigational Site
City
Vieux Condé
Country
France
Facility Name
1245.31.33018 Boehringer Ingelheim Investigational Site
City
Wattrelos
Country
France
Facility Name
1245.31.49001 Boehringer Ingelheim Investigational Site
City
Dormagen
Country
Germany
Facility Name
1245.31.49013 Boehringer Ingelheim Investigational Site
City
Dresden
Country
Germany
Facility Name
1245.31.49016 Boehringer Ingelheim Investigational Site
City
Düsseldorf
Country
Germany
Facility Name
1245.31.49009 Boehringer Ingelheim Investigational Site
City
Flörsheim
Country
Germany
Facility Name
1245.31.49015 Boehringer Ingelheim Investigational Site
City
Frankfurt
Country
Germany
Facility Name
1245.31.49019 Boehringer Ingelheim Investigational Site
City
Haag
Country
Germany
Facility Name
1245.31.49004 Boehringer Ingelheim Investigational Site
City
Hatten
Country
Germany
Facility Name
1245.31.49020 Boehringer Ingelheim Investigational Site
City
Hohenmölsen
Country
Germany
Facility Name
1245.31.49007 Boehringer Ingelheim Investigational Site
City
Künzing
Country
Germany
Facility Name
1245.31.49002 Boehringer Ingelheim Investigational Site
City
Neuwied
Country
Germany
Facility Name
1245.31.49008 Boehringer Ingelheim Investigational Site
City
Nürnberg
Country
Germany
Facility Name
1245.31.49010 Boehringer Ingelheim Investigational Site
City
Rednitzhembach
Country
Germany
Facility Name
1245.31.49006 Boehringer Ingelheim Investigational Site
City
Rehburg-Loccum
Country
Germany
Facility Name
1245.31.49011 Boehringer Ingelheim Investigational Site
City
Rehlingen-Siersburg
Country
Germany
Facility Name
1245.31.49005 Boehringer Ingelheim Investigational Site
City
Saarbrücken
Country
Germany
Facility Name
1245.31.49022 Boehringer Ingelheim Investigational Site
City
Schauenburg
Country
Germany
Facility Name
1245.31.49017 Boehringer Ingelheim Investigational Site
City
St. Ingbert/Oberwürzbach
Country
Germany
Facility Name
1245.31.49003 Boehringer Ingelheim Investigational Site
City
Unterschneidheim
Country
Germany
Facility Name
1245.31.30004 Boehringer Ingelheim Investigational Site
City
Thessaloniki
Country
Greece
Facility Name
1245.31.91005 Boehringer Ingelheim Investigational Site
City
Bangalore
Country
India
Facility Name
1245.31.91006 Boehringer Ingelheim Investigational Site
City
Bangalore
Country
India
Facility Name
1245.31.91008 Boehringer Ingelheim Investigational Site
City
Bangalore
Country
India
Facility Name
1245.31.91003 Boehringer Ingelheim Investigational Site
City
Belgaum
Country
India
Facility Name
1245.31.91004 Boehringer Ingelheim Investigational Site
City
Chennai
Country
India
Facility Name
1245.31.91009 Boehringer Ingelheim Investigational Site
City
Chennai
Country
India
Facility Name
1245.31.91001 Boehringer Ingelheim Investigational Site
City
Coimbatore
Country
India
Facility Name
1245.31.91101 Boehringer Ingelheim Investigational Site
City
Coimbatore
Country
India
Facility Name
1245.31.91015 Boehringer Ingelheim Investigational Site
City
Gulbarga
Country
India
Facility Name
1245.31.91104 Boehringer Ingelheim Investigational Site
City
Indore
Country
India
Facility Name
1245.31.91103 Boehringer Ingelheim Investigational Site
City
Maharashtra
Country
India
Facility Name
1245.31.91007 Boehringer Ingelheim Investigational Site
City
Mumbai, Maharastra
Country
India
Facility Name
1245.31.91002 Boehringer Ingelheim Investigational Site
City
Mumbai
Country
India
Facility Name
1245.31.91010 Boehringer Ingelheim Investigational Site
City
Nagpur
Country
India
Facility Name
1245.31.91012 Boehringer Ingelheim Investigational Site
City
New Delhi
Country
India
Facility Name
1245.31.91014 Boehringer Ingelheim Investigational Site
City
Pune
Country
India
Facility Name
1245.31.91105 Boehringer Ingelheim Investigational Site
City
Pune
Country
India
Facility Name
1245.31.35304 Boehringer Ingelheim Investigational Site
City
Birr, Co. Offaly
Country
Ireland
Facility Name
1245.31.35302 Boehringer Ingelheim Investigational Site
City
Co. Cork
Country
Ireland
Facility Name
1245.31.35305 Boehringer Ingelheim Investigational Site
City
Co. Galway
Country
Ireland
Facility Name
1245.31.35303 Boehringer Ingelheim Investigational Site
City
Co. Wexford
Country
Ireland
Facility Name
1245.31.35306 Boehringer Ingelheim Investigational Site
City
Co. Wexford
Country
Ireland
Facility Name
1245.31.81007 Boehringer Ingelheim Investigational Site
City
Chiyoda-ku, Tokyo
Country
Japan
Facility Name
1245.31.81001 Boehringer Ingelheim Investigational Site
City
Chuo-ku, Tokyo
Country
Japan
Facility Name
1245.31.81002 Boehringer Ingelheim Investigational Site
City
Chuo-ku, Tokyo
Country
Japan
Facility Name
1245.31.81005 Boehringer Ingelheim Investigational Site
City
Ebetsu, Hokkaido
Country
Japan
Facility Name
1245.31.81004 Boehringer Ingelheim Investigational Site
City
Kamakura, Kanagawa
Country
Japan
Facility Name
1245.31.81003 Boehringer Ingelheim Investigational Site
City
Minato-ku, Tokyo
Country
Japan
Facility Name
1245.31.81006 Boehringer Ingelheim Investigational Site
City
Shinjuku-ku, Tokyo
Country
Japan
Facility Name
1245.31.81008 Boehringer Ingelheim Investigational Site
City
Shinjuku-ku, Tokyo
Country
Japan
Facility Name
1245.31.81009 Boehringer Ingelheim Investigational Site
City
Suita, Osaka
Country
Japan
Facility Name
1245.31.81010 Boehringer Ingelheim Investigational Site
City
Ube, Yamaguchi
Country
Japan
Facility Name
1245.31.81012 Boehringer Ingelheim Investigational Site
City
Urasoe, Okinawa
Country
Japan
Facility Name
1245.31.81013 Boehringer Ingelheim Investigational Site
City
Urasoe, Okinawa
Country
Japan
Facility Name
1245.31.82012 Boehringer Ingelheim Investigational Site
City
Anyang
Country
Korea, Republic of
Facility Name
1245.31.82011 Boehringer Ingelheim Investigational Site
City
Goyang
Country
Korea, Republic of
Facility Name
1245.31.82009 Boehringer Ingelheim Investigational Site
City
Ilsan
Country
Korea, Republic of
Facility Name
1245.31.82001 Boehringer Ingelheim Investigational Site
City
Incheon
Country
Korea, Republic of
Facility Name
1245.31.82006 Boehringer Ingelheim Investigational Site
City
Jeonju
Country
Korea, Republic of
Facility Name
1245.31.82004 Boehringer Ingelheim Investigational Site
City
Pusan
Country
Korea, Republic of
Facility Name
1245.31.82005 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1245.31.82007 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1245.31.82008 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1245.31.82010 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1245.31.82014 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1245.31.82002 Boehringer Ingelheim Investigational Site
City
Suwon
Country
Korea, Republic of
Facility Name
1245.31.82003 Boehringer Ingelheim Investigational Site
City
Wonju
Country
Korea, Republic of
Facility Name
1245.31.52003 Boehringer Ingelheim Investigational Site
City
Guadalajara
Country
Mexico
Facility Name
1245.31.52004 Boehringer Ingelheim Investigational Site
City
Guadalajara
Country
Mexico
Facility Name
1245.31.52001 Boehringer Ingelheim Investigational Site
City
Monterrey
Country
Mexico
Facility Name
1245.31.52002 Boehringer Ingelheim Investigational Site
City
Monterrey
Country
Mexico
Facility Name
1245.31.63002 Boehringer Ingelheim Investigational Site
City
Cebu
Country
Philippines
Facility Name
1245.31.63003 Boehringer Ingelheim Investigational Site
City
Davao City
Country
Philippines
Facility Name
1245.31.63001 Boehringer Ingelheim Investigational Site
City
Manila
Country
Philippines
Facility Name
1245.31.63004 Boehringer Ingelheim Investigational Site
City
Manila
Country
Philippines
Facility Name
1245.31.63005 Boehringer Ingelheim Investigational Site
City
Manila
Country
Philippines
Facility Name
1245.31.74005 Boehringer Ingelheim Investigational Site
City
Bratislava
Country
Slovakia
Facility Name
1245.31.74002 Boehringer Ingelheim Investigational Site
City
Lucenec
Country
Slovakia
Facility Name
1245.31.74006 Boehringer Ingelheim Investigational Site
City
Nitra
Country
Slovakia
Facility Name
1245.31.74014 Boehringer Ingelheim Investigational Site
City
Nove Zamky
Country
Slovakia
Facility Name
1245.31.74001 Boehringer Ingelheim Investigational Site
City
Povazska Bystrica
Country
Slovakia
Facility Name
1245.31.74004 Boehringer Ingelheim Investigational Site
City
Presov
Country
Slovakia
Facility Name
1245.31.74003 Boehringer Ingelheim Investigational Site
City
Trebisov
Country
Slovakia
Facility Name
1245.31.38003 Boehringer Ingelheim Investigational Site
City
Celje
Country
Slovenia
Facility Name
1245.31.38002 Boehringer Ingelheim Investigational Site
City
Koper
Country
Slovenia
Facility Name
1245.31.38001 Boehringer Ingelheim Investigational Site
City
Maribor
Country
Slovenia
Facility Name
1245.31.41004 Boehringer Ingelheim Investigational Site
City
Lugano
Country
Switzerland
Facility Name
1245.31.41003 Boehringer Ingelheim Investigational Site
City
Rorschach
Country
Switzerland
Facility Name
1245.31.88010 Boehringer Ingelheim Investigational Site
City
Kaohsiung
Country
Taiwan
Facility Name
1245.31.88011 Boehringer Ingelheim Investigational Site
City
Kaohsiung
Country
Taiwan
Facility Name
1245.31.88012 Boehringer Ingelheim Investigational Site
City
Kaohsiung
Country
Taiwan
Facility Name
1245.31.88013 Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
1245.31.88009 Boehringer Ingelheim Investigational Site
City
Taichung
Country
Taiwan
Facility Name
1245.31.88014 Boehringer Ingelheim Investigational Site
City
Tainan
Country
Taiwan
Facility Name
1245.31.88006 Boehringer Ingelheim Investigational Site
City
Taipei
Country
Taiwan
Facility Name
1245.31.88021 Boehringer Ingelheim Investigational Site
City
Taipei
Country
Taiwan
Facility Name
1245.31.88008 Boehringer Ingelheim Investigational Site
City
Taoyuan County
Country
Taiwan
Facility Name
1245.31.90003 Boehringer Ingelheim Investigational Site
City
Erzurum
Country
Turkey
Facility Name
1245.31.90001 Boehringer Ingelheim Investigational Site
City
Gaziantep
Country
Turkey
Facility Name
1245.31.90002 Boehringer Ingelheim Investigational Site
City
Istanbul
Country
Turkey
Facility Name
1245.31.90006 Boehringer Ingelheim Investigational Site
City
Istanbul
Country
Turkey
Facility Name
1245.31.90004 Boehringer Ingelheim Investigational Site
City
Izmir
Country
Turkey
Facility Name
1245.31.75002 Boehringer Ingelheim Investigational Site
City
Dnepropetrovsk
Country
Ukraine
Facility Name
1245.31.75001 Boehringer Ingelheim Investigational Site
City
Kharkiv
Country
Ukraine
Facility Name
1245.31.75006 Boehringer Ingelheim Investigational Site
City
Lviv
Country
Ukraine
Facility Name
1245.31.75004 Boehringer Ingelheim Investigational Site
City
Vinnitsa
Country
Ukraine
Facility Name
1245.31.75003 Boehringer Ingelheim Investigational Site
City
Vinnytsya
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
35472672
Citation
Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
Results Reference
derived
PubMed Identifier
33084149
Citation
Inzucchi SE, Davies MJ, Khunti K, Trivedi P, George JT, Zwiener I, Johansen OE, Sattar N. Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Feb;23(2):425-433. doi: 10.1111/dom.14234. Epub 2020 Nov 20.
Results Reference
derived
PubMed Identifier
28753486
Citation
Shiba T, Ishii S, Okamura T, Mitsuyoshi R, Pfarr E, Koiwai K. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: A sub-analysis by body mass index and age of pooled data from three clinical trials. Diabetes Res Clin Pract. 2017 Sep;131:169-178. doi: 10.1016/j.diabres.2017.07.004. Epub 2017 Jul 8.
Results Reference
derived
PubMed Identifier
26701110
Citation
Roden M, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, Stella P, Woerle HJ, Broedl UC; EMPA-REG EXTEND MONO investigators. Safety, tolerability and effects on cardiometabolic risk factors of empagliflozin monotherapy in drug-naive patients with type 2 diabetes: a double-blind extension of a Phase III randomized controlled trial. Cardiovasc Diabetol. 2015 Dec 23;14:154. doi: 10.1186/s12933-015-0314-0.
Results Reference
derived
PubMed Identifier
26324220
Citation
Haering HU, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, Meinicke T, Woerle HJ, Broedl UC; EMPA-REG EXTEND METSU investigators. Empagliflozin as add-on to metformin plus sulphonylurea in patients with type 2 diabetes. Diabetes Res Clin Pract. 2015 Oct;110(1):82-90. doi: 10.1016/j.diabres.2015.05.044. Epub 2015 May 29.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1245/1245.31_c02645257-DS.pdf
Description
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Learn more about this trial

Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes

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