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

NCT ID: NCT01289990

Last Updated: 2014-07-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2705 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-05-31

Brief Summary

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This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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BI 10773 low (drug naive)

BI 10773 tablets once daily

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

BI 10773 tablets once daily

Placebo

Intervention Type DRUG

Placebo matching Sitagliptin

Placebo

Intervention Type DRUG

Placebo matching BI 10773 high dose

BI 10773 high (drug naive)

BI 10773 tablets once daily

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo matching Sitagliptin

BI 10773

Intervention Type DRUG

BI 10773 tablets once daily

Placebo

Intervention Type DRUG

Placebo matching BI 10773 low dose

Placebo (drug naive)

Placebo tablets matching BI 10773 / Sitagliptin once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching BI 10773 low dose

Placebo

Intervention Type DRUG

Placebo matching Sitagliptin

Placebo

Intervention Type DRUG

Placebo matching BI 10773 high dose

Sitagliptin 100mg (drug naive)

Sitagliptin once daily

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching BI 10773 high dose

Placebo

Intervention Type DRUG

Placebo matching BI 10773 low dose

Sitagliptin 100mg

Intervention Type DRUG

Sitagliptin once daily

BI 10773 low (pioglitazone)

BI 10773 tablets once daily

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

BI 10773 tablets once daily

Placebo

Intervention Type DRUG

Placebo matching BI 10773 high dose

BI 10773 high (pioglitazone)

BI 10773 tablets once daily

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

BI 10773 tablets once daily

Placebo

Intervention Type DRUG

Placebo matching BI 10773 low dose

Placebo (pioglitazone)

Placebo tablets matching BI 10773 once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching BI 10773 low dose

Placebo

Intervention Type DRUG

Placebo matching BI 10773 high dose

BI 10773 low (metformin)

BI 10773 tablets once daily

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo matching BI 10773 high dose

BI 10773

Intervention Type DRUG

BI 10773 tablets once daily

BI 10773 high (metformin)

BI 10773 tablets once daily

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

BI 10773 tablets once daily

Placebo

Intervention Type DRUG

Placebo matching BI 10773 low dose

Placebo (metformin)

Placebo tablets matching BI 10773 once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching BI 10773 low dose

Placebo

Intervention Type DRUG

Placebo matching BI 10773 high dose

BI 10773 low (metformin+sulfonylurea)

BI 10773 tablets once daily

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

BI 10773 tablets once daily

Placebo

Intervention Type DRUG

Placebo matching BI 10773 high dose

BI 10773 high (metformin+sulfonylurea)

BI 10773 tablets once daily

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

BI 10773 tablets once daily

Placebo

Intervention Type DRUG

Placebo matching BI 10773 low dose

Placebo (metformin+sulfonylurea)

Placebo tablets matching BI 10773

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching BI 10773 low dose

Placebo

Intervention Type DRUG

Placebo matching BI 10773 high dose

Interventions

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BI 10773

BI 10773 tablets once daily

Intervention Type DRUG

Placebo

Placebo matching BI 10773 low dose

Intervention Type DRUG

Placebo

Placebo matching BI 10773 high dose

Intervention Type DRUG

Placebo

Placebo matching Sitagliptin

Intervention Type DRUG

Placebo

Placebo matching BI 10773 high dose

Intervention Type DRUG

Placebo

Placebo matching BI 10773 high dose

Intervention Type DRUG

BI 10773

BI 10773 tablets once daily

Intervention Type DRUG

Placebo

Placebo matching BI 10773 low dose

Intervention Type DRUG

Placebo

Placebo matching BI 10773 low dose

Intervention Type DRUG

BI 10773

BI 10773 tablets once daily

Intervention Type DRUG

Placebo

Placebo matching BI 10773 low dose

Intervention Type DRUG

Placebo

Placebo matching BI 10773 high dose

Intervention Type DRUG

Placebo

Placebo matching Sitagliptin

Intervention Type DRUG

BI 10773

BI 10773 tablets once daily

Intervention Type DRUG

BI 10773

BI 10773 tablets once daily

Intervention Type DRUG

BI 10773

BI 10773 tablets once daily

Intervention Type DRUG

Placebo

Placebo matching BI 10773 high dose

Intervention Type DRUG

BI 10773

BI 10773 tablets once daily

Intervention Type DRUG

Placebo

Placebo matching BI 10773 low dose

Intervention Type DRUG

Placebo

Placebo matching BI 10773 high dose

Intervention Type DRUG

Placebo

Placebo matching Sitagliptin

Intervention Type DRUG

Sitagliptin 100mg

Sitagliptin once daily

Intervention Type DRUG

BI 10773

BI 10773 tablets once daily

Intervention Type DRUG

Placebo

Placebo matching BI 10773 low dose

Intervention Type DRUG

Placebo

Placebo matching BI 10773 low dose

Intervention Type DRUG

Placebo

Placebo matching BI 10773 low dose

Intervention Type DRUG

Placebo

Placebo matching BI 10773 high dose

Intervention Type DRUG

Placebo

Placebo matching BI 10773 low dose

Intervention Type DRUG

Placebo

Placebo matching BI 10773 high dose

Intervention Type DRUG

Placebo

Placebo matching BI 10773 high dose

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1245.31.10145 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

1245.31.10162 Boehringer Ingelheim Investigational Site

Glendale, Arizona, United States

Site Status

1245.31.10124 Boehringer Ingelheim Investigational Site

Mesa, Arizona, United States

Site Status

1245.31.10108 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Site Status

1245.31.10046 Boehringer Ingelheim Investigational Site

Tempe, Arizona, United States

Site Status

1245.31.10154 Boehringer Ingelheim Investigational Site

Chino, California, United States

Site Status

1245.31.10149 Boehringer Ingelheim Investigational Site

Rancho Cucamonga, California, United States

Site Status

1245.31.10131 Boehringer Ingelheim Investigational Site

West Hills, California, United States

Site Status

1245.31.10038 Boehringer Ingelheim Investigational Site

Northglenn, Colorado, United States

Site Status

1245.31.10127 Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

Site Status

1245.31.10137 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Site Status

1245.31.10133 Boehringer Ingelheim Investigational Site

Jupiter, Florida, United States

Site Status

1245.31.10006 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

1245.31.10085 Boehringer Ingelheim Investigational Site

Plantation, Florida, United States

Site Status

1245.31.10080 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

Site Status

1245.31.10077 Boehringer Ingelheim Investigational Site

Perry, Georgia, United States

Site Status

1245.31.10001 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

1245.31.10159 Boehringer Ingelheim Investigational Site

Des Moines, Iowa, United States

Site Status

1245.31.10014 Boehringer Ingelheim Investigational Site

Dubuque, Iowa, United States

Site Status

1245.31.10117 Boehringer Ingelheim Investigational Site

Arkansas City, Kansas, United States

Site Status

1245.31.10157 Boehringer Ingelheim Investigational Site

Newton, Kansas, United States

Site Status

1245.31.10146 Boehringer Ingelheim Investigational Site

Louisville, Kentucky, United States

Site Status

1245.31.10003 Boehringer Ingelheim Investigational Site

Dearborn, Michigan, United States

Site Status

1245.31.10059 Boehringer Ingelheim Investigational Site

New Hyde Park, New York, United States

Site Status

1245.31.10034 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

Site Status

1245.31.10123 Boehringer Ingelheim Investigational Site

Smithtown, New York, United States

Site Status

1245.31.10071 Boehringer Ingelheim Investigational Site

Asheboro, North Carolina, United States

Site Status

1245.31.10086 Boehringer Ingelheim Investigational Site

Salisbury, North Carolina, United States

Site Status

1245.31.10129 Boehringer Ingelheim Investigational Site

Carlisle, Ohio, United States

Site Status

1245.31.10045 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

1245.31.10119 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

1245.31.10130 Boehringer Ingelheim Investigational Site

Gallipolis, Ohio, United States

Site Status

1245.31.10158 Boehringer Ingelheim Investigational Site

Mt. Pleasant, South Carolina, United States

Site Status

1245.31.10015 Boehringer Ingelheim Investigational Site

Simpsonville, South Carolina, United States

Site Status

1245.31.10033 Boehringer Ingelheim Investigational Site

Chattanooga, Tennessee, United States

Site Status

1245.31.10112 Boehringer Ingelheim Investigational Site

Memphis, Tennessee, United States

Site Status

1245.31.10156 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1245.31.10151 Boehringer Ingelheim Investigational Site

Hurst, Texas, United States

Site Status

1245.31.10143 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Site Status

1245.31.10155 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

1245.31.32008 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1245.31.32023 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1245.31.32003 Boehringer Ingelheim Investigational Site

De Pinte, , Belgium

Site Status

1245.31.32015 Boehringer Ingelheim Investigational Site

Deurne, , Belgium

Site Status

1245.31.32016 Boehringer Ingelheim Investigational Site

Deurne, , Belgium

Site Status

1245.31.32025 Boehringer Ingelheim Investigational Site

Gozée, , Belgium

Site Status

1245.31.32019 Boehringer Ingelheim Investigational Site

Leopoldsburg, , Belgium

Site Status

1245.31.32024 Boehringer Ingelheim Investigational Site

Linkebeek, , Belgium

Site Status

1245.31.32021 Boehringer Ingelheim Investigational Site

Mouscron, , Belgium

Site Status

1245.31.32020 Boehringer Ingelheim Investigational Site

Sint-Gillis-Waas, , Belgium

Site Status

1245.31.32018 Boehringer Ingelheim Investigational Site

Tielt, , Belgium

Site Status

1245.31.32026 Boehringer Ingelheim Investigational Site

Tremelo, , Belgium

Site Status

1245.31.20032 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

1245.31.20023 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Site Status

1245.31.20011 Boehringer Ingelheim Investigational Site

Chilliwack, British Columbia, Canada

Site Status

1245.31.20028 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1245.31.20018 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

Site Status

1245.31.20033 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

Site Status

1245.31.20015 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Site Status

1245.31.20012 Boehringer Ingelheim Investigational Site

Moncton, New Brunswick, Canada

Site Status

1245.31.20016 Boehringer Ingelheim Investigational Site

Mount Pearl, Newfoundland and Labrador, Canada

Site Status

1245.31.20024 Boehringer Ingelheim Investigational Site

Paradise, Newfoundland and Labrador, Canada

Site Status

1245.31.20008 Boehringer Ingelheim Investigational Site

St. John's, Newfoundland and Labrador, Canada

Site Status

1245.31.20026 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

Site Status

1245.31.20022 Boehringer Ingelheim Investigational Site

Brampton, Ontario, Canada

Site Status

1245.31.20057 Boehringer Ingelheim Investigational Site

Brampton, Ontario, Canada

Site Status

1245.31.20035 Boehringer Ingelheim Investigational Site

Corunna, Ontario, Canada

Site Status

1245.31.20030 Boehringer Ingelheim Investigational Site

Etobicoke, Ontario, Canada

Site Status

1245.31.20019 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

1245.31.20017 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Site Status

1245.31.20029 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Site Status

1245.31.20060 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Site Status

1245.31.20003 Boehringer Ingelheim Investigational Site

Markham, Ontario, Canada

Site Status

1245.31.20009 Boehringer Ingelheim Investigational Site

Newmarket, Ontario, Canada

Site Status

1245.31.20040 Boehringer Ingelheim Investigational Site

Oakville, Ontario, Canada

Site Status

1245.31.20034 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Site Status

1245.31.20005 Boehringer Ingelheim Investigational Site

Strathroy, Ontario, Canada

Site Status

1245.31.20002 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1245.31.20006 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1245.31.20007 Boehringer Ingelheim Investigational Site

Montague, Prince Edward Island, Canada

Site Status

1245.31.20027 Boehringer Ingelheim Investigational Site

Laval, Quebec, Canada

Site Status

1245.31.20025 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

1245.31.20058 Boehringer Ingelheim Investigational Site

Saint Romuald, Quebec, Canada

Site Status

1245.31.20038 Boehringer Ingelheim Investigational Site

Saint-Laurent, Quebec, Canada

Site Status

1245.31.20036 Boehringer Ingelheim Investigational Site

Sherbrooke, Quebec, Canada

Site Status

1245.31.20021 Boehringer Ingelheim Investigational Site

Trois-Rivières, Quebec, Canada

Site Status

1245.31.20041 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Site Status

1245.31.86007 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1245.31.86008 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1245.31.86031 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1245.31.86032 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1245.31.86033 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1245.31.86034 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1245.31.86035 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1245.31.86058 Boehringer Ingelheim Investigational Site

Chongqing, , China

Site Status

1245.31.86038 Boehringer Ingelheim Investigational Site

Dalian, , China

Site Status

1245.31.86001 Boehringer Ingelheim Investigational Site

Guangzhou, , China

Site Status

1245.31.86003 Boehringer Ingelheim Investigational Site

Guangzhou, , China

Site Status

1245.31.86052 Boehringer Ingelheim Investigational Site

Guangzhou, , China

Site Status

1245.31.86012 Boehringer Ingelheim Investigational Site

Guiyang, , China

Site Status

1245.31.86037 Boehringer Ingelheim Investigational Site

Haerbin, , China

Site Status

1245.31.86020 Boehringer Ingelheim Investigational Site

Hangzhou, , China

Site Status

1245.31.86049 Boehringer Ingelheim Investigational Site

Jinan, , China

Site Status

1245.31.86053 Boehringer Ingelheim Investigational Site

Jinan, , China

Site Status

1245.31.86018 Boehringer Ingelheim Investigational Site

Jingzhou, , China

Site Status

1245.31.86019 Boehringer Ingelheim Investigational Site

Nanchang, , China

Site Status

1245.31.86042 Boehringer Ingelheim Investigational Site

Nanjing, , China

Site Status

1245.31.86043 Boehringer Ingelheim Investigational Site

Nanjing, , China

Site Status

1245.31.86055 Boehringer Ingelheim Investigational Site

Nanning, , China

Site Status

1245.31.86056 Boehringer Ingelheim Investigational Site

Nanning, , China

Site Status

1245.31.86016 Boehringer Ingelheim Investigational Site

Qingdao, , China

Site Status

1245.31.86039 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1245.31.86054 Boehringer Ingelheim Investigational Site

Shantou, , China

Site Status

1245.31.86057 Boehringer Ingelheim Investigational Site

Shenyang, , China

Site Status

1245.31.86045 Boehringer Ingelheim Investigational Site

Shijiazhuang, , China

Site Status

1245.31.86017 Boehringer Ingelheim Investigational Site

Shiyan, , China

Site Status

1245.31.86013 Boehringer Ingelheim Investigational Site

Suzhou, , China

Site Status

1245.31.86015 Boehringer Ingelheim Investigational Site

Taiyuan, , China

Site Status

1245.31.86036 Boehringer Ingelheim Investigational Site

Tianjin, , China

Site Status

1245.31.86011 Boehringer Ingelheim Investigational Site

Xi'an, , China

Site Status

1245.31.86041 Boehringer Ingelheim Investigational Site

Xi'an, , China

Site Status

1245.31.86014 Boehringer Ingelheim Investigational Site

Xiamen, , China

Site Status

1245.31.33008 Boehringer Ingelheim Investigational Site

Bersée, , France

Site Status

1245.31.33020 Boehringer Ingelheim Investigational Site

Bischheim, , France

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1245.31.33002 Boehringer Ingelheim Investigational Site

Bondy, , France

Site Status

1245.31.33016 Boehringer Ingelheim Investigational Site

Bruay-la-Buissière, , France

Site Status

1245.31.33001 Boehringer Ingelheim Investigational Site

Corbeil-Essonnes, , France

Site Status

1245.31.33010 Boehringer Ingelheim Investigational Site

Croix, , France

Site Status

1245.31.33009 Boehringer Ingelheim Investigational Site

Hautmont, , France

Site Status

1245.31.33003 Boehringer Ingelheim Investigational Site

La Rochelle, , France

Site Status

1245.31.33045 Boehringer Ingelheim Investigational Site

Marseille, , France

Site Status

1245.31.33004 Boehringer Ingelheim Investigational Site

Narbonne, , France

Site Status

1245.31.33012 Boehringer Ingelheim Investigational Site

Schiltigheim, , France

Site Status

1245.31.33013 Boehringer Ingelheim Investigational Site

Strasbourg, , France

Site Status

1245.31.33019 Boehringer Ingelheim Investigational Site

Strasbourg, , France

Site Status

1245.31.33007 Boehringer Ingelheim Investigational Site

Vieux-Condé, , France

Site Status

1245.31.33018 Boehringer Ingelheim Investigational Site

Wattrelos, , France

Site Status

1245.31.49001 Boehringer Ingelheim Investigational Site

Dormagen, , Germany

Site Status

1245.31.49013 Boehringer Ingelheim Investigational Site

Dresden, , Germany

Site Status

1245.31.49016 Boehringer Ingelheim Investigational Site

Düsseldorf, , Germany

Site Status

1245.31.49009 Boehringer Ingelheim Investigational Site

Flörsheim, , Germany

Site Status

1245.31.49015 Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

Site Status

1245.31.49019 Boehringer Ingelheim Investigational Site

Haag, , Germany

Site Status

1245.31.49004 Boehringer Ingelheim Investigational Site

Hatten, , Germany

Site Status

1245.31.49020 Boehringer Ingelheim Investigational Site

Hohenmölsen, , Germany

Site Status

1245.31.49007 Boehringer Ingelheim Investigational Site

Künzing, , Germany

Site Status

1245.31.49002 Boehringer Ingelheim Investigational Site

Neuwied, , Germany

Site Status

1245.31.49008 Boehringer Ingelheim Investigational Site

Nuremberg, , Germany

Site Status

1245.31.49010 Boehringer Ingelheim Investigational Site

Rednitzhembach, , Germany

Site Status

1245.31.49006 Boehringer Ingelheim Investigational Site

Rehburg-Loccum, , Germany

Site Status

1245.31.49011 Boehringer Ingelheim Investigational Site

Rehlingen-Siersburg, , Germany

Site Status

1245.31.49005 Boehringer Ingelheim Investigational Site

Saarbrücken, , Germany

Site Status

1245.31.49017 Boehringer Ingelheim Investigational Site

Saint Ingbert/Oberwürzbach, , Germany

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1245.31.49022 Boehringer Ingelheim Investigational Site

Schauenburg, , Germany

Site Status

1245.31.49003 Boehringer Ingelheim Investigational Site

Unterschneidheim, , Germany

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1245.31.30004 Boehringer Ingelheim Investigational Site

Thessaloniki, , Greece

Site Status

1245.31.91005 Boehringer Ingelheim Investigational Site

Bangalore, , India

Site Status

1245.31.91006 Boehringer Ingelheim Investigational Site

Bangalore, , India

Site Status

1245.31.91008 Boehringer Ingelheim Investigational Site

Bangalore, , India

Site Status

1245.31.91003 Boehringer Ingelheim Investigational Site

Belagavi, , India

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1245.31.91004 Boehringer Ingelheim Investigational Site

Chennai, , India

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1245.31.91009 Boehringer Ingelheim Investigational Site

Chennai, , India

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1245.31.91001 Boehringer Ingelheim Investigational Site

Coimbatore, , India

Site Status

1245.31.91101 Boehringer Ingelheim Investigational Site

Coimbatore, , India

Site Status

1245.31.91104 Boehringer Ingelheim Investigational Site

Indore, , India

Site Status

1245.31.91015 Boehringer Ingelheim Investigational Site

Kalaburagi, , India

Site Status

1245.31.91103 Boehringer Ingelheim Investigational Site

Maharashtra, , India

Site Status

1245.31.91002 Boehringer Ingelheim Investigational Site

Mumbai, , India

Site Status

1245.31.91007 Boehringer Ingelheim Investigational Site

Mumbai, Maharastra, , India

Site Status

1245.31.91010 Boehringer Ingelheim Investigational Site

Nagpur, , India

Site Status

1245.31.91012 Boehringer Ingelheim Investigational Site

New Delhi, , India

Site Status

1245.31.91014 Boehringer Ingelheim Investigational Site

Pune, , India

Site Status

1245.31.91105 Boehringer Ingelheim Investigational Site

Pune, , India

Site Status

1245.31.35304 Boehringer Ingelheim Investigational Site

Birr, Co. Offaly, , Ireland

Site Status

1245.31.35302 Boehringer Ingelheim Investigational Site

Co. Cork, , Ireland

Site Status

1245.31.35305 Boehringer Ingelheim Investigational Site

Co. Galway, , Ireland

Site Status

1245.31.35303 Boehringer Ingelheim Investigational Site

Co. Wexford, , Ireland

Site Status

1245.31.35306 Boehringer Ingelheim Investigational Site

Co. Wexford, , Ireland

Site Status

1245.31.81007 Boehringer Ingelheim Investigational Site

Chiyoda-ku, Tokyo, , Japan

Site Status

1245.31.81001 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, , Japan

Site Status

1245.31.81002 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, , Japan

Site Status

1245.31.81005 Boehringer Ingelheim Investigational Site

Ebetsu, Hokkaido, , Japan

Site Status

1245.31.81004 Boehringer Ingelheim Investigational Site

Kamakura, Kanagawa, , Japan

Site Status

1245.31.81003 Boehringer Ingelheim Investigational Site

Minato-ku, Tokyo, , Japan

Site Status

1245.31.81006 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, , Japan

Site Status

1245.31.81008 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, , Japan

Site Status

1245.31.81009 Boehringer Ingelheim Investigational Site

Suita, Osaka, , Japan

Site Status

1245.31.81010 Boehringer Ingelheim Investigational Site

Ube, Yamaguchi, , Japan

Site Status

1245.31.81012 Boehringer Ingelheim Investigational Site

Urasoe, Okinawa, , Japan

Site Status

1245.31.81013 Boehringer Ingelheim Investigational Site

Urasoe, Okinawa, , Japan

Site Status

1245.31.52003 Boehringer Ingelheim Investigational Site

Guadalajara, , Mexico

Site Status

1245.31.52004 Boehringer Ingelheim Investigational Site

Guadalajara, , Mexico

Site Status

1245.31.52001 Boehringer Ingelheim Investigational Site

Monterrey, , Mexico

Site Status

1245.31.52002 Boehringer Ingelheim Investigational Site

Monterrey, , Mexico

Site Status

1245.31.63002 Boehringer Ingelheim Investigational Site

Cebu, , Philippines

Site Status

1245.31.63003 Boehringer Ingelheim Investigational Site

Davao City, , Philippines

Site Status

1245.31.63001 Boehringer Ingelheim Investigational Site

Manila, , Philippines

Site Status

1245.31.63004 Boehringer Ingelheim Investigational Site

Manila, , Philippines

Site Status

1245.31.63005 Boehringer Ingelheim Investigational Site

Manila, , Philippines

Site Status

1245.31.74005 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

Site Status

1245.31.74002 Boehringer Ingelheim Investigational Site

Lučenec, , Slovakia

Site Status

1245.31.74006 Boehringer Ingelheim Investigational Site

Nitra, , Slovakia

Site Status

1245.31.74014 Boehringer Ingelheim Investigational Site

Nové Zámky, , Slovakia

Site Status

1245.31.74001 Boehringer Ingelheim Investigational Site

Považská Bystrica, , Slovakia

Site Status

1245.31.74004 Boehringer Ingelheim Investigational Site

Prešov, , Slovakia

Site Status

1245.31.74003 Boehringer Ingelheim Investigational Site

Trebišov, , Slovakia

Site Status

1245.31.38003 Boehringer Ingelheim Investigational Site

Celje, , Slovenia

Site Status

1245.31.38002 Boehringer Ingelheim Investigational Site

Koper, , Slovenia

Site Status

1245.31.38001 Boehringer Ingelheim Investigational Site

Maribor, , Slovenia

Site Status

1245.31.82012 Boehringer Ingelheim Investigational Site

Anyang, , South Korea

Site Status

1245.31.82011 Boehringer Ingelheim Investigational Site

Goyang, , South Korea

Site Status

1245.31.82009 Boehringer Ingelheim Investigational Site

Ilsan, , South Korea

Site Status

1245.31.82001 Boehringer Ingelheim Investigational Site

Incheon, , South Korea

Site Status

1245.31.82006 Boehringer Ingelheim Investigational Site

Jeonju, , South Korea

Site Status

1245.31.82004 Boehringer Ingelheim Investigational Site

Pusan, , South Korea

Site Status

1245.31.82005 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1245.31.82007 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1245.31.82008 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1245.31.82010 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1245.31.82014 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1245.31.82002 Boehringer Ingelheim Investigational Site

Suwon, , South Korea

Site Status

1245.31.82003 Boehringer Ingelheim Investigational Site

Wŏnju, , South Korea

Site Status

1245.31.41004 Boehringer Ingelheim Investigational Site

Lugano, , Switzerland

Site Status

1245.31.41003 Boehringer Ingelheim Investigational Site

Rorschach, , Switzerland

Site Status

1245.31.88010 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

Site Status

1245.31.88011 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

Site Status

1245.31.88012 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

Site Status

1245.31.88013 Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

1245.31.88009 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

Site Status

1245.31.88014 Boehringer Ingelheim Investigational Site

Tainan City, , Taiwan

Site Status

1245.31.88006 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1245.31.88021 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1245.31.88008 Boehringer Ingelheim Investigational Site

Taoyuan, , Taiwan

Site Status

1245.31.90003 Boehringer Ingelheim Investigational Site

Erzurum, , Turkey (Türkiye)

Site Status

1245.31.90001 Boehringer Ingelheim Investigational Site

Gaziantep, , Turkey (Türkiye)

Site Status

1245.31.90002 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

1245.31.90006 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

1245.31.90004 Boehringer Ingelheim Investigational Site

Izmir, , Turkey (Türkiye)

Site Status

1245.31.75002 Boehringer Ingelheim Investigational Site

Dnipro, , Ukraine

Site Status

1245.31.75001 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1245.31.75006 Boehringer Ingelheim Investigational Site

Lviv, , Ukraine

Site Status

1245.31.75004 Boehringer Ingelheim Investigational Site

Vinnitsa, , Ukraine

Site Status

1245.31.75003 Boehringer Ingelheim Investigational Site

Vinnytsia, , Ukraine

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Belgium Canada China France Germany Greece India Ireland Japan Mexico Philippines Slovakia Slovenia South Korea Switzerland Taiwan Turkey (Türkiye) Ukraine

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35472672 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33084149 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28753486 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26701110 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26324220 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010-022718-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1245.31

Identifier Type: -

Identifier Source: org_study_id

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