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COMPLETEDPHASE2

Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension

A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 10773 as Monotherapy or in Combination With Metformin in Type 2 Diabetic Patients

NCT00881530•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•patients completing one of double blind phase II trials 1245.9 or 1245.10
•informed consent

Exclusion Criteria

•patients meeting withdrawal criteria of preceding trial
•significant hepatic impairment
•significant renal impairment with creatinine clearance \< 50 ml/min
•contraindication to Metformin for all patients treated with Metformin
•premenopausal women that are nursing or pregnant or not practicing acceptable methods of birth control
•drug or alcohol abuse

Locations (137)

1245.24.101001 Boehringer Ingelheim Investigational Site

Mission Viejo, California, United States

1245.24.101028 Boehringer Ingelheim Investigational Site

Spring Valley, California, United States

1245.24.101027 Boehringer Ingelheim Investigational Site

Walnut Creek, California, United States

1245.24.101004 Boehringer Ingelheim Investigational Site

Clearwarter, Florida, United States

1245.24.101005 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

1245.24.101024 Boehringer Ingelheim Investigational Site

Saint Cloud, Florida, United States

1245.24.101014 Boehringer Ingelheim Investigational Site

Roswell, Georgia, United States

1245.24.101016 Boehringer Ingelheim Investigational Site

Staten Island, New York, United States

1245.24.101006 Boehringer Ingelheim Investigational Site

Wadsworth, Ohio, United States

1245.24.101023 Boehringer Ingelheim Investigational Site

Norristown, Pennsylvania, United States

Key Dates

Start Date

March 1, 2009

Primary Completion Date

May 1, 2011

Last Updated

June 16, 2014

Enrollment

660

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

BI 10773

DRUG

Metformin

DRUG

BI 10773

DRUG

Sitagliptin

DRUG

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

NCT06959901

Obesity and Diabetes Mellitus, Type 2Diabetes Prevention

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RECRUITINGNA

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

NCT06574035

Diabetes Mellitus, Type 2Depressive Symptoms+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 16, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes

Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use

Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes

Implementing Scalable, PAtient-centered, Team-based, Technology-enabled Care for Adults With Type 2 Diabetes (iPATH)