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

COMPLETEDPHASE3

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

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

NCT01422876•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosis of type 2 diabetes mellitus prior to informed consent
•2. Male and female patients on diet and exercise regimen who are drug-naïve (defined as absence of any oral antidiabetic therapy, glucagon like peptide-1 analog or insulin for 12 weeks prior to randomization) or pre-treated with metformin (=1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
•3. Glycosylated hemoglobin (HbA1c) = 7.0% and = 10.5% (= 53.0 mmol/mol and = 91.3 mmol/mol) at Visit 1 (screening)

Exclusion Criteria

•1. Uncontrolled hyperglycemia with a glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
•2. Any other antidiabetic drug within 12 weeks prior to randomization (except metformin background therapy as defined via inclusion criterion 2)
•3. Acute coronary syndrome (non-ST elevation myocardial infarction, ST elevation myocardial infarction and unstable angina pectoris), stroke or (transient ischemic attack) TIA within 3 months prior to informed consent

Locations (211)

1275.1.01103 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

1275.1.01107 Boehringer Ingelheim Investigational Site

Foley, Alabama, United States

1275.1.01043 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

1275.1.01066 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

1275.1.01047 Boehringer Ingelheim Investigational Site

Pell City, Alabama, United States

1275.1.01089 Boehringer Ingelheim Investigational Site

Mesa, Arizona, United States

1275.1.01064 Boehringer Ingelheim Investigational Site

Tempe, Arizona, United States

1275.1.01028 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

1275.1.01086 Boehringer Ingelheim Investigational Site

Cerritos, California, United States

1275.1.01067 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

Key Dates

Start Date

August 1, 2011

Primary Completion Date

September 1, 2013

Completion Date

September 1, 2013

Last Updated

April 2, 2015

Enrollment

1,405

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

high dose FDC

DRUG

BI 10773 high dose

DRUG

high dose FDC placebo

DRUG

low dose FDC placebo

DRUG

high dose FDC placebo

DRUG

high dose FDC placebo

DRUG

low dose FDC placebo

DRUG

low dose FDC placebo

DRUG

high dose BI 10773 placebo

DRUG

low dose FDC

DRUG

high dose FDC placebo

DRUG

BI 10773 low dose

DRUG

high dose BI 10773 placebo

DRUG

high dose BI 10773 placebo

DRUG

linagliptin

DRUG

low dose FDC placebo

DRUG

linagliptin placebo

DRUG

BI 10773 low dose placebo

DRUG

linagliptin placebo

DRUG

low dose BI 10773 placebo

DRUG

linagliptin placebo

DRUG

high dose BI 10773 placebo

DRUG

BI 10773 low dose placebo

DRUG

low dose BI 10773 placebo

DRUG

linagliptin placebo

DRUG

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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: April 2, 2015Data 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.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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