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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Eli Lilly and Company

Information provided by (Responsible Party):

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01422876

First received: August 23, 2011

Last updated: May 15, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 23, 2011

Last Updated Date

May 15, 2013

Start Date ^ICMJE

August 2011

Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in glycosylated hemoglobin (HbA1c) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01422876 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in fasting plasma glucose [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Change from baseline in body weight [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: BI 10773
high dose monotherapy
Drug: BI 10773 high dose
once daily
Drug: high dose FDC placebo
once daily
Drug: linagliptin
montherapy
Drug: low dose FDC placebo
once daily
Drug: BI 10773 linagliptin FDC
low dose FDC
Drug: high dose BI 10773 placebo
once daily
Drug: linagliptin
once daily
Drug: BI 10773 low dose
low dose once daily
Drug: linagliptin placebo
once daily
Drug: BI 10773
high dose montherapy
Drug: low dose BI 10773 placebo
once daily
Drug: BI 10773
low dose once daily
Drug: BI 10773
low dose montherapy

Study Arm (s)

Experimental: BI 10773/linagliptin FDC (high dose)
Patients receive BI 10773/linagliptin FDC (high dose) once daily
Interventions:
- Drug: BI 10773
- Drug: linagliptin
- Drug: BI 10773 linagliptin FDC
- Drug: BI 10773
- Drug: BI 10773
Experimental: BI 10773/linagliptin FDC (low dose)
Patients receive BI 10773/linagliptin FDC (low dose) once daily
Interventions:
- Drug: high dose FDC placebo
- Drug: linagliptin
- Drug: high dose BI 10773 placebo
- Drug: low dose BI 10773 placebo
- Drug: linagliptin placebo
- Drug: BI 10773
Active Comparator: BI 10773 (high dose)
Patients receive BI 10773 (high dose) once daily
Interventions:
- Drug: BI 10773 high dose
- Drug: high dose FDC placebo
- Drug: low dose FDC placebo
- Drug: low dose BI 10773 placebo
- Drug: linagliptin placebo
Active Comparator: BI 10773 (low dose)
Patients receive BI 10773 (low dose) once daily
Interventions:
- Drug: high dose FDC placebo
- Drug: low dose FDC placebo
- Drug: high dose BI 10773 placebo
- Drug: BI 10773 low dose
- Drug: linagliptin placebo
Active Comparator: Linagliptin
Patients receive linagliptin once daily
Interventions:
- Drug: low dose FDC placebo
- Drug: high dose FDC placebo
- Drug: linagliptin
- Drug: high dose BI 10773 placebo
- Drug: low dose BI 10773 placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

1386

Estimated Completion Date

September 2013

Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

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

Exclusion criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Australia, Brazil, Bulgaria, Canada, Colombia, Denmark, Estonia, Hungary, Italy, Lebanon, Malaysia, Mexico, Peru, Philippines, Poland, Romania, Russian Federation, Spain, Sweden, Taiwan

Administrative Information

NCT Number ^ICMJE

NCT01422876

Other Study ID Numbers ^ICMJE

1275.1, 2011-000383-10

Has Data Monitoring Committee

Not Provided

Responsible Party

Boehringer Ingelheim Pharmaceuticals

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Eli Lilly and Company

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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