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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: high dose FDC; Drug: low dose FDC placebo; Drug: BI 10773 high dose; Drug: high dose FDC placebo; Drug: low dose FDC; Drug: high dose BI 10773 placebo; Drug: linagliptin; Drug: low dose BI 10773 placebo; Drug: BI 10773 low dose placebo; Drug: BI 10773 low dose; Drug: linagliptin placebo

• Registration Number: NCT01422876
• Lead Sponsor: Boehringer Ingelheim

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 available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-23
• Study First Submitted QC: 2011-08-23
• Study First Posted: 2011-08-25
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Disposition First Submitted: 2014-05-15
• Disposition First Submitted QC: 2014-05-15
• Disposition First Posted: 2014-05-28
• Results First Submitted: 2015-01-15
• Status Verified: 2015-03
• Results First Submitted QC: 2015-04-01
• Last Update Submitted: 2015-04-01
• Results First Posted: 2015-04-02
• Last Update Posted: 2015-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1405

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 10773/linagliptin FDC (high dose)	linagliptin placebo	Patients receive BI 10773/linagliptin FDC (high dose) once daily
BI 10773 (high dose)	linagliptin placebo	Patients receive BI 10773 (high dose) once daily
BI 10773 (low dose)	linagliptin placebo	Patients receive BI 10773 (low dose) once daily
BI 10773/linagliptin FDC (high dose)	high dose FDC	Patients receive BI 10773/linagliptin FDC (high dose) once daily
BI 10773/linagliptin FDC (high dose)	high dose BI 10773 placebo	Patients receive BI 10773/linagliptin FDC (high dose) once daily
BI 10773 (low dose)	high dose BI 10773 placebo	Patients receive BI 10773 (low dose) once daily
Linagliptin	high dose BI 10773 placebo	Patients receive linagliptin once daily
BI 10773/linagliptin FDC (low dose)	linagliptin placebo	Patients receive BI 10773/linagliptin FDC (low dose) once daily
BI 10773 (high dose)	high dose FDC placebo	Patients receive BI 10773 (high dose) once daily
Linagliptin	high dose FDC placebo	Patients receive linagliptin once daily
Linagliptin	linagliptin	Patients receive linagliptin once daily
BI 10773/linagliptin FDC (low dose)	high dose FDC placebo	Patients receive BI 10773/linagliptin FDC (low dose) once daily
BI 10773/linagliptin FDC (low dose)	high dose BI 10773 placebo	Patients receive BI 10773/linagliptin FDC (low dose) once daily
Linagliptin	low dose FDC placebo	Patients receive linagliptin once daily
BI 10773/linagliptin FDC (high dose)	low dose FDC placebo	Patients receive BI 10773/linagliptin FDC (high dose) once daily
BI 10773 (high dose)	low dose BI 10773 placebo	Patients receive BI 10773 (high dose) once daily
BI 10773/linagliptin FDC (high dose)	BI 10773 low dose placebo	Patients receive BI 10773/linagliptin FDC (high dose) once daily
BI 10773/linagliptin FDC (low dose)	low dose FDC	Patients receive BI 10773/linagliptin FDC (low dose) once daily
BI 10773/linagliptin FDC (low dose)	BI 10773 low dose placebo	Patients receive BI 10773/linagliptin FDC (low dose) once daily
BI 10773 (high dose)	BI 10773 high dose	Patients receive BI 10773 (high dose) once daily
BI 10773 (low dose)	high dose FDC placebo	Patients receive BI 10773 (low dose) once daily
BI 10773 (low dose)	BI 10773 low dose	Patients receive BI 10773 (low dose) once daily
Linagliptin	low dose BI 10773 placebo	Patients receive linagliptin once daily
BI 10773 (high dose)	low dose FDC placebo	Patients receive BI 10773 (high dose) once daily
BI 10773 (low dose)	low dose FDC placebo	Patients receive BI 10773 (low dose) once daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients	Baseline and 24 weeks	Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients	Baseline and 24 weeks	Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Body Weight for Metformin Background Patients	Baseline and 24 Weeks	Change from baseline in body weight for Metformin Background patients.
Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients	Baseline and 24 Weeks	Change from baseline in fasting plasma glucose at week 24 for Metformin Background patients.
Change From Baseline in Fasting Plasma Glucose at Week 24 for Treatment Naive Patients	Baseline and 24 Weeks	Change from baseline in fasting plasma glucose at week 24 for Treatment Naive patients.
Change From Baseline in Body Weight for Treatment Naive Patients	Baseline and 24 Weeks	Change from baseline in body weight for Treatment Naive patients.
Occurrence of Treat to Target Efficacy Response for Metformin Background Patients	24 Weeks	Occurrence of the treat-to-target efficacy response for Metformin Background patients measured as HbA1c \< 7.0% after 24 weeks of treatment for patients with HbA1c \>=7.0% at baseline.
Occurrence of Treat to Target Efficacy Response for Treatment Naive Patients	24 Weeks	Occurrence of the treat-to-target efficacy response for Treatment Naive patients measured as HbA1c \< 7.0% after 24 weeks of treatment for patients with HbA1c \>=7.0% at baseline.

Trial Locations

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

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