Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: BI 10773; Drug: BI 10773 / BI 1356 Placebo; Drug: BI 10773 / BI 1356; Drug: BI 10773 Placebo

• Registration Number: NCT01778049
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-24
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-29
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-03
• Results First Submitted: 2016-03-04
• Results First Submitted QC: 2016-03-04
• Last Update Submitted: 2016-03-04
• Results First Posted: 2016-04-04
• Last Update Posted: 2016-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 708

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empagliflozin 10 mg dose	BI 10773	Empagliflozin open label treatment period
Placebo add on 10 mg dose	BI 10773 / BI 1356 Placebo	Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo add on run-in
Empagliflozin/Linagliptin 25/5 mg Dose	BI 10773 / BI 1356	Empagliflozin / Linagliptin 25/5 mg Dose FDC active
Empagliflozin/Linagliptin 25/5 mg Dose	BI 10773 Placebo	Empagliflozin / Linagliptin 25/5 mg Dose FDC active
Empagliflozin/Linagliptin 10/5 mg Dose.	BI 10773 / BI 1356 Placebo	Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo
Empagliflozin/Linagliptin 10/5 mg Dose	BI 10773 Placebo	Empagliflozin / Linagliptin 10/5 mg Dose FDC active
Empagliflozin/Linagliptin 10/5 mg Dose	BI 10773 / BI 1356	Empagliflozin / Linagliptin 10/5 mg Dose FDC active
Empagliflozin/Linagliptin 25/5 mg Dose.	BI 10773 / BI 1356 Placebo	Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
Placebo add on 25 mg dose	BI 10773 / BI 1356 Placebo	Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo add on run-in
Placebo add on 10 mg dose	BI 10773	Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo add on run-in
Empagliflozin 25 mg dose	BI 10773	Empagliflozin open label treatment period
Empagliflozin/Linagliptin 10/5 mg Dose.	BI 10773	Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo
Empagliflozin/Linagliptin 25/5 mg Dose.	BI 10773	Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
Placebo add on 25 mg dose	BI 10773	Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo add on run-in

Primary Outcome Measures

Name	Time	Method
Change From Baseline of HbA1c After 24 Weeks of Treatment.	Baseline and 24 weeks	Change from baseline in Glycated haemoglobin (HbA1c) \[%\] after 24 weeks of treatment with double-blind trial medication, i.e. HbA1c change from baseline at Week 24. The term "baseline" was not used to refer to measurements prior to the administration of open-label medication. Such measurements were referred to as "pre-treatment". Analyses of change from pre-treatment used the last value before first administration of open-label medication as point of reference.; Observed Case (OC): This method analyse only available data that were observed while patients were on treatment, i.e., excluding the missing data. All values measured after rescue medication taken were set to missing. Full Analysis Set (FAS): Includes all patients in the Treated set who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial.

Secondary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose (FPG) Change From Baseline at 24 Weeks.	Baseline and 24 weeks	Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication, i.e. FPG change from baseline at Week 24.

Trial Locations

Locations (114)

1275.10.01019 Boehringer Ingelheim Investigational Site; 🇺🇸 Chino, California, United States

1275.10.01008 Boehringer Ingelheim Investigational Site; 🇺🇸 Huntington Beach, California, United States

1275.10.01003 Boehringer Ingelheim Investigational Site; 🇺🇸 San Diego, California, United States

1275.10.01024 Boehringer Ingelheim Investigational Site; 🇺🇸 San Diego, California, United States

1275.10.01002 Boehringer Ingelheim Investigational Site; 🇺🇸 Sylmar, California, United States

1275.10.01011 Boehringer Ingelheim Investigational Site; 🇺🇸 Miami, Florida, United States

1275.10.01009 Boehringer Ingelheim Investigational Site; 🇺🇸 Orlando, Florida, United States

1275.10.01023 Boehringer Ingelheim Investigational Site; 🇺🇸 Oviedo, Florida, United States

1275.10.01006 Boehringer Ingelheim Investigational Site; 🇺🇸 Tamarac, Florida, United States

1275.10.01017 Boehringer Ingelheim Investigational Site; 🇺🇸 Conyers, Georgia, United States

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