Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Linagliptin; Drug: Empagliflozin + Linagliptin; Drug: Empagliflozin placebo + Linagliptin placebo

• Registration Number: NCT01734785
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-16
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-28
• Study Start: 2013-01
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Results First Submitted: 2016-03-17
• Results First Submitted QC: 2016-03-17
• Results First Posted: 2016-04-18
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-09
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 607

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Linagliptin	Linagliptin	5 mg once daily
Linagliptin	Empagliflozin placebo + Linagliptin placebo	5 mg once daily
Empagliflozin + Linagliptin low dose	Empagliflozin + Linagliptin	1 tablet once daily
Empagliflozin + Linagliptin high dose	Empagliflozin + Linagliptin	1 tablet once daily

Primary Outcome Measures

Name	Time	Method
HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment	Baseline and 24 weeks	Change from baseline in Glycated haemoglobin (HbA1c) \[%\] after 24 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The term 'baseline' was not used to refer to measurements before the administration of open-label medication.

Secondary Outcome Measures

Name	Time	Method
Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment	Baseline and 24 weeks	Change from baseline Body weight after 24 weeks of treatment with double-blind trial medication.
Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment.	Baseline and 24 weeks	Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication.

Trial Locations

Locations (90)

1275.9.01013 Boehringer Ingelheim Investigational Site; 🇺🇸 Gulf Shores, Alabama, United States

1275.9.01009 Boehringer Ingelheim Investigational Site; 🇺🇸 Norwalk, California, United States

1275.9.01015 Boehringer Ingelheim Investigational Site; 🇺🇸 San Diego, California, United States

1275.9.01017 Boehringer Ingelheim Investigational Site; 🇺🇸 San Diego, California, United States

1275.9.01011 Boehringer Ingelheim Investigational Site; 🇺🇸 Northglenn, Colorado, United States

1275.9.01010 Boehringer Ingelheim Investigational Site; 🇺🇸 Coral Gables, Florida, United States

1275.9.01004 Boehringer Ingelheim Investigational Site; 🇺🇸 Miami, Florida, United States

1275.9.01006 Boehringer Ingelheim Investigational Site; 🇺🇸 Oldsmar, Florida, United States

1275.9.01001 Boehringer Ingelheim Investigational Site; 🇺🇸 Palm Coast, Florida, United States

1275.9.01027 Boehringer Ingelheim Investigational Site; 🇺🇸 Port Orange, Florida, United States

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