Linagliptin 2.5 mg Twice Daily Versus 5 mg Once Daily as add-on Therapy to Twice Daily Metformin in Type 2 Diabetes

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: linagliptin medium dose; Drug: linagliptin low dose; Drug: placebo

• Registration Number: NCT01012037
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-10
• Study First Submitted QC: 2009-11-10
• Study First Posted: 2009-11-11
• Primary Completion: 2010-09
• Results First Submitted: 2011-09-21
• Results First Submitted QC: 2011-09-21
• Results First Posted: 2011-10-31
• Status Verified: 2013-12
• Last Update Submitted: 2014-06-17
• Last Update Posted: 2014-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 491

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
linagliptin medium dose	linagliptin medium dose	linagliptin medium dose once daily
linagliptin low dose	linagliptin low dose	linagliptin low dose twice daily
placebo	placebo	placebo matching linagliptin

Primary Outcome Measures

Name	Time	Method
HbA1c Change From Baseline at Week 12	Baseline and week 12	HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Treatment means are adjusted for baseline HbA1c and use of prior oral antidiabetics (OADs) in addition to background metformin.

Secondary Outcome Measures

Name	Time	Method
The Occurrence of a Treat to Target Efficacy Response (HbA1c <6.5 %) After 12 Weeks of Treatment	12 weeks	Percentage of those patients with baseline HbA1c \>= 6.5% who had HbA1c \< 6.5% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF.
HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis	Baseline and week 6	Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis	Baseline and week 12	Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
FPG Change From Baseline at Week 12	Baseline and week 12	Change from baseline reflects the Week 12 FPG minus the baseline FPG. Treatment means are adjusted for baseline HbA1c, baseline fasting plasma glucose and use of prior oral antidiabetics (OADs) in addition to background metformin.
FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis	Baseline and week 6	Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis	Baseline and week 12	Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
Percentage of Patients With HbA1c Lowering by 0.5% or More at Week 12	Week 12	Percentage of patients with HbA1c lowering by at least 0.5% after 12 weeks. The analysis was performed on the full analysis set (FAS) using NCF.
Percentage of Patients With Rescue Therapy	12 weeks	Percentage of patients with rescue therapy at Week 12. The analysis was performed on the full analysis set (FAS) using OC.
The Occurrence of a Treat to Target Efficacy Response (HbA1c <7.0%) After 12 Weeks of Treatment	12 weeks	Percentage of those patients with baseline HbA1c \>= 7.0% who had HbA1c \< 7% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF.

Trial Locations

Locations (84)

1218.62.32003 Boehringer Ingelheim Investigational Site; 🇧🇪 De Pinte, Belgium

1218.62.32008 Boehringer Ingelheim Investigational Site; 🇧🇪 Kortenaken, Belgium

1218.62.32009 Boehringer Ingelheim Investigational Site; 🇧🇪 Kumtich, Belgium

1218.62.32005 Boehringer Ingelheim Investigational Site; 🇧🇪 Massemen-Wetteren, Belgium

1218.62.32004 Boehringer Ingelheim Investigational Site; 🇧🇪 Natoye, Belgium

1218.62.32007 Boehringer Ingelheim Investigational Site; 🇧🇪 Sint-Job-in't-Goor, Belgium

1218.62.32002 Boehringer Ingelheim Investigational Site; 🇧🇪 Tessenderlo, Belgium

1218.62.32006 Boehringer Ingelheim Investigational Site; 🇧🇪 Wilsele, Belgium

1218.62.11012 Boehringer Ingelheim Investigational Site; 🇨🇦 Calgary, Alberta, Canada

1218.62.11007 Boehringer Ingelheim Investigational Site; 🇨🇦 Burnaby, British Columbia, Canada

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