A Phase III Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of Linagliptin (5 mg) Administered Orally Once Daily Over 24 Weeks in Type 2 Diabetic Patients (Age >= 70 Years) With Insufficient Glycaemic Control( HbA1c >= 7.0) Despite Metformin and/or Sulphonylurea and/or Insulin Therapy

Boehringer Ingelheim34 sites in 5 countries241 target enrollmentMarch 2010

ConditionsDiabetes Mellitus, Type 2

Interventionslinagliptin placebo

Drugslinagliptin placebo

Overview

Phase: Phase 3
Intervention: linagliptin
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Enrollment: 241
Locations: 34
Primary Endpoint: HbA1c Change From Baseline to Week 24
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to stable treatment in elderly patients with T2DM with insufficient glycaemic control

Registry

clinicaltrials.gov

Start Date

March 2010

End Date

June 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

linagliptin

patients receive linagliptin 5 mg tablets once daily

Intervention: linagliptin

placebo

patients receive placebo tablets matching linagliptin 5 mg once daily

Intervention: placebo

Outcomes

Primary Outcomes

HbA1c Change From Baseline to Week 24

Time Frame: Baseline and week 24

HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and prior use of insulin.

Secondary Outcomes

HbA1c Change From Baseline to Week 6(Baseline and week 6)
HbA1c Change From Baseline to Week 12(Baseline and week 12)
HbA1c Change From Baseline to Week 18(Baseline and week 18)
FPG Change From Baseline to Week 24(Baseline and week 24)
FPG Change From Baseline to Week 6(Baseline and week 6)
FPG Change From Baseline to Week 12(Baseline and week 12)
FPG Change From Baseline to Week 18(Baseline and week 18)
Percentage of Patients With HbA1c <7.0% at Week 24(Baseline and week 24)
Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5% at Week 24(Baseline and week 24)
Number of Patients With Rescue Therapy(week 24)