Efficacy and Safety of Linagliptin in Elderly Patients With Type 2 Diabetes

Phase 3

Completed

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

• Registration Number: NCT01084005
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2010-03-09
• Study First Posted: 2010-03-10
• Primary Completion: 2011-06
• Results First Submitted: 2012-06-14
• Results First Submitted QC: 2012-06-14
• Results First Posted: 2012-07-18
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	patients receive placebo tablets matching linagliptin 5 mg once daily
linagliptin	linagliptin	patients receive linagliptin 5 mg tablets once daily

Primary Outcome Measures

Name	Time	Method
HbA1c Change From Baseline to Week 24	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 Outcome Measures

Name	Time	Method
HbA1c Change From Baseline to Week 6	Baseline and week 6	HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and prior use of insulin.
HbA1c Change From Baseline to 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. Means are treatment adjusted for baseline HbA1c and prior use of insulin.
HbA1c Change From Baseline to Week 18	Baseline and week 18	HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and prior use of insulin.
FPG Change From Baseline to Week 24	Baseline and week 24	This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin.
FPG Change From Baseline to Week 6	Baseline and week 6	This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin, week repeated within patient and week by treatment interaction.
FPG Change From Baseline to Week 12	Baseline and week 12	This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin, week repeated within patient and week by treatment interaction.
FPG Change From Baseline to Week 18	Baseline and week 18	This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin, week repeated within patient and week by treatment interaction.
Percentage of Patients With HbA1c <7.0% at Week 24	Baseline and week 24	The percentage of patients with an HbA1c value below 7% at week 24 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.
Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5% at Week 24	Baseline and week 24	The percentage of patients with an HbA1c reduction of ≥0.5% at week 24 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%
Number of Patients With Rescue Therapy	week 24	The use of rescue therapy was planned for patients failing to achieve preset criteria based on glucose levels during the randomised treatment period of the trial

Trial Locations

Locations (34)

1218.63.45007 Boehringer Ingelheim Investigational Site; 🇩🇰 Aalborg, Denmark

1218.63.45003 Boehringer Ingelheim Investigational Site; 🇩🇰 Aarhus C, Denmark

1218.63.45001 Boehringer Ingelheim Investigational Site; 🇩🇰 Birkerød, Denmark

1218.63.61005 Boehringer Ingelheim Investigational Site; 🇦🇺 Gosford, New South Wales, Australia

1218.63.45002 Boehringer Ingelheim Investigational Site; 🇩🇰 Aarhus C, Denmark

1218.63.46003 Boehringer Ingelheim Investigational Site; 🇸🇪 Järfälla, Sweden

1218.63.61003 Boehringer Ingelheim Investigational Site; 🇦🇺 Adelaide, South Australia, Australia

1218.63.10007 Boehringer Ingelheim Investigational Site; 🇨🇦 Newmarket, Ontario, Canada

1218.63.10006 Boehringer Ingelheim Investigational Site; 🇨🇦 Toronto, Ontario, Canada

1218.63.61001 Boehringer Ingelheim Investigational Site; 🇦🇺 Parkville, Victoria, Australia

1218.63.10003 Boehringer Ingelheim Investigational Site; 🇨🇦 Hamilton, Ontario, Canada

1218.63.10002 Boehringer Ingelheim Investigational Site; 🇨🇦 St-Romuald, Quebec, Canada

1218.63.45008 Boehringer Ingelheim Investigational Site; 🇩🇰 Hellerup, Denmark

1218.63.45006 Boehringer Ingelheim Investigational Site; 🇩🇰 Hillerød, Denmark

1218.63.45004 Boehringer Ingelheim Investigational Site; 🇩🇰 Hvidovre, Denmark

1218.63.31008 Boehringer Ingelheim Investigational Site; 🇳🇱 Beek en Donk, Netherlands

1218.63.45005 Bispebjerg Hospital; 🇩🇰 København NV, Denmark

1218.63.31012 Boehringer Ingelheim Investigational Site; 🇳🇱 Doetinchem, Netherlands

1218.63.31009 Boehringer Ingelheim Investigational Site; 🇳🇱 Oude Pekela, Netherlands

1218.63.31001 Boehringer Ingelheim Investigational Site; 🇳🇱 Tubbergen, Netherlands

1218.63.46004 Boehringer Ingelheim Investigational Site; 🇸🇪 Göteborg, Sweden

1218.63.46002 Boehringer Ingelheim Investigational Site; 🇸🇪 Sundsvall, Sweden

1218.63.46005 Boehringer Ingelheim Investigational Site; 🇸🇪 Uppsala, Sweden

1218.63.46001 Boehringer Ingelheim Investigational Site; 🇸🇪 Malmö, Sweden

1218.63.10005 Boehringer Ingelheim Investigational Site; 🇨🇦 Hawkesbury, Ontario, Canada

1218.63.10008 Boehringer Ingelheim Investigational Site; 🇨🇦 Vancouver, British Columbia, Canada

1218.63.61007 Boehringer Ingelheim Investigational Site; 🇦🇺 East Ringwood, Victoria, Australia

1218.63.10001 Boehringer Ingelheim Investigational Site; 🇨🇦 Montreal, Quebec, Canada

1218.63.61002 Boehringer Ingelheim Investigational Site; 🇦🇺 Daw Park, South Australia, Australia

1218.63.10004 Boehringer Ingelheim Investigational Site; 🇨🇦 Saskatoon, Saskatchewan, Canada

1218.63.31007 Boehringer Ingelheim Investigational Site; 🇳🇱 Beerzerveld, Netherlands

1218.63.31014 Boehringer Ingelheim Investigational Site; 🇳🇱 Etten-Leur, Netherlands

1218.63.61006 Boehringer Ingelheim Investigational Site; 🇦🇺 Herston, Queensland, Australia

1218.63.61004 Boehringer Ingelheim Investigational Site; 🇦🇺 Reservoir, Victoria, Australia