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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084005
• Other study ID #: 1218.63
• Secondary ID: 2009-015255-25
• Status: Completed
• Phase: Phase 3
• First received: March 9, 2010
• Last updated: December 11, 2013
• Start date: March 2010

Study information

• Verified date: December 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Dept of Health and Ageing Therapeutic Goods AdminCanada: Health CanadaDenmark: Danish Medicines AgencyNetherlands: Central Committee Research Involving Human SubjectsSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

Inclusion criteria:

1. Type 2 diabetes mellitus

2. HbA1c >= 7.0%

3. Age >= 70 years

4. Signed and dated written informed consent

Exclusion criteria:

1. Myocardial infarction, stroke or TIA within 3 months prior to informed consent

2. Impaired hepatic function

3. Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors or rapid acting or pre-mixed insulins

4. Treatment with anti-obesity drugs

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• linagliptin
patients receive linagliptin 5 mg tablets once daily
• placebo
patients receive placebo matching linagliptin 5 mg once daily

Locations

Country	Name	City	State
Australia	1218.63.61003 Boehringer Ingelheim Investigational Site	Adelaide	South Australia
Australia	1218.63.61002 Boehringer Ingelheim Investigational Site	Daw Park	South Australia
Australia	1218.63.61007 Boehringer Ingelheim Investigational Site	East Ringwood	Victoria
Australia	1218.63.61005 Boehringer Ingelheim Investigational Site	Gosford	New South Wales
Australia	1218.63.61006 Boehringer Ingelheim Investigational Site	Herston	Queensland
Australia	1218.63.61001 Boehringer Ingelheim Investigational Site	Parkville	Victoria
Australia	1218.63.61004 Boehringer Ingelheim Investigational Site	Reservoir	Victoria
Canada	1218.63.10003 Boehringer Ingelheim Investigational Site	Hamilton	Ontario
Canada	1218.63.10005 Boehringer Ingelheim Investigational Site	Hawkesbury	Ontario
Canada	1218.63.10001 Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	1218.63.10007 Boehringer Ingelheim Investigational Site	Newmarket	Ontario
Canada	1218.63.10004 Boehringer Ingelheim Investigational Site	Saskatoon	Saskatchewan
Canada	1218.63.10002 Boehringer Ingelheim Investigational Site	St-Romuald	Quebec
Canada	1218.63.10006 Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	1218.63.10008 Boehringer Ingelheim Investigational Site	Vancouver	British Columbia
Denmark	1218.63.45007 Boehringer Ingelheim Investigational Site	Aalborg
Denmark	1218.63.45002 Boehringer Ingelheim Investigational Site	Aarhus C
Denmark	1218.63.45003 Boehringer Ingelheim Investigational Site	Aarhus C
Denmark	1218.63.45001 Boehringer Ingelheim Investigational Site	Birkerød
Denmark	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	1218.63.45005 Bispebjerg Hospital	København NV
Netherlands	1218.63.31008 Boehringer Ingelheim Investigational Site	Beek en Donk
Netherlands	1218.63.31007 Boehringer Ingelheim Investigational Site	Beerzerveld
Netherlands	1218.63.31012 Boehringer Ingelheim Investigational Site	Doetinchem
Netherlands	1218.63.31014 Boehringer Ingelheim Investigational Site	Etten-Leur
Netherlands	1218.63.31009 Boehringer Ingelheim Investigational Site	Oude Pekela
Netherlands	1218.63.31001 Boehringer Ingelheim Investigational Site	Tubbergen
Sweden	1218.63.46004 Boehringer Ingelheim Investigational Site	Göteborg
Sweden	1218.63.46003 Boehringer Ingelheim Investigational Site	Järfälla
Sweden	1218.63.46001 Boehringer Ingelheim Investigational Site	Malmö
Sweden	1218.63.46002 Boehringer Ingelheim Investigational Site	Sundsvall
Sweden	1218.63.46005 Boehringer Ingelheim Investigational Site	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company

Countries where clinical trial is conducted

Australia,  Canada,  Denmark,  Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c Change From Baseline to 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.	Baseline and week 24	No
Secondary	HbA1c Change From Baseline to 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.	Baseline and week 6	No
Secondary	HbA1c Change From Baseline to 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.	Baseline and week 12	No
Secondary	HbA1c Change From Baseline to 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.	Baseline and week 18	No
Secondary	FPG Change From Baseline to 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.	Baseline and week 24	No
Secondary	FPG Change From Baseline to 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.	Baseline and week 6	No
Secondary	FPG Change From Baseline to 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.	Baseline and week 12	No
Secondary	FPG Change From Baseline to 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.	Baseline and week 18	No
Secondary	Percentage of Patients With HbA1c <7.0% at Week 24	The percentage of patients with an HbA1c value below 7% at week 24 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 above 7%. Only patients with baseline HbA1c >= 7%	Baseline and week 24	No
Secondary	Percentage of Patients With HbA1c <7.0% at 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%.	Baseline and week 24	No
Secondary	Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5% at 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%	Baseline and week 24	No
Secondary	Number of Patients With Rescue Therapy	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	week 24	No

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