Clinical trial NCT01084005: Efficacy and Safety of Linagliptin in Elderly Patients With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2010-03-10
Enrollment: 241
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: HbA1c Change From Baseline to Week 24
timeFrame: Baseline and week 24
Secondary outcomes:
measure: HbA1c Change From Baseline to Week 6
timeFrame: Baseline and week 6
measure: HbA1c Change From Baseline to Week 12
timeFrame: Baseline and week 12
measure: HbA1c Change From Baseline to Week 18
timeFrame: Baseline and week 18
measure: FPG Change From Baseline to Week 24
timeFrame: Baseline and week 24
measure: FPG Change From Baseline to Week 6
timeFrame: Baseline and week 6
measure: FPG Change From Baseline to Week 12
timeFrame: Baseline and week 12
measure: FPG Change From Baseline to Week 18
timeFrame: Baseline and week 18
measure: Percentage of Patients With HbA1c <7.0% at Week 24
timeFrame: Baseline and week 24
measure: Percentage of Patients With HbA1c <7.0% at Week 24
timeFrame: Baseline and week 24
measure: Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5% at Week 24
timeFrame: Baseline and week 24
measure: Number of Patients With Rescue Therapy
timeFrame: week 24
Other outcomes:
Locations:
city: Gosford
country: Australia
facility: 1218.63.61005 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Herston
country: Australia
facility: 1218.63.61006 Boehringer Ingelheim Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: 1218.63.61003 Boehringer Ingelheim Investigational Site
state: South Australia
city: Daw Park
country: Australia
facility: 1218.63.61002 Boehringer Ingelheim Investigational Site
state: South Australia
city: East Ringwood
country: Australia
facility: 1218.63.61007 Boehringer Ingelheim Investigational Site
state: Victoria
city: Parkville
country: Australia
facility: 1218.63.61001 Boehringer Ingelheim Investigational Site
state: Victoria
city: Reservoir
country: Australia
facility: 1218.63.61004 Boehringer Ingelheim Investigational Site
state: Victoria
city: Vancouver
country: Canada
facility: 1218.63.10008 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Hamilton
country: Canada
facility: 1218.63.10003 Boehringer Ingelheim Investigational Site
state: Ontario
city: Hawkesbury
country: Canada
facility: 1218.63.10005 Boehringer Ingelheim Investigational Site
state: Ontario
city: Newmarket
country: Canada
facility: 1218.63.10007 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1218.63.10006 Boehringer Ingelheim Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: 1218.63.10001 Boehringer Ingelheim Investigational Site
state: Quebec
city: St-Romuald
country: Canada
facility: 1218.63.10002 Boehringer Ingelheim Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: 1218.63.10004 Boehringer Ingelheim Investigational Site
state: Saskatchewan
city: Aalborg
country: Denmark
facility: 1218.63.45007 Boehringer Ingelheim Investigational Site
city: Aarhus C
country: Denmark
facility: 1218.63.45002 Boehringer Ingelheim Investigational Site
city: Aarhus C
country: Denmark
facility: 1218.63.45003 Boehringer Ingelheim Investigational Site
city: Birkerød
country: Denmark
facility: 1218.63.45001 Boehringer Ingelheim Investigational Site
city: Hellerup
country: Denmark
facility: 1218.63.45008 Boehringer Ingelheim Investigational Site
city: Hillerød
country: Denmark
facility: 1218.63.45006 Boehringer Ingelheim Investigational Site
city: Hvidovre
country: Denmark
facility: 1218.63.45004 Boehringer Ingelheim Investigational Site
city: København NV
country: Denmark
facility: 1218.63.45005 Bispebjerg Hospital
city: Beek en Donk
country: Netherlands
facility: 1218.63.31008 Boehringer Ingelheim Investigational Site
city: Beerzerveld
country: Netherlands
facility: 1218.63.31007 Boehringer Ingelheim Investigational Site
city: Doetinchem
country: Netherlands
facility: 1218.63.31012 Boehringer Ingelheim Investigational Site
city: Etten-Leur
country: Netherlands
facility: 1218.63.31014 Boehringer Ingelheim Investigational Site
city: Oude Pekela
country: Netherlands
facility: 1218.63.31009 Boehringer Ingelheim Investigational Site
city: Tubbergen
country: Netherlands
facility: 1218.63.31001 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1218.63.46004 Boehringer Ingelheim Investigational Site
city: Järfälla
country: Sweden
facility: 1218.63.46003 Boehringer Ingelheim Investigational Site
city: Malmö
country: Sweden
facility: 1218.63.46001 Boehringer Ingelheim Investigational Site
city: Sundsvall
country: Sweden
facility: 1218.63.46002 Boehringer Ingelheim Investigational Site
city: Uppsala
country: Sweden
facility: 1218.63.46005 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Lajara R, Aguilar R, Hehnke U, Woerle HJ, von Eynatten M. Efficacy and safety of linagliptin in subjects with long-standing type 2 diabetes mellitus (>10 years): evidence from pooled data of randomized, double-blind, placebo-controlled, phase III trials. Clin Ther. 2014 Nov 1;36(11):1595-605. doi: 10.1016/j.clinthera.2014.07.020. Epub 2014 Sep 16.
citation: McGill JB, Barnett AH, Lewin AJ, Patel S, Neubacher D, von Eynatten M, Woerle HJ. Linagliptin added to sulphonylurea in uncontrolled type 2 diabetes patients with moderate-to-severe renal impairment. Diab Vasc Dis Res. 2014 Jan;11(1):34-40. doi: 10.1177/1479164113507068. Epub 2013 Oct 29.
citation: Barnett AH, Huisman H, Jones R, von Eynatten M, Patel S, Woerle HJ. Linagliptin for patients aged 70 years or older with type 2 diabetes inadequately controlled with common antidiabetes treatments: a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Oct 26;382(9902):1413-23. doi: 10.1016/S0140-6736(13)61500-7. Epub 2013 Aug 13.