NCT01084005

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P25-P50 for phase_3 diabetes-mellitus-type-2

Geographic Reach
5 countries

34 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 18, 2012

Completed
Last Updated

January 29, 2014

Status Verified

December 1, 2013

Enrollment Period

1.3 years

First QC Date

March 9, 2010

Results QC Date

June 14, 2012

Last Update Submit

December 11, 2013

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (2)

linagliptin

EXPERIMENTAL

patients receive linagliptin 5 mg tablets once daily

Drug: linagliptin

placebo

PLACEBO COMPARATOR

patients receive placebo tablets matching linagliptin 5 mg once daily

Drug: placebo

Interventions

linagliptinDRUG

patients receive linagliptin 5 mg tablets once daily

linagliptin
placeboDRUG

patients receive placebo matching linagliptin 5 mg once daily

placebo

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus
  • HbA1c \>= 7.0%
  • Age \>= 70 years
  • Signed and dated written informed consent

You may not qualify if:

  • Myocardial infarction, stroke or TIA within 3 months prior to informed consent
  • Impaired hepatic function
  • Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors or rapid acting or pre-mixed insulins
  • Treatment with anti-obesity drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

1218.63.61005 Boehringer Ingelheim Investigational Site

Gosford, New South Wales, Australia

Location

1218.63.61006 Boehringer Ingelheim Investigational Site

Herston, Queensland, Australia

Location

1218.63.61003 Boehringer Ingelheim Investigational Site

Adelaide, South Australia, Australia

Location

1218.63.61002 Boehringer Ingelheim Investigational Site

Daw Park, South Australia, Australia

Location

1218.63.61007 Boehringer Ingelheim Investigational Site

East Ringwood, Victoria, Australia

Location

1218.63.61001 Boehringer Ingelheim Investigational Site

Parkville, Victoria, Australia

Location

1218.63.61004 Boehringer Ingelheim Investigational Site

Reservoir, Victoria, Australia

Location

1218.63.10008 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1218.63.10003 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1218.63.10005 Boehringer Ingelheim Investigational Site

Hawkesbury, Ontario, Canada

Location

1218.63.10007 Boehringer Ingelheim Investigational Site

Newmarket, Ontario, Canada

Location

1218.63.10006 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1218.63.10001 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1218.63.10002 Boehringer Ingelheim Investigational Site

Saint Romuald, Quebec, Canada

Location

1218.63.10004 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Location

1218.63.45007 Boehringer Ingelheim Investigational Site

Aalborg, Denmark

Location

1218.63.45002 Boehringer Ingelheim Investigational Site

Aarhus C, Denmark

Location

1218.63.45003 Boehringer Ingelheim Investigational Site

Aarhus C, Denmark

Location

1218.63.45001 Boehringer Ingelheim Investigational Site

Birkerød, Denmark

Location

1218.63.45008 Boehringer Ingelheim Investigational Site

Hellerup, Denmark

Location

1218.63.45006 Boehringer Ingelheim Investigational Site

Hillerød, Denmark

Location

1218.63.45004 Boehringer Ingelheim Investigational Site

Hvidovre, Denmark

Location

1218.63.45005 Bispebjerg Hospital

København NV, Denmark

Location

1218.63.31008 Boehringer Ingelheim Investigational Site

Beek en Donk, Netherlands

Location

1218.63.31007 Boehringer Ingelheim Investigational Site

Beerzerveld, Netherlands

Location

1218.63.31012 Boehringer Ingelheim Investigational Site

Doetinchem, Netherlands

Location

1218.63.31014 Boehringer Ingelheim Investigational Site

Etten-Leur, Netherlands

Location

1218.63.31009 Boehringer Ingelheim Investigational Site

Oude Pekela, Netherlands

Location

1218.63.31001 Boehringer Ingelheim Investigational Site

Tubbergen, Netherlands

Location

1218.63.46004 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1218.63.46003 Boehringer Ingelheim Investigational Site

Järfälla, Sweden

Location

1218.63.46001 Boehringer Ingelheim Investigational Site

Malmo, Sweden

Location

1218.63.46002 Boehringer Ingelheim Investigational Site

Sundsvall, Sweden

Location

1218.63.46005 Boehringer Ingelheim Investigational Site

Uppsala, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 25236917DERIVED

  • 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.

    PMID: 24169807DERIVED

  • 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.

    PMID: 23948125DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolines

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2010

First Posted

March 10, 2010

Study Start

March 1, 2010

Primary Completion

June 1, 2011

Last Updated

January 29, 2014

Results First Posted

July 18, 2012

Record last verified: 2013-12

Locations

SE(5)CA(8)AU(7)DK(8)NL(6)