Efficacy and Safety of Linagliptin in Elderly Patients With Type 2 Diabetes
NCT ID: NCT01084005
Last Updated: 2014-01-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
241 participants
INTERVENTIONAL
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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linagliptin
patients receive linagliptin 5 mg tablets once daily
linagliptin
patients receive linagliptin 5 mg tablets once daily
placebo
patients receive placebo tablets matching linagliptin 5 mg once daily
placebo
patients receive placebo matching linagliptin 5 mg once daily
Interventions
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linagliptin
patients receive linagliptin 5 mg tablets once daily
placebo
patients receive placebo matching linagliptin 5 mg once daily
Eligibility Criteria
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Inclusion Criteria
2. HbA1c \>= 7.0%
3. Age \>= 70 years
4. Signed and dated written informed consent
Exclusion Criteria
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
70 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1218.63.61005 Boehringer Ingelheim Investigational Site
Gosford, New South Wales, Australia
1218.63.61006 Boehringer Ingelheim Investigational Site
Herston, Queensland, 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
1218.63.61001 Boehringer Ingelheim Investigational Site
Parkville, Victoria, Australia
1218.63.61004 Boehringer Ingelheim Investigational Site
Reservoir, Victoria, Australia
1218.63.10008 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1218.63.10003 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1218.63.10005 Boehringer Ingelheim Investigational Site
Hawkesbury, Ontario, Canada
1218.63.10007 Boehringer Ingelheim Investigational Site
Newmarket, Ontario, Canada
1218.63.10006 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1218.63.10001 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1218.63.10002 Boehringer Ingelheim Investigational Site
Saint Romuald, Quebec, Canada
1218.63.10004 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada
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, , Denmark
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, , Netherlands
1218.63.46004 Boehringer Ingelheim Investigational Site
Gothenburg, , Sweden
1218.63.46003 Boehringer Ingelheim Investigational Site
Järfälla, , Sweden
1218.63.46001 Boehringer Ingelheim Investigational Site
Malmo, , Sweden
1218.63.46002 Boehringer Ingelheim Investigational Site
Sundsvall, , Sweden
1218.63.46005 Boehringer Ingelheim Investigational Site
Uppsala, , Sweden
Countries
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References
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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.
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.
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.
Related Links
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Other Identifiers
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2009-015255-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1218.63
Identifier Type: -
Identifier Source: org_study_id
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