Efficacy and Safety of Linagliptin in Elderly Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01084005
First received: March 9, 2010
Last updated: September 12, 2012
Last verified: September 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: linagliptin Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- HbA1c Change From Baseline to Week 24 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]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:
- HbA1c Change From Baseline to Week 6 [ Time Frame: Baseline and week 6 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and week 18 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and week 6 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and week 18 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]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%
- Percentage of Patients With HbA1c <7.0% at Week 24 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]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 [ Time Frame: week 24 ] [ Designated as safety issue: No ]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
| Enrollment: | 241 |
| Study Start Date: | March 2010 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: linagliptin
patients receive linagliptin 5 mg tablets once daily
|
Drug: linagliptin
patients receive linagliptin 5 mg tablets once daily
|
|
Placebo Comparator: placebo
patients receive placebo tablets matching linagliptin 5 mg once daily
|
Drug: placebo
patients receive placebo matching linagliptin 5 mg once daily
|
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Type 2 diabetes mellitus
- HbA1c >= 7.0%
- Age >= 70 years
- Signed and dated written informed consent
Exclusion criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084005
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Hide Study LocationsLocations
| Australia, New South Wales | |
| 1218.63.61005 Boehringer Ingelheim Investigational Site | |
| Gosford, New South Wales, Australia | |
| Australia, Queensland | |
| 1218.63.61006 Boehringer Ingelheim Investigational Site | |
| Herston, Queensland, Australia | |
| Australia, South Australia | |
| 1218.63.61003 Boehringer Ingelheim Investigational Site | |
| Adelaide, South Australia, Australia | |
| 1218.63.61002 Boehringer Ingelheim Investigational Site | |
| Daw Park, South Australia, Australia | |
| Australia, Victoria | |
| 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 | |
| Canada, British Columbia | |
| 1218.63.10008 Boehringer Ingelheim Investigational Site | |
| Vancouver, British Columbia, Canada | |
| Canada, Ontario | |
| 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 | |
| Canada, Quebec | |
| 1218.63.10001 Boehringer Ingelheim Investigational Site | |
| Montreal, Quebec, Canada | |
| 1218.63.10002 Boehringer Ingelheim Investigational Site | |
| St-Romuald, Quebec, Canada | |
| Canada, Saskatchewan | |
| 1218.63.10004 Boehringer Ingelheim Investigational Site | |
| Saskatoon, Saskatchewan, Canada | |
| Denmark | |
| 1218.63.45007 Boehringer Ingelheim Investigational Site | |
| Aalborg, Denmark | |
| 1218.63.45003 Boehringer Ingelheim Investigational Site | |
| Aarhus C, Denmark | |
| 1218.63.45002 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 | |
| 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, Netherlands | |
| 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, Sweden | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Eli Lilly and Company
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01084005 History of Changes |
| Other Study ID Numbers: | 1218.63, 2009-015255-25 |
| Study First Received: | March 9, 2010 |
| Results First Received: | June 14, 2012 |
| Last Updated: | September 12, 2012 |
| Health Authority: | Australia: Dept of Health and Ageing Therapeutic Goods Admin Canada: Health Canada Denmark: Danish Medicines Agency Netherlands: Central Committee Research Involving Human Subjects Sweden: Medical Products Agency |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases BI 1356 Dipeptidyl-Peptidase IV Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013