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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01084005
First received: March 9, 2010
Last updated: December 11, 2013
Last verified: December 2013
  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:

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:

  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084005

  Show 34 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
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: December 11, 2013
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 April 21, 2014