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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
March 9, 2010
December 11, 2013
March 2010
June 2011   (Final data collection date for primary outcome measure)
HbA1c Change From Baseline to Week 24 [ Time Frame: Baseline and 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.
Change from baseline in HbA1c after 24 weeks of treatment [ Time Frame: 24 weeks ]
Complete list of historical versions of study NCT01084005 on ClinicalTrials.gov Archive Site
  • HbA1c Change From Baseline to Week 6 [ Time Frame: Baseline and week 6 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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
  • HbA1c of <7.0% [ Time Frame: 24 weeks unless specified differently ]
  • HbA1c lowering by a least 0.5% [ Time Frame: 24 weeks unless specified differently ]
  • Change in HbA1c by visit over time [ Time Frame: 24 weeks unless specified differently ]
  • Change in fasting plasma glucose (FPG) [ Time Frame: 24 weeks unless specified differently ]
  • Change in FPG by visit over time [ Time Frame: 24 weeks unless specified differently ]
Not Provided
Not Provided
 
Efficacy and Safety of Linagliptin in Elderly Patients With Type 2 Diabetes
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
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: linagliptin
    patients receive linagliptin 5 mg tablets once daily
  • Drug: placebo
    patients receive placebo matching linagliptin 5 mg once daily
  • Experimental: linagliptin
    patients receive linagliptin 5 mg tablets once daily
    Intervention: Drug: linagliptin
  • Placebo Comparator: placebo
    patients receive placebo tablets matching linagliptin 5 mg once daily
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
241
Not Provided
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
70 Years and older   (Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Denmark,   Netherlands,   Sweden
 
 
NCT01084005
1218.63
2009-015255-25 ( EudraCT Number: EudraCT )
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP