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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01084005




Trial ID
NCT01084005
Ethics application status
Date submitted
9/03/2010
Date registered
9/03/2010
Date last updated
11/12/2013

Titles & IDs
Public title
Efficacy and Safety of Linagliptin in Elderly Patients With Type 2 Diabetes
Scientific 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
Secondary ID [1] 0 0
2009-015255-25
Secondary ID [2] 0 0
1218.63
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - linagliptin
Treatment: Drugs - placebo

Experimental: linagliptin - patients receive linagliptin 5 mg tablets once daily

Placebo Comparator: placebo - patients receive placebo tablets matching linagliptin 5 mg once daily


Treatment: Drugs: linagliptin
patients receive linagliptin 5 mg tablets once daily

Treatment: Drugs: placebo
patients receive placebo matching linagliptin 5 mg once daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline and week 24
Secondary outcome [1] 0 0
HbA1c Change From Baseline to 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.
Timepoint [1] 0 0
Baseline and week 6
Secondary outcome [2] 0 0
HbA1c Change From Baseline to 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.
Timepoint [2] 0 0
Baseline and week 12
Secondary outcome [3] 0 0
HbA1c Change From Baseline to 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.
Timepoint [3] 0 0
Baseline and week 18
Secondary outcome [4] 0 0
FPG Change From Baseline to 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.
Timepoint [4] 0 0
Baseline and week 24
Secondary outcome [5] 0 0
FPG Change From Baseline to 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.
Timepoint [5] 0 0
Baseline and week 6
Secondary outcome [6] 0 0
FPG Change From Baseline to 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.
Timepoint [6] 0 0
Baseline and week 12
Secondary outcome [7] 0 0
FPG Change From Baseline to 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.
Timepoint [7] 0 0
Baseline and week 18
Secondary outcome [8] 0 0
Percentage of Patients With HbA1c <7.0% at 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%
Timepoint [8] 0 0
Baseline and week 24
Secondary outcome [9] 0 0
Percentage of Patients With HbA1c <7.0% at 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%.
Timepoint [9] 0 0
Baseline and week 24
Secondary outcome [10] 0 0
Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5% at 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%
Timepoint [10] 0 0
Baseline and week 24
Secondary outcome [11] 0 0
Number of Patients With Rescue Therapy - 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
Timepoint [11] 0 0
week 24

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Type 2 diabetes mellitus

2. HbA1c >= 7.0%

3. Age >= 70 years

4. Signed and dated written informed consent
Minimum age
70 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
1218.63.61005 Boehringer Ingelheim Investigational Site - Gosford
Recruitment hospital [2] 0 0
1218.63.61006 Boehringer Ingelheim Investigational Site - Herston
Recruitment hospital [3] 0 0
1218.63.61003 Boehringer Ingelheim Investigational Site - Adelaide
Recruitment hospital [4] 0 0
1218.63.61002 Boehringer Ingelheim Investigational Site - Daw Park
Recruitment hospital [5] 0 0
1218.63.61007 Boehringer Ingelheim Investigational Site - East Ringwood
Recruitment hospital [6] 0 0
1218.63.61001 Boehringer Ingelheim Investigational Site - Parkville
Recruitment hospital [7] 0 0
1218.63.61004 Boehringer Ingelheim Investigational Site - Reservoir
Recruitment postcode(s) [1] 0 0
- Gosford
Recruitment postcode(s) [2] 0 0
- Herston
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Daw Park
Recruitment postcode(s) [5] 0 0
- East Ringwood
Recruitment postcode(s) [6] 0 0
- Parkville
Recruitment postcode(s) [7] 0 0
- Reservoir
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
Canada
State/province [4] 0 0
Saskatchewan
Country [5] 0 0
Denmark
State/province [5] 0 0
Aalborg
Country [6] 0 0
Denmark
State/province [6] 0 0
Aarhus C
Country [7] 0 0
Denmark
State/province [7] 0 0
Birkerød
Country [8] 0 0
Denmark
State/province [8] 0 0
Hellerup
Country [9] 0 0
Denmark
State/province [9] 0 0
Hillerød
Country [10] 0 0
Denmark
State/province [10] 0 0
Hvidovre
Country [11] 0 0
Denmark
State/province [11] 0 0
København NV
Country [12] 0 0
Netherlands
State/province [12] 0 0
Beek en Donk
Country [13] 0 0
Netherlands
State/province [13] 0 0
Beerzerveld
Country [14] 0 0
Netherlands
State/province [14] 0 0
Doetinchem
Country [15] 0 0
Netherlands
State/province [15] 0 0
Etten-Leur
Country [16] 0 0
Netherlands
State/province [16] 0 0
Oude Pekela
Country [17] 0 0
Netherlands
State/province [17] 0 0
Tubbergen
Country [18] 0 0
Sweden
State/province [18] 0 0
Göteborg
Country [19] 0 0
Sweden
State/province [19] 0 0
Järfälla
Country [20] 0 0
Sweden
State/province [20] 0 0
Malmö
Country [21] 0 0
Sweden
State/province [21] 0 0
Sundsvall
Country [22] 0 0
Sweden
State/province [22] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT01084005
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries