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

Boehringer Ingelheim241 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

241

Conditions

Diabetes Mellitus, Type 2

Interventions

linagliptinDRUG

patients receive linagliptin 5 mg tablets once daily

placeboDRUG

patients receive placebo matching linagliptin 5 mg once daily

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

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

Locations (34)

Outcomes

Primary Outcomes

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.

Time frame: Baseline and week 24

Secondary Outcomes

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.

Time frame: Baseline and week 6

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.

Time frame: Baseline and week 12

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.

Time frame: Baseline and week 18

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.

Time frame: Baseline and week 24

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.

Data from ClinicalTrials.gov

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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

...and 24 more locations

Time frame: Baseline and week 6

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.

Time frame: Baseline and week 12

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.

Time frame: Baseline and week 18

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%

Time frame: Baseline and week 24

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%.

Time frame: Baseline and week 24

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%

Time frame: Baseline and week 24

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

Time frame: week 24