linagliptin as add on to basal insulin in the elderly

• Register: EUCTR
• Last refreshed on: 3 October 2016
• Main ID: EUCTR2014-000904-88-ES
• Date of registration: 04/07/2014
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim España, S.A.
• Public title: linagliptin as add on to basal insulin in the elderly
• Scientific title: A 24 week randomized, double-blind, placebo-controlled, parallel group, efficacy and safety trial of once daily linagliptin, 5 milligrams orally, as add on to basal insulin in elderly Type 2 Diabetes Mellitus patients with insufficient glycaemic control
• Date of first enrolment: 13/08/2014
• Target sample size: 2198
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000904-88
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Australia, Belgium, Colombia, Denmark, Finland, Germany, Greece, Ireland, Japan, Mexico, New Zealand, Poland, Romania, South Africa, Spain, United Kingdom, United States

Contacts

• Name: QRPE PSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

• Name: QRPE PSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

Key inclusion & exclusion criteria

Inclusion criteria:
- Patients must sign and date an Informed Consent consistent with International Conference on Harmonisation and Good Clinical Practice guidelines and local regulations prior to any evaluation and participation in the trial.
- Male and female patients with a clinical diagnosis of Type 2 Diabetes Mellitus, at the time of Informed Consent, who are:
- 70 years of age or older at informed consent or Screen Visit,
- taking stable doses of basal insulin [strictly inclusive of: insulin neutral protamine Hagedorn and isophane insulin; insulin degludec; insulin detemir; and insulin glargine] for at least 4 weeks prior to randomisation (Visit 3) with dose adjustments up to a maximum of plus or minus 20% of baseline being allowed,
- may or may not be taking metformin immediate release or extended release [if the patient is taking metformin, stable dose must be maintained for at least twelve weeks without dose adjustments prior to randomisation (Visit 3)], and
- may or may not be taking alpha-glucosidase inhibitors [acarbose, miglitol, and voglibose; if the patient is taking alpha-glucosidase inhibitors, stable dose must be maintained for at least twelve weeks without dose adjustments prior to randomisation (Visit 3)].
- Patients must have an glycosylated Haemoglobin of 7.5% (58 millimoles per mole) to 10.0% (86 millimoles per mole) at the first visit (Screen).
- Patients must have a Body Mass Index of 45 kilogram/meter squared or less at the Screen Visit.
- In the investigator's opinion, patients must be reliable, compliant, and agree to cooperate with all planned future trial evaluations as explained in detail during the informed consent process and to be able to perform them.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 800

Exclusion criteria:
- Impaired cognitive ability as supported by the Saint Louis University Mental Status Examination, additional assessment if necessary, and verified by the investigator at the Screen Visit.
- Depressed mood as supported by a score of 10 or more on the Patient Health Questionnaire at the Screen Visit.
- Type 1 Diabetes Mellitus as determined by past medical records and history.
- Acute coronary syndrome (non-ST Elevation Myocardial Infarction, stroke or transient ischemic attack within 3 months prior to Screen Visit.
- Indication of liver disease determined during Screen and/or Run-In Period, defined by a serum level above 3 times the upper limit of normal in any of the following: alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase.
- Bariatric, gastric bypass, and other gastrointestinal procedures or surgeries (including all types of gastric banding, restriction, and/or LapBand) with the objective of promoting weight loss within the past two years at Screen Visit.
- Medical history of cancer (except for resected non-invasive basal or squamous cell carcinoma) and/or treatment for cancer within the last 5 years.
- Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (malaria, babesiosis, haemolytic anaemia).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

Trade Name: Trajenta
Product Name: Trajenta
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): 1: The primary endpoint in this trial is the change from baseline in HbA1c after 24 weeks of treatment.

Timepoint(s) of evaluation of this end point: 1: 24 weeks

Main Objective: Change in glycated haemoglobin (HbA1c) after 24 weeks

Secondary Objective: the proportion of patients experiencing at least one confirmed hypoglycaemic event during 24 weeks of treatment

Secondary Outcome(s)

Secondary end point(s): 1: The key secondary endpoint, to be tested following the primary efficacy endpoint in a hierarchical order is the proportion of patients experiencing at least one confirmed hypoglycaemic event during 24 weeks of treatment.

2: Proportion of patients with HbA1c on treatment <8.0% after 24 weeks of treatment

3: Proportion of patients with HbA1c on treatment <7.5% after 24 weeks of treatment

4: Proportion of patients with HbA1c lowering by at least 0.5% after 24 weeks of treatment

5: Change from baseline in Fasting Plasma Glucose (FPG) after 24 weeks of treatment

6: Incidence and intensity of Adverse Events

7: Withdrawal due to Adverse Events

8: Incidence of hypoglycaemic events

Timepoint(s) of evaluation of this end point: 1: 24 weeks

2: 24 weeks

3: 24 weeks

4: 24 weeks

5: 24 weeks

6: 24 weeks

7: 24 weeks

8: 24 weeks

Secondary ID(s)

2014-000904-88-GR

1218.149

Source(s) of Monetary Support

Boehringer Ingelheim España, S.A.