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 diabetes mellitus…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Efficacy: change in HbA1c after 24 weeks of treatment
Safety: (serious) adverse events; hypoglycemic events; significant events;
cardiovascular events; change in: ECG, vital signs, labparameters, background
medication; use of rescue medication.
Secondary outcome
Occurrence of HbA1c <7.0% or decrease of >=0.5% after 24 weeks of treatment;
change in HbA1c each visit; change in fasting plasma glucose after 24 weeks of
treatment; change in fasting plasma glucose each visit.
Background summary
Diabetes Mellitus type 2 is a disease which is characterized by increased blood
glucose levels. It is a condition that eventually causes damage in many organs
and tissues, resulting in a marked decrease of life expectancy and quality of
life. Therefore, treatment to maintain the blood glucose levels within normal
ranges remains important.
There is no cure for Diabetes Mellitus type 2, but it can be treated by a diet,
excercise, several oral medications and insulin. Not all medications are well
tolerated and many compounds cause side-effects. Linagliptin is a DPP-4
inhibitor that enhances the function of certain hormones. These hormones play a
role in decreasing blood glucose levels by signaling the liver and pancreas.
With increasing life expectancy, the management of the elderly population is
becoming more important. Treatment of diabetes in the elderly is complicated by
age-related occurrences, such as co-morbidities, polypharmacy and changes in
metabolism. Relatively little is known about linagliptin in elderly >=70 years.
Study objective
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
diabetes mellitus type 2 with insufficient glycaemic control.
Study design
Approximately 240 diabetes patients will participate in this study. 2/3 will be
randomized to receive treatment with 5 mg once daily linagliptin, and 1/3 of
patients will be randomized to once-daily placebo during 24 weeks as add-on to
their stable background treatment. The treatment period is preceded by a 2-week
placebo run-in period, and concluded with a follow-up visit 1 week after study
medication termination (may be done by phone).
This is a randomized, double-blind, placebo controlled study.
Intervention
At visit 2, the 2-week once-daily placebo run-in period starts.
At visit 3, patients are randomized to either once daily linagliptin 5 mg or
once daily placebo (ratio 2:1).
Study burden and risks
Assuming a treatment period of 24 weeks + 2 weeks run-in + 1 week follow up:
- Total of 8 visits (visit 8 may be done by phone)
- Physical exam: visit 2 and 7
- Urine sample: visit 1, 3, 5, 7
- Blood sample: all visits except visit 8
- Height and weight: visit 2, 3, 7
- Diet and exercise counseling: visit 2
- ECG: visit 2, 3, 7
- Questionnaire EQ-5D: visit 3, 4, 5, 7
- Questionnaire SF 36: visit 3
- HGBM test: visit 2 to 8 (preferably daily, at least once a week)
Comeniusstraat 6
1817 MS Alkmaar
Nederland
Comeniusstraat 6
1817 MS Alkmaar
Nederland
Listed location countries
Age
Inclusion criteria
(see page 18 of the protocol for the complete list)
1. Male and female patients with diagnosis of T2DM and stable treatment prior to informed consent. Treatment with metformin and/or sulphonylurea has to be unchanged for 8 weeks prior to informed consent; the insulin dose should not have changed within the 8 weeks prior to informed consent by more than 20% from the baseline value at randomisation.
2. Glycosylated haemoglobin A1 (HbA1c) >= 7.0 % at Visit 1
3. Age >= 70 years at Visit 1
4. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation
Exclusion criteria
(see page 19 of the protocol for the complete list)
1. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
2. Myocardial infarction, stroke or TIA within 3 months prior to informed consent
3. Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1
4. Bariatric surgery
5. Known hypersensitivity or allergy to the investigational product or its excipients or the patients* baseline drug(s) or placebo
6. Treatment with glitazones, GLP-1 analogues or DPP-4 inhibitors within 3 months prior to informed consent
7. Treatment with rapid acting or pre-mixed insulins
8. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent
9. Active alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation
10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-015255-25-NL |
| ClinicalTrials.gov | NCT01084005 |
| CCMO | NL31120.028.09 |