Home » Trials » SLCTR/2015/022
Effect of sitagliptin compared to glimepiride on vascular risk factors among patients with type 2 diabetes mellitus
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SLCTR Registration Number
SLCTR/2015/022
Date of Registration
The date of last modification
Apr 30, 2019
Scientific Title of Trial
Effect of sitagliptin compared to glimepiride on vascular risk factors among patients with type 2 diabetes mellitus
Public Title of Trial
Sitagliptin compared to glimepiride on vascular risk factors among patients with type 2 diabetes mellitus
Disease or Health Condition(s) Studied
Type 2 Diabetes Mellitus
Scientific Acronym
None
Public Acronym
None
Brief title
Sitagliptin compared to glimepiride on vascular risk factors among patients with type 2 diabetes mellitus
Universal Trial Number
U1111-1172-2205
Any other number(s) assigned to the trial and issuing authority
ERC Ruhuna Ref:26.02.2015:3.14
What is the research question being addressed?
What is the effect of sitagliptin compared to glimepiride on glycaemic control, selected vascular risk factors and selected biochemical markers among patients with type 2 diabetes mellitus?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
Patients will be selected from the Medical and Endocrinology clinics of the Teaching Hospital, Karapitiya. Following screening and recruitment based on eligibility criteria by the principal investigator, the participants will be allocated using block randomization method to either the intervention or control arms.
The intervention arm will receive sitagliptin 50mg daily with maximum tolerable dose of metformin (2g daily or less depending on patient adverse effects) per a day for three months duration. The control arm will receive glimepiride 1mg daily with maximum tolerable dose of metformin (2g daily or less depending on patient adverse effects) per a day for three months duration.
Randomization and treatment will be provided by independent doctors. The patients and the principal investigator will be blind to the group assignment and type of therapy.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
|
[ At baseline and at the end of 3 months ] |
Secondary outcome(s)
|
1.
Blood pressure |
[ Baseline and monthly for 3 months ] |
Target number/sample size
190 (95 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2015-09-28
Anticipated end date
2016-09-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
University Grants Commission, Sri Lanka.
Regulatory approvals
Status
Approved
Date of Approval
2015-05-20
Approval number
26.02.2015:3.14
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | PO Box 70, Labuduwa Rd, Galle, Sri Lanka |
| Telephone: | +94-91-2234801/803 (Extension: 161) |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Aruma Thantirige Isuru Madushika Amarasinghe
Lecturer (Probationary)
Department of Pharmacology,
Faculty of Medicine
University of Ruhuna
Galle
Sri Lanka
Tel: 0912246877
Mob: 0772332651
amarasingheisuru@yahoo.com
Contact Person for Public Queries
Professor Sarath Lekamwasam
Dean and Professor in Medicine
Faculty of Medicine
University of Ruhuna
Galle, Sri Lanka
Mob: 0777275360
slekamwasam@gmail.com
Primary study sponsor/organization
University Grants Commission, Sri Lanka
Post box 1406
No 20, Ward place
Colombo -07, Sri Lanka
Tel: 0112695301
http:/www.ugc.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
