Home » Trials » SLCTR/2025/014
Comparison of Metformin versus Repaglinide monotherapy in the treatment of new-onset type 2 diabetes mellitus
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SLCTR Registration Number
SLCTR/2025/014
Date of Registration
The date of last modification
Apr 09, 2025
Scientific Title of Trial
Comparison of Metformin versus Repaglinide monotherapy in the treatment of new-onset type 2 diabetes mellitus
Public Title of Trial
Glycemic control [using HbA1c (%) levels] after three months of treatment with repaglinide versus metformin monotherapy; as initial treatment in patients with newly diagnosed type 2 diabetes mellitus naive to oral hypoglycemic agents
Disease or Health Condition(s) Studied
Type 2 Diabetes Mellitus
Scientific Acronym
None
Public Acronym
None
Brief title
Comparison of glycemic control with the use of Repaglinide vs Metformin in T2DM
Universal Trial Number
U1111-1318-5820
Any other number(s) assigned to the trial and issuing authority
ERC - 1546/NMU
What is the research question being addressed?
What is the difference in achievement of glycemic control (HbA1c) among new onset Type 2 diabetes patients after three months of treatment with Metformin versus Repaglinide monotherapy?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
Study setting: Department of Medicine, Nishtar Hospital Multan, Pakistan.
Randomization: Lottery method using sealed opaque envelopes.
Intervention: (A) Active / Experimental: Repaglinide monotherapy 0.75-1.5 mg/day. (B) Standard therapy / Practice: Metformin monotherapy 750-1500mg/day.
The administration of Metformin or Repaglinide will be adjusted according to the blood glucose levels in the first week after treatment assignment.
All patients will be given diet and lifestyle advice and will be asked to keep behavior modification programme as a part of routine care of diabetic patients.
Compliance will be monitored by assessing a checklist which the participants will mark after taking the medication and will be checked by weekly telephone contact.
Inclusion criteria
Exclusion criteria
1.Existing coronary artery disease 2. Renal disease 3. Liver disease 4. Gastrointestinal diseases assessed on history and medical record review.
Primary outcome(s)
|
1.
Outcome: Glycemic control Metric: HbA1c (%) Method of Measurement: Measured by high pressure liquid chromatography |
[ Three months after treatment assignment ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
Total 60 patients, 30 in each group
Countries of recruitment
Pakistan
Anticipated start date
2025-04-10
Anticipated end date
2025-08-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2025-01-31
Approval number
1546/NMU
Details of Ethics Review Committee
| Name: | Institutional Ethical Review Board |
| Institutional Address: | Nishtar Medical University, Nishtar Roadd, Gillani Colony, Multan, Pakistan |
| Telephone: | 061-9200993, 061-9200231 |
| Email: | info@nmu.edu.pk |
Contact person for Scientific Queries/Principal Investigator
Waseem Ahmad
Postgraduate Resident
Nishtar Medical University, Nishtar Road, Gillani Colony, Multan, Punjab 66000
061-9200993, 061-9200231
03321878602
waseemghani302@gmail.com
https://nmu.edu.pk/
Contact Person for Public Queries
Dr. Shahzad Alam Khan
Associate Professor
Department of Medicine Nishtar Medical University & Hospital Multan
0300-7195857
03321878602
shahzadalam177735@gmail.com
https://nmu.edu.pk/
Primary study sponsor/organization
Waseem Ahmad
Postgraduate Resident
Nishtar Medical University, Nishtar Road, Gillani Colony, Multan, Punjab 66000
061-9200993, 061-9200231
waseemghani302@gmail.com
https://nmu.edu.pk/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
De-identified individual patient data underlying the results reported in publication will be shared, beginning one year ending 3 years after the research publication, on reasonable request made to the Principal investigator at waseemghani302@gmail.com
Study protocol available
No
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
