Comparing medications for newly diagnosed Type 2 Diabetes
Clinical Efficacy and Safety of Glimepiride, Empagliflozin and Sitagliptin With Metformin in Type 2 Diabetes Mellitus: A Double and Triple Drug Therapy
This study is testing which combination of diabetes medications works best to help people aged 30 to 55 with newly diagnosed Type 2 diabetes manage their blood sugar levels.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 172 (estimated) |
| Ages | 30 Years to 55 Years |
| Sex | All |
| Sponsor | Bahria University Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT06759922 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of four different medication combinations for newly diagnosed Type 2 Diabetes Mellitus patients. Participants aged 30 to 55 will be randomly assigned to receive either Metformin with Glimepiride, Empagliflozin, Sitagliptin, or a combination of Empagliflozin and Sitagliptin alongside Metformin. The study will monitor participants over a 90-day treatment period with assessments at baseline, 6 weeks, and 12 weeks to measure blood sugar levels and other health parameters. The goal is to determine which combination is most effective for managing blood sugar levels in this patient population.
Who should consider this trial
Good fit: Ideal candidates are newly diagnosed males and females aged 30 to 55 with specific HbA1c and BMI criteria.
Not a fit: Patients with severe diabetes (HbA1c >10 mmol/mol) or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for managing Type 2 Diabetes Mellitus.
How similar studies have performed: Other studies have shown promising results with similar medication combinations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females * Age 30-55yrs * HbA1c = ≥ 8.5 \<10 mmol/mol (ADA. 2018) * BMI \>18.5- \<29.9 (WHO Asian Criteria) * Treatment naïve patients * With / without dyslipidemia. Exclusion Criteria: * HbA1c \>10 mmol/mol * BMI \> 30 * Pregnancy or lactation * Systemic diseases such as: hypertension, thyroid, liver, renal diseases etc. * Known allergy or intolerance to Metformin, Glimepiride, Sitagliptin or Empagliflozin.
Where this trial is running
Karachi, Sindh
- National Medical Center — Karachi, Sindh, Pakistan (Recruiting)
Study contacts
- Principal investigator: Saima Chandio, MBBS — Bahria University Islamabad
- Study coordinator: Saima Chandio
- Email: saimaabid278@gmail.com
- Phone: +923337824440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.