CTRI/2023/11/060291Not yet recruitingPhase 3
Comparative Efficacy And Safety Of Imeglimin Plus Metformin Versus Vildagliptin Plus Metformin In Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Patients: A Randomized, Open-Label Study - Nil
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1.Age: =18-60 years (both male and female).
- •2.Newly diagnosed type 2 diabetes mellitus (T2DM) patients (FBG =126mg/dl, PPBS = 200mg/dl with symptoms like polyuria, polydipsia and polyphagia, 2 hours plasma glucose OGTT = 200mg/dl and HbA1C = 6.5%) diagnosed within 6 months from starting of this study and attending the Endocrinology outpatient department (OPD).
- •3.HbA1C 6.5-8 %
- •4.Those who are willing to participate and give their consent shall be included in the study.
Exclusion Criteria
- •1.Age <18 years and > 60 years
- •2.Type 1 Diabetes Mellitus patients.
- •3.T2DM patients having renal dysfunction with eGFR = 45ml/min.
- •4.T2DM patients with hepatic impairment with child Turcotte Pugh (CTP) class C.
- •5.Steroid induced T2DM/ Syndromic diabetes.
- •6.Pregnant/ lactating women with diabetes.
- •7.Patients not able to tolerate the therapy or presented with adverse drug reaction.
- •8.Unwilling to participate
Investigators
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