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Clinical Trials/CTRI/2023/11/060291
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

Government Medical College, Jammu0 sites0 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

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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