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Clinical Trials/CTRI/2018/06/014353
CTRI/2018/06/014353
Not yet recruiting
Phase 4

A Comparative study to evaluate the Efficacy and Safety of Teneligliptin versus Vildagliptin as an add-on to Metformin in the treatment of Type 2 Diabetes Mellitus at a tertiary care hospital

Praveen A 0 sites0 target enrollmentTBD
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Praveen A
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Praveen A

Eligibility Criteria

Inclusion Criteria

  • •1\.Patients willing to give written informed consent.(Annexure 1\)
  • •2\.Patients of either sex aged 18 \-80 years
  • •3\.Patients with Type 2 DM according to American Diabetes Association (ADA) criteria (FBS \>126 mg/dl, PPBS \>200 mg/dl.)
  • •4\.Type 2 DM who do not achieve glycemic target with metformin alone (upto 2g/day) for 6 months.
  • •5\.Patients with HbA1c levels between 7% and 9% on monotherapy with Metformin 1\.5 \-2g/day for 6 months prior to visit

Exclusion Criteria

  • •. Exclusion criteria :
  • •1\.Patients who suffered an attack of acute coronary syndrome, transient ischemic attack or stroke in the past three months.
  • •2\.Patients with hepatic disease (serum level of ALT, AST, Alkaline phosphatase \>3times the upper limit of normal)
  • •3\.Patients with severe ketosis, coma or reduced level of consciousness within the past 6 months due to diabetes.
  • •4\.Severe infection, pre or post operative, severe trauma.
  • •5\.History of a chronic intestinal disease associated with absorption and digestive problems.
  • •6\.Moderate or severe renal dysfunction (creatinine clearance \<50ml/min, serum creatine level \>1\.5mg/dl in men and 1\.3mg/dl in females.
  • •7\.Subjects with history of type 1 DM or secondary form of diabetes due to pancreatic diseases, pancreatic tumors pheochromocytoma, cushings syndrome, haemochromatosis drugs ,insulin receptors etc.
  • •8\.Medical history of pancreatitis with history of alcohol and drug abuse.
  • •9\.Pregnant and lactating mothers

Outcomes

Primary Outcomes

Not specified

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