The beneficial effects of newer antidiabetic drugs(Sodium Glucose Co-Transporters type 2) inhibitors for the treatment of raised blood glucose level

Recruiting

Conditions: Type 2 diabetes mellitus,

Registration Number: CTRI/2019/03/018307

Lead Sponsor: Jawaharlal Nehru Medical College and Hospital

Brief Summary: The presentstudy has been designed to study the safety and efficacy of SGLT2 inhibitors intype 2 diabetes patients. The study will help to compare the efficacy of SGLT2 inhibitors and their safety profile.The study willbe conducted in the Department of Pharmacology and Rajiv Gandhi Centre forDiabetes and Endocrinology, JNMC, AMU Aligarh on the patients of Type 2 DMattending the OPD of Rajiv Gandhi Centre for Diabetes and Endocrinology, J.N.Medical College & Hospital, A.M.U, Aligarh-202002.

This will be anobservational, prospective and open labelled study. The patients will be dividedinto different groups based on the pharmacotherapy at the end of study.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 160

Inclusion Criteria

Patients having age 18 years and above with type 2 DM on SGLT2 inhibitors and/ or on other oral antidiabetics.

Exclusion Criteria

Type 1 Diabetes Mellitus Patients on insulin or other injectable agents Patients on systemic corticosteroids and other drugs which may affect the glycaemic parameters History of Diabetic Ketoacidosis (DKA) Significant Diabetic nephropathy Patients with significant liver disease Congestive Heart Failure (CHF) Patients with significant lung disease Septicaemia Psychotic patient Pregnancy Known cases of HIV / HBsAg / Anti-HCV and immunocompromised patients Any other severe systemic illness.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimation of HbA1c	HbA1c at Baseline, 12 weeks and 24 weeks \| FPG and 2HPG at baseline, 6 weeks, 12 weeks, 18 weeks and 24 weeks
Fasting Plasma Glucose (FPG)	HbA1c at Baseline, 12 weeks and 24 weeks \| FPG and 2HPG at baseline, 6 weeks, 12 weeks, 18 weeks and 24 weeks
2Hour Plasma Glucose (2HPG)	HbA1c at Baseline, 12 weeks and 24 weeks \| FPG and 2HPG at baseline, 6 weeks, 12 weeks, 18 weeks and 24 weeks

Secondary Outcome Measures

Name	Time	Method
Reduction in HbA1C from baseline values.	Effects of SGLT2 inhibitors on Renal system, cardiovascular system

Trial Locations

Locations (1): Jawaharlal Nehru Medical College AMU Aligarh
🇮🇳
Aligarh, UTTAR PRADESH, India
Jawaharlal Nehru Medical College AMU Aligarh
🇮🇳Aligarh, UTTAR PRADESH, India
Mohammad Zeeshan
Principal investigator
9386717259
zeeshan.alam20132@gmail.com