Role of Linagliptin and Dapagliflozin versus Vildagliptin and Dapagliflozin in Diabetes patients

Phase 4

Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

Registration Number: CTRI/2024/04/066007

Lead Sponsor: All India Institute of Medical Sciences, Jodhpur

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Age 18 to 65yr

2. Diagnosis of type 2 diabetes mellitus as per ADA criteria.

3. Newly diagnosed Type 2 DM patients.

4. Previously diagnosed DM patient on lifestyle modifications and anti-diabetic drugs.

HbA1c more than 7 percentage.

Exclusion Criteria

1. History of cardiac diseases (NYHA grade 3 – 4) or cardiac anomalies

2. Renal insufficiency - serum creatinine more than or equal to 1.8mg/dl

3. Patients with significant thyroid dysfunction and hepatic impairment (serum bilirubin more than 4. times, AST, ALT, and ALP more than three times the upper limit of normal)

5.Patient have any malignancy

6.Patient have any substance abuse(alcohol/drugs)

7.Pregnant & Lactating Woman

8.Those being treated with any investigational drug within the last 30 days

9.The patient is with severe illness/ infections

HbA1c more than 11%

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effect of combination of dapagliflozin plus linagliptin versus dapagliflozin plus vildagliptin on HbA1c in T2 DM after 3 months from baselineTimepoint: 3 months from baseline

Secondary Outcome Measures

Name	Time	Method
To evaluate the effect on fasting blood glucose (FBG) and HOMA index (HOMA-IR and HOMA- beta cell function) of dapagliflozin plus linagliptin versus dapagliflozin plus vildagliptin in T2 DM after 3 months from baseline.Timepoint: 3 months from baseline;To evaluate the effect on lipid profile parameters of dapagliflozin plus linagliptin versus dapagliflozin plus vildagliptin in T2 DM after 3 months from baseline.Timepoint: 3 months from baseline.;To evaluate the effect on QOL score (DQOL) of dapagliflozin plus linagliptin versus dapagliflozin plus vildagliptin in T2 DM after 3 months from baselineTimepoint: 3 months from baseline;To evaluate the safety of dapagliflozin plus linagliptin versus dapagliflozin plus vildagliptin in T2 DM over 3 monthsTimepoint: 3 months from baseline