Comparison of Remogliflozin with vildagliptin in the treatment of diabetes

Completed

Conditions: Type 2 diabetes mellitus without complications,

Registration Number: CTRI/2020/02/023120

Lead Sponsor: Maulana azad medical college

Brief Summary: Diabetes mellitus is one of the most common chronic diseasesglobally responsible for increased morbidity and mortality. The globalprevalence of diabetes among adults is estimated to be 6.4%, affecting 285million people, in 2010, and is expected to increase to 7.7%, affecting 439million people by 2030.

The position statement of the American Diabetes Association (ADA)and European Association for the Study of Diabetes (EASD) recommends the use ofone of six commonly used antihyperglycemic agents i.e. 1) sulfonylurea (SU), 2)thiazolidinedione, 3) dipeptidyl peptidase-4 (DPP4) inhibitor, 4)sodium-glucose cotransporter-2 (SGLT2) inhibitor, 5) glucagon-like peptide-1(GLP-1) receptor agonist, or 6) basal insulin analogue, as an add-on therapywhen the individualized HbA1c target is not achieved after 3 months oftreatment with metformin alone.

Vildagliptin, a potent and selective inhibitor of dipeptidylpeptidase-4 (DPP-4), improves glycemic control by increasing the availabilityof endogenous incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependentinsulinotropic polypeptide (GIP).

Remogliflozin, a selective inhibitor of sodium-glucosecotransporter subtype 2 (SGLT2), which is to be administered as RemogliflozinEtabonate, the prodrug for Remogliflozin.Inhibition of SGLT2(which is selectively expressed in the proximal convoluted tubules of kidney)leads to increased excretion of glucose in urine, resulting in reduced bloodglucose concentrations and has therapeutic benefit in T2DM.Remogliflozinis available relatively at lower cost than the existing medications of sameclass being marketed in india. Remogliflozin thus can prove to be acost-effective drug in treatment of type 2 diabetes mellitus in developingcountry like India.

This study is proposed with the hypothesis that remogliflozin maybe non-inferior to vildagliptin in the treatment of type 2 diabetes mellitus.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

1.Patients with age between 35 to 70 years of all sexes.
2.Patients with diagnosis of type 2 diabetes mellitus with uncontrolled glycaemia on taking metformin alone.

Exclusion Criteria

1.Patients on any other anti-diabetic medications other than metformin.
Patients having hepatic dysfunction (aspartate aminotransferase/alanine aminotransferase â‰¥2.5 times of upper normal limit [UNL] or bilirubin > 2 times of UNL).
3.Patient with renal dysfunction (with estimated glomerular filtration rate [eGFR] as per MDRD formula < 45 ml/min/1.73 m2.
4.Patients with genitourinary tract infections.
5.Patients with lower limb cellulitis, ulcer and amputations.
6.Patients with osteoporosis and bone fractures.
7.Patients with acute pancreatitis.
8.Patients with comorbid serious illness such as tuberculosis, HIV, malignancy.
9.Patients allergic to the study medications.
Pregnant female patients and nursing mothers will also be excluded.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Haemoglobin A1c levels from baseline to 12 weeks of treatment.	Change in Haemoglobin A1c levels from baseline to 12 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
1.Change in lipid profile.	2.Change in weight.

Trial Locations

Locations (1): lok Nayak Hospital
🇮🇳
Central, DELHI, India
lok Nayak Hospital
🇮🇳Central, DELHI, India
Dr Vikram Sharma
Principal investigator
8826012309
vikramsharma161@gmail.com