An study to assess the safety and efficacy of vildagliptin vs voglibose in management of post-prandial blood sugar in patients with T2DM

Phase 4

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

Registration Number: CTRI/2024/08/072355

Lead Sponsor: Dr Mahima V

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Patient willing to give Informed Consent.

2.Age above 18 years of either gender.

3.Patients who are a known case of Type-II Diabetes diagnosed as per American Diabetes Association(ADA) Guidelines[5] with failure of PPBS control even on a maximum daily dose of Metformin 2gm along with Glimeperide 4mg for a period of 12 weeks or more.

4.Raised Postprandial Blood Glucose PPBS

morw than 180mg/dl even after dual therapy.

5.FBS normal (80-130mg/dl) on dual therapy.

6.HbA1c less than 10gm/dl on dual therapy.

Exclusion Criteria

1.Patient with known micro and macro vascular complications of diabetes.

2.Pregnant women and lactating mothers.

3.Patients on any other oral hypoglycemic agent apart from metformin and glimepiride or on insulin.

4.Patients diagnosed with Type I Diabetes.

5.Patients with HbA1c more than 10gm/dl or other associated conditions warranting use of insulin.

6.Patients with other co-existing medical illness like cardiac, pulmonary, renal, hepatic, pancreatic, GI or neurological disease or severe infections.

7.Chronic alcoholics/alcohol abusers.

8.Patients with known hypersensitivity to study medication.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Efficacy Parameters <br/ ><br>a)Body Weight and BMI <br/ ><br>b)Sugar Profile – Serum levels of FBS, PPBS, HbA1c <br/ ><br>2.Safety Parameters <br/ ><br>a)Metformin – abdominal discomfort, diarrhoea, lactic acidosis, Vit B12 defeciency <br/ ><br>b)Glimepiride – hypoglycaemia, photosensitivity reactions, skin rash, leucopenia, anaemia, thrombocytopenia. <br/ ><br>c)Vildagliptin – sternal pain, flu like symptoms <br/ ><br>d)Voglibose – abdominal discomort, flatulence. <br/ ><br>e)Any other <br/ ><br>Timepoint: Baseline - FBS, PPBS, HbA1C <br/ ><br>4th week - FBS, PPBs <br/ ><br>8th week - FBS, PPBS <br/ ><br>12th week - FBS, PPBS, HbA1C

Secondary Outcome Measures