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

Evaluation of efficacy and safety of Vildagliptin versus Voglibose as add-onin control of Post Prandial Blood Glucose in patients with Type 2 Diabetes Mellitus with Dual Therapy Failure - A Randomised Controlled Study - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072355

Enrollment

120

Registered

2024-08-12

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Tab Vildagliptin 50mg: Tab Vildagliptin 50mg twice daily for 12 weeks Control Intervention1: Tab Voglibose 0.2mg: Tab Voglibose 0.2mg thrice daily for 12 weeks

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr Geetha A

Bangalore Medical College and Research Institute

geethaanantharamaiah@gmail.com9886224085

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026