FindTrial
Sign In

ââ?¬Å?A Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Test Product, Fixed Dose Combination of Vildagliptin and Pioglitazone Hydrochloride Tablets 50mg/15mg of USV Private Limited., India in Patients with Type 2 Diabetes Mellitus Inadequately controlled on monotherapy.

ââ?¬Å?A Phase III, Prospective, Randomized, Open Label, Comparative, Parallel Group, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Test Product, Fixed Dose Combination of Vildagliptin and Pioglitazone Hydrochloride Tablets 50mg/15mg of USV Private Limited., India with concomitant administration of Reference Products, GalvusÃ?® 50mg tablets (vildagliptin) of Novartis Pharmaceuticals UK Ltd., and PioglitÃ?® 15mg tablets (Pioglitazone Hydrochloride) of Sun Pharmaceutical Industries Ltd., India in Patients with Type 2 Diabetes Mellitus Inadequately controlled on monotherapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/036039
Enrollment
195
Registered
2021-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: Fixed Dose Combination of Vildagliptin and Pioglitazone Hydrochloride Tablets 50mg/15mg: Name of Investigational Product Test Product: Fixed Dose Combination of Vildagliptin and Piogli

Sponsors

USV pvt ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male or Female Patients aged between 18 to 65 (both inclusive) years with diagnosis of Type 2 diabetes mellitus.

Exclusion criteria

Exclusion criteria: Patients with a history of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus.

Design outcomes

Primary

MeasureTime frame
ïÆ?Ë? Mean change in glycosylated hemoglobin (HbA1c) from baseline to end of the study visit.Timepoint: ïÆ?Ë? Mean change in glycosylated hemoglobin (HbA1c) from baseline to end of the study visit. Follow up visits will be done on week 2/day 14(Ã?±2), week 6/day 42(Ã?±2), week 12/day (Final Visit) of treatment to assess efficacy, safety and tolerability.—

Secondary

MeasureTime frame
ïÆ?Ë? Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit.Timepoint: Follow up visits will be done on week 2/day 14(Ã?±2), week 6/day 42(Ã?±2), week 12/day (Final Visit) of treatment to assess efficacy, safety and tolerability.—

Countries

India

Contacts

Public ContactDrSridhar SB

USV pvt ltd

sridhar.sb@usv.in9739180005

Outcome results

None listed

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