Safety and Efficacy of Galvus (Vildagliptin) as add-on Therapy to Metformin Plus Glimepiride.

A Multi-center, Randomized, Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin 50 mg Bid as add-on Therapy to Metformin Plus Glimepiride in Patients With Type 2 Diabetes

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/002990

Enrollment

290

Registered

2010-11-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Type 2 Diabetes Mellitus

Interventions

Intervention1: Vildagliptin: 50 microgram tablets bid twice daily through orally, throughout the study duration Control Intervention1: Placebo: Vildagliptin 50 microgram matching placebo tablets twice

Eligibility

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of T2DM by standard criteria. 2. Treatment with oral anti-diabetic therapy, on stable dose for at least 12 weeks prior to the screening visit. Acceptable background anti-diabetic therapy includes: metformin (greater than or equal to 1500 mg) as monotherapy or in combination with SU, TZDs, or glinides 3. Age greater than or equal to 18 to less than or equal to 80 years 4. HbA1c of greater than or equal to 7.5 and less than or equal to 11.0% 5. Body Mass Index (BMI) greater than or equal to 22 to less than or equal to 45 kg/m2

Exclusion criteria

Exclusion criteria: 1. FPG greater than or equal to 270 mg per dL (greater than or equal to 15.0 mmol per L) 2. Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months 3. Any of following within past 6 months: Myocardial infarction, TIA or stroke, coronary artery bypass surgery or percutaneous coronary intervention 4. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes 5. Acute infections which may affect blood glucose control within 4 weeks prior to screening Other protocol-defined inclusion or exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
HbA1c ReductionTimepoint: 24 weeks	—

Secondary

Measure	Time frame
FPG reductionTimepoint: 24 weeks;Responder RateTimepoint: 24 weeks;Safety and tolerability-frequency of treatment emergent adverse events (incl. overall Aes, SAEs, death, Aes leading ot study discontinuation or study drug interruption, pre-specified potential AEs)Timepoint: 24 weeks	—

Countries

Australia, Germany, Hungary, India, Italy, Mexico, Philippines, Republic of Korea, Romania, Taiwan

Contacts

Public ContactMurugananthan K

Novartis Healthcare Private Limited

murugananthan.k@novartis.com02224958545

Outcome results

None listed

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