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Efficacy and Long-Term Safety of Vildagliptin as Monotherapy in Patients With Type 2 Diabetes

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Novartis

Status and phase

Completed
Phase 3
Phase 2

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Vildagliptin
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00821977
CLAF237B2201

Details and patient eligibility

About

This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as monotherapy.

Enrollment

338 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients at least 18 years of age at Visit 1
  • Drug naïve patients with T2DM diagnosed at least 2 months prior to Visit 1
  • HbA1c ≥ 7.0 % and ≤ 10.0% at Visit 1
  • Body Mass Index (BMI) in the range of 22-45 kg/m2 at Visit 1

Exclusion criteria

  • Pregnant or lactating female
  • FPG ≥ 270 mg/dL (≥15 mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

338 participants in 3 patient groups, including a placebo group

Vildagliptin Dose 1
Experimental group
Treatment:
Drug: Vildagliptin
Drug: Vildagliptin
Vildagliptin Dose 2
Experimental group
Treatment:
Drug: Vildagliptin
Drug: Vildagliptin
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

176

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Data sourced from clinicaltrials.gov

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