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Long-term Safety Study of Vildagliptin in Patients With Type 2 Diabetes

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Novartis

Status and phase

Completed
Phase 3

Conditions

Type 2 Diabetes

Treatments

Drug: Vildagliptin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01159249
CLAF237A1308

Details and patient eligibility

About

This study is designed to demonstrate the long-term safety of vildagliptin in patients with type 2 diabetes. This study will study vildagliptin as add-on therapy with metformin, thiazolidinedione, α-glucosidase inhibitor (α-GI), rapid-acting insulin secretagogues in the treatment of type 2 diabetes in Japan.

Enrollment

245 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients with type 2 diabetes inadequately controlled with diet, exercise and metformin, thiazolidinedione, or α-GI, or glinides monotherapy
  • Age in the 20 years or over inclusive
  • HbA1c in the range of ≥ 6.5 to ≤ 10%

Exclusion criteria

  • Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
  • Significant heart diseases
  • Significant diabetic complications

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

245 participants in 4 patient groups

Open Met add-on vildagliptin
Other group
Treatment:
Drug: Vildagliptin
Open TZD add-on vildagliptin
Other group
Treatment:
Drug: Vildagliptin
Open α-GI add-on vildagliptin
Other group
Treatment:
Drug: Vildagliptin
Glinides add-on vildagliptin
Other group
Treatment:
Drug: Vildagliptin

Trial contacts and locations

24

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Data sourced from clinicaltrials.gov

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