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Study of Efficacy and Safety of Vildagliptin as add-on Insulin Therapy in T2DM Patients

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Novartis

Status and phase

Completed
Phase 4

Conditions

Type 2 Diabetes Mellitus (T2DM)

Treatments

Drug: Placebo
Drug: Metformin
Drug: Vildagliptin (LAF237)
Drug: Insulin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02002221
CLAF237A1405

Details and patient eligibility

About

The purpose of this study was to assess the efficacy and safety of vildagliptin 50 mg bid add-on therapy to improve overall glycemic control in patients with T2DM inadequately controlled by insulin, with or without concomitant metformin treatment. It was agreed with PMDA to conduct a postmarketing clinical trial to further collect the efficacy and safety data of vildagliptin especially in Japanese patients when it iwas used on top of insulin.

Enrollment

156 patients

Sex

All

Ages

20 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Confirmed diagnosis of T2DM by standard criteria.
  • HbA1c ≥ 7.0 to ≤ 10% at Visit 1.
  • Age: ≥ 20 to < 75 years old at Visit 1.
  • BMI ≥ 20 to ≤ 35 kg/m2 at Visit 1.

Exclusion criteria

  • FPG ≥ 270 mg/dL (≥15 mmol/L) at Visit 1.
  • Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.
  • Significant heart diseases
  • Hepatic disorder

Other protocol defined inclusion/exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

156 participants in 2 patient groups, including a placebo group

Vildagliptin (LAF237)
Experimental group
Description:
Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
Treatment:
Drug: Vildagliptin (LAF237)
Drug: Metformin
Drug: Insulin
Placebo
Placebo Comparator group
Description:
In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
Treatment:
Drug: Placebo
Drug: Metformin
Drug: Insulin

Trial contacts and locations

31

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Data sourced from clinicaltrials.gov

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