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Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone

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Novartis

Status and phase

Completed
Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: metformin
Drug: Vildagliptin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00396357
CLAF237A23104

Details and patient eligibility

About

This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.

Enrollment

914 patients

Sex

All

Ages

18 to 78 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18-78 years inclusive
  • Type 2 diabetes diagnosis at least 2 months prior to study entry
  • Body mass index in the range of 22-45 kg/m2
  • HbA1c in the range of 6.5 to 9% inclusive
  • Fasting plasma glucose <270 mg/dL (15 mmol/L)

Exclusion criteria

  • A history of type 1 diabetes
  • Evidence of significant diabetic complications
  • Treatment with insulin or any other oral antidiabetic agents
  • Congestive heart failure requiring pharmacologic treatment
  • Clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels >/= 1.5 mg/dl (males) and >/= 1.4 mg/dl (females)

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

914 participants in 2 patient groups

vildagliptin + metformin
Experimental group
Treatment:
Drug: Vildagliptin
Metformin
Active Comparator group
Treatment:
Drug: metformin

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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