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Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan

NCT01758380 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 557

Last updated 2013-10-17

No results posted yet for this study

Summary

To evaluate vildagliptin as compared to gliclazide, given in combination with metformin in Muslim patients with type 2 diabetes fasting during Ramadan.

Conditions

Interventions

DRUG

Vildagliptin

Patients will be instructed to take Vildagliptin tablets at a fixed dose of 50 mg twice daily (double blind therapy)

DRUG

Gliclazide

Patients will be instructed to take Gliclazide capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy)

DRUG

Metformin

Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion

DRUG

Placebo to Gliclazide

Patients will be instructed to take the Gliclazide matching placebo capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy)

DRUG

Placebo to Vildagliptin

Patients will be instructed to take Vildagliptin matching placebo tablets at a fixed dose of 50 mg twice daily (double blind therapy).

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharma AG · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Denmark
  • Egypt
  • Germany
  • Indonesia
  • Jordan
  • Kuwait
  • Lebanon
  • Malaysia
  • Russia
  • Saudi Arabia
  • Singapore
  • Spain
  • Tunisia
  • Turkey (Türkiye)
  • United Arab Emirates
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01758380 on ClinicalTrials.gov