Vildagliptin compared to gliclazide as dual therapy with metformin in Muslim patients with type 2 diabetes fasting during Ramada

Phase 1

• Conditions: Type 2 Diabetes Mellitus; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-005499-41-ES
• Lead Sponsor: ovartis Farmacéutica S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-30
• Study Completion: 2013-09-05
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 557

Inclusion Criteria

- Confirmed T2DM diagnose
- Plan to fast during Ramadan
-Treated with a combination of a stable dose of metformin and an SU for at least 12 weeks and HbA1c <= 8.5% at Visit 1
- Taking a sulfonylurea treatment less than 3 years prior to Visit 1
- Body mass index (BMI) >= 22 AND <= 45 KG/M2 at Visit 1

Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 497
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

-Pregnant or nursing (lactating) women
-History of hypersensitivity to any of the study drugs
-Patients taking any other anti-diabetes drug (oral or injection) other than metformin and an SU component
- Inability to comply with the study procedures or medications
Other protocol-definied exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified