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

• Register: EUCTR
• Last refreshed on: 16 June 2014
• Main ID: EUCTR2011-005499-41-DK
• Date of registration: 11/10/2012
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Vildagliptin compared to gliclazide as dual therapy with metformin in Muslim patients with type 2 diabetes fasting during Ramadan
• Scientific title: A double blind, double dummy, randomised, multi-centre study to assess the tolerability and efficacy profile of vildagliptin compared to gliclazide as dual therapy with metformin in Muslim patients with type 2 diabetes fasting during Ramadan
• Date of first enrolment: 05/12/2012
• Target sample size: 552
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005499-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Denmark, Egypt, Germany, India, Indonesia, Jordan, Kuwait, Lebanon, Malaysia, Russian Federation, Saudi Arabia, Spain, Sweden, Tunisia, Turkey, United Arab Emirates, United Kingdom

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Type 2 Diabetes Mellitus
MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Intervention(s)

Trade Name: Galvus
Product Name: Vildagliptin
Product Code: LAF237
Pharmaceutical Form: Tablet
INN or Proposed INN: VILDAGLIPTIN
CAS Number: 274901-16-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Etform 500
Product Name: Metformin
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: METFORMIN HYDROCHLORIDE
CAS Number: 1115-70-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-

Trade Name: GLICLAZIDE SANDOZ
Product Name: Gliclazide
Pharmaceutical Form: Capsule
INN or Proposed INN: GLICLAZIDE
CAS Number: 21187-98-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To evaluate in Muslim patients with T2DM who plan to fast during the Ramadan fasting period:
1. The proportion of patients with at least one HE (Hypoglycaemic event) is lower in the vildagliptin plus metformin arm compared to the gliclazide plus metformin arm during the Ramadan fasting period.
2. The efficacy of vildagliptin plus metformin by testing the hypothesis that the HbA1C reduction with vildagliptin plus metformin is not inferior to that of gliclazide plus metformin from randomisation to the last visit.
The study needs to meet both co-primary objectives to declare positive.

Secondary Objective: 1. evaluate the proportion of patients with an increase in HbA1c (<=0.3%), taken at visit 3 to the last visit with no HEs during Ramadan in the vildagliptin plus metformin (A) arm versus the gliclazide plus metformin arm (B).
2. evaluate the efficacy of A by testing the hypothesis that the HbA1c reduction with A is superior to that of B from randomisation to the last visit
3. Evaluate HbA1c change, taken at Visit 3 to study end.
4. Evaluate the incidence of severe HEs during Ramadan
5. Evaluate, in a selected sub-group (approx 25 patients/arm), 72h continuous subcutaneous glucose monitoring (CGM, masked to patients) comparing glucose fluctuation during the first 10 days of Ramadan.
6. Evaluate the treatment adherence during Ramadan
7. Evaluate the body weight change taken at Visit 3 to the last visit
8. Evaluate the unscheduled visits to the HCP, at Visit 3 to the last visit
9. Evaluate the number of days fasted during Ramadan
10. Safety and tolerability

Primary end point(s): 1.Proportion of patients experiencing at least one Hypoglycaemic Evenet (HE) during the Ramadan fasting period
2. Change in glycosylated hemoglobin (HbA1c) level from "Baseline" to "endpoint" to test non-inferiority

Timepoint(s) of evaluation of this end point: 1. 1 month
2. from baseline to endpoint (average of 21 weeks)

Secondary Outcome(s)

Secondary end point(s): 1. Proportion of patients without an increase in HbA1c (<=0.3%) with no HE
2. Change in HbA1c from visit 3 to endpoint
3. Number of serious HE during the Ramadan fasting period
4. Mean amplitude of glycaemic excursions (MAGE) to measure glucose fluctuations during the day
5. Change in body weight from pre-Ramadan visit (Visit 3 ) to end of study
6. Treatment adhererence during the Ramadan fasting period
7. Number of unscheduled visit to health care professional
8. Number of days fasted during the Ramadan fasting period
9. Change in HbA1c level from baseline to endpoint to test superiority

Timepoint(s) of evaluation of this end point: 1.HbA1c timeframe: From any time within (week -4) to (day-1) before the start of Ramadan fasting period to within 4 weeks post-Ramadan fasting period; HE timeframe: 1month
2. From anytime within (week -4) to (day -1) before the start of Ramadan fasting period to within 4 weeks post-Ramadan fasting period
3. 1 month
4. 10 days
5. From any time within (week-4) to (day -1) before the start of Ramadan fasting period to within 4 weeks post-Ramadan fasting period
6. 1month
7. visit 3 (anytime from week-4 to day-1 before the start of the Ramadan fasting period) to visit 4 (within 4 weeks post-Ramadan fasting period)
8. 1 month
9. from baseline to endpoint (average of 21 weeks)

Secondary ID(s)

CLAF237A2411

Source(s) of Monetary Support

Novartis Pharma Services AG