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

• Register: EUCTR
• Last refreshed on: 27 July 2020
• Main ID: EUCTR2011-005499-41-GB
• Date of registration: 30/11/2012
• Prospective Registration: No
• 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: 28/11/2012
• 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

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

Contacts

• Name: Medical Information Services
• Affiliation: Novartis Pharmaceuticals UK Ltd

• Name: Medical Information Services
• Affiliation: Novartis Pharmaceuticals UK Ltd

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

Intervention(s)

Trade Name: Galvus 50mg
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)

Primary end point(s): Proportion of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period

Main Objective: To evaluate in Muslim patients with T2DM who plan to fast during the
Ramadan fasting period:

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.

Timepoint(s) of evaluation of this end point: 1 month

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 change in HbA1C from randomisation to the last visit, in
the A arm versus B arm
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

Secondary Outcome(s)

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

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. baseline to visit 4 (within 4 weeks post-Ramadan fasting period)
(minimum 12.5 weeks to maximum 30 weeks)
3. From anytime within (week -4) to (day -1) before the start of
Ramadan fasting period to within 4 weeks post-Ramadan fasting period
4. 1 month
5. 10 days
6. From any time within (week-4) to (day -1) before the start of
Ramadan fasting period to within 4 weeks post-Ramadan fasting period
7. 1 month
8. 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)
9. 1 month
10. baseline to visit 4

Secondary ID(s)

CLAF237A2411

2011-005499-41-DK

Source(s) of Monetary Support

Novartis Pharma Services AG

Ethics review

Status: Approved
Approval date: 28/11/2012
Contact:

Results

• Results available: Yes
• Date Posted: 24/07/2015
• Date Completed: 05/09/2013
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-005499-41/results