Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus, Ramadan, Vildagliptin, Hypoglycemia
Brief summary
To evaluate vildagliptin as compared to gliclazide, given in combination with metformin in Muslim patients with type 2 diabetes fasting during Ramadan.
Interventions
DRUGVildagliptin
Patients will be instructed to take Vildagliptin tablets at a fixed dose of 50 mg twice daily (double blind therapy)
DRUGGliclazide
Patients will be instructed to take Gliclazide capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy)
DRUGMetformin
Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion
DRUGPlacebo 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)
DRUGPlacebo 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
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed Type 2 Diabetes diagnosis * Plan to fast during Ramadan * Treated with a combination of metformin and an Sulfonylurea (SU) for at least 12 weeks and HbA1c ≤8.5% at Visit 1 * Taking a sulfonylurea treatment for less than 3 years prior to Visit 1 * Body mass index (BMI) ≥22 and ≤45 kg/m2 at Visit 1
Exclusion criteria
* Pregnant or nursing (lactating) women * History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. * Patients who are 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-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority | 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to endpoint in glycosylated hemoglobin (HbA1c) | baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks) | Endpoint is defined as the visit 4 (post-Ramadan) measurement or the last observation obtained during or after Ramadan, prior to or at initiation of rescue medication |
| Change from visit 3 (pre-Ramadan visit) to endpoint in glycosylated hemoglobin (HbA1c) | visit 3 (anytime from week-4 to day-1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks) | Endpoint is defined as the visit 4 (post-Ramadan) measurement or the last observation obtained during or after Ramadan, prior to or at initiation of rescue medication |
| Proportion of patients experiencing severe hypoglycemic events during the Ramadan fasting period | 1 month | — |
| mean amplitude of glycemic excursions (MAGE) to measure glucose fluctuations during the day | 72 hours | assessed in a selected subgroup of patients |
| Percentage of patients without an increase in HbA1c (≤ 0.3%) and with no Hypoglycaemic Events (HEs) | visit 3 (anytime from week -4 to day -1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks) for HbA1c; and during 1 month (Ramadan) for HEs | — |
| Change from visit 3 (pre-Ramadan visit) to endpoint in body weight | From visit 3 (anytime from week-4 to day-1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks) | Endpoint is defined as the visit 4 (post-Ramadan) measurement or the last observation obtained during or after Ramadan, prior to or at initiation of rescue medication |
| Number of unscheduled visit to health care professional | From visit 3 (anytime from week-4 to day-1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks) | — |
| Number of days fasted during the Ramadan fasting period | 1 month | — |
| Number of patients with treatment emergent adverse events (AEs), serious AEs, discontinuation due to AEs, deaths or laboratory abnormalities as assessment of safety and tolerability | Baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks) | — |
| Treatment adherence during the Ramadan fasting period | 1 month | — |
Countries
Denmark, Egypt, Germany, Indonesia, Jordan, Kuwait, Lebanon, Malaysia, Russia, Saudi Arabia, Singapore, Spain, Tunisia, Turkey (Türkiye), United Arab Emirates, United Kingdom
Outcome results
None listed