Clinical trial NCT01758380: Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Ramadan
Vildagliptin
Hypoglycemia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-01-01
Enrollment: 557
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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/exclusion criteria may apply"

Primary outcomes:
measure: Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority
timeFrame: 1 month
Secondary outcomes:
measure: Percentage of patients without an increase in HbA1c (≤ 0.3%) and with no Hypoglycaemic Events (HEs)
timeFrame: 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
measure: Change from baseline to endpoint in glycosylated hemoglobin (HbA1c)
timeFrame: baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks)
measure: Change from visit 3 (pre-Ramadan visit) to endpoint in glycosylated hemoglobin (HbA1c)
timeFrame: 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)
measure: Proportion of patients experiencing severe hypoglycemic events during the Ramadan fasting period
timeFrame: 1 month
measure: mean amplitude of glycemic excursions (MAGE) to measure glucose fluctuations during the day
timeFrame: 72 hours
measure: Treatment adherence during the Ramadan fasting period
timeFrame: 1 month
measure: Change from visit 3 (pre-Ramadan visit) to endpoint in body weight
timeFrame: 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)
measure: Number of unscheduled visit to health care professional
timeFrame: 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)
measure: Number of days fasted during the Ramadan fasting period
timeFrame: 1 month
measure: 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
timeFrame: Baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks)
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Novartis Investigative Site
city: Alexandria
country: Egypt
facility: Novartis Investigative Site
city: Cairo
country: Egypt
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Bad Oeynhausen
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Dortmund
country: Germany
facility: Novartis Investigative Site
city: Einbeck
country: Germany
facility: Novartis Investigative Site
city: Loehne
country: Germany
facility: Novartis Investigative Site
city: Meine
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Saarlouis
country: Germany
facility: Novartis Investigative Site
city: Malang
country: Indonesia
facility: Novartis Investigative Site
state: East Java
city: Surabaya
country: Indonesia
facility: Novartis Investigative Site
state: East Java
city: Padang
country: Indonesia
facility: Novartis Investigative Site
state: Sumatera Barat
city: Jakarta
country: Indonesia
facility: Novartis Investigative Site
city: Jakarta
country: Indonesia
facility: Novartis Investigative Site
city: Amman
country: Jordan
facility: Novartis Investigative Site
city: Kuwait
country: Kuwait
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Hazmieh
country: Lebanon
facility: Novartis Investigative Site
city: Saida
country: Lebanon
facility: Novartis Investigative Site
city: Kota Bahru
country: Malaysia
facility: Novartis Investigative Site
state: Kelantan
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
city: Krasnodar
country: Russian Federation
facility: Novartis Investigative Site
city: Penza
country: Russian Federation
facility: Novartis Investigative Site
city: Rostov on Don
country: Russian Federation
facility: Novartis Investigative Site
city: Rostov-on-Don
country: Russian Federation
facility: Novartis Investigative Site
city: Saratov
country: Russian Federation
facility: Novartis Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St.- Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Ufa
country: Russian Federation
facility: Novartis Investigative Site
city: Dammam
country: Saudi Arabia
facility: Novartis Investigative Site
city: Riyadh
country: Saudi Arabia
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Málaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Girona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Salt
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Santa Coloma de Gramanet
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Vic
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Ceuta
country: Spain
facility: Novartis Investigative Site
city: Melilla
country: Spain
facility: Novartis Investigative Site
city: Le Belvedere - Tunis
country: Tunisia
facility: Novartis Investigative Site
state: Tunisie
city: Sfax
country: Tunisia
facility: Novartis Investigative Site
state: Tunisie
city: Tunis
country: Tunisia
facility: Novartis Investigative Site
state: Tunisie
city: Monastir
country: Tunisia
facility: Novartis Investigative Site
city: Sousse
country: Tunisia
facility: Novartis Investigative Site
city: Tunis
country: Tunisia
facility: Novartis Investigative Site
city: Tunis
country: Tunisia
facility: Novartis Investigative Site
city: Diskapi / Ankara
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Kahramanmaras
country: Turkey
facility: Novartis Investigative Site
city: Dubai
country: United Arab Emirates
facility: Novartis Investigative Site
city: Leicester
country: United Kingdom
facility: Novartis Investigative Site
state: Leicestershire
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
city: Bolton
country: United Kingdom
facility: Novartis Investigative Site
city: Derby
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharma AG
role: STUDY_DIRECTOR
References:
citation: Hassanein M, Abdallah K, Schweizer A. A double-blind, randomized trial, including frequent patient-physician contacts and Ramadan-focused advice, assessing vildagliptin and gliclazide in patients with type 2 diabetes fasting during Ramadan: the STEADFAST study. Vasc Health Risk Manag. 2014 May 28;10:319-26. doi: 10.2147/VHRM.S64038. eCollection 2014.