Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan

Type 2 Diabetes Mellitus Clinical Trial

— STEADFAST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01758380
• Other study ID #: CLAF237A2411
• Secondary ID: 2011-005499-41
• Status: Completed
• Phase: Phase 4
• First received: December 24, 2012
• Last updated: October 16, 2013
• Start date: January 2013
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityEgypt: Egyptian Drug AuthorityGermany: BfArmIndia: Ministry of Health and Family WelfareIndonesia: Ministry of Health (MoH)Jordan: Ministry of Health (MoH)Kuwait: Ministry of Health (MoH)Lebanon: Ministry of Public HealthMalaysia: Ministry of Health (MoH)Russia: Ministry of Health (MoH)Saudi Arabia: Ministry of Health (MoH)Singapore: HSASpain: Spanish Agency for Medicines and Health ProductsTunisia: Ministry of Public HealthTurkey: Ministry of Health (MoH)UAE: Ministry of Health (MoH)United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 557
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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"

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Vildagliptin
Patients will be instructed to take Vildagliptin tablets at a fixed dose of 50 mg twice daily (double blind therapy)
• Gliclazide
Patients will be instructed to take Gliclazide capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy)
• Metformin
Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion
• Placebo 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)
• Placebo to Vildagliptin
Patients will be instructed to take Vildagliptin matching placebo tablets at a fixed dose of 50 mg twice daily (double blind therapy).

Locations

Country	Name	City	State
Denmark	Novartis Investigative Site	Frederiksberg
Egypt	Novartis Investigative Site	Alexandria
Egypt	Novartis Investigative Site	Cairo
Germany	Novartis Investigative Site	Augsburg
Germany	Novartis Investigative Site	Augsburg
Germany	Novartis Investigative Site	Bad Oeynhausen
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Dortmund
Germany	Novartis Investigative Site	Einbeck
Germany	Novartis Investigative Site	Loehne
Germany	Novartis Investigative Site	Meine
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Saarlouis
Indonesia	Novartis Investigative Site	Jakarta
Indonesia	Novartis Investigative Site	Jakarta
Indonesia	Novartis Investigative Site	Malang	East Java
Indonesia	Novartis Investigative Site	Padang	Sumatera Barat
Indonesia	Novartis Investigative Site	Surabaya	East Java
Jordan	Novartis Investigative Site	Amman
Kuwait	Novartis Investigative Site	Kuwait
Lebanon	Novartis Investigative Site	Beirut
Lebanon	Novartis Investigative Site	Beirut
Lebanon	Novartis Investigative Site	Hazmieh
Lebanon	Novartis Investigative Site	Saida
Malaysia	Novartis Investigative Site	Kota Bahru	Kelantan
Malaysia	Novartis Investigative Site	Kuala Lumpur
Russian Federation	Novartis Investigative Site	Krasnodar
Russian Federation	Novartis Investigative Site	Penza
Russian Federation	Novartis Investigative Site	Rostov on Don
Russian Federation	Novartis Investigative Site	Rostov-on-Don
Russian Federation	Novartis Investigative Site	Saratov
Russian Federation	Novartis Investigative Site	St. Petersburg
Russian Federation	Novartis Investigative Site	St.- Petersburg
Russian Federation	Novartis Investigative Site	Ufa
Saudi Arabia	Novartis Investigative Site	Dammam
Saudi Arabia	Novartis Investigative Site	Riyadh
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Ceuta
Spain	Novartis Investigative Site	Girona	Cataluña
Spain	Novartis Investigative Site	Málaga	Andalucia
Spain	Novartis Investigative Site	Melilla
Spain	Novartis Investigative Site	Salt	Cataluña
Spain	Novartis Investigative Site	Santa Coloma de Gramanet	Cataluña
Spain	Novartis Investigative Site	Vic	Cataluña
Tunisia	Novartis Investigative Site	Le Belvedere - Tunis	Tunisie
Tunisia	Novartis Investigative Site	Monastir
Tunisia	Novartis Investigative Site	Sfax	Tunisie
Tunisia	Novartis Investigative Site	Sousse
Tunisia	Novartis Investigative Site	Tunis
Tunisia	Novartis Investigative Site	Tunis
Tunisia	Novartis Investigative Site	Tunis	Tunisie
Turkey	Novartis Investigative Site	Diskapi / Ankara
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Kahramanmaras
United Arab Emirates	Novartis Investigative Site	Dubai
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Bolton
United Kingdom	Novartis Investigative Site	Derby
United Kingdom	Novartis Investigative Site	Leicester	Leicestershire
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority		1 month	Yes
Secondary	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	No
Secondary	Change from baseline to endpoint in glycosylated hemoglobin (HbA1c)	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	baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks)	No
Secondary	Change from visit 3 (pre-Ramadan visit) to endpoint in glycosylated hemoglobin (HbA1c)	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	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)	No
Secondary	Proportion of patients experiencing severe hypoglycemic events during the Ramadan fasting period		1 month	Yes
Secondary	mean amplitude of glycemic excursions (MAGE) to measure glucose fluctuations during the day	assessed in a selected subgroup of patients	72 hours	No
Secondary	Treatment adherence during the Ramadan fasting period		1 month	No
Secondary	Change from visit 3 (pre-Ramadan visit) to endpoint in body weight	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	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)	No
Secondary	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)	No
Secondary	Number of days fasted during the Ramadan fasting period		1 month	No
Secondary	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)	Yes