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

Purpose

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

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Vildagliptin Drug: Gliclazide Drug: Metformin Drug: Placebo to Gliclazide Drug: Placebo to Vildagliptin	Phase 4


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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Percentage of patients without an increase in HbA1c (≤ 0.3%) and with no Hypoglycaemic Events (HEs) [ Time Frame: 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 ] [ Designated as safety issue: No ]
Change from baseline to endpoint in glycosylated hemoglobin (HbA1c) [ Time Frame: baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks) ] [ Designated as safety issue: No ]
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) [ Time Frame: 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) ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
mean amplitude of glycemic excursions (MAGE) to measure glucose fluctuations during the day [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
assessed in a selected subgroup of patients
Treatment adherence during the Ramadan fasting period [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Change from visit 3 (pre-Ramadan visit) to endpoint in body weight [ Time Frame: 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) ] [ Designated as safety issue: No ]
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 [ Time Frame: 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) ] [ Designated as safety issue: No ]
Number of days fasted during the Ramadan fasting period [ Time Frame: 1 month ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks) ] [ Designated as safety issue: Yes ]


Enrollment:	557
Study Start Date:	January 2013
Study Completion Date:	September 2013
Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vildagliptin + placebo to Gliclazide Vildagliptin tablets will be given at 50mg twice daily (bid). Placebo to Gliclazide capsules will be given at an equivalent dose to previous sulfonylurea in multiples of 80mg only (80-320 mg/day). Patients will continue their open-label metformin therapy at dosage between 1500-2500 mg daily.	Drug: Vildagliptin Patients will be instructed to take Vildagliptin tablets at a fixed dose of 50 mg twice daily (double blind therapy) Other Name: Galvus Drug: Metformin Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion Drug: 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)
Active Comparator: Gliclazide + placebo to Vildagliptin Gliclazide capsules will be given in multiples of 80 mg (80-320 mg/day) at a dose equivalent to previous sulfonylurea dose, unless at the investigator's discretion it could be up-titrated to the next available dose (if HbA1c is higher than 7.5%). Placebo to Vildagliptin tablets will be given at 50mg twice daily (bid). Patients will continue their open-label metformin therapy at dosage between 1500-2500 mg daily.	Drug: Gliclazide Patients will be instructed to take Gliclazide capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy) Drug: Metformin Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion Drug: 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).

Arms

Assigned Interventions

Experimental: Vildagliptin + placebo to Gliclazide

Vildagliptin tablets will be given at 50mg twice daily (bid). Placebo to Gliclazide capsules will be given at an equivalent dose to previous sulfonylurea in multiples of 80mg only (80-320 mg/day). Patients will continue their open-label metformin therapy at dosage between 1500-2500 mg daily.

Drug: Vildagliptin

Patients will be instructed to take Vildagliptin tablets at a fixed dose of 50 mg twice daily (double blind therapy)

Other Name: Galvus

Drug: Metformin

Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion

Drug: 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)

Active Comparator: Gliclazide + placebo to Vildagliptin

Gliclazide capsules will be given in multiples of 80 mg (80-320 mg/day) at a dose equivalent to previous sulfonylurea dose, unless at the investigator's discretion it could be up-titrated to the next available dose (if HbA1c is higher than 7.5%). Placebo to Vildagliptin tablets will be given at 50mg twice daily (bid). Patients will continue their open-label metformin therapy at dosage between 1500-2500 mg daily.

Drug: Gliclazide

Patients will be instructed to take Gliclazide capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy)

Drug: Metformin

Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion

Drug: 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).

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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"

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758380

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Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators


Study Director:	Novartis Pharma AG	Novartis Pharmaceuticals

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01758380 History of Changes
Other Study ID Numbers:	CLAF237A2411 2011-005499-41
Study First Received:	December 24, 2012
Last Updated:	October 16, 2013
Health Authority:	Denmark: Danish Health and Medicines Authority Egypt: Egyptian Drug Authority Germany: BfArm India: Ministry of Health and Family Welfare Indonesia: Ministry of Health (MoH) Jordan: Ministry of Health (MoH) Kuwait: Ministry of Health (MoH) Lebanon: Ministry of Public Health Malaysia: Ministry of Health (MoH) Russia: Ministry of Health (MoH) Saudi Arabia: Ministry of Health (MoH) Singapore: HSA Spain: Spanish Agency for Medicines and Health Products Tunisia: Ministry of Public Health Turkey: Ministry of Health (MoH) UAE: Ministry of Health (MoH) United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:


Type 2 Diabetes Mellitus Ramadan Vildagliptin Hypoglycemia

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vildagliptin Metformin	Gliclazide Hypoglycemic Agents Physiological Effects of Drugs Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 23, 2016

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