Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan (STEADFAST)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01758380
First received: December 24, 2012
Last updated: October 16, 2013
Last verified: October 2013
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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:
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).
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01758380
Show 68 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758380
Show 68 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharma AG | Novartis Pharmaceuticals |
More Information
No publications provided by Novartis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis ( 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, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Gliclazide Metformin Vildagliptin |
Dipeptidyl-Peptidase IV Inhibitors Enzyme Inhibitors Hypoglycemic Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Protease Inhibitors |
ClinicalTrials.gov processed this record on March 03, 2015