Journal Article

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

Abdallah, Khalifa, Schweizer, Anja, Hassanein, Mohamed

2014

Overview

Several observational studies were conducted with vildagliptin in patients with type 2 diabetes mellitus (T2DM) fasting during Ramadan, showing significantly lower incidences of hypoglycemia with vildagliptin versus sulfonylureas, including gliclazide. It was of interest to complement the existing real-life evidence with data from a randomized, double-blind, clinical trial. NCT01758380. This multiregional, double-blind study randomized 557 patients with T2DM (mean glycated hemoglobin [HbA1c], 6.9%), previously treated with metformin and any sulfonylurea to receive either vildagliptin (50 mg twice daily) or gliclazide plus metformin. The study included four office visits (three pre-Ramadan) and multiple telephone contacts, as well as Ramadan-focused advice. Hypoglycemic events were assessed during Ramadan; HbA(1c) and weight were analyzed before and after Ramadan. The proportion of patients reporting confirmed (<3.9 mmol/L and/or severe) hypoglycemic events during Ramadan was 3.0% with vildagliptin and 7.0% with gliclazide (P=0.039; one-sided test), and this was 6.0% and 8.7%, respectively, for any hypoglycemic events (P=0.173). The adjusted mean change pre- to post-Ramadan in HbA(1c) was 0.05%±0.04% with vildagliptin and -0.03%±0.04% with gliclazide, from baselines of 6.84% and 6.79%, respectively (P=0.165). In both groups, the adjusted mean decrease in weight was -1.1±0.2 kg (P=0.987). Overall safety was similar between the treatments. In line with the results from previous observational studies, vildagliptin was shown in this interventional study to be an effective, safe, and well-tolerated treatment in patients with T2DM fasting during Ramadan, with a consistently low incidence of hypoglycemia across studies, accompanied by good glycemic and weight control. In contrast, gliclazide showed a lower incidence of hypoglycemia in the present interventional than the previous observational studies. This is suggested to be linked to the specific circumstances of this study, including frequent patient-physician contacts, Ramadan-focused advice, a recent switch in treatment, and very well-controlled patients, which is different from what is often seen in real life.

• Publisher: Dove Medical Press Limited,Taylor & Francis Ltd,Dove Press,Dove Medical Press
• Subject: Adamantane - adverse effects / Adamantane - analogs & derivatives / Adamantane - therapeutic use / Asia / Biomarkers - blood / Blood Glucose - drug effects / Blood Glucose - metabolism / Body Weight - drug effects / Clinical trials / Counseling / Diabetes / Diabetes Mellitus, Type 2 - blood / Diabetes Mellitus, Type 2 - diagnosis / Diabetes Mellitus, Type 2 - drug therapy / dipeptidyl peptidase 4 / Dipeptidyl-Peptidase IV Inhibitors - adverse effects / Dipeptidyl-Peptidase IV Inhibitors - therapeutic use / Dosage and administration / Double-Blind Method / Double-blind studies / Drug therapy / Europe / Evidence-based medicine / Fasting / Fasting - blood / Female / Gliclazide / Gliclazide - adverse effects / Gliclazide - therapeutic use / Glucose / Glycated Hemoglobin A / Health aspects / Humans / Hypoglycemia / Hypoglycemia - blood / Hypoglycemia - chemically induced / Hypoglycemic Agents - adverse effects / Hypoglycemic Agents - therapeutic use / incretin / Insulin resistance / Islam / Male / Medication Adherence / Middle Aged / Middle East / Muslims / Nitriles - adverse effects / Nitriles - therapeutic use / Office Visits / Original Research / Patient outcomes / Patients / Physician-patient relations / Pyrrolidines - adverse effects / Pyrrolidines - therapeutic use / Ramadan / Religion and Medicine / Religious aspects / Telephone / Time Factors / Treatment Outcome / Type 2 diabetes / type 2 diabetes mellitus