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.

Abstract

BACKGROUND:

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.

CLINICAL TRIALS IDENTIFIER:

NCT01758380.

METHODS:

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.

RESULTS:

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.

CONCLUSION:

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.

• Authors: Mohamed Hassanein, Khalifa Abdallah, Anja Schweizer
• Journal: Vascular health and risk management (Vasc Health Risk Manag) Vol. 10 Pg. 319-26 ( 2014) ISSN: 1178-2048 [Electronic] New Zealand
• PMID: 24920915 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Biomarkers
• Blood Glucose
• Dipeptidyl-Peptidase IV Inhibitors
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Nitriles
• Pyrrolidines
• hemoglobin A1c protein, human
• Gliclazide
• Vildagliptin
• Adamantane

Topics

• Adamantane (adverse effects, analogs & derivatives, therapeutic use)
• Asia
• Biomarkers (blood)
• Blood Glucose (drug effects, metabolism)
• Body Weight (drug effects)
• Counseling
• Diabetes Mellitus, Type 2 (blood, diagnosis, drug therapy)
• Dipeptidyl-Peptidase IV Inhibitors (adverse effects, therapeutic use)
• Double-Blind Method
• Europe
• Fasting (blood)
• Female
• Gliclazide (adverse effects, therapeutic use)
• Glycated Hemoglobin
• Humans
• Hypoglycemia (blood, chemically induced)
• Hypoglycemic Agents (adverse effects, therapeutic use)
• Islam
• Male
• Medication Adherence
• Middle Aged
• Middle East
• Nitriles (adverse effects, therapeutic use)
• Office Visits
• Pyrrolidines (adverse effects, therapeutic use)
• Religion and Medicine
• Telephone
• Time Factors
• Treatment Outcome
• Vildagliptin