A real-world study in patients with type 2 diabetes mellitus treated with gliclazide modified-release during fasting: DIA-RAMADAN.
Diabetes Res Clin Pract
; 163: 108154, 2020 May.
Article
in En
| MEDLINE
| ID: mdl-32330510
ABSTRACT
AIMS:
To explore the real-world safety and effectiveness of gliclazide modified release (MR) in patients with type 2 diabetes mellitus (T2DM) fasting during Ramadan.METHODS:
DIA-RAMADAN (NCT04132934) was a prospective, international, observational study conducted in nine countries. Patients >18 years of age with T2DM (N = 1244) were examined at an inclusion visit (V0) occurring 6-8 weeks before the start of Ramadan. Patients received a diary to report treatment changes, hypoglycaemic events (HEs), and other adverse events. Gliclazide MR was taken once daily for 14-18 weeks. A second visit (V1) was conducted 4-6 weeks after the end of Ramadan. The primary endpoint was the proportion of patients reporting ≥1 symptomatic HE. Changes in HbA1c, fasting plasma glucose (FPG), and body weight were secondary endpoints.RESULTS:
The proportion of patients reporting ≥1 symptomatic HE during Ramadan was low (2.2%) with no reported severe HEs. There was a significant reduction in HbA1c (-0.3%), FPG (-9.7 mg/dL), body weight (-0.5 kg) and body mass index (-0.2 kg/m2) between V0 and V1 (p < 0.001).CONCLUSIONS:
Patients with T2DM treated with gliclazide MR during Ramadan have a low risk of hypoglycaemia and maintain glycaemic control and weight while fasting.Key words
Full text:
1
Database:
MEDLINE
Main subject:
Fasting
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Diabetes Mellitus, Type 2
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Gliclazide
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Hypoglycemic Agents
Type of study:
Observational_studies
/
Risk_factors_studies
Limits:
Aged
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Female
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Humans
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Male
/
Middle aged
Language:
En
Journal:
Diabetes Res Clin Pract
Journal subject:
ENDOCRINOLOGIA
Year:
2020
Type:
Article