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Indonesia DIA-RAMADAN Study: A Real-life, Prospective and Observational of Gliclazide MR in Type-2 Diabetes Patients During Ramadan Fasting

ACTA MEDICA INDONESIANA · Vol. 54 No. 1 (2022)

ISSN
2338-2732, 0125-9326
Terbit
2022-04-08
Penerbit
The Indonesian Society of Internal Medicine
Bahasa
eng

Abstrak

Background: Sulfonylureas (SUs) have been widely used in many countries for T2DM treatment. Gliclazide is one of the SUs with the lowest risk of hypoglycemia; however, the safety and effectiveness of gliclazide MR during Ramadan has not yet been reported in Indonesia. This study aimed to assess safety, efficacy, and tolerability of gliclazide modified release (MR) during Ramadan fasting. Methods: The study was a part of DIA-RAMADAN study, a prospective observational study with subjects of T2DM patients aged >18 years, who had either controlled or sub-optimally controlled blood glucose level, performed Ramadan fasting. Subjects had been treated with gliclazide MR for at least 90 days prior the study, and were examined for their body mass index (BMI), fasting plasma glucose (FPG) and HbA1c levels 6 to 8 weeks before Ramadan (V0) and 4 to 6 weeks after the end of Ramadan (V1). Results: Out of 198 subjects participating in the study, there were only two subjects (1.0%) who reported symptomatic HEs (either confirmed or not confirmed) and no severe HEs had been reported. There were no significant changes in HbA1c and FPG levels (p>0.05). Interestingly, there was a reduction of bodyweight (-0.4kg) from pre- to post-Ramadan (p < 0.001). Almost no subjects reported discontinuation of gliclazide MR throughout the entire study; however, there was one subject who reported a change of diabetic treatment into diet only. Conclusion: gliclazide MR is safe, well tolerated and can maintain glycemic control effectively for Indonesian patients with T2DM who perform Ramadan fasting.

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Sumber metadata: OAI-PMH (metadata jurnal) http://www.actamedindones.org/index.php/ijim/oai, pertama di-harvest 8 Nov 2026, terakhir terlihat 8 Nov 2026.
Metadata asli (oai_dc) 
<oai_dc:dc xmlns="http://www.openarchives.org/OAI/2.0/" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:oai_dc="http://www.openarchives.org/OAI/2.0/oai_dc/" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://www.openarchives.org/OAI/2.0/oai_dc/  http://www.openarchives.org/OAI/2.0/oai_dc.xsd">
	<dc:title xml:lang="en-US">Indonesia DIA-RAMADAN Study: A Real-life, Prospective and Observational of Gliclazide MR in Type-2 Diabetes Patients During Ramadan Fasting</dc:title>
	<dc:creator>Soelistijo, Soebagijo Adi</dc:creator>
	<dc:creator>Aman, Andi Makbul</dc:creator>
	<dc:creator>Zufry, Hendra</dc:creator>
	<dc:creator>Pranoto, Agung</dc:creator>
	<dc:creator>Rudijanto, Achmad</dc:creator>
	<dc:creator>Hassanien, Mohamed</dc:creator>
	<dc:subject xml:lang="en-US">type 2 diabetes mellitus</dc:subject>
	<dc:subject xml:lang="en-US">diabetes mellitus</dc:subject>
	<dc:subject xml:lang="en-US">gliclazide MR</dc:subject>
	<dc:subject xml:lang="en-US">DIA-RAMADAN</dc:subject>
	<dc:subject xml:lang="en-US">Indonesia</dc:subject>
	<dc:subject xml:lang="en-US">Dibetes mellitus</dc:subject>
	<dc:description xml:lang="en-US">Background: Sulfonylureas (SUs) have been widely used in many countries for T2DM treatment. Gliclazide is one of the SUs with the lowest risk of hypoglycemia; however, the safety and effectiveness of gliclazide MR during Ramadan has not yet been reported in Indonesia. This study aimed to assess safety, efficacy, and tolerability of gliclazide modified release (MR) during Ramadan fasting. Methods: The study was a part of DIA-RAMADAN study, a prospective observational study with subjects of T2DM patients aged &amp;gt;18 years, who had either controlled or sub-optimally controlled blood glucose level, performed Ramadan fasting. Subjects had been treated with gliclazide MR for at least 90 days prior the study, and were examined for their body mass index (BMI), fasting plasma glucose (FPG) and HbA1c levels 6 to 8 weeks before Ramadan (V0) and 4 to 6 weeks after the end of Ramadan (V1). Results: Out of 198 subjects participating in the study, there were only two subjects (1.0%) who reported symptomatic HEs (either confirmed or not confirmed) and no severe HEs had been reported. There were no significant changes in HbA1c and FPG levels (p&amp;gt;0.05). Interestingly, there was a reduction of bodyweight (-0.4kg) from pre- to post-Ramadan (p &amp;lt; 0.001). Almost no subjects reported discontinuation of gliclazide MR throughout the entire study; however, there was one subject who reported a change of diabetic treatment into diet only. Conclusion: gliclazide MR is safe, well tolerated and can maintain glycemic control effectively for Indonesian patients with T2DM who perform Ramadan fasting.</dc:description>
	<dc:publisher xml:lang="en-US">The Indonesian Society of Internal Medicine</dc:publisher>
	<dc:date>2022-04-08</dc:date>
	<dc:type>info:eu-repo/semantics/article</dc:type>
	<dc:type>info:eu-repo/semantics/publishedVersion</dc:type>
	<dc:type xml:lang="en-US">a prospective and observational study</dc:type>
	<dc:format>application/pdf</dc:format>
	<dc:identifier>http://www.actamedindones.org/index.php/ijim/article/view/1758</dc:identifier>
	<dc:source xml:lang="en-US">Acta Medica Indonesiana; Vol. 54 No. 1 (2022): Acta Medica Indonesiana; 3</dc:source>
	<dc:source>2338-2732</dc:source>
	<dc:source>0125-9326</dc:source>
	<dc:language>eng</dc:language>
	<dc:relation>http://www.actamedindones.org/index.php/ijim/article/view/1758/pdf</dc:relation>
	<dc:rights xml:lang="en-US">Copyright (c) 2022 Acta Medica Indonesiana</dc:rights>
</oai_dc:dc>