Indian Sub-analysis of DIA-RAMADAN Study: Gliclazide XR 60 mg found safe, effective in blood sugar management during Ramadan
New Delhi: Gliclazide XR 60 mg given to type 2 diabetes (T2D) patients during Ramadan fast helped in a significant reduction of blood sugar levels and body weight without causing hypoglycemia, the recent Indian data based on the real-world study has pointed out. This implies that Indian patients with T2D can continue to take gliclazide while still maintaining optimal blood sugar levels during Ramadan fast.
Ramadan is a period of religious fasting observed by Muslims. As the intake of oral antidiabetic drugs is forbidden during daylight in Ramadan fast, optimal glycemic control becomes challenging for T2D patients. In this scenario, a treatment that allows the stabilization of blood glucose levels while carrying a low risk of hypoglycemia during fasting is highly valuable.
DIA-RAMADAN study was a prospective, observational, global study funded by Servier that assessed the real-world safety and effectiveness of gliclazide XR 60 mg in T2D patients fasting during Ramadan. DIA-RAMADAN enrolled 1214 patients in 9 countries (Bangladesh, Egypt, India, Indonesia, Kuwait, Malaysia, Pakistan, Saudi Arabia & United Arab Emirates). The highest number of participants from a country were that from India, which included 246 participants.
Study outcomes included the proportion of patients reporting ≥1 symptomatic hypoglycemic events, changes in HbA1c, fasting plasma glucose (FPG), bodyweight & safety.
The global study results have been published. Given the high number of participants from India as well as the importance of Ramadan in the country, Dr Shehla Shaikh, Saifee Hospital, Mumbai, from India and colleagues, conducted a sub-analysis of DIA-RAMADAN study to explore the safety & effectiveness of gliclazide XR 60 mg in Indian patients.
The same was presented as a poster at the recent European Association for the Study of Diabetes (EASD) 2020 Virtual Meeting.
" When we were using the earlier conventional medication, we would simply ask our patients not to fast during Ramadan but slowly with newer medications which are causing less hypoglycemia and medicines with potentially fewer side effects, we have been allowing our patients to fast. Also, there are many patients which despite our advice continue to observe the fasts. Hence, we need to make fasting more safer for our patients," Dr Shela Shaikh, Lead investigator of the sub-analysis informed Medical Dialogues team
"This entire study was done with a background of a molecule, Gliclazide, which has been there for a very long time and which is being used in patients during Ramadan," she added
The sub-analysis included 246 Indian patients of the DIA-RAMADAN study (mean age 53.0 years; mean duration of diabetes 5.8 years, and 45.5% were women). 194 patients (78.9%) were at moderate/low risk as defined by IDF-DAR guidelines. The average BMI was around 28
Adults with type 2 diabetes (aged >18 years) willing to fast during Ramadan, with HbA1C<9%, already treated with gliclazide XR 60 mg for at least 90 days prior to enrolment were included in the analysis
Those requiring Insulin therapy requirement or having HbA1c ≥9%, severe liver or renal failure, contraindication to gliclazide according to SmPC, pregnancy or breastfeeding, or having previous experience of severe or repeated hypoglycemia events without triggered factor within the previous year were excluded.
These patients were treated with gliclazide XR 60 mg. Baseline visit was conducted 6-8 weeks before Ramadan end-of-study visit was 4-6 weeks after Ramadan. Study outcomes included the proportion of patients reporting ≥1 symptomatic hypoglycemic events, changes in HbA1c, fasting plasma glucose (FPG), bodyweight & safety.
At baseline, mean HbA1c was 7.3±0.8%; 69% of the patients were on gliclazide XR as monotherapy, 22% on gliclazide XR + metformin & 9.3% on gliclazide XR + other antidiabetic with/without metformin.
Patients observed fast for 29.1±1.7 days, & for 13.9±1.9 hours/day. Gliclazide XR treatment was received as per the prescription by 240 (97.6%) patients during Ramadan.
The authors observed the following results
- Mean HbA1c reduced from 7.3 ± 0.8% at baseline to 6.9 ± 0.8%
- Proportion of patients achieving target HbA1c increased from 48.4% at baseline to 89.6% after Ramadan. Reduction in HbA1c level was consistent across the age groups
- Similarly, FPG levels reduced from 142.7 ± 53 mg/dL at baseline to 122.3 ± 29 mg/dL
- Patient's weight was also significantly reduced between visit V0 and V1
- No hypoglycemic event was reported during the study in the Indian sub-group
The authors noted that overall, the efficacy and safety of gliclazide XR in Indian patients were similar to that in the global DIA-RAMADAN cohort. Gliclazide XR significantly reduced HbA1c with no incidence of hypoglycemic event in Indian patients with type 2 diabetes during Ramadan fasting suggesting it can be used without dose modification at Iftar to maintain optimal glycemic control during Ramadan
" The main aim of the study was to ascertain how safe and efficacious Gliclazide XR was in Indian patients and it showed that you can continue using the medication during Ramadan - you don't need change the dose or stop the medication during Ramadan. The only thing you need to do is to change the timing of the medicine to Iftaar," explained Dr Shaikh
"The results were pleasantly surprising as in the Indian subset there was no hypoglycemia reported in the Indian subset. Also, apart from that, maybe because patients were given focused care during the study, their fasting blood sugar also reduced and there was also a weight reduction was 0.5 kg," she further added
"Our results indicate that gliclazide XR 60 mg based treatment significantly reduced HbA1c, FPG & weight in patients observing Ramadan fast, with no reported hypoglycemic event, suggesting that Indian patients with T2D on gliclazide XR 60 mg can safely fast while maintaining optimal glycemic control during Ramadan," concluded the authors.
Note: Global study was conducted with Gliclazide MR, available as gliclazide XR in India.. SmPC- Summary of Product Characteristics, XR- Extended release,FPG – Fasting plasma glucose, BMI – Body Mass Index, HbA1c – glycated hemoglobin