Safety and Effectiveness of Concomitant iGlarLixi and SGLT-2i Use in People with T2D During Ramadan Fasting: A SoliRam Study Sub-analysis

Abstract

Introduction: The aim of this work was to assess the safety and effectiveness of concomitant iGlarLixi and sodium-glucose co-transporter-2 inhibitors (SGLT-2i) use in adults with type 2 diabetes (T2D) who fasted during Ramadan.

Methods: Of the 420 eligible participants from the SoliRam study, 174 were using SGLT-2i in addition to iGlarLixi and 246 were not using SGLT-2i, referred to as SGLT-2i user and non-user, respectively. The primary endpoint was the proportion of participants experiencing ≥ 1 severe and/or symptomatic documented (< 70 mg/dl [< 3.9 mmol/l]) hypoglycemia.

Results: More than 50% of participants in both groups were male. The mean weight, glycated hemoglobin (HbA1c), and fasting plasma glucose (FPG) were similar in both groups. Approximately half of participants in the SGLT-2i-user group and ~ 25% participants in the SGLT-2i-non-user group were on two oral anti-hyperglycemic drugs (OADs), whereas ~ 20% in the SGLT-2i-user group and ~ 1% of participants in the SGLT-2i-non-user group were on three OADs in addition to iGlarLixi. Around 35% and 55% of participants in the SGLT-2i-user and SGLT-2i-non-user groups, respectively, were taking concurrent sulphonylureas. About 97% of participants in both groups were able to fast for ≥ 25 days. The incidence of primary endpoint was low in both groups; SGLT-2i user: 0.6%, 4.2%, and 0.6% and SGLT-2i-non-user: 1.3%, 0.9% and 0% during pre-Ramadan, Ramadan, and post-Ramadan period, respectively. The incidence of severe and/or symptomatic documented (< 54 mg/dl [< 3.0 mmol/l]) hypoglycemia events was also low throughout the study, including during Ramadan. No severe hypoglycemia occurred during Ramadan in either group. Improvements in HbA1c and FPG, with a small reduction in weight, were observed from pre- to post-Ramadan in both groups. No serious adverse event was reported in either group.

Conclusions: Concomitant iGlarLixi and SGLT-2i therapy with or without other OADs was demonstrated to be safe in adults with T2D during Ramadan fast, with a low risk of hypoglycemia and improvements in glycemic outcomes.

Keywords: Fasting; Hypoglycemia; Ramadan; SGLT-2i; Type 2 diabetes; iGlarLixi.

Fig. 1

Proportion of participants with severe and/or symptomatic documented hypoglycemia: A < 70 mg/dl (< 3.9 mmol/l) and B < 54 mg/dl (< 3.0 mmol/l). *Last month of pre-Ramadan. ^†First month of post-Ramadan. The analysis included eligible population, defined as all participants included in the study who met the inclusion criteria and did not meet exclusion criteria. CI confidence interval, n number of participants reporting hypoglycemia event, N total number of participants, NA not applicable, SGLT-2i sodium-glucose co-transporter-2 inhibitor

Fig. 2

Change in A HbA1c (%), B FPG (mg/dl), C SMPG (mg/dl), and D weight (kg) from the pre-Ramadan to the post-Ramadan period. ^*SGLT-2i user, n = 171 and SGLT-2i-non-user, n = 245. ^†SGLT-2i user, n = 141 and SGLT-2i-non-user, n = 215. The analysis included the evaluable population, defined as all participants who had glycemic endpoint for both pre-Ramadan and post-Ramadan periods (HbA1c, FPG, and fasting SMPG). CI confidence interval, FPG fasting plasma glucose, HbA1c glycated hemoglobin, SMPG self-monitoring of plasma glucose, SD standard deviation, SGLT-2i sodium-glucose co-transporter-2 inhibitor