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Safety of lixisenatide plus basal insulin treatment regimen in Indian people with type 2 diabetes mellitus during Ramadan fast: A post hoc analysis of the LixiRam randomized trial.
Diabetes Res Clin Pract. 2020 May; 163:108148.DR

Abstract

AIMS

Hypoglycemia is one of the most important complications associated with Ramadan fasting in people with type 2 diabetes. LixiRam (NCT02941367) was the first randomized trial comparing safety and efficacy of lixisenatide + basal insulin (BI) vs. sulphonylurea + BI in people with type 2 diabetes who fast during Ramadan. This post hoc analysis focuses on the LixiRam study population from India.

METHODS

Adults with type 2 diabetes insufficiently controlled with sulphonylurea + BI ± another oral anti-hyperglycemic drug were randomized 1:1 to receive lixisenatide + BI or to continue sulphonylurea + BI treatment.

RESULTS

In total, 150 participants were randomized in India. One participant (1.3%) with lixisenatide + BI vs. 5 participants (6.8%) with sulphonylurea + BI experienced ≥1 documented symptomatic hypoglycemic event during the Ramadan fast (odds ratio [OR]: 0.22; 95% confidence interval [CI]: 0.02-1.93). Incidence of any hypoglycemia was numerically lower with lixisenatide + BI vs. sulphonylurea + BI during Ramadan fasting (1.3% [1/75] vs. 14.7% [11/75], respectively; OR: 0.09; 95% CI: 0.01-0.69). No new safety signals were identified.

CONCLUSIONS

A combination of lixisenatide prandial GLP1-RA + BI may be a suitable treatment option for people with type 2 diabetes who elect to fast during Ramadan. Clinical Trial Registry: clinicaltrials.gov (NCT02941367).

Authors+Show Affiliations

Department of Endocrinology, Osmania Medical College, Hyderabad, India. Electronic address: sahayrk@gmail.com.Rashid Hospital, Dubai, United Arab Emirates.Sanofi, Paris, France.Sanofi, Paris, France.American University of Beirut Medical Center, Beirut, Lebanon.Rambam Medical Center, Haifa, Israel.University Hospital Birmingham, Birmingham, UK.Dubai Hospital, Dubai, United Arab Emirates.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

32302665

Citation

Sahay, Rakesh, et al. "Safety of Lixisenatide Plus Basal Insulin Treatment Regimen in Indian People With Type 2 Diabetes Mellitus During Ramadan Fast: a Post Hoc Analysis of the LixiRam Randomized Trial." Diabetes Research and Clinical Practice, vol. 163, 2020, p. 108148.
Sahay R, Hafidh K, Djaballah K, et al. Safety of lixisenatide plus basal insulin treatment regimen in Indian people with type 2 diabetes mellitus during Ramadan fast: A post hoc analysis of the LixiRam randomized trial. Diabetes Res Clin Pract. 2020;163:108148.
Sahay, R., Hafidh, K., Djaballah, K., Coudert, M., Azar, S., Shehadeh, N., Hanif, W., & Hassanein, M. (2020). Safety of lixisenatide plus basal insulin treatment regimen in Indian people with type 2 diabetes mellitus during Ramadan fast: A post hoc analysis of the LixiRam randomized trial. Diabetes Research and Clinical Practice, 163, 108148. https://doi.org/10.1016/j.diabres.2020.108148
Sahay R, et al. Safety of Lixisenatide Plus Basal Insulin Treatment Regimen in Indian People With Type 2 Diabetes Mellitus During Ramadan Fast: a Post Hoc Analysis of the LixiRam Randomized Trial. Diabetes Res Clin Pract. 2020;163:108148. PubMed PMID: 32302665.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety of lixisenatide plus basal insulin treatment regimen in Indian people with type 2 diabetes mellitus during Ramadan fast: A post hoc analysis of the LixiRam randomized trial. AU - Sahay,Rakesh, AU - Hafidh,Khadijah, AU - Djaballah,Khier, AU - Coudert,Mathieu, AU - Azar,Sami, AU - Shehadeh,Naim, AU - Hanif,Wasim, AU - Hassanein,Mohamed, Y1 - 2020/04/14/ PY - 2020/02/11/received PY - 2020/04/04/accepted PY - 2020/4/18/pubmed PY - 2020/8/1/medline PY - 2020/4/18/entrez KW - Basal insulin KW - Hypoglycemia KW - India KW - Lixisenatide KW - Ramadan KW - Type 2 diabetes mellitus SP - 108148 EP - 108148 JF - Diabetes research and clinical practice JO - Diabetes Res. Clin. Pract. VL - 163 N2 - AIMS: Hypoglycemia is one of the most important complications associated with Ramadan fasting in people with type 2 diabetes. LixiRam (NCT02941367) was the first randomized trial comparing safety and efficacy of lixisenatide + basal insulin (BI) vs. sulphonylurea + BI in people with type 2 diabetes who fast during Ramadan. This post hoc analysis focuses on the LixiRam study population from India. METHODS: Adults with type 2 diabetes insufficiently controlled with sulphonylurea + BI ± another oral anti-hyperglycemic drug were randomized 1:1 to receive lixisenatide + BI or to continue sulphonylurea + BI treatment. RESULTS: In total, 150 participants were randomized in India. One participant (1.3%) with lixisenatide + BI vs. 5 participants (6.8%) with sulphonylurea + BI experienced ≥1 documented symptomatic hypoglycemic event during the Ramadan fast (odds ratio [OR]: 0.22; 95% confidence interval [CI]: 0.02-1.93). Incidence of any hypoglycemia was numerically lower with lixisenatide + BI vs. sulphonylurea + BI during Ramadan fasting (1.3% [1/75] vs. 14.7% [11/75], respectively; OR: 0.09; 95% CI: 0.01-0.69). No new safety signals were identified. CONCLUSIONS: A combination of lixisenatide prandial GLP1-RA + BI may be a suitable treatment option for people with type 2 diabetes who elect to fast during Ramadan. Clinical Trial Registry: clinicaltrials.gov (NCT02941367). SN - 1872-8227 UR - https://www.unboundmedicine.com/medline/citation/32302665/Safety_of_lixisenatide_plus_basal_insulin_treatment_regimen_in_Indian_people_with_type_2_diabetes_mellitus_during_Ramadan_fast:_A_post_hoc_analysis_of_the_LixiRam_randomized_trial L2 - https://linkinghub.elsevier.com/retrieve/pii/S0168-8227(20)30398-3 DB - PRIME DP - Unbound Medicine ER -