Study S000235

Variability of Glucose Assessed in a Randomized Trial Comparing the Initiation of A Treatment Approach With Biosimilar Basal Insulin Analog Or a Titratable iGlarLixi combinatioN in Type 2 Diabetes Among South Asian Subjects (VARIATION 2 SA Trial)

ClinicalTrials.gov record

Registration

Registration: NCT03819790
Acronym: VARIATION 2 SA
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: NONE
Status: COMPLETED
Enrollment: 119
Start: 2018-10-02
Primary completion: 2019-11-19
Lead sponsor: LMC Diabetes & Endocrinology Ltd.
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Basal insulin glargine and lixisenatide; DRUG:Basal insulin Basaglar/Lantus + gliclazide MR; DRUG:Metformin
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Time in range at week 13 [7 days]
Time in range within 12-hours (6 AM -6 PM) at week 13 [7 days]

Linked records (10)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0018032	Randomized Comparison of Initiating the Fixed-Ratio Combination of iGlarLixi or Biosimilar Insulin Glargine Together With Gliclazide in Participants of South Asian Origin With Type 2 Diabetes: VARIATION 2 SA Trial. Bajaj HS, Canadian journal of diabetes	2022	Randomized trial	PMID 35752566 DOI	cites ClinicalTrials.gov:NCT03819790; registry reference DERIVED:35752566
R0010249	[Not Available]. Leiter LA, Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association	2017	Other trial	PMID 28724168 DOI	registry reference BACKGROUND:28724168
R0013267	Lowest Glucose Variability and Hypoglycemia Are Observed With the Combination of a GLP-1 Receptor Agonist and Basal Insulin (VARIATION Study). Bajaj HS, Diabetes care	2017	Nonrandomized study	PMID 27913575 DOI	registry reference BACKGROUND:27913575
R0044409	Randomized Comparison of initiating insulin Glargine or Iglarlixi in South Asian Subjects With T2D : Variation 2 Sa Trial Chu, Lisa, BiblioBoard Library Catalog (Open Research Library)	2017	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03819790
R0007707	Benefits and Harms of Once-Weekly Glucagon-like Peptide-1 Receptor Agonist Treatments: A Systematic Review and Network Meta-analysis. Zaccardi F, Annals of internal medicine	2016	Systematic review	PMID 26642233 DOI	registry reference BACKGROUND:26642233
R0016788	Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes. Diamant M, Diabetes care	2014	Randomized trial	PMID 25011946 DOI	registry reference BACKGROUND:25011946
R0018442	Combating the dual burden: therapeutic targeting of common pathways in obesity and type 2 diabetes. Scheen AJ, The lancet. Diabetes & endocrinology	2014	Narrative review	PMID 24731666 DOI	registry reference BACKGROUND:24731666
R0020558	Advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents: a comparison of adding albiglutide, a weekly GLP-1 receptor agonist, versus thrice-daily prandial insulin lispro. Rosenstock J, Diabetes care	2014	Randomized trial	PMID 24898300 DOI	registry reference BACKGROUND:24898300
R0025482	Effect of intravenous infusion of exenatide (synthetic exendin-4) on glucose-dependent insulin secretion and counterregulation during hypoglycemia. Degn KB, Diabetes	2004	Randomized trial	PMID 15331551 DOI	registry reference BACKGROUND:15331551
R0026486	One week's treatment with the long-acting glucagon-like peptide 1 derivative liraglutide (NN2211) markedly improves 24-h glycemia and alpha- and beta-cell function and reduces endogenous glucose release in patients with type 2 diabetes. Degn KB, Diabetes	2004	Randomized trial	PMID 15111485 DOI	registry reference BACKGROUND:15111485