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VARIATION 2 SA

CompletedPhase 4

The Effect of Soliqua on Glucose Variability in Type 2 Patients Among South Asians

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)

Lead sponsor

LMC Diabetes & Endocrinology Ltd.

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

119

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 20-40•HbA1c 7.1-11%•eGFR ≥30

Primary endpoint

•CGM time-in-range

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03819790

Org study IDVARIATION 2 SA

Timeline

Milestones

Study start2018-10-02actual

Study first posted2019-01-29actual

Primary completion2019-11-19actual

Study completion2019-11-19actual

Last update posted2021-02-25actual

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male and female adults with clinical diagnosis of T2DM diagnosed at least 1 year before screening and in stable health as assessed by investigator

•Age between 18 and 80 years (inclusive)

•Body mass index (BMI) between 20-40 kg/m2 (inclusive)

•South Asian origin including Afghanistani, Bangladeshi, Indian, Nepali, Pakistani and Sri Lankan. This includes those patients who identify themselves as South Asian origin because their ancestors moved from South Asian to another country (e.g. Caribbean islands, Fiji, etc.)

•A1C in range of 7.1-11% (inclusive)

•Fasting glucose on self-monitoring of blood glucose (SMBG) or laboratory testing < 15 mmol/L within the last 30 days

•Insulin naïve, uncontrolled on oral hypoglycemic medications

•Kidney function assessment with eGFR >30 mL/min/1.73 m2

•Written informed consent obtained

Exclusion criteria

•History of insulin use (except emergency short-term use defined as less than 12 weeks for acute illness, hospitalization, pregnancy or with steroid use)

•Use of GLP-1 receptor agonist in the past 3 months

•Previous discontinuation of a GLP-1 receptor agonist due to safety, tolerability or lack of efficacy

•Pregnant or anticipating pregnancy

•Current use of steroid

•Currently on any supervised, intensive, weight-loss dietary or exercise program

•History of gastroparesis with moderate or higher severity

•History of pancreatitis

•Amylase and /or lipase more than three times the upper limit of normal or calcitonin ≥ 20 pg/mL (5.9 pmol/L)

•Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (MEN) syndrome

•Allergic reaction to insulin secretagogues

•History of weight loss surgery (bariatric bypass surgery or gastric banding)

•Inability to check SMBG or wear CGM

•History of severe liver disease or alcohol abuse

•Severe hypoglycemic reaction (defined as third-party or ambulance assistance or emergency department visit) within the last 3 months before screening visit

•Night-shift workers

•Patients who are recommended to achieve relaxed targets of A1C up to 8.5% by Diabetes Canada 2018 clinical practice guidelines

•Current enrollment in another intervention study

•Patients who miss ≥1 injections of Basaglar/Lantus or discontinue the CGM device or can not record carbohydrate intake correctly during the run-in phase

Endpoints (30)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Safety / tolerability / PK

Patient-reported / QoL

Weight & body composition

Other (unclassified)

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change in weight

Time frame:15 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:15 weeks

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

19 endpoints

Primary/protocol endpoint

Time in range at week 13

Time frame:7 days

CGM time-in-range

descriptive, improvement

Primary/protocol endpoint

Time in range within 12-hours (6 AM -6 PM) at week 13

Time frame:7 days

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Daily glucose standard deviation (SD) at week 13

Time frame:7 days

descriptive

Secondary/protocol endpoint

Overall SD of CGM glucose at week 13

Time frame:7 days

descriptive, improvement

Secondary/protocol endpoint

Mean of glucose at week 13

Time frame:7 days

descriptive, improvement

Secondary/protocol endpoint

Frequency of hyperglycemia at week 13

Time frame:7 days

CGM time-above-range

event count, improvement

Secondary/protocol endpoint

Time in hyperglycemia at week 13

Time frame:7 days

CGM time-above-range

descriptive, improvement

Secondary/protocol endpoint

Daily glucose standard deviation (SD) within 12 hours (6AM-6PM) at week 13

Time frame:7 days

descriptive, improvement

Secondary/protocol endpoint/low confidence

Overall SD of glucose within 12 hours (6AM-6PM) at week 13

Time frame:7 days

descriptive, improvement

Secondary/protocol endpoint/low confidence

Mean of glucose within 12 hours (6AM-6PM) at week 13

Time frame:7 days

descriptive, improvement

Secondary/protocol endpoint

Frequency of hyperglycemia within 12 hours (6AM-6PM) at week 13

Time frame:7 days

event count, event

Secondary/protocol endpoint

Time in hyperglycemia within 12 hours (6AM-6PM) at week 13

Time frame:7 days

CGM time-above-range

descriptive, improvement

Secondary/protocol endpoint

A1C mean at week 13

Time frame:Week 13

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Changes A1C

Time frame:15 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of A1C <7% at week 13

Time frame:Week 13

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of A1C <8% at week 13

Time frame:Week 13

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of patients who have A1C ≤ 7% with no hypoglycemia and no weight gain from baseline

Time frame:Week 13

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Documented hypoglycemia, Body weight, absolute change (kg)

LOINC 4548-4

Secondary/protocol endpoint

Proportion of patients who have A1C ≤ 7% with no hypoglycemia and weight gain <3% from baseline

Time frame:Week 13

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of patients who have fasting blood glucose ≤ 5.5 mmol/L without nocturnal hypoglycemia

Time frame:Week 13

threshold achievement, improvement

LOINC 1558-6

Patient-reported / QoL

3 endpoints

Secondary/protocol endpoint

Change in DiabMedSat Score

Time frame:14 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in HFS Score

Time frame:14 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

HCP treatment satisfaction score

Time frame:Week 13

descriptive, improvement

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Frequency of hypoglycemia at week 13

Time frame:7 days

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Time in hypoglycemia at week 13

Time frame:7 days

CGM time-below-range

descriptive, event

Secondary/protocol endpoint

Frequency of hypoglycemia within 12 hours (6AM-6PM) at week 13

Time frame:7 days

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Time in hypoglycemia within 12 hours (6AM-6PM) at week 13

Time frame:7 days

CGM time-below-range

descriptive, event

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Mean basal insulin dose at week 13

Time frame:Week 13

descriptive

Secondary/protocol endpoint/low confidence

Change in carbohydrate intake

Time frame:14 weeks

change from baseline, descriptive

Publications (22)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.
Canadian journal of diabetes2022 Jul (month)PMID35752566doi:10.1016/j.jcjd.2022.02.003via clinicaltrials gov reference derived + pubmed nct search
TITRATION: A Randomized Study to Assess 2 Treatment Algorithms with New Insulin Glargine 300 units/mL.
Canadian journal of diabetes2017 Oct (month)PMID28803820doi:10.1016/j.jcjd.2017.06.007via CT.gov background
Efficacy and Safety of GLP-1 Receptor Agonists Across the Spectrum of Type 2 Diabetes Mellitus.
Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association2017 Jul (month)PMID28724168doi:10.1055/s-0043-103969via CT.gov background
Trends in Drug Utilization, Glycemic Control, and Rates of Severe Hypoglycemia, 2006-2013.
Diabetes care2017 Apr (month)PMID27659408doi:10.2337/dc16-0985via CT.gov background
Lowest Glucose Variability and Hypoglycemia Are Observed With the Combination of a GLP-1 Receptor Agonist and Basal Insulin (VARIATION Study).
Diabetes care2017 Feb (month)PMID27913575doi:10.2337/dc16-1582via CT.gov background
Benefits and Harms of Once-Weekly Glucagon-like Peptide-1 Receptor Agonist Treatments: A Systematic Review and Network Meta-analysis.
Annals of internal medicine2016 Jan 19PMID26642233doi:10.7326/M15-1432via CT.gov background
Temporal trends in cardiovascular disease risk factors among white, South Asian, Chinese and black groups in Ontario, Canada, 2001 to 2012: a population-based study.
BMJ open2015 Aug 10PMID26260346doi:10.1136/bmjopen-2014-007232via CT.gov background
Association between 7 years of intensive treatment of type 1 diabetes and long-term mortality.
JAMA2015 Jan 6PMID25562265doi:10.1001/jama.2014.16107via CT.gov background
Glycemic control and excess mortality in type 1 diabetes.
The New England journal of medicine2014 Nov 20PMID25409370doi:10.1056/NEJMoa1408214via CT.gov background
Combating the dual burden: therapeutic targeting of common pathways in obesity and type 2 diabetes.
The lancet. Diabetes & endocrinology2014 Nov (month)PMID24731666doi:10.1016/S2213-8587(14)70004-Xvia CT.gov background
Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
Diabetes care2014 Oct (month)PMID25011946doi:10.2337/dc14-0876via CT.gov background
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.
Diabetes care2014 Aug (month)PMID24898300doi:10.2337/dc14-0001via CT.gov background
Body-mass index and mortality among adults with incident type 2 diabetes.
The New England journal of medicine2014 Jan 16PMID24428469doi:10.1056/NEJMoa1304501via CT.gov background
Type 2 diabetes in South Asians: similarities and differences with white Caucasian and other populations.
Annals of the New York Academy of Sciences2013 Apr (month)PMID23317344doi:10.1111/j.1749-6632.2012.06838.xvia CT.gov background
Comparison of cardiovascular risk profiles among ethnic groups using population health surveys between 1996 and 2007.
CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne2010 May 18PMID20403888doi:10.1503/cmaj.091676via CT.gov background
A1C variability and the risk of microvascular complications in type 1 diabetes: data from the Diabetes Control and Complications Trial.
Diabetes care2008 Nov (month)PMID18650371doi:10.2337/dc08-0864via CT.gov background
10-year follow-up of intensive glucose control in type 2 diabetes.
The New England journal of medicine2008 Oct 9PMID18784090doi:10.1056/NEJMoa0806470via CT.gov background
Effect of intravenous infusion of exenatide (synthetic exendin-4) on glucose-dependent insulin secretion and counterregulation during hypoglycemia.
Diabetes2004 Sep (month)PMID15331551doi:10.2337/diabetes.53.9.2397via CT.gov background
Regression of carotid atherosclerosis by control of postprandial hyperglycemia in type 2 diabetes mellitus.
Circulation2004 Jul 13PMID15197140doi:10.1161/01.CIR.0000134501.57864.66via CT.gov background
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.
Diabetes2004 May (month)PMID15111485doi:10.2337/diabetes.53.5.1187via CT.gov background
Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group.
Lancet (London, England)1998 Sep 12PMID9742976via CT.gov background
Glucagon-like peptide 1 promotes satiety and suppresses energy intake in humans.
The Journal of clinical investigation1998 Feb 1PMID9449682doi:10.1172/JCI990via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.