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Diabetes Mellitus, Type 2Phase 4VARIATION 2 SANCT03819790

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

A Phase 4 study testing Basal insulin glargine and lixisenatide, Basal insulin Basaglar/Lantus + gliclazide MR and Metformin in people with Diabetes Mellitus, Type 2, run by LMC Diabetes & Endocrinology Ltd. at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The overall objective of this study is to compare the effects of Soliqua, a titratable combination of insulin and GLP-1 receptor agonist in a single pen versus Glargine U100 insulin (Basaglar or Lantus) and gliclazide MR, both added to metformin, on measures of glucose variability using masked CGM data among people of… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Basal insulin glargine and lixisenatide, Basal insulin Basaglar/Lantus + gliclazide MR and Metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
3 sitesCanada
Study dates
2 Oct 2018to 19 Nov 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Insulin naïve, uncontrolled on oral hypoglycemic medications
  • Kidney function assessment with eGFR >30 mL/min/1.73 m2
  • Written informed consent obtained

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • LMC Brampton

    Brampton, Ontario, L6S 0C9

  • LMC Etobicoke

    Etobicoke, Ontario

  • LMC Scarborough

    Toronto, Ontario, M1R 0B1

Other trials in Canada

About this study

Official title: 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)

The overall objective of this study is to compare the effects of Soliqua, a titratable combination of insulin and GLP-1 receptor agonist in a single pen versus Glargine U100 insulin (Basaglar or Lantus) and gliclazide MR, both added to metformin, on measures of glucose variability using masked CGM data among people of South Asian origin living in Canada with type 2 diabetes (T2DM).

Read the detailed description

The VARIATION 2 SA study is a prospective, open-label, randomized controlled, multi-centre trial to compare the efficacy of two insulin initiation approaches (Soliqua vs Glargine U100 insulin (Basaglar or Lantus) + gliclazide MR) added to maximum tolerated metformin on glucose variability (using masked CGM) in South Asians with T2DM who will initiate insulin therapy with HbA1c of 7.1-11% (inclusive). After giving informed consent and being assessed by eligibility, the patient will stop other oral hypoglycemic agents except metformin (SGLT2 inhibitor may be continued if the patient has cardiovascular diseases history) and enter a 1-week run-in phase with Basaglar or Lantus insulin. During this week (considered as baseline), the patient will: 1) be administered Basaglar or Lantus insulin at an initial dose of 10 units in the morning and increase 1 U/day if fasting glucose >5.5 mmol/L; 2) complete 2 questionnaires to assess the patient-reported outcomes (PROs); 3) wear a masked continuous glucose monitor (CGM) to assess glucose variability; 4) record carbohydrate intake for at least 3 consecutive days. If a patient demonstrates good adherence to Basaglar or Lantus insulin therapy, proper CGM wearing and proper record of carbohydrate intake, and is willing to adhere to insulin treatment will be randomly assigned (1:1) to receive either Soliqua or Glargine U100 insulin (Basaglar or Lantus) + gliclazide MR treatment. The patients will initiate insulin Soliqua or Basaglar/Lantus at their end-of run-in phase insulin dose (minimum dose of 15 units in both arms) every morning (before first meal of day) and titrate by 1 U/day until fasting glucose reaches 4-5.5 mmol/L. In the next 12 weeks, the patients will be optimized their insulin doses via clinic visits or phone calls. They will also be instructed to record their daily fasting glucose, insulin dose, hypoglycemic episodes and any adverse events in a logbook. The primary outcome is to compare the difference of average percentage of Time in Range (4.0-10.0 mmol/L) within 24 hours over the CGM period between two treatments at week 13 after randomization. The co-primary is to compare the difference average percentage of Time in Range (4.0-10.0 mmol/L) within 12 hours (6 AM- 6 PM) over the CGM period between two treatments at week 13 after randomization. The secondary outcomes include the differences on other measurements of glucose variability and patient-reported outcomes (PROs).

Being tested
Basal insulin glargine and lixisenatide, Basal insulin Basaglar/Lantus + gliclazide MR, Metformin
Keywords
Diabetes, type 2, GLP-1 RA, Insulin glargine, Glucose variability, Insulin Titration, South Asians
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Basal insulin glargine and lixisenatideDrug

    Soliqua (insulin glargine and lixisenatide): a titratable combination of long-acting basal insulin glargine and lixisenatide (Glucagon-like peptide-1 receptor agonist)

  • Basal insulin Basaglar/Lantus + gliclazide MRDrug

    basal long-acting insulin Basaglar/Lantus with gliclazide MR 60 mg OD

  • MetforminDrug

    Patients can be administered with most tolerant dose of metformin

Study groups in NCT03819790
Study groupRoleWhat they receive
Insulin Glargine + GLP-1 RAExperimentalInsulin Soliqua (a titratable combination of insulin Glargine + GLP-1 RA) will be administered at the subject's end-of run-in phase insulin dose (minimum dose of 15 units in both arms) every morning (before first meal of day) and titrate by one unit per day until fasting glucose level of 4-5.5 mmol/L is obtained, with or without metformin.
Receives: Drug: Basal insulin glargine and lixisenatide; Drug: Metformin
Basaglar/Lantus + gliclazide MRActive comparatorBasal insulin Basaglar/Lantus will be administered at the subject's end-of run-in phase insulin dose (minimum dose of 15 units in both arms) every morning (before first meal of day) and titrate by one unit per day until fasting glucose level of 4-5.5 mmol/L is obtained, with gliclazide MR 60 mg OD, with or without metformin.
Receives: Drug: Basal insulin Basaglar/Lantus + gliclazide MR; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time in range at week 13

    Time with CGM glucose between 4.0 - 10.0 mmol/L within 24 hours over the 7-day CGM period at week 13 after randomization

    Measured: 7 days

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

    Time with CGM glucose between 4.0 - 10.0 mmol/L within 12-hours (6 AM -6 PM) over the 7-day CGM period at week 13 after randomization

    Measured: 7 days

Secondary outcomes (28)

  1. Daily glucose standard deviation (SD) at week 13

    Daily SD of CGM glucose over the 7-day CGM period at week 13 after randomization

    Measured: 7 days

  2. Overall SD of CGM glucose at week 13

    Overall SD of CGM glucose over the 7-day CGM period at week 13 after randomization

    Measured: 7 days

  3. Mean of glucose at week 13

    Mean of CGM glucose over the 7-day CGM period at week 13 after randomization

    Measured: 7 days

  4. Frequency of hypoglycemia at week 13

    Number of hypoglycemic event which is defined as CGM glucose <4.0 mmol/L for at least 15 mins (3 consecutive CGM readings) over the 7-day CGM period at week 13 after randomization

    Measured: 7 days

  5. Time in hypoglycemia at week 13

    Time with CGM glucose < 4.0 mmol/L over the 7-day CGM period at week 13 after randomization

    Measured: 7 days

  6. Frequency of hyperglycemia at week 13

    Number of hyperglycemic event which is defined as CGM glucose >10.0 mmol/L at least 15 mins (3 consecutive CGM readings) over the 7-day CGM period at week 13 after randomization

    Measured: 7 days

  7. Time in hyperglycemia at week 13

    Time with CGM glucose >10.0 mmol/L over the 7-day CGM period at week 13 after randomization

    Measured: 7 days

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

    Daily SD of CGM glucose within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization

    Measured: 7 days

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

    Overall SD of CGM glucose within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization

    Measured: 7 days

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

    Mean of CGM glucose within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization

    Measured: 7 days

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

    Number of hypoglycemic event which is defined as CGM glucose <4.0 mmol/L for at least 15 mins (3 consecutive CGM readings) within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization

    Measured: 7 days

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

    Time with CGM glucose <4.0 mmol/L within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization

    Measured: 7 days

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

    Number of hypoglycemic event which is defined as CGM glucose >10.0 mmol/L for at least 15 mins (3 consecutive CGM readings) within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization

    Measured: 7 days

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

    Time with CGM glucose >10.0 mmol/L within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization

    Measured: 7 days

  15. A1C mean at week 13

    Average of A1C at week 13 after randomization

    Measured: Week 13

  16. Changes A1C

    A1C value at Visit10 at 13 weeks after randomization minus A1C value at Visit 1 at week -2 (2 weeks before randomization)

    Measured: 15 weeks

  17. Proportion of A1C <7% at week 13

    the number of patients who have A1C <7% divided by the total number of patients who have A1C measurement at week 13 after randomization

    Measured: Week 13

  18. Proportion of A1C <8% at week 13

    the number of patients who have A1C <8% divided by the total number of patients who have A1C measurement at week 13 after randomization

    Measured: Week 13

  19. Mean basal insulin dose at week 13

    Average of basal insulin dose from patients' diary at week 13 after randomization

    Measured: Week 13

  20. Change in weight

    Weight difference between week 13 after randomization and baseline at week -2 (2 weeks before randomization) = weight at Visit 10 at week 13 - weight at Visit 1 at week -2.

    Measured: 15 weeks

  21. Change in waist circumference

    Waist circumference change between week 13 after randomization and baseline at week -2 (2 week before randomization)= waist circumference at Visit 10 at week 13- waist circumference at Visit 1 at week -2

    Measured: 15 weeks

  22. Change in carbohydrate intake

    Carbohydrate intake change between week 13 after randomization and baseline at week -1 = carbohydrate intake at Visit 10 at week 13 - carbohydrate intake at Visit 2 at week -1 (1 week before randomization)

    Measured: 14 weeks

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

    the number of patients who have A1C ≤ 7% with no hypoglycemia and no weight gain from baseline divided by the total number of patients at Week 13 after randomization

    Measured: Week 13

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

    the number of patients who have A1C ≤ 7% with no hypoglycemia and weight gain <3% from baseline divided by the total number of patients at Week 13 after randomization

    Measured: Week 13

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

    the number of patients who have fasting blood glucose ≤ 5.5 mmol/L without nocturnal hypoglycemia divided by the total number of patients at Week 13 after randomization

    Measured: Week 13

  26. Change in DiabMedSat Score

    DiabMedSat Score will be generated using Diabetes Medication Satisfaction (DiabMedSat) questionnaire. It measures the levels of the subjects' satisfaction with their diabetes medication(s). The range of the score is 0 to 100. The higher the score, the greater the satisfaction. The changes in the score will measure the score difference between Visit 10 at week 13 after randomization and Visit 2 at week -1 (1 week before randomization)

    Measured: 14 weeks

  27. Change in HFS Score

    HFS Score will be measured by the Hypoglycemia Fear Survey which assesses the subject's behaviors to avoid hypoglycemia and to measure the subjects' worries about hypoglycemia and its consequences in the past 3 months. The range of the score will be 0 to 132. The higher the score, the greater the fear.

    The changes will be the score difference between Visit 10 at week 13 after randomization and Visit 2 at week -1 (1 week before randomization).

    Measured: 14 weeks

  28. HCP treatment satisfaction score

    HCP treatment satisfaction score will be generated from Healthcare Provider treatment satisfaction questionnaire. It measures the levels of satisfaction of physicians in this study when prescribing this medication at Visit 10 at week 13 after randomization. The range is 0 to 15. The higher the score, the greater the satisfaction.

    Measured: Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2019
  2. Study start2 Oct 2018
  3. Primary completion19 Nov 2019
  4. Study completion19 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized into either of two arms by an interactive system in a 1:1 ratio. Randomization will be stratified based on the use of sodium-glucose co-transporter-2 (SGLT2) inhibitors.
Masking
None (open label)
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03819790
Sponsor's protocol ID
VARIATION 2 SA
Acronym
VARIATION 2 SA
Status last verified
Feb 2021
First submitted
24 Sep 2018
Last updated
25 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. 1998 Sep 12;352(9131):837-53.

    PubMed 9742976

  • Lipska KJ, Yao X, Herrin J, McCoy RG, Ross JS, Steinman MA, Inzucchi SE, Gill TM, Krumholz HM, Shah ND. Trends in Drug Utilization, Glycemic Control, and Rates of Severe Hypoglycemia, 2006-2013. Diabetes Care. 2017 Apr;40(4):468-475. doi: 10.2337/dc16-0985. Epub 2016 Sep 22.

    PubMed 27659408

  • Tobias DK, Pan A, Jackson CL, O'Reilly EJ, Ding EL, Willett WC, Manson JE, Hu FB. Body-mass index and mortality among adults with incident type 2 diabetes. N Engl J Med. 2014 Jan 16;370(3):233-44. doi: 10.1056/NEJMoa1304501.

    PubMed 24428469

  • Scheen AJ, Van Gaal LF. Combating the dual burden: therapeutic targeting of common pathways in obesity and type 2 diabetes. Lancet Diabetes Endocrinol. 2014 Nov;2(11):911-22. doi: 10.1016/S2213-8587(14)70004-X. Epub 2014 Feb 19.

    PubMed 24731666

  • Degn KB, Brock B, Juhl CB, Djurhuus CB, Grubert J, Kim D, Han J, Taylor K, Fineman M, Schmitz O. Effect of intravenous infusion of exenatide (synthetic exendin-4) on glucose-dependent insulin secretion and counterregulation during hypoglycemia. Diabetes. 2004 Sep;53(9):2397-403. doi: 10.2337/diabetes.53.9.2397.

    PubMed 15331551

  • Degn KB, Juhl CB, Sturis J, Jakobsen G, Brock B, Chandramouli V, Rungby J, Landau BR, Schmitz O. 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. Diabetes. 2004 May;53(5):1187-94. doi: 10.2337/diabetes.53.5.1187.

    PubMed 15111485

  • Flint A, Raben A, Astrup A, Holst JJ. Glucagon-like peptide 1 promotes satiety and suppresses energy intake in humans. J Clin Invest. 1998 Feb 1;101(3):515-20. doi: 10.1172/JCI990.

    PubMed 9449682

  • Leiter LA, Nauck MA. Efficacy and Safety of GLP-1 Receptor Agonists Across the Spectrum of Type 2 Diabetes Mellitus. Exp Clin Endocrinol Diabetes. 2017 Jul;125(7):419-435. doi: 10.1055/s-0043-103969. Epub 2017 Jul 19. German.

    PubMed 28724168

  • Zaccardi F, Htike ZZ, Webb DR, Khunti K, Davies MJ. Benefits and Harms of Once-Weekly Glucagon-like Peptide-1 Receptor Agonist Treatments: A Systematic Review and Network Meta-analysis. Ann Intern Med. 2016 Jan 19;164(2):102-13. doi: 10.7326/M15-1432. Epub 2015 Dec 8.

    PubMed 26642233

  • Rosenstock J, Fonseca VA, Gross JL, Ratner RE, Ahren B, Chow FC, Yang F, Miller D, Johnson SL, Stewart MW, Leiter LA; Harmony 6 Study Group. 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 Care. 2014 Aug;37(8):2317-25. doi: 10.2337/dc14-0001. Epub 2014 Jun 4.

    PubMed 24898300

  • Diamant M, Nauck MA, Shaginian R, Malone JK, Cleall S, Reaney M, de Vries D, Hoogwerf BJ, MacConell L, Wolffenbuttel BH; 4B Study Group. Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes. Diabetes Care. 2014 Oct;37(10):2763-73. doi: 10.2337/dc14-0876. Epub 2014 Jul 10.

    PubMed 25011946

  • Writing Group for the DCCT/EDIC Research Group; Orchard TJ, Nathan DM, Zinman B, Cleary P, Brillon D, Backlund JY, Lachin JM. Association between 7 years of intensive treatment of type 1 diabetes and long-term mortality. JAMA. 2015 Jan 6;313(1):45-53. doi: 10.1001/jama.2014.16107.

    PubMed 25562265

  • Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008 Oct 9;359(15):1577-89. doi: 10.1056/NEJMoa0806470. Epub 2008 Sep 10.

    PubMed 18784090

  • Lind M, Svensson AM, Kosiborod M, Gudbjornsdottir S, Pivodic A, Wedel H, Dahlqvist S, Clements M, Rosengren A. Glycemic control and excess mortality in type 1 diabetes. N Engl J Med. 2014 Nov 20;371(21):1972-82. doi: 10.1056/NEJMoa1408214.

    PubMed 25409370

  • Esposito K, Giugliano D, Nappo F, Marfella R; Campanian Postprandial Hyperglycemia Study Group. Regression of carotid atherosclerosis by control of postprandial hyperglycemia in type 2 diabetes mellitus. Circulation. 2004 Jul 13;110(2):214-9. doi: 10.1161/01.CIR.0000134501.57864.66. Epub 2004 Jun 14.

    PubMed 15197140

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Basal insulin glargine and lixisenatide, Basal insulin Basaglar/Lantus + gliclazide MR and Metformin in people with Diabetes Mellitus, Type 2, run by LMC Diabetes & Endocrinology Ltd. at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time in range at week 13 (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03819790, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.

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