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Trial · Interventional

CompletedPhase 4Registry data

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

Short name VARIATION 2 SA

NCTNCT03819790 (opens ClinicalTrials.gov in a new tab)Other idVARIATION 2 SA
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
119 participants (actual)
Sponsor
LMC Diabetes & Endocrinology Ltd. · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Canada

Start
2 Oct 2018
Primary completion
19 Nov 2019
Completion
19 Nov 2019
First posted
29 Jan 2019
Last update posted
25 Feb 2021
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201820192020
  1. Ph 4

    VARIATION 2 SA

    NCT03819790

    2 Oct 2018 to 19 Nov 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • Basal insulin glargine and lixisenatideDrug
  • Basal insulin Basaglar/Lantus + gliclazide MRDrug
  • MetforminDrug

Arms2

  • Experimental

    Insulin Glargine + GLP-1 RA

    Insulin 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.

  • Active comparator

    Basaglar/Lantus + gliclazide MR

    Basal 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.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Time in range at week 13

    Time frame · 7 days

    Registry description

    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

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

    Time frame · 7 days

    Registry description

    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

Secondary outcomes(20)

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

    Time frame · 7 days

    Registry description

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

  2. Overall SD of CGM glucose at week 13

    Time frame · 7 days

    Registry description

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

  3. Mean of glucose at week 13

    Time frame · 7 days

    Registry description

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

  4. Frequency of hypoglycemia at week 13

    Time frame · 7 days

    Registry description

    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

  5. Time in hypoglycemia at week 13

    Time frame · 7 days

    Registry description

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

  6. Frequency of hyperglycemia at week 13

    Time frame · 7 days

    Registry description

    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

  7. Time in hyperglycemia at week 13

    Time frame · 7 days

    Registry description

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

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

    Time frame · 7 days

    Registry description

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

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

    Time frame · 7 days

    Registry description

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

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

    Time frame · 7 days

    Registry description

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

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

    Time frame · 7 days

    Registry description

    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

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

    Time frame · 7 days

    Registry description

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

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

    Time frame · 7 days

    Registry description

    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

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

    Time frame · 7 days

    Registry description

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

  15. A1C mean at week 13

    Time frame · Week 13

    Registry description

    Average of A1C at week 13 after randomization

  16. Changes A1C

    Time frame · 15 weeks

    Registry description

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

  17. Proportion of A1C <7% at week 13

    Time frame · Week 13

    Registry description

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

  18. Proportion of A1C <8% at week 13

    Time frame · Week 13

    Registry description

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

  19. Mean basal insulin dose at week 13

    Time frame · Week 13

    Registry description

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

  20. Change in weight

    Time frame · 15 weeks

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2022

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 et al. 2022Canadian journal of diabetescited by 9

PMID 35752566DOI 10.1016/j.jcjd.2022.02.003PUB-35752566

Full text at the publisher
Publisher page

Indexing hint: Systematic review · 2016

6 results

Benefits and Harms of Once-Weekly Glucagon-like Peptide-1 Receptor Agonist Treatments: A Systematic Review and Network Meta-analysis.

Zaccardi et al. 2016Annals of internal medicinecited by 65

PMID 26642233DOI 10.7326/m15-1432PUB-26642233

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Randomized controlled trial · 2004

14 results

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 et al. 2004Diabetescited by 328

PMID 15111485DOI 10.2337/diabetes.53.5.1187PUB-15111485

Full text at the publisher14 results
Publisher pageSee results (14)

Indexing hint: Randomized controlled trial · 2004

11 results

Effect of intravenous infusion of exenatide (synthetic exendin-4) on glucose-dependent insulin secretion and counterregulation during hypoglycemia.

Degn et al. 2004Diabetescited by 189

PMID 15331551DOI 10.2337/diabetes.53.9.2397PUB-15331551

Rights unknown11 results
Source linkSee results (11)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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