The Effect of Soliqua on Glucose Variability in Type 2 Patients Among South Asians
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

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 South Asian origin living in Canada
      with type 2 diabetes (T2DM).
    

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).
    

Intervention name(s): Basal insulin glargine and lixisenatide; Basal insulin Basaglar/Lantus + gliclazide MR; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Soliqua (insulin glargine and lixisenatide): a titratable combination of long-acting basal insulin glargine and lixisenatide (Glucagon-like peptide-1 receptor agonist); basal long-acting insulin Basaglar/Lantus with gliclazide MR 60 mg OD; Patients can be administered with most tolerant dose of metformin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Lixisenatide; Gliclazide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Treatment
Keywords: Diabetes, type 2; GLP-1 RA; Insulin glargine; Glucose variability; Insulin Titration; South Asians