A Phase 4 interventional study of Basal insulin glargine and lixisenatide and Basal insulin Basaglar/Lantus + gliclazide MR in Diabetes Mellitus, Type 2, sponsored by LMC Diabetes & Endocrinology Ltd.. Completed at 3 sites in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-25.
Sponsored by LMC Diabetes & Endocrinology Ltd. · Phase 4, Interventional, and Treatment
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).
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).
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Exclusion Criteria:
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.
Drug: Basal insulin glargine and lixisenatide · Drug: Metformin
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.
Drug: Basal insulin Basaglar/Lantus + gliclazide MR · Drug: Metformin
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
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
Time frame: 7 days
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
Time frame: 7 days
Daily glucose standard deviation (SD) at week 13
Daily SD of CGM glucose over the 7-day CGM period at week 13 after randomization
Time frame: 7 days
Overall SD of CGM glucose at week 13
Overall SD of CGM glucose over the 7-day CGM period at week 13 after randomization
Time frame: 7 days
Mean of glucose at week 13
Mean of CGM glucose over the 7-day CGM period at week 13 after randomization
Time frame: 7 days
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
Time frame: 7 days
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
Time frame: 7 days
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
Time frame: 7 days
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
Time frame: 7 days
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
Time frame: 7 days
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
Time frame: 7 days
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
Time frame: 7 days
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
Time frame: 7 days
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
Time frame: 7 days
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
Time frame: 7 days
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
Time frame: 7 days
A1C mean at week 13
Average of A1C at week 13 after randomization
Time frame: Week 13
Changes A1C
A1C value at Visit10 at 13 weeks after randomization minus A1C value at Visit 1 at week -2 (2 weeks before randomization)
Time frame: 15 weeks
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
Time frame: Week 13
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
Time frame: Week 13
Mean basal insulin dose at week 13
Average of basal insulin dose from patients' diary at week 13 after randomization
Time frame: Week 13
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.
Time frame: 15 weeks
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
Time frame: 15 weeks
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)
Time frame: 14 weeks
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
Time frame: Week 13
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
Time frame: Week 13
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
Time frame: Week 13
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)
Time frame: 14 weeks
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).
Time frame: 14 weeks
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.
Time frame: Week 13
Plan to share: No
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LMC Diabetes & Endocrinology Ltd.