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

• Status: Completed
• Trial end date: 2019-11-19
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LMC Diabetes & Endocrinology Ltd.
• Collaborator: Sanofi
• Treatments: Gliclazide; Insulin; Insulin Glargine; Insulin, Globin Zinc; Lixisenatide; Metformin

Criteria

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