Status:
COMPLETED
The Effect of Soliqua on Glucose Variability in Type 2 Patients Among South Asians
Lead Sponsor:
LMC Diabetes & Endocrinology Ltd.
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 Lantu...
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 (Basagla...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2019
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT03819790
Start Date
October 2 2018
End Date
November 19 2019
Last Update
February 25 2021
Active Locations (3)
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1
LMC Brampton
Brampton, Ontario, Canada, L6S 0C9
2
LMC Etobicoke
Etobicoke, Ontario, Canada
3
LMC Scarborough
Toronto, Ontario, Canada, M1R 0B1