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

NCT03819790 | Completed Phase 4

• 1 other identifier: VARIATION 2 SA
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 3

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 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).

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes, type 2; GLP-1 RA; Insulin glargine; Glucose variability; Insulin Titration; South Asians

Outcome Measures

Primary Outcomes (2)

• 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

  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

  7 days

Secondary Outcomes (28)

• Daily glucose standard deviation (SD) at week 13

  7 days

• Overall SD of CGM glucose at week 13

  7 days

• Mean of glucose at week 13

  7 days

• Frequency of hypoglycemia at week 13

  7 days

• Time in hypoglycemia at week 13

  7 days

Study Arms (2)

Insulin Glargine + GLP-1 RA

EXPERIMENTAL

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

Basaglar/Lantus + gliclazide MR

ACTIVE COMPARATOR

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

Interventions

Basal insulin glargine and lixisenatide DRUG

Soliqua (insulin glargine and lixisenatide): a titratable combination of long-acting basal insulin glargine and lixisenatide (Glucagon-like peptide-1 receptor agonist)

Insulin Glargine + GLP-1 RA

Basal insulin Basaglar/Lantus + gliclazide MR DRUG

basal long-acting insulin Basaglar/Lantus with gliclazide MR 60 mg OD

Basaglar/Lantus + gliclazide MR

Metformin DRUG

Patients can be administered with most tolerant dose of metformin

Basaglar/Lantus + gliclazide MR; Insulin Glargine + GLP-1 RA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LMC Diabetes & Endocrinology Ltd.: lead

Study Sites (3)

LMC Brampton

Brampton, Ontario, L6S 0C9, Canada

Location

LMC Etobicoke

Etobicoke, Ontario, Canada

Location

LMC Scarborough

Toronto, Ontario, M1R 0B1, Canada

Location

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  PMID: 35752566 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lixisenatide; Insulin Glargine; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: January 29, 2019
• Study Start: October 2, 2018
• Primary Completion: November 19, 2019
• Study Completion: November 19, 2019
• Last Updated: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)