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

NCT03819790 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2021-02-25

No results posted yet for this study

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

Interventions

DRUG

Basal insulin glargine and lixisenatide

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

DRUG

Basal insulin Basaglar/Lantus + gliclazide MR

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

DRUG

Metformin

Patients can be administered with most tolerant dose of metformin

Sponsors & Collaborators

  • LMC Diabetes & Endocrinology Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-02
Primary Completion
2019-11-19
Completion
2019-11-19

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03819790 on ClinicalTrials.gov