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Toujeo Versus NPH Self-titration Study

NCT03389490 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-08-03

No results posted yet for this study

Summary

This is a 24 week, multicentre, prospective, randomized, controlled, parallel-designed (1:1) pilot study.The study will compare glycemic variability in patients treated with insulin glargine U300/ml insulin versus conventional (NPH) insulin using a self titration algorithm.50 type 2 diabetes patients who are newly started on insulin will be recruited. They will be randomly allocated to either insulin glargine U300 or NPH insulin for 26 weeks. All subjects will follow a insulin-self titration algorithm. The study will consist of 9 visits over 26 weeks. Blood glucose variability will be collected by CGM for 7 consecutive days at baseline (week -1) and at week 24.Secondary endpoints other than data on glycemic variability, including HbA1c, fasting plasma glucose, inflammatory markers will be measured during three periods (week 0, week 12 and week 24).

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin Glargine 300 UNT/ML

Self titration of insulin glargine U300

DRUG

Neutral protamine hagedorn insulin

Self titration of NPH insulin

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Elaine Chow

    lead OTHER

Principal Investigators

  • Elaine Chow · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2019-12-17
Completion
2020-05-01

Countries

  • Hong Kong

Study Locations

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Entities

Companies

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 NCT03389490 on ClinicalTrials.gov