NCT03389490

Toujeo Versus NPH Self-titration Study

A Pilot Study to Describe the Glycaemic Variability of Insulin Glargine 300U/ml Versus NPH (Neutral Protamine Hagedorn) in the Insulin-naïve Type 2 Diabetes Patients Following a Patient-adjusted Insulin Algorithm in Hong Kong

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Elaine Chow · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Insulin Glargine 300 UNT/ML	Self titration of insulin glargine U300
DRUG	Neutral protamine hagedorn insulin	Self titration of NPH insulin

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-12-17
• Completion: 2020-05-01
• First posted: 2018-01-03
• Last updated: 2021-08-03

Locations

1 site across 1 country: Hong Kong