Toujeo Versus NPH Self-titration Study

Sponsor

Elaine Chow (Other)

Overall Status

Completed

CT.gov ID

NCT03389490

Collaborator

Sanofi (Industry)

Enrollment

Location

Arms

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Insulin Glargine 300 UNT/ML Drug: Neutral protamine hagedorn insulin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Dec 17, 2019

Actual Study Completion Date :

May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Insulin glargine 300U/ml	Drug: Insulin Glargine 300 UNT/ML Self titration of insulin glargine U300
Active Comparator: Control Neutral Protamine Hagedorn insulin	Drug: Neutral protamine hagedorn insulin Self titration of NPH insulin

Arm

Intervention/Treatment

Experimental: Active

Insulin glargine 300U/ml

Drug: Insulin Glargine 300 UNT/ML

Self titration of insulin glargine U300

Active Comparator: Control

Neutral Protamine Hagedorn insulin

Drug: Neutral protamine hagedorn insulin

Self titration of NPH insulin

Outcome Measures

Primary Outcome Measures

Glycemic variability [24 weeks]
Standard deviation of glucose from continuous glucose monitoring

Secondary Outcome Measures

Glycemic variability [24 weeks]
Mean Amplitude of Glycemic excursions and Means of Daily Differences
Percentage time in target [24 weeks]
Percentage of time <3.0mmol/L and >10.0mmol/L
Glycated haemoglobin [24 weeks]
HbA1c
Fasting blood glucose [24 weeks]
FPG
Incidence of hypoglycemia [24 weeks]
Overall incidence of hypoglycemia and nocturnal hypoglycemia
Proportion of patients achieving HbA1c <7.0% [24 weeks]
Proportion of patients achieving HbA1c <7.0% at week 24 without confirmed hypoglycemia
Treatment satisfaction [24 weeks]
ITSQ questionnaire
Inflammatory markers [24 weeks]
change in hs C reactive protein
Heart rate variability [24 weeks]
Change in heart rate variability

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Type 2 diabetic suboptimally controlled on their previous antidiabetic treatment
18 ≤ age ≤ 75
Stable dose of oral antidiabetic treatment for > 8 weeks
The number of OADs that the patients used should be "3" or less
HbA1c level > 7.0% and < 10%
Fasting plasma glucose > 8mmol/L and <15mmol
BMI < 40 kg/m2
Patient who is capable and willing to perform regular SMBG
Patient who is capable and willing for insulin injection
Confirmed written consent
Insulin naïve

Exclusion Criteria:

Participation in a clinical trial with any investigational drug used with curative intent and within 30 days prior to study entry
Patient known to have hypoglycaemia unawareness or recurrent major hypoglycaemia
Any product containing prandial insulin
Concomitant medication known to interface with glucose metabolism (such as systematic steroids)
Change in dose of non-insulin anti-diabetic treatment or initiation of new anti-diabetic medications in the last 8 weeks prior to screening
Patients treated with steroid or nonsteroidal anti-inflammatory drugs
Patient who had experienced an acute concurrent illness during the 3-month period before the investigation
Patient with hepatic disease and end-stage renal disease
Patients unable to comply with follow-up visits
Pregnant or breastfeeding women