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

Sponsors

Lead Sponsor: Elaine Chow

Collaborator: Sanofi

Source Chinese University of Hong Kong
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).

Overall Status Recruiting
Start Date January 1, 2018
Completion Date December 18, 2019
Primary Completion Date December 18, 2019
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Glycemic variability 24 weeks
Secondary Outcome
Measure Time Frame
Glycemic variability 24 weeks
Percentage time in target 24 weeks
Glycated haemoglobin 24 weeks
Fasting blood glucose 24 weeks
Incidence of hypoglycemia 24 weeks
Proportion of patients achieving HbA1c <7.0% 24 weeks
Treatment satisfaction 24 weeks
Inflammatory markers 24 weeks
Heart rate variability 24 weeks
Enrollment 50
Condition
Intervention

Intervention Type: Drug

Intervention Name: Insulin Glargine 300 UNT/ML

Description: Self titration of insulin glargine U300

Arm Group Label: Active

Intervention Type: Drug

Intervention Name: Neutral protamine hagedorn insulin

Description: Self titration of NPH insulin

Arm Group Label: Control

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Elaine Chow Principal Investigator Chinese University of Hong Kong
Overall Contact

Last Name: Elaine Chow

Phone: 35051549

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Prince of Wales Hospital Cherry Chiu Elaine Chow Principal Investigator Juliana CN Chan Sub-Investigator
Location Countries

Hong Kong

Verification Date

July 2019

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Chinese University of Hong Kong

Investigator Full Name: Elaine Chow

Investigator Title: Dr, Clinical Lecturer

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Active

Type: Experimental

Description: Insulin glargine 300U/ml

Label: Control

Type: Active Comparator

Description: Neutral Protamine Hagedorn insulin

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov