Toujeo Versus NPH Self-titration Study

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389490
• Other study ID #: GLARGL08588
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: August 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 1, 2020
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin Glargine 300 UNT/ML
Self titration of insulin glargine U300
• Neutral protamine hagedorn insulin
Self titration of NPH insulin

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong	Shatin

Sponsors (2)

Lead Sponsor	Collaborator
Elaine Chow	Sanofi

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic variability	Standard deviation of glucose from continuous glucose monitoring	24 weeks
Secondary	Glycemic variability	Mean Amplitude of Glycemic excursions and Means of Daily Differences	24 weeks
Secondary	Percentage time in target	Percentage of time <3.0mmol/L and >10.0mmol/L	24 weeks
Secondary	Glycated haemoglobin	HbA1c	24 weeks
Secondary	Fasting blood glucose	FPG	24 weeks
Secondary	Incidence of hypoglycemia	Overall incidence of hypoglycemia and nocturnal hypoglycemia	24 weeks
Secondary	Proportion of patients achieving HbA1c <7.0%	Proportion of patients achieving HbA1c <7.0% at week 24 without confirmed hypoglycemia	24 weeks
Secondary	Treatment satisfaction	ITSQ questionnaire	24 weeks
Secondary	Inflammatory markers	change in hs C reactive protein	24 weeks
Secondary	Heart rate variability	Change in heart rate variability	24 weeks