Toujeo Versus NPH Self-titration Study

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulin Glargine 300 UNT/ML
* Drug: Neutral protamine hagedorn insulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Insulin glargine 300U/ml | Drug: Insulin Glargine 300 UNT/ML<br>* Self titration of insulin glargine U300<br>|
| Active Comparator: Control<br>Neutral Protamine Hagedorn insulin | Drug: Neutral protamine hagedorn insulin<br>* Self titration of NPH insulin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic variability | Standard deviation of glucose from continuous glucose monitoring | 24 weeks | 

Secondary Outcome Measures

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