Toujeo Versus NPH Self-titration Study
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: Neutral protamine hagedorn insulinDrug: Insulin Glargine 300 UNT/ML
- Registration Number
- NCT03389490
- Lead Sponsor
- Elaine Chow
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Neutral protamine hagedorn insulin Neutral Protamine Hagedorn insulin Active Insulin Glargine 300 UNT/ML Insulin glargine 300U/ml
- Primary Outcome Measures
Name Time Method Glycemic variability 24 weeks Standard deviation of glucose from continuous glucose monitoring
- Secondary Outcome Measures
Name Time Method Inflammatory markers 24 weeks change in hs C reactive protein
Glycemic variability 24 weeks Mean Amplitude of Glycemic excursions and Means of Daily Differences
Incidence of hypoglycemia 24 weeks Overall incidence of hypoglycemia and nocturnal hypoglycemia
Percentage time in target 24 weeks Percentage of time \<3.0mmol/L and \>10.0mmol/L
Fasting blood glucose 24 weeks FPG
Proportion of patients achieving HbA1c <7.0% 24 weeks Proportion of patients achieving HbA1c \<7.0% at week 24 without confirmed hypoglycemia
Heart rate variability 24 weeks Change in heart rate variability
Glycated haemoglobin 24 weeks HbA1c
Treatment satisfaction 24 weeks ITSQ questionnaire
Trial Locations
- Locations (1)
Prince of Wales Hospital
🇭🇰Hong Kong, Shatin, Hong Kong