Diabetes Mellitus, Type 2
Conditions
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).
Interventions
DRUGInsulin Glargine 300 UNT/ML
Self titration of insulin glargine U300
Self titration of NPH insulin
Sponsors
Sanofi
Elaine Chow
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic variability | 24 weeks | Standard deviation of glucose from continuous glucose monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Glycemic variability | 24 weeks | Mean Amplitude of Glycemic excursions and Means of Daily Differences |
| 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 |
| Proportion of patients achieving HbA1c <7.0% | 24 weeks | Proportion of patients achieving HbA1c \<7.0% at week 24 without confirmed hypoglycemia |
Countries
Hong Kong
Outcome results
None listed