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
Overview
- Phase
- Phase 4
- Intervention
- Insulin Glargine 300 UNT/ML
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Elaine Chow
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Glycemic variability
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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).
Investigators
Elaine Chow
Dr, Clinical Lecturer
Chinese University of Hong Kong
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
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
Arms & Interventions
Active
Insulin glargine 300U/ml
Intervention: Insulin Glargine 300 UNT/ML
Control
Neutral Protamine Hagedorn insulin
Intervention: Neutral protamine hagedorn insulin
Outcomes
Primary Outcomes
Glycemic variability
Time Frame: 24 weeks
Standard deviation of glucose from continuous glucose monitoring
Secondary Outcomes
- Inflammatory markers(24 weeks)
- Glycemic variability(24 weeks)
- Incidence of hypoglycemia(24 weeks)
- Percentage time in target(24 weeks)
- Fasting blood glucose(24 weeks)
- Proportion of patients achieving HbA1c <7.0%(24 weeks)
- Heart rate variability(24 weeks)
- Glycated haemoglobin(24 weeks)
- Treatment satisfaction(24 weeks)