Prince of Wales Hospital
Hong Kong, Shatin
NCT Number: NCT03389490
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).
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Notify Me18 year–75 year
All sexes
Interventional
Phase 4
Hong Kong, Shatin
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Self titration of insulin glargine U300
Self titration of NPH insulin
Time frame: 24 weeks
Standard deviation of glucose from continuous glucose monitoring
Time frame: 24 weeks
Mean Amplitude of Glycemic excursions and Means of Daily Differences
Time frame: 24 weeks
Percentage of time <3.0mmol/L and >10.0mmol/L
Time frame: 24 weeks
HbA1c
Time frame: 24 weeks
FPG
Time frame: 24 weeks
Overall incidence of hypoglycemia and nocturnal hypoglycemia
Time frame: 24 weeks
Proportion of patients achieving HbA1c <7.0% at week 24 without confirmed hypoglycemia
Time frame: 24 weeks
ITSQ questionnaire
Time frame: 24 weeks
change in hs C reactive protein
Time frame: 24 weeks
Change in heart rate variability
Elaine Chow
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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