A Phase 4 interventional study of Insulin Glargine 300 UNT/ML and Neutral protamine hagedorn insulin in Diabetes Mellitus, Type 2, sponsored by Elaine Chow. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-08-03.
Sponsored by Elaine Chow · Phase 4, Interventional, and Treatment
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).
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 50 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Elaine Chow is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Type 2 diabetic suboptimally controlled on their previous antidiabetic treatment
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Insulin glargine 300U/ml
Drug: Insulin Glargine 300 UNT/ML
Neutral Protamine Hagedorn insulin
Drug: Neutral protamine hagedorn insulin
Self titration of insulin glargine U300
Self titration of NPH insulin
Glycemic variability
Standard deviation of glucose from continuous glucose monitoring
Time frame: 24 weeks
Glycemic variability
Mean Amplitude of Glycemic excursions and Means of Daily Differences
Time frame: 24 weeks
Percentage time in target
Percentage of time \<3.0mmol/L and \>10.0mmol/L
Time frame: 24 weeks
Glycated haemoglobin
HbA1c
Time frame: 24 weeks
Fasting blood glucose
FPG
Time frame: 24 weeks
Incidence of hypoglycemia
Overall incidence of hypoglycemia and nocturnal hypoglycemia
Time frame: 24 weeks
Proportion of patients achieving HbA1c <7.0%
Proportion of patients achieving HbA1c \<7.0% at week 24 without confirmed hypoglycemia
Time frame: 24 weeks
Treatment satisfaction
ITSQ questionnaire
Time frame: 24 weeks
Inflammatory markers
change in hs C reactive protein
Time frame: 24 weeks
Heart rate variability
Change in heart rate variability
Time frame: 24 weeks
Plan to share: No
Ran from Jan 2018 to primary completion in Dec 2019, 23 months.
Of 320 non-industry phase 4 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 49. This study's 23 months is below that.
Counting every sponsor, half of 452 studies reached it within 24 months; a quarter within 13 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Elaine Chow