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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Insulin glargine 300U/ml |
|
| Control | Active Comparator | Neutral Protamine Hagedorn insulin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargine 300 UNT/ML | Drug | Self titration of insulin glargine U300 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic variability | Standard deviation of glucose from continuous glucose monitoring | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic variability | Mean Amplitude of Glycemic excursions and Means of Daily Differences | 24 weeks |
| Percentage time in target | Percentage of time <3.0mmol/L and >10.0mmol/L |
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Inclusion Criteria:
Type 2 diabetic suboptimally controlled on their previous antidiabetic treatment
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elaine Chow | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Hong Kong | Shatin | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33738774 | Derived | Ling J, Poon EWM, Yang A, Yeung T, Loo K, Ozaki R, Ma RCW, Luk AOY, Kong APS, Chan JCN, Chow E. Glycemic Variability and Time in Range During Self-titration of Once Daily Insulin Glargine 300 U/ml Versus Neutral Protamine Hagedorn Insulin in Insulin-naive Chinese Type 2 Diabetes Patients. Diabetes Ther. 2021 May;12(5):1399-1413. doi: 10.1007/s13300-021-01046-6. Epub 2021 Mar 18. | |
| 33166419 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007336 | Insulin, Isophane |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Neutral protamine hagedorn insulin |
| Drug |
Self titration of NPH insulin |
|
| 24 weeks |
| Glycated haemoglobin | HbA1c | 24 weeks |
| Fasting blood glucose | FPG | 24 weeks |
| Incidence of hypoglycemia | Overall incidence of hypoglycemia and nocturnal hypoglycemia | 24 weeks |
| Proportion of patients achieving HbA1c <7.0% | Proportion of patients achieving HbA1c <7.0% at week 24 without confirmed hypoglycemia | 24 weeks |
| Treatment satisfaction | ITSQ questionnaire | 24 weeks |
| Inflammatory markers | change in hs C reactive protein | 24 weeks |
| Heart rate variability | Change in heart rate variability | 24 weeks |
| Derived |
| Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4. |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |