Toujeo Versus NPH Self-titration Study
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
| Sponsors |
Lead Sponsor: Elaine Chow Collaborator: Sanofi |
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| Source | Chinese University of Hong Kong | ||||||||||||||||||||
| 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). |
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| Overall Status | Recruiting | ||||||||||||||||||||
| Start Date | January 1, 2018 | ||||||||||||||||||||
| Completion Date | December 18, 2019 | ||||||||||||||||||||
| Primary Completion Date | December 18, 2019 | ||||||||||||||||||||
| Phase | Phase 4 | ||||||||||||||||||||
| Study Type | Interventional | ||||||||||||||||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 50 | ||||||||||||||||||||
| Condition | |||||||||||||||||||||
| Intervention |
Intervention Type: Drug Intervention Name: Insulin Glargine 300 UNT/ML Description: Self titration of insulin glargine U300 Arm Group Label: Active Intervention Type: Drug Intervention Name: Neutral protamine hagedorn insulin Description: Self titration of NPH insulin Arm Group Label: Control |
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| 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 - 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 Gender: All Minimum Age: 18 Years Maximum Age: 75 Years Healthy Volunteers: No |
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| Overall Official |
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| Overall Contact |
Last Name: Elaine Chow Phone: 35051549 Email: [email protected] |
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| Location |
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| Location Countries |
Hong Kong |
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| Verification Date |
July 2019 |
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| Responsible Party |
Type: Sponsor-Investigator Investigator Affiliation: Chinese University of Hong Kong Investigator Full Name: Elaine Chow Investigator Title: Dr, Clinical Lecturer |
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| Has Expanded Access | No | ||||||||||||||||||||
| Condition Browse | |||||||||||||||||||||
| Number Of Arms | 2 | ||||||||||||||||||||
| Arm Group |
Label: Active Type: Experimental Description: Insulin glargine 300U/ml Label: Control Type: Active Comparator Description: Neutral Protamine Hagedorn insulin |
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| Patient Data | No | ||||||||||||||||||||
| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Masking: Single (Outcomes Assessor) |
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