Status:
COMPLETED
Toujeo Versus NPH Self-titration Study
Lead Sponsor:
Elaine Chow
Collaborating Sponsors:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03389490
Start Date
January 1 2018
End Date
May 1 2020
Last Update
August 3 2021
Active Locations (1)
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1
Prince of Wales Hospital
Hong Kong, Shatin, Hong Kong