Clinical trial NCT03389490: Toujeo Versus NPH Self-titration Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2018-01-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Glycemic variability
timeFrame: 24 weeks
Secondary outcomes:
measure: Glycemic variability
timeFrame: 24 weeks
measure: Percentage time in target
timeFrame: 24 weeks
measure: Glycated haemoglobin
timeFrame: 24 weeks
measure: Fasting blood glucose
timeFrame: 24 weeks
measure: Incidence of hypoglycemia
timeFrame: 24 weeks
measure: Proportion of patients achieving HbA1c <7.0%
timeFrame: 24 weeks
measure: Treatment satisfaction
timeFrame: 24 weeks
measure: Inflammatory markers
timeFrame: 24 weeks
measure: Heart rate variability
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: Shatin
Study officials:
affiliation: Chinese University of Hong Kong
name: Elaine Chow
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.