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
Toujeo Versus NPH Self-titration Study
Sponsors
Source
Chinese University of Hong Kong
Oversight Info
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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).
Overall Status
Recruiting
Start Date
2018-01-01
Completion Date
2019-12-18
Primary Completion Date
2019-12-18
Phase
Phase 4
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Glycemic variability |
24 weeks |
Secondary Outcome
Measure |
Time Frame |
|
Glycemic variability |
24 weeks |
|
Percentage time in target |
24 weeks |
|
Glycated haemoglobin |
24 weeks |
|
Fasting blood glucose |
24 weeks |
|
Incidence of hypoglycemia |
24 weeks |
|
Proportion of patients achieving HbA1c <7.0% |
24 weeks |
|
Treatment satisfaction |
24 weeks |
|
Inflammatory markers |
24 weeks |
|
Heart rate variability |
24 weeks |
Enrollment
50
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
Self titration of insulin glargine U300
Arm Group Label
Active
Intervention Type
Drug
Intervention Name
Description
Self titration of NPH insulin
Arm Group Label
Control
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
Overall Official
Last Name |
Role |
Affiliation |
|
Elaine Chow |
Principal Investigator |
Chinese University of Hong Kong |
Overall Contact
Location
Facility |
Status |
Contact |
Investigator |
|
Prince of Wales Hospital Hong Kong Shatin Hong Kong |
Recruiting |
Last Name: Cherry Chiu |
Last Name: Elaine Chow Role: Principal Investigator Last Name: Juliana CN Chan Role: Sub-Investigator |
Location Countries
Country
Hong Kong
Verification Date
2019-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor-Investigator
Investigator Affiliation
Chinese University of Hong Kong
Investigator Full Name
Elaine Chow
Investigator Title
Dr, Clinical Lecturer
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin, Isophane
Isophane Insulin, Human
Isophane insulin, beef
Protamines
Arm Group
Arm Group Label
Active
Arm Group Type
Experimental
Description
Insulin glargine 300U/ml
Arm Group Label
Control
Arm Group Type
Active Comparator
Description
Neutral Protamine Hagedorn insulin
Firstreceived Results Date
N/A
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Study First Submitted
December 26, 2017
Study First Submitted Qc
December 26, 2017
Study First Posted
January 3, 2018
Last Update Submitted
July 23, 2019
Last Update Submitted Qc
July 23, 2019
Last Update Posted
July 24, 2019
ClinicalTrials.gov processed this data on May 29, 2020
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.