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Toujeo Versus NPH Self-titration Study

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Insulin Glargine 300 UNT/ML
Neutral protamine hagedorn insulin
Sponsored by
Elaine Chow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active

Control

Arm Description

Insulin glargine 300U/ml

Neutral Protamine Hagedorn insulin

Outcomes

Primary Outcome Measures

Glycemic variability
Standard deviation of glucose from continuous glucose monitoring

Secondary Outcome Measures

Glycemic variability
Mean Amplitude of Glycemic excursions and Means of Daily Differences
Percentage time in target
Percentage of time <3.0mmol/L and >10.0mmol/L
Glycated haemoglobin
HbA1c
Fasting blood glucose
FPG
Incidence of hypoglycemia
Overall incidence of hypoglycemia and nocturnal hypoglycemia
Proportion of patients achieving HbA1c <7.0%
Proportion of patients achieving HbA1c <7.0% at week 24 without confirmed hypoglycemia
Treatment satisfaction
ITSQ questionnaire
Inflammatory markers
change in hs C reactive protein
Heart rate variability
Change in heart rate variability

Full Information

First Posted
December 26, 2017
Last Updated
August 2, 2021
Sponsor
Elaine Chow
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT03389490
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 17, 2019 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elaine Chow
Collaborators
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Insulin glargine 300U/ml
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Neutral Protamine Hagedorn insulin
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine 300 UNT/ML
Intervention Description
Self titration of insulin glargine U300
Intervention Type
Drug
Intervention Name(s)
Neutral protamine hagedorn insulin
Intervention Description
Self titration of NPH insulin
Primary Outcome Measure Information:
Title
Glycemic variability
Description
Standard deviation of glucose from continuous glucose monitoring
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Glycemic variability
Description
Mean Amplitude of Glycemic excursions and Means of Daily Differences
Time Frame
24 weeks
Title
Percentage time in target
Description
Percentage of time <3.0mmol/L and >10.0mmol/L
Time Frame
24 weeks
Title
Glycated haemoglobin
Description
HbA1c
Time Frame
24 weeks
Title
Fasting blood glucose
Description
FPG
Time Frame
24 weeks
Title
Incidence of hypoglycemia
Description
Overall incidence of hypoglycemia and nocturnal hypoglycemia
Time Frame
24 weeks
Title
Proportion of patients achieving HbA1c <7.0%
Description
Proportion of patients achieving HbA1c <7.0% at week 24 without confirmed hypoglycemia
Time Frame
24 weeks
Title
Treatment satisfaction
Description
ITSQ questionnaire
Time Frame
24 weeks
Title
Inflammatory markers
Description
change in hs C reactive protein
Time Frame
24 weeks
Title
Heart rate variability
Description
Change in heart rate variability
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Chow
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
State/Province
Shatin
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33738774
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.
Results Reference
derived
PubMed Identifier
33166419
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.
Results Reference
derived

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Toujeo Versus NPH Self-titration Study

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