AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 4NCT03389490

Toujeo Versus NPH Self-titration Study

A Phase 4 study testing Insulin Glargine 300 UNT/ML and Neutral protamine hagedorn insulin in people with Diabetes Mellitus, Type 2, run by Elaine Chow at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Insulin Glargine 300 UNT/ML and Neutral protamine hagedorn insulin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteHong Kong
Study dates
1 Jan 2018to 1 May 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Prince of Wales Hospital

    Hong Kong, Shatin

Other trials in Hong Kong

About this 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

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).

Being tested
Insulin Glargine 300 UNT/ML, Neutral protamine hagedorn insulin
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin Glargine 300 UNT/MLDrug

    Self titration of insulin glargine U300

  • Neutral protamine hagedorn insulinDrug

    Self titration of NPH insulin

Study groups in NCT03389490
Study groupRoleWhat they receive
ActiveExperimentalInsulin glargine 300U/ml
Receives: Drug: Insulin Glargine 300 UNT/ML
ControlActive comparatorNeutral Protamine Hagedorn insulin
Receives: Drug: Neutral protamine hagedorn insulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycemic variability

    Standard deviation of glucose from continuous glucose monitoring

    Measured: 24 weeks

Secondary outcomes (9)

  1. Glycemic variability

    Mean Amplitude of Glycemic excursions and Means of Daily Differences

    Measured: 24 weeks

  2. Percentage time in target

    Percentage of time <3.0mmol/L and >10.0mmol/L

    Measured: 24 weeks

  3. Glycated haemoglobin

    HbA1c

    Measured: 24 weeks

  4. Fasting blood glucose

    FPG

    Measured: 24 weeks

  5. Incidence of hypoglycemia

    Overall incidence of hypoglycemia and nocturnal hypoglycemia

    Measured: 24 weeks

  6. Proportion of patients achieving HbA1c <7.0%

    Proportion of patients achieving HbA1c <7.0% at week 24 without confirmed hypoglycemia

    Measured: 24 weeks

  7. Treatment satisfaction

    ITSQ questionnaire

    Measured: 24 weeks

  8. Inflammatory markers

    change in hs C reactive protein

    Measured: 24 weeks

  9. Heart rate variability

    Change in heart rate variability

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2018
  2. Study start1 Jan 2018
  3. Primary completion17 Dec 2019
  4. Study completion1 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03389490
Sponsor's protocol ID
GLARGL08588
Status last verified
Aug 2021
First submitted
26 Dec 2017
Last updated
3 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33738774

  • 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.

    PubMed 33166419

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin Glargine 300 UNT/ML and Neutral protamine hagedorn insulin in people with Diabetes Mellitus, Type 2, run by Elaine Chow at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycemic variability (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03389490, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in