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Type I DiabetesPhase 4NCT06674135

Evaluating the Impact of Introducing Basaglar, a Long-acting Analog Insulin, on Clinical and Quality of Life Outcomes in Youth with Diabetes in Bangladesh

A Phase 4 study testing biosimilar insulin glargine in people with Type I Diabetes, run by Life for a Child Program, Diabetes Australia at 1 site in Bangladesh.

Completed

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

Official record
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Trial summary

This study aimed to determine the effect of introducing Basaglar and insulin pen injection devices on clinical and quality of life (QOL) parameters in children and young adults with type 1 diabetes in Bangladesh Read more about this study

Who is it for?
Ages 10 to 25 years
Conditions the study is for
Type I Diabetes
What is being tested?
biosimilar insulin glargine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
202 participants
Where
1 siteBangladesh
Study dates
1 Jun 2022to 31 Aug 2023
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 10 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Diagnosed with type 1 diabetes (T1D). Diabetes was diagnosed in accordance with World Health Organization (WHO) criteria. Determination of diabetes type was made by the local investigators according to available clinical features and history: T1D was diagnosed upon abrupt onset of typical symptoms of diabetes with insulin required from diagnosis, and no acanthosis nigricans. They were usually non-obese.
  • Duration of T1D at enrolment >12 months
  • Aged 10-25 years (inclusive) at time of enrolment
  • Current insulin regimen consisting of Humulin NPH® and R, or pre-mixed insulin (30/70 R/NPH), with no prior use of analogue insulin
  • Attending Life for a Child, BIRDEM Hospital, Dhaka for their usual diabetes care

Who cannot join

  • Previous use of analog insulin

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

  • BIRDEM, the Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders

    Dhaka

Other trials in Bangladesh

About this study

This study aimed to determine the effect of introducing Basaglar and insulin pen injection devices on clinical and quality of life (QOL) parameters in children and young adults with type 1 diabetes in Bangladesh

Read the detailed description

Analog insulins are widely used in middle- and high-income countries. However, use of analog insulin remains limited in lower-income countries due to their increased cost and lack of access, and human insulin remains the mainstay of treatment in these settings.

Long-acting (basal) analog insulin such as glargine have the benefit of a longer duration (up to 24 hours) and a minimal peak action, and generally, only one injection per day is required. Although glargine insulin has been shown to reduce the risk of overnight hypoglycemia, consistent improvement in blood glucose control (measured by HbA1c) when compared to human insulin has not been shown, and its impact on quality of life is also inconclusive. Furthermore, these studies have all been done in highly resourced countries.

Life for a Child (LFAC) provides diabetes supplies (insulin, syringes, meters and strips for blood glucose self-monitoring), diabetes-related education, mentoring and technical support to the team managing youth with type 1 diabetes (T1D) managed at the Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM) Hospital in Dhaka, Bangladesh. In 2022, LFAC commenced supplying Basaglar (glargine) insulin with insulin pen devices (HumaPen Ergo ll). This provided a unique opportunity to investigate the effect of introducing glargine (Basaglar) insulin in the low-resource setting of Bangladesh.

Conditions
Type I Diabetes
Being tested
biosimilar insulin glargine
Keywords
Analog insulin, Basaglar, Bangladesh, Children and Adolescents, Type 1 diabetes, insulin pen-devices
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • biosimilar insulin glargineDrug

    Also called Basaglar

    Switched to once daily injection of biosimilar insulin glargine via reusable pen and three mealtime bolus insulin injections of short-acting human insulin via needle and syringe

Study groups in NCT06674135
Study groupRoleWhat they receive
Introduction of Basaglar to insulin treatment regimenExperimentalSwitched to once daily injection of biosimilar insulin glargine via reusable pen and three mealtime bolus insulin injections of short-acting human insulin via needle and syringe
Receives: Drug: biosimilar insulin glargine

What is being measured

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

  1. Mean and median HbA1c (% and mmol/mol)

    HbA1c was measured at each study time point using the Minicap Sebia Autoanalyzer with venous blood

    Measured: Baseline, 3-, 6-, 9- and 12-month follow-up visits

Secondary outcomes (4)

  1. Proportion of participants experiencing episodes of diabetic ketoacidosis

    Diabetic ketoacidosis was defined as hyperglycaemia (BGL>11mmol/L/200mg/dL) with a venous pH<7·3 or serum bicarbonate <15mmol/L and ketonaemia and ketonuria

    Measured: Baseline, 3-, 6-, 9- and 12-month follow-up visits

  2. Proportion of participants experiencing episodes of severe hypoglycaemia

    Severe hypoglycaemia was defined as an event with severe cognitive impairment (with or without coma and convulsions) requiring assistance by another person to administer carbohydrates, glucagon, or intravenous dextrose to restore glycaemia

    Measured: Baseline, 3-, 6-, 9- and 12-month follow-up visits

  3. Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)

    The 21- item Diabetes Quality of Life in Youth - Short Form scale [1] was administered to participants to assess their health-related quality of life after the change in their insulin treatment regimen.

    Each item has 5 possible scores with a value from 0 to 4, with 0 representing "never" and 4 "all the time". Higher scores represent a higher impact of diabetes and a poorer quality of life; lower scores indicate greater quality of life. The highest possible score is 84 (21 x 4 i.e. "all the time" for all 21 items) and lowest possible score is 0 (21 x 0 i.e. "never" for all 21 items)

    Measured: Baseline, 6- and 12-month follow-up visits

  4. Participant self-reported satisfaction

    A 5-item structured questionnaire was administered to participants in the intervention group to evaluate their satisfaction with the new insulin regimen, experience of using reusable insulin pens, and their experience of hypo- and hyperglycaemic episodes over the study period

    Measured: 12-month follow-up visit

Timeline

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

  1. First posted5 Nov 2024
  2. Study start1 Jun 2022
  3. Primary completion31 Aug 2023
  4. Study completion31 Aug 2023

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06674135
Sponsor's protocol ID
BADAS-ERC/EC/22/00325
Status last verified
Nov 2024
First submitted
3 Nov 2024
Last updated
7 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Due local privacy regulations, individual de-identified participant data will not be shared

Publications

  • Skinner TC, Hoey H, McGee HM, Skovlund SE; Hvidore Study Group on Childhood Diabetes. A short form of the Diabetes Quality of Life for Youth questionnaire: exploratory and confirmatory analysis in a sample of 2,077 young people with type 1 diabetes mellitus. Diabetologia. 2006 Apr;49(4):621-8. doi: 10.1007/s00125-005-0124-0. Epub 2006 Jan 26.

    PubMed 16525844

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing biosimilar insulin glargine in people with Type I Diabetes, run by Life for a Child Program, Diabetes Australia at 1 site in Bangladesh.

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 5 inclusion and 1 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 7 Nov 2024. 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 Bangladesh. 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?

Mean and median HbA1c (% and mmol/mol) (time frame: Baseline, 3-, 6-, 9- and 12-month follow-up visits). 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 NCT06674135, which also lists 1 linked publication.

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 7 Nov 2024.

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