Type 1 DiabetesPhase 4NCT06717191
Impact of Introducing Basaglar Insulin to the Treatment Regimen of Youth With Diabetes in Pakistan
A Phase 4 study testing biosimilar insulin glargine in people with Type 1 Diabetes, run by Life for a Child Program, Diabetes Australia at 1 site in Pakistan.
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 Pakistan Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Type 1 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
- 296 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Jun 2022to 2 Aug 2024
- 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 Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with type 1 diabetes according to a combination of clinical (polyuria, polydipsia, and weight loss) and biochemical characteristics (High blood glucose levels (fasting glucose ≥ 126 mg/dL or random glucose ≥ 200 mg/dL) and/or C-peptide levels indicating low insulin production, along with the presence of islet autoantibodies (e.g., GAD65, IA-2))
- Duration of T1D ≥ 12 months at time of enrolment
- Willing to conduct self-monitoring of blood glucose (SMBG) at least twice daily
- No prior use of analog insulin (either long-acting or short-acting)
- Attending BIDE for their routine diabetes care and management
- No history of other significant medical conditions (e.g., severe renal disease or other autoimmune conditions)
- Willing to adhere to the study protocol, including attending follow-up visits and participating in the required education sessions
Who cannot join
- Prior use of analog insulin
- Other medical conditions that would interfere with study participation
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Baqai Institute of Diabetology and Endocrinology (BIDE)
Karachi, Sindh, 74600
About this study
Official title: Evaluating the Impact of Introducing Basaglar, a Long-acting Analog Insulin, on Clinical and Quality of Life Outcomes in Youth With Diabetes in Pakistan
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 Pakistan
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 Baqai Institute of Diabetology and Endocrinology (BIDE) in Karachi, Pakistan. 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 Pakistan.
- Conditions
- Type 1 Diabetes
- Being tested
- biosimilar insulin glargine
- Keywords
- Analog insulin, Basaglar, Pakistan, 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 group | Role | What they receive |
|---|---|---|
| Introduction of Basaglar to insulin treatment regimen | Experimental | 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 Receives: Drug: biosimilar insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean and median HbA1c (% and mmol/mol)
HbA1c was measured at each study time point using High Performance Liquid Chromatography (HPLC (BIO-RAD, D10))
Measured: Baseline, 3-, 6-, 9- and 12-month follow-up visits
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
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
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start9 Jun 2022
- Primary completion15 Jun 2024
- Study completion2 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Life for a Child Program, Diabetes Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Baqai Institute of Diabetology and Endocrinology
- Responsible party
- Sponsor
- Investigators
- Prof. Asher Fawwad, Principal investigator, Baqai Insitute of Diabetology and Endocrinology (BIDE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717191
- Sponsor's protocol ID
- PROF.DR.FAWWAD/006/08/22/0157
- Status last verified
- Jul 2025
- First submitted
- 1 Dec 2024
- Last updated
- 30 Jul 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Due to local privacy regulations, individual de-identified participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Introducing Basaglar, a Long-acting Analog Insulin, on Clinical and Quality of Life Outcomes in Youth With Diabetes in Pakistan
- ClinicalTrials.gov ID
- NCT06717191
- Acronym / sponsor ID
- PROF.DR.FAWWAD/006/08/22/0157
- Conditions
- Type 1 Diabetes
- Keywords
- Analog insulin, Basaglar, Pakistan, Children and Adolescents, Type 1 diabetes, insulin pen-devices
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Life for a Child Program, Diabetes AustraliaUniversity, hospital or other
- Collaborators
- Baqai Institute of Diabetology and Endocrinology
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Pakistan
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 Baqai Institute of Diabetology and Endocrinology (BIDE) in Karachi, Pakistan. 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 Pakistan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Introduction of Basaglar to insulin treatment regimen | Experimental | Drug: biosimilar insulin glargineSwitched 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 |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Diagnosed with type 1 diabetes according to a combination of clinical (polyuria, polydipsia, and weight loss) and biochemical characteristics (High blood glucose levels (fasting glucose ≥ 126 mg/dL or random glucose ≥ 200 mg/dL) and/or C-peptide levels indicating low insulin production, along with the presence of islet autoantibodies (e.g., GAD65, IA-2))
- Duration of T1D ≥ 12 months at time of enrolment
- Willing to conduct self-monitoring of blood glucose (SMBG) at least twice daily
- No prior use of analog insulin (either long-acting or short-acting)
- Attending BIDE for their routine diabetes care and management
Key exclusion criteria (2 listed)
- Prior use of analog insulin
- Other medical conditions that would interfere with study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biosimilar insulin glargineAlso: BasaglarSwitched 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 | Drug | Introduction of Basaglar to insulin treatment regimen |
Primary outcome
Mean and median HbA1c (% and mmol/mol)
Time frame: Baseline, 3-, 6-, 9- and 12-month follow-up visits
HbA1c was measured at each study time point using High Performance Liquid Chromatography (HPLC (BIO-RAD, D10))
Proportion of participants experiencing episodes of severe hypoglycaemia
Time frame: Baseline, 3-, 6-, 9- and 12-month follow-up visits
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
Proportion of participants experiencing episodes of diabetic ketoacidosis
Time frame: Baseline, 3-, 6-, 9- and 12-month follow-up visits
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
1 secondary outcome
Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)
Time frame: Baseline, 6- and 12-month follow-up visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No. Due to local privacy regulations, individual de-identified participant data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Asher Fawwad principal investigator
Baqai Insitute of Diabetology and Endocrinology (BIDE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing biosimilar insulin glargine in people with Type 1 Diabetes, run by Life for a Child Program, Diabetes Australia at 1 site in Pakistan.
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 7 inclusion and 2 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 30 Jul 2025. 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 Pakistan. 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2025.