Type 1 Diabetes MellitusPhase 4NCT07872475

Randomized Transition to Gla-300 in Pediatric Type 1 Diabetes: CGM-Derived Outcomes

A Phase 4 study testing Insulin glargine U-300 in people with Type 1 Diabetes Mellitus, run by Marmara University at 1 site in Turkey (Türkiye).

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

Who is it for?: Ages 6 to 18 years
Conditions the study is for: Type 1 Diabetes Mellitus
What is being tested?: Insulin glargine U-300
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 May 2025to 1 May 2026
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 6 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Children and adolescents aged 6-18 years with type 1 diabetes mellitus.
Treatment with insulin glargine U-100 as basal insulin before study enrollment.
Use of a continuous glucose monitoring (CGM) system with sufficient sensor data for assessment of glycemic outcomes.
Written informed consent from the parent/legal guardian and assent from the participant, when applicable.

Who cannot join

Presence of a significant chronic disease other than type 1 diabetes that could affect glycemic control or insulin requirements.
Use of medications known to significantly affect glucose metabolism.
Acute diabetic complications or severe intercurrent illness at enrollment.
Inadequate CGM data for assessment of study outcomes.
Inability or unwillingness of the participant or family to comply with the study procedures.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Marmara University School of Mecidine
Istanbul, Maltepe, 34854

Other trials in Turkey (Türkiye)

About this study

Official title: Optimizing the Transition to Insulin Glargine U-300 in Children and Adolescents With Type 1 Diabetes: A Randomized Study of Initial Dose Strategies and Longitudinal CGM-Derived Glycemic Outcomes

This study evaluated two different starting dose strategies when switching children and adolescents with type 1 diabetes from insulin glargine U-100 to insulin glargine U-300. Participants were randomly assigned to start insulin glargine U-300 either at the same basal insulin dose they had been using or at a 20% higher dose. Continuous glucose monitoring data were used to compare glucose control and hypoglycemia before and after the switch. Participants were also followed to evaluate longer-term changes in glucose control and insulin requirements

Read the detailed description

Insulin glargine U-300 has a more prolonged and stable pharmacokinetic and pharmacodynamic profile than insulin glargine U-100. However, the optimal initial dose when switching children and adolescents with type 1 diabetes from insulin glargine U-100 to U-300 has not been clearly established.

In this randomized study, participants were assigned to switch from insulin glargine U-100 to U-300 either at the same basal insulin dose or at a 20% higher initial dose. Continuous glucose monitoring data obtained before and after the switch were used to evaluate early changes in glycemic control, including time in range, time above range, and time below range, with particular attention to nighttime glucose control and hypoglycemia.

A subset of participants with adequate continuous glucose monitoring data was also followed at 3 and 6 months to evaluate longer-term glycemic outcomes, insulin requirements, and changes in anthropometric measures.

Conditions: Type 1 Diabetes Mellitus
Being tested: Insulin glargine U-300
Keywords: Type 1 diabetes, children and adolescents, continuous glucose monitoring, insulin glargine U-300, basal insulin, transition strategy
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.

Insulin glargine U-300Drug
Insulin glargine U-300 was administered once daily as basal insulin. Participants switched from insulin glargine U-100 to insulin glargine U-300 using either the same basal insulin dose or an initial dose 20% higher than their previous U-100 dose, according to randomized group assignment. Subsequent dose adjustments were made according to glycemic control.

Study groups in NCT07872475
Study group	Role	What they receive
Same-dose group	Active comparator	Participants switched from insulin glargine U-100 to insulin glargine U-300 at the same initial basal insulin dose. Receives: Drug: Insulin glargine U-300
20% higher-dose group	Experimental	Participants switched from insulin glargine U-100 to insulin glargine U-300 at an initial basal insulin dose 20% higher than their previous insulin glargine U-100 dose. Receives: Drug: Insulin glargine U-300

What is being measured

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

Early glycemic outcomes after switching from insulin glargine U-100 to U-300
Glycemic outcomes were assessed using continuous glucose monitoring (CGM) data during the 2 weeks before and 2 weeks after switching from insulin glargine U-100 to insulin glargine U-300. CGM metrics included time in range (70-180 mg/dL), time above range (>180 and >250 mg/dL), time below range (<70 and <54 mg/dL), mean sensor glucose, and coefficient of variation. Early glycemic outcomes were also compared between participants randomized to the same-dose and 20% higher initial dose strategies.
Measured: 2 weeks before and 2 weeks after switching from insulin glargine U-100 to U-300

Secondary outcomes (1)

Long-term glycemic outcomes after switching to insulin glargine U-300
Glycemic control was evaluated at 3 and 6 months after switching from insulin glargine U-100 to insulin glargine U-300 using HbA1c and CGM-derived glycemic metrics, including time in range, time above range, time below range, mean sensor glucose, and coefficient of variation.
Measured: Baseline, 3 months, and 6 months after switching to insulin glargine U-300

Timeline

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

1 May 20251 May 2026

First posted13 Oct 2026
Study start1 May 2025
Primary completion1 Nov 2025
Study completion1 May 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Marmara UniversityThe sponsor's other registered studies.
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: Randomised
Intervention model: Parallel groups
Model description: Participants were randomized in a 1:1 ratio to two parallel groups when switching from insulin glargine U-100 to U-300: either the same basal insulin dose or a 20% higher initial basal insulin dose.
Masking: None (open label)
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07872475
Sponsor's protocol ID: 09.2025.25-0319
Status last verified: Oct 2026
First submitted: 7 Oct 2026
Last updated: 13 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: De-identified individual participant data underlying the results reported in the published article may be made available upon reasonable request to the corresponding author, subject to institutional and ethical requirements.

Publications

Danne T, Tamborlane WV, Malievsky OA, Franco DR, Kawamura T, Demissie M, Niemoeller E, Goyeau H, Wardecki M, Battelino T. Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6-17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial. Diabetes Care. 2020 Jul;43(7):1512-1519. doi: 10.2337/dc19-1926. Epub 2020 May 19.
PubMed 32430458
Matsuhisa M, Koyama M, Cheng X, Takahashi Y, Riddle MC, Bolli GB, Hirose T; EDITION JP 1 study group. New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese adults with type 1 diabetes using basal and mealtime insulin: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 1). Diabetes Obes Metab. 2016 Apr;18(4):375-83. doi: 10.1111/dom.12619. Epub 2016 Feb 1.
PubMed 26662964
Golz S, Mader JK, Bilz S, Kenzler J, Danne T. Safety and Effectiveness of Glargine 300 U/ml After Switching from Basal Insulins in Patients with Type 1 Diabetes: COMET-T Study. Diabetes Ther. 2025 Jan;16(1):121-134. doi: 10.1007/s13300-024-01670-y. Epub 2024 Dec 2.
PubMed 39621296
Pettus J, Gill J, Paranjape S, Stewart J, Malla S, Edelman S, Bergenstal RM, Bode B. Efficacy and safety of a morning injection of insulin glargine 300 units/mL versus insulin glargine 100 units/mL in adult patients with type 1 diabetes: A multicentre, randomized controlled trial using continuous glucose monitoring. Diabetes Obes Metab. 2019 Aug;21(8):1906-1913. doi: 10.1111/dom.13751. Epub 2019 May 9.
PubMed 30993855
Rabbone I, Pozzi E, Savastio S, Luca G, Elisa M, Giulio F, Bolli GB, Bonfanti R. A comparison of the effectiveness and safety of insulin glargine 300 U/ml versus 100 U/ml in children and adolescents with newly diagnosed type 1 diabetes: A retrospective, observational, short-term study. Diabetes Obes Metab. 2022 Dec;24(12):2474-2477. doi: 10.1111/dom.14839. Epub 2022 Sep 5. No abstract available.
PubMed 35971275
Rabbone I, Bonfanti R, Graziano G, Lombardo F, Nicolucci A, Marigliano M, Rossi MC, Vespasiani G, Cherubini V. Comparative Effectiveness of Switching From First-Generation Basal Insulins to Either Glargine 300 U/mL or Degludec 100 U/mL in Children and Adolescents With Type 1 Diabetes: Results From the ISPED CARD Clinical Registry. Pediatr Diabetes. 2025 Nov 21;2025:5514402. doi: 10.1155/pedi/5514402. eCollection 2025.
PubMed 41323155
Pozzi E, Savastio S, Ricotti R, Zanetta S, Rabbone I. Effectiveness and safety of glargine 300 U/mL versus glargine 100 U/mL in a cohort of patients with type 1 diabetes. Pediatr Diabetes. 2021;22(suppl 30):eP136. doi:10.1111/pedi.13269.
Rossi MC, Bonfanti R, Graziano G, Larosa M, Lombardo F, Nicolucci A, Vespasiani G, Zucchini S, Rabbone I; ISPED CARD Study Group. Effectiveness of switching from first-generation basal insulin to Glargine 300 U/mL in children and adolescents with type 1 diabetes: results from the ISPED CARD database. Acta Diabetol. 2024 Sep;61(9):1169-1176. doi: 10.1007/s00592-024-02304-2. Epub 2024 May 24.
PubMed 38789610
Al Hayek AA, Alwin Robert A, Al Saeed AH, Al Dawish MA. Evaluation of Patient Reported Satisfaction and Clinical Efficacy of Insulin Glargine 300 U/mL Versus 100 U/mL in Patients With Type 1 Diabetes Using Flash Glucose Monitoring System. Clin Med Insights Endocrinol Diabetes. 2022 May 18;15:11795514221098415. doi: 10.1177/11795514221098415. eCollection 2022.
PubMed 35601879
Home PD, Bergenstal RM, Bolli GB, Ziemen M, Rojeski M, Espinasse M, Riddle MC. Glycaemic control and hypoglycaemia during 12 months of randomized treatment with insulin glargine 300 U/mL versus glargine 100 U/mL in people with type 1 diabetes (EDITION 4). Diabetes Obes Metab. 2018 Jan;20(1):121-128. doi: 10.1111/dom.13048. Epub 2017 Aug 8.
PubMed 28661585
Jinnouchi H, Koyama M, Amano A, Takahashi Y, Yoshida A, Hieshima K, Sugiyama S, Kurinami N, Jinnouchi T, Becker R. Continuous Glucose Monitoring During Basal-Bolus Therapy Using Insulin Glargine 300 U mL(-1) and Glargine 100 U mL (-1) in Japanese People with Type 1 Diabetes Mellitus: A Crossover Pilot Study. Diabetes Ther. 2015 Jun;6(2):143-52. doi: 10.1007/s13300-015-0115-1. Epub 2015 Jun 9.
PubMed 26055218
Pang T, Bain SC, Black RNA, Boyle JG, Elliott J, Holcombe A, Lee KCS, Mulligan C, Saunders L, Yousseif A, Baxter M. A multicentre, UK, retrospective, observational study to assess the effectiveness of insulin glargine 300 units/ml in treating people with Type 1 diabetes mellitus in routine clinical practice (SPARTA). Diabet Med. 2019 Jan;36(1):110-119. doi: 10.1111/dme.13847. Epub 2018 Nov 16.
PubMed 30362181
Oriot P, Jeremie W, Buysschaert M. Outcomes of glycemic control in type 1 diabetic patients switched from basal insulin glargine 100 U/ml to glargine 300 U/ml in real life. Expert Rev Endocrinol Metab. 2018 May;13(3):167-171. doi: 10.1080/17446651.2018.1469405. Epub 2018 May 2.
PubMed 30058899
Mathieu C, Weisnagel SJ, Stella P, Bruhwyler J, Alexandre K. Impact of Switching from Twice-Daily Basal Insulin to Once-Daily Insulin Glargine 300 U/mL in People with Type 1 Diabetes on Basal-Bolus Insulin: Phase 4 OPTIMIZE Study. Diabetes Ther. 2020 Feb;11(2):495-507. doi: 10.1007/s13300-019-00749-1. Epub 2020 Jan 10.
PubMed 31925722
Matsuhisa M, Odawara M, Hirose T, Koshida R, Senda M, Tanaka Y, Terauchi Y. Real-world data on the use of insulin glargine 300 U/mL in Japanese patients with type 1 diabetes: twelve-month results from a post-marketing surveillance study (X-STAR study). Expert Opin Pharmacother. 2021 Feb;22(2):249-256. doi: 10.1080/14656566.2020.1810665. Epub 2020 Aug 25.
PubMed 32840155

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing the Transition to Insulin Glargine U-300 in Children and Adolescents With Type 1 Diabetes: A Randomized Study of Initial Dose Strategies and Longitudinal CGM-Derived Glycemic Outcomes
ClinicalTrials.gov ID: NCT07872475
Acronym / sponsor ID: 09.2025.25-0319
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 diabetes, children and adolescents, continuous glucose monitoring, insulin glargine U-300, basal insulin, transition strategy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Marmara UniversityUniversity, hospital or other
Study start: 1 May 2025 (actual)
Primary completion: 1 Nov 2025 (actual)
Study completion: 1 May 2026 (actual)
First posted: 13 Oct 2026 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants were randomized in a 1:1 ratio to two parallel groups when switching from insulin glargine U-100 to U-300: either the same basal insulin dose or a 20% higher initial basal insulin dose.

Arm	Type	Receives
Same-dose group	Active comparator	Drug: Insulin glargine U-300Participants switched from insulin glargine U-100 to insulin glargine U-300 at the same initial basal insulin dose.
20% higher-dose group	Experimental	Drug: Insulin glargine U-300Participants switched from insulin glargine U-100 to insulin glargine U-300 at an initial basal insulin dose 20% higher than their previous insulin glargine U-100 dose.

Who may qualify

Ages: 6 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

Children and adolescents aged 6-18 years with type 1 diabetes mellitus.
Treatment with insulin glargine U-100 as basal insulin before study enrollment.
Use of a continuous glucose monitoring (CGM) system with sufficient sensor data for assessment of glycemic outcomes.
Written informed consent from the parent/legal guardian and assent from the participant, when applicable.

Key exclusion criteria (5 listed)

Presence of a significant chronic disease other than type 1 diabetes that could affect glycemic control or insulin requirements.
Use of medications known to significantly affect glucose metabolism.
Acute diabetic complications or severe intercurrent illness at enrollment.
Inadequate CGM data for assessment of study outcomes.
Inability or unwillingness of the participant or family to comply with the study procedures.

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
Insulin glargine U-300Insulin glargine U-300 was administered once daily as basal insulin. Participants switched from insulin glargine U-100 to insulin glargine U-300 using either the same basal insulin dose or an initial dose 20% higher than their previous U-100 dose, according to randomized group assignment. Subsequent dose adjustments were made according to glycemic control.	Drug	20% higher-dose group, Same-dose group

Primary outcome

Early glycemic outcomes after switching from insulin glargine U-100 to U-300
Time frame: 2 weeks before and 2 weeks after switching from insulin glargine U-100 to U-300
Glycemic outcomes were assessed using continuous glucose monitoring (CGM) data during the 2 weeks before and 2 weeks after switching from insulin glargine U-100 to insulin glargine U-300. CGM metrics included time in range (70-180 mg/dL), time above range (>180 and >250 mg/dL), time below range (<70 and <54 mg/dL), mean sensor glucose, and coefficient of variation. Early glycemic outcomes were also compared between participants randomized to the same-dose and 20% higher initial dose strategies.

1 secondary outcome

Long-term glycemic outcomes after switching to insulin glargine U-300
Time frame: Baseline, 3 months, and 6 months after switching to insulin glargine U-300

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 13 Oct 2026.
Background: PubMed 32430458Danne T, Tamborlane WV, Malievsky OA, Franco DR, Kawamura T, Demissie M, Niemoeller E, Goyeau H, Wardecki M, Battelino T. Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6-17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial. Diabetes Care. 2020 Jul;43(7):1512-1519. doi: 10.2337/dc19-1926. Epub 2020 May 19.
Background: PubMed 26662964Matsuhisa M, Koyama M, Cheng X, Takahashi Y, Riddle MC, Bolli GB, Hirose T; EDITION JP 1 study group. New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese adults with type 1 diabetes using basal and mealtime insulin: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 1). Diabetes Obes Metab. 2016 Apr;18(4):375-83. doi: 10.1111/dom.12619. Epub 2016 Feb 1.
Background: PubMed 39621296Golz S, Mader JK, Bilz S, Kenzler J, Danne T. Safety and Effectiveness of Glargine 300 U/ml After Switching from Basal Insulins in Patients with Type 1 Diabetes: COMET-T Study. Diabetes Ther. 2025 Jan;16(1):121-134. doi: 10.1007/s13300-024-01670-y. Epub 2024 Dec 2.
Background: PubMed 30993855Pettus J, Gill J, Paranjape S, Stewart J, Malla S, Edelman S, Bergenstal RM, Bode B. Efficacy and safety of a morning injection of insulin glargine 300 units/mL versus insulin glargine 100 units/mL in adult patients with type 1 diabetes: A multicentre, randomized controlled trial using continuous glucose monitoring. Diabetes Obes Metab. 2019 Aug;21(8):1906-1913. doi: 10.1111/dom.13751. Epub 2019 May 9.
Background: PubMed 35971275Rabbone I, Pozzi E, Savastio S, Luca G, Elisa M, Giulio F, Bolli GB, Bonfanti R. A comparison of the effectiveness and safety of insulin glargine 300 U/ml versus 100 U/ml in children and adolescents with newly diagnosed type 1 diabetes: A retrospective, observational, short-term study. Diabetes Obes Metab. 2022 Dec;24(12):2474-2477. doi: 10.1111/dom.14839. Epub 2022 Sep 5. No abstract available.
Background: PubMed 41323155Rabbone I, Bonfanti R, Graziano G, Lombardo F, Nicolucci A, Marigliano M, Rossi MC, Vespasiani G, Cherubini V. Comparative Effectiveness of Switching From First-Generation Basal Insulins to Either Glargine 300 U/mL or Degludec 100 U/mL in Children and Adolescents With Type 1 Diabetes: Results From the ISPED CARD Clinical Registry. Pediatr Diabetes. 2025 Nov 21;2025:5514402. doi: 10.1155/pedi/5514402. eCollection 2025.
BackgroundPozzi E, Savastio S, Ricotti R, Zanetta S, Rabbone I. Effectiveness and safety of glargine 300 U/mL versus glargine 100 U/mL in a cohort of patients with type 1 diabetes. Pediatr Diabetes. 2021;22(suppl 30):eP136. doi:10.1111/pedi.13269.
Background: PubMed 38789610Rossi MC, Bonfanti R, Graziano G, Larosa M, Lombardo F, Nicolucci A, Vespasiani G, Zucchini S, Rabbone I; ISPED CARD Study Group. Effectiveness of switching from first-generation basal insulin to Glargine 300 U/mL in children and adolescents with type 1 diabetes: results from the ISPED CARD database. Acta Diabetol. 2024 Sep;61(9):1169-1176. doi: 10.1007/s00592-024-02304-2. Epub 2024 May 24.
Background: PubMed 35601879Al Hayek AA, Alwin Robert A, Al Saeed AH, Al Dawish MA. Evaluation of Patient Reported Satisfaction and Clinical Efficacy of Insulin Glargine 300 U/mL Versus 100 U/mL in Patients With Type 1 Diabetes Using Flash Glucose Monitoring System. Clin Med Insights Endocrinol Diabetes. 2022 May 18;15:11795514221098415. doi: 10.1177/11795514221098415. eCollection 2022.
Background: PubMed 28661585Home PD, Bergenstal RM, Bolli GB, Ziemen M, Rojeski M, Espinasse M, Riddle MC. Glycaemic control and hypoglycaemia during 12 months of randomized treatment with insulin glargine 300 U/mL versus glargine 100 U/mL in people with type 1 diabetes (EDITION 4). Diabetes Obes Metab. 2018 Jan;20(1):121-128. doi: 10.1111/dom.13048. Epub 2017 Aug 8.
Background: PubMed 26055218Jinnouchi H, Koyama M, Amano A, Takahashi Y, Yoshida A, Hieshima K, Sugiyama S, Kurinami N, Jinnouchi T, Becker R. Continuous Glucose Monitoring During Basal-Bolus Therapy Using Insulin Glargine 300 U mL(-1) and Glargine 100 U mL (-1) in Japanese People with Type 1 Diabetes Mellitus: A Crossover Pilot Study. Diabetes Ther. 2015 Jun;6(2):143-52. doi: 10.1007/s13300-015-0115-1. Epub 2015 Jun 9.
Background: PubMed 30362181Pang T, Bain SC, Black RNA, Boyle JG, Elliott J, Holcombe A, Lee KCS, Mulligan C, Saunders L, Yousseif A, Baxter M. A multicentre, UK, retrospective, observational study to assess the effectiveness of insulin glargine 300 units/ml in treating people with Type 1 diabetes mellitus in routine clinical practice (SPARTA). Diabet Med. 2019 Jan;36(1):110-119. doi: 10.1111/dme.13847. Epub 2018 Nov 16.
Individual participant dataSharing planned: Undecided. De-identified individual participant data underlying the results reported in the published article may be made available upon reasonable request to the corresponding author, subject to institutional and ethical requirements.

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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.

Belma Haliloglu, Prof.,M.D.,PhD principal investigator

Marmara University

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 Insulin glargine U-300 in people with Type 1 Diabetes Mellitus, run by Marmara University at 1 site in Turkey (Türkiye).

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 4 inclusion and 5 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 13 Oct 2026. 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 Turkey (Türkiye). 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?

Early glycemic outcomes after switching from insulin glargine U-100 to U-300 (time frame: 2 weeks before and 2 weeks after switching from insulin glargine U-100 to U-300). 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 NCT07872475, which also lists 15 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 13 Oct 2026.