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Type I Diabetes MellitusPhase 4TOP1NCT03406000

Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL

A Phase 4 study testing INSULIN GLARGINE (U300) in people with Type I Diabetes Mellitus, run by Sanofi at 11 sites in Brazil.

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

Primary Objective: To evaluate the efficacy of switching treatment from twice-daily basal insulin to once-daily insulin glargine (U300) as part of basal bolus regime in terms of glycated hemoglobin improvement (reduction by at least 0.3%), in uncontrolled type 1 diabetes mellitus patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type I Diabetes Mellitus
What is being tested?
INSULIN GLARGINE (U300)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
11 sitesBrazil
Study dates
22 Jan 2018to 4 Feb 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or Female.
  • Age ≥ 18 years.
  • With Type 1 diabetes mellitus.
  • Being treated twice-daily with any basal insulin in combination with prandial rapid-acting insulin analogue for at least one year.
  • Have an glycated hemoglobin (HbA1c) measurement of 7.5% - 10.0% at study entry.
  • Patients who have signed an Informed Consent Form.

Who cannot join

  • Type 2 diabetes mellitus.
  • Known hypoglycemia unawareness
  • Repeated episodes of severe hypoglycemia or diabetes ketoacidosis within the last 12 months.
  • End-stage renal failure or being on hemodialysis.
  • Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening or baseline, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study.
  • Known hypersensitivity / intolerance to insulin glargine or any of its excipients.
Show all 12Show fewer
  • Patients treated with glucagon like peptide agonists.
  • Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 90 days prior to the time of screening.
  • Pregnant or lactating women.
  • Women of childbearing potential with no effective contraceptive method.
  • Participation in another clinical trial.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Brazil11 sites

  • Investigational Site Number 076013

    Campinas, 13092-132

  • Investigational Site Number 076016

    Curitiba, 80030-110

  • Investigational Site Number 076007

    Curitiba, 80810-140

  • Investigational Site Number 076005

    Fortaleza

  • Investigational Site Number 076002

    Goiânia, 74175-100

  • Investigational Site Number 076004

    Porto Alegre, 91350-250

  • Investigational Site Number 076011

    Ribeirão Preto, 14049900

  • Investigational Site Number 076006

    São José dos Campos, 12243-280

  • Investigational Site Number 076015

    São Paulo, 04022-001

  • Investigational Site Number 076012

    São Paulo, 05403-000

  • Investigational Site Number 076001

    São Paulo

Other trials in Brazil

About this study

Official title: A 28-week, Prospective, Single-arm, Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL in Combination With Prandial Rapid-acting Insulin Analogue in Patients With Type 1 Diabetes Previously Uncontrolled on Twice-daily Basal Insulin as Part of Basal-bolus Therapy

Primary Objective:

To evaluate the efficacy of switching treatment from twice-daily basal insulin to once-daily insulin glargine (U300) as part of basal bolus regime in terms of glycated hemoglobin improvement (reduction by at least 0.3%), in uncontrolled type 1 diabetes mellitus patients.

Secondary Objectives:

  • To evaluate other efficacy parameters in terms of glycemic control as well as safety including hypoglycemia events, weight changes, and adverse events.
  • To evaluate the effect of insulin glargine (U300) on diabetes treatment satisfaction and fear of hypoglycemia as well as patient's satisfaction regarding the number of daily injections.
Read the detailed description

The estimated average study duration is 29 weeks, including run-in period of 4 weeks; treatment period of 24 weeks, and follow-up period of 1 week.

Being tested
INSULIN GLARGINE (U300)
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 (U300)Drug

    Also called Toujeo, HOE901

    Pharmaceutical form: Solution for Injection

    Route of administration: Subcutaneous injection

Study groups in NCT03406000
Study groupRoleWhat they receive
Insulin glargine (U300)ExperimentalSelf-administered subcutaneously once daily in the morning, at the same time.The initial dose for patients switching from insulin glargine is 80% of the total daily dose of basal insulin agent that was discontinued. Thereafter, insulin glargine (U300) will follow a titration algorithm for dose adjustment.
Receives: Drug: INSULIN GLARGINE (U300)

What is being measured

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

  1. Mean change in HbA1c

    Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 (%)

    Measured: From baseline to Week 24

Secondary outcomes (16)

  1. Mean change in HbA1c

    Mean HbA1c change from baseline to Week 12

    Measured: From baseline to Week 12

  2. Mean change in fasting plasma glucose (FPG)

    Mean change in FPG from baseline to Week 12 and Week 24

    Measured: From baseline to Week 12 and Week 24

  3. Mean change in fasting SMBG

    Mean change in fasting self-monitored blood glucose (SMBG) from baseline to Week 12 and Week 24

    Measured: From baseline to Week 12 and Week 24

  4. Mean change in 8-point SMBG

    Mean change in 8-point SMBG from baseline to Week 12 and Week 24

    Measured: From baseline to Week 12 and Week 24

  5. Proportion of patients achieving HbA1c target of <7.0%

    Proportion of patients achieving HbA1c target of <7.0% at Week 12 and Week 24

    Measured: At Weeks 12 and 24

  6. Proportion of patients achieving HbA1c target of <7.0% without hypoglycemia event

    Proportion of patients achieving HbA1c target of <7.0% without hypoglycemia event during the last 4 weeks of treatment

    Measured: At Weeks 12 and 24

  7. Proportion of patients achieving HbA1c improvement of at least 0.3% without nocturnal hypoglycemia

    Proportion of patients achieving HbA1c improvement from baseline to week 24 of at least 0.3% without nocturnal hypoglycemia (documented <70 mg/dL) and/or severe hypoglycemia (between 00.00 and 05:59 am SMBG) during the last 4 weeks of treatment

    Measured: From baseline to Week 24

  8. Proportion of patients with any improvement in HbA1c

    Proportion of patients with any improvement in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia (nocturnal defined as time between 00.00 and 05:59 am) evaluated from baseline to Week 24

    Measured: From baseline to Week 24

  9. Proportion of patients with no deterioration in HbA1c

    Proportion of patients with no deterioration in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia

    Measured: From baseline to Week 24

  10. Proportion of patients with no deterioration in HbA1c

    Proportion of patients with no deterioration in HbA1c from baseline to week 24 and no increase in occurrence of nocturnal hypoglycemia

    Measured: From baseline to Week 24

  11. Adverse events (AEs)

    Number of adverse events and serious adverse events

    Measured: Up to 28 weeks

  12. Mean change in body weight

    Mean change in body weight from baseline to Weeks 12 and 24

    Measured: From baseline to Week 12 and Week 24

  13. Mean change in daily insulin doses

    Insulin glargine (U300) dose: Mean change in daily insulin doses (basal, prandial, total) from baseline to Week 24

    Measured: From baseline to Week 24

  14. Number of patients experiencing hypoglycemia

    Measured: Up to 28 weeks

  15. Proportion of patients experiencing hypoglycemia

    Measured: Up to 28 weeks

  16. Number of hypoglycemic events per patient-year

    Measured: Up to 28 weeks

Timeline

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

  1. First posted23 Jan 2018
  2. Study start22 Jan 2018
  3. Primary completion4 Feb 2019
  4. Study completion4 Feb 2019

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
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03406000
Sponsor's protocol ID
GLARGL08200
Other IDs
U1111-1186-2485
Acronym
TOP1
Status last verified
Apr 2022
First submitted
15 Jan 2018
Last updated
25 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Dualib PM, Dib SA, Augusto GA, Truzzi AC, de Paula MA, Rea RR. Effect of switching from twice-daily basal insulin to once-daily insulin glargine 300 U/mL (Gla-300) in Brazilian people with type 1 diabetes. Diabetol Metab Syndr. 2024 Jul 9;16(1):152. doi: 10.1186/s13098-024-01385-x.

    PubMed 38982528

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing INSULIN GLARGINE (U300) in people with Type I Diabetes Mellitus, run by Sanofi at 11 sites in Brazil.

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 6 inclusion and 12 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 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Brazil. 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 change in HbA1c (time frame: From baseline to Week 24). 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 NCT03406000, 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 25 Apr 2022.

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