A Phase 4 interventional study of INSULIN GLARGINE (U300) in Type I Diabetes Mellitus, sponsored by Sanofi. Completed at 11 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Sanofi · Phase 4, Interventional, and Treatment
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:
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.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Self-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.
Drug: INSULIN GLARGINE (U300)
Pharmaceutical form: Solution for Injection Route of administration: Subcutaneous injection
Also known as: Toujeo, HOE901
Mean change in HbA1c
Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 (%)
Time frame: From baseline to Week 24
Mean change in HbA1c
Mean HbA1c change from baseline to Week 12
Time frame: From baseline to Week 12
Mean change in fasting plasma glucose (FPG)
Mean change in FPG from baseline to Week 12 and Week 24
Time frame: From baseline to Week 12 and Week 24
Mean change in fasting SMBG
Mean change in fasting self-monitored blood glucose (SMBG) from baseline to Week 12 and Week 24
Time frame: From baseline to Week 12 and Week 24
Mean change in 8-point SMBG
Mean change in 8-point SMBG from baseline to Week 12 and Week 24
Time frame: From baseline to Week 12 and Week 24
Proportion of patients achieving HbA1c target of <7.0%
Proportion of patients achieving HbA1c target of \<7.0% at Week 12 and Week 24
Time frame: At Weeks 12 and 24
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
Time frame: At Weeks 12 and 24
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
Time frame: From baseline to Week 24
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
Time frame: From baseline to Week 24
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
Time frame: From baseline to Week 24
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
Time frame: From baseline to Week 24
Adverse events (AEs)
Number of adverse events and serious adverse events
Time frame: Up to 28 weeks
Mean change in body weight
Mean change in body weight from baseline to Weeks 12 and 24
Time frame: From baseline to Week 12 and Week 24
Mean change in daily insulin doses
Insulin glargine (U300) dose: Mean change in daily insulin doses (basal, prandial, total) from baseline to Week 24
Time frame: From baseline to Week 24
Number of patients experiencing hypoglycemia
Time frame: Up to 28 weeks
Proportion of patients experiencing hypoglycemia
Time frame: Up to 28 weeks
Number of hypoglycemic events per patient-year
Time frame: Up to 28 weeks
Plan to share: 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
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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