Status:
COMPLETED
Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL
Lead Sponsor:
Sanofi
Conditions:
Type I Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 i...
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.
Eligibility Criteria
Inclusion
- Inclusion criteria :
- 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.
- Exclusion criteria:
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
January 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2019
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT03406000
Start Date
January 22 2018
End Date
February 4 2019
Last Update
April 25 2022
Active Locations (11)
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1
Investigational Site Number 076013
Campinas, Brazil, 13092-132
2
Investigational Site Number 076016
Curitiba, Brazil, 80030-110
3
Investigational Site Number 076007
Curitiba, Brazil, 80810-140
4
Investigational Site Number 076005
Fortaleza, Brazil