Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL (TOP1)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Type I Diabetes Mellitus

Treatments: Drug: INSULIN GLARGINE (U300)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03406000

GLARGL08200

U1111-1186-2485 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 1 patient group

Insulin glargine (U300)

Experimental group

Description:

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.

Treatment:

Drug: INSULIN GLARGINE (U300)