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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-22

Study Completion Date

2019-02-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type I Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin glargine (U300)

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.

Group Type EXPERIMENTAL

INSULIN GLARGINE (U300)

Intervention Type DRUG

Pharmaceutical form: Solution for Injection

Route of administration: Subcutaneous injection

Interventions

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INSULIN GLARGINE (U300)

Pharmaceutical form: Solution for Injection

Route of administration: Subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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Toujeo, HOE901

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No