NCT03406000

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

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.

Conditions

• Type I Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	INSULIN GLARGINE (U300)	Pharmaceutical form: Solution for Injection Route of administration: Subcutaneous injection

Timeline

• Start date: 2018-01-22
• Primary completion: 2019-02-04
• Completion: 2019-02-04
• First posted: 2018-01-23
• Last updated: 2022-04-25

Locations

11 sites across 1 country: Brazil