Clinical trial NCT03406000: Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type I Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2018-01-23
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility 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.

Primary outcomes:
measure: Mean change in HbA1c
timeFrame: From baseline to Week 24
Secondary outcomes:
measure: Mean change in HbA1c
timeFrame: From baseline to Week 12
measure: Mean change in fasting plasma glucose (FPG)
timeFrame: From baseline to Week 12 and Week 24
measure: Mean change in fasting SMBG
timeFrame: From baseline to Week 12 and Week 24
measure: Mean change in 8-point SMBG
timeFrame: From baseline to Week 12 and Week 24
measure: Proportion of patients achieving HbA1c target of <7.0%
timeFrame: At Weeks 12 and 24
measure: Proportion of patients achieving HbA1c target of <7.0% without hypoglycemia event
timeFrame: At Weeks 12 and 24
measure: Proportion of patients achieving HbA1c improvement of at least 0.3% without nocturnal hypoglycemia
timeFrame: From baseline to Week 24
measure: Proportion of patients with any improvement in HbA1c
timeFrame: From baseline to Week 24
measure: Proportion of patients with no deterioration in HbA1c
timeFrame: From baseline to Week 24
measure: Proportion of patients with no deterioration in HbA1c
timeFrame: From baseline to Week 24
measure: Adverse events (AEs)
timeFrame: Up to 28 weeks
measure: Mean change in body weight
timeFrame: From baseline to Week 12 and Week 24
measure: Mean change in daily insulin doses
timeFrame: From baseline to Week 24
measure: Number of patients experiencing hypoglycemia
timeFrame: Up to 28 weeks
measure: Proportion of patients experiencing hypoglycemia
timeFrame: Up to 28 weeks
measure: Number of hypoglycemic events per patient-year
timeFrame: Up to 28 weeks
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Investigational Site Number 076013
city: Curitiba
country: Brazil
facility: Investigational Site Number 076016
city: Curitiba
country: Brazil
facility: Investigational Site Number 076007
city: Fortaleza
country: Brazil
facility: Investigational Site Number 076005
city: Goiânia
country: Brazil
facility: Investigational Site Number 076002
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076004
city: Ribeirão Preto
country: Brazil
facility: Investigational Site Number 076011
city: São José dos Campos
country: Brazil
facility: Investigational Site Number 076006
city: São Paulo
country: Brazil
facility: Investigational Site Number 076015
city: São Paulo
country: Brazil
facility: Investigational Site Number 076012
city: SãO Paulo
country: Brazil
facility: Investigational Site Number 076001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: