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

Sanofi170 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

170

Conditions

Type I Diabetes Mellitus

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

Investigational Site Number 076013

Campinas, Brazil

Investigational Site Number 076016

Curitiba, Brazil

Investigational Site Number 076007

Curitiba, Brazil

Investigational Site Number 076005

Fortaleza, Brazil

Investigational Site Number 076002

Goiânia, Brazil

Investigational Site Number 076004

Porto Alegre, Brazil

Investigational Site Number 076011

Ribeirão Preto, Brazil

Investigational Site Number 076006

São José dos Campos, Brazil

Investigational Site Number 076015

São Paulo, Brazil

Investigational Site Number 076012

São Paulo, Brazil

...and 1 more locations

Outcomes

Primary Outcomes

Mean change in HbA1c

Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 (%)

Time frame: From baseline to Week 24

Secondary Outcomes

Mean change in HbA1c

Mean HbA1c change from baseline to Week 12

Time frame: From baseline to Week 12

Mean change in fasting plasma glucose (FPG)

Mean change in FPG from baseline to Week 12 and Week 24

Time frame: From baseline to Week 12 and Week 24

Mean change in fasting SMBG

Mean change in fasting self-monitored blood glucose (SMBG) from baseline to Week 12 and Week 24

Time frame: From baseline to Week 12 and Week 24

Mean change in 8-point SMBG

Mean change in 8-point SMBG from baseline to Week 12 and Week 24

Time frame: From baseline to Week 12 and Week 24

Proportion of patients achieving HbA1c target of <7.0%

Proportion of patients achieving HbA1c target of \<7.0% at Week 12 and Week 24

Time frame: At Weeks 12 and 24

Proportion of patients achieving HbA1c target of <7.0% without hypoglycemia event

Proportion of patients achieving HbA1c target of \<7.0% without hypoglycemia event during the last 4 weeks of treatment

Time frame: At Weeks 12 and 24

Proportion of patients achieving HbA1c improvement of at least 0.3% without nocturnal hypoglycemia

Proportion of patients achieving HbA1c improvement from baseline to week 24 of at least 0.3% without nocturnal hypoglycemia (documented \<70 mg/dL) and/or severe hypoglycemia (between 00.00 and 05:59 am SMBG) during the last 4 weeks of treatment

Time frame: From baseline to Week 24

Proportion of patients with any improvement in HbA1c

Proportion of patients with any improvement in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia (nocturnal defined as time between 00.00 and 05:59 am) evaluated from baseline to Week 24

Time frame: From baseline to Week 24

Proportion of patients with no deterioration in HbA1c

Proportion of patients with no deterioration in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia

Time frame: From baseline to Week 24

Proportion of patients with no deterioration in HbA1c

Proportion of patients with no deterioration in HbA1c from baseline to week 24 and no increase in occurrence of nocturnal hypoglycemia

Time frame: From baseline to Week 24

Adverse events (AEs)

Number of adverse events and serious adverse events

Time frame: Up to 28 weeks

Mean change in body weight

Mean change in body weight from baseline to Weeks 12 and 24

Time frame: From baseline to Week 12 and Week 24

Mean change in daily insulin doses

Insulin glargine (U300) dose: Mean change in daily insulin doses (basal, prandial, total) from baseline to Week 24

Time frame: From baseline to Week 24

Number of patients experiencing hypoglycemia

Time frame: Up to 28 weeks

Proportion of patients experiencing hypoglycemia

Time frame: Up to 28 weeks

Number of hypoglycemic events per patient-year

Time frame: Up to 28 weeks