Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL
- Registration Number
- NCT03406000
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 170
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Insulin glargine (U300) 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.
- Primary Outcome Measures
Name Time Method Mean change in HbA1c From baseline to Week 24 Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 (%)
- Secondary Outcome Measures
Name Time Method Number of patients experiencing hypoglycemia Up to 28 weeks Mean change in daily insulin doses From baseline to Week 24 Insulin glargine (U300) dose: Mean change in daily insulin doses (basal, prandial, total) from baseline to Week 24
Proportion of patients with no deterioration in HbA1c From baseline to Week 24 Proportion of patients with no deterioration in HbA1c from baseline to week 24 and no increase in occurrence of nocturnal hypoglycemia
Mean change in HbA1c From baseline to Week 12 Mean HbA1c change from baseline to Week 12
Mean change in fasting plasma glucose (FPG) From baseline to Week 12 and Week 24 Mean change in FPG from baseline to Week 12 and Week 24
Adverse events (AEs) Up to 28 weeks Number of adverse events and serious adverse events
Mean change in body weight From baseline to Week 12 and Week 24 Mean change in body weight from baseline to Weeks 12 and 24
Proportion of patients experiencing hypoglycemia Up to 28 weeks Mean change in fasting SMBG From baseline to Week 12 and Week 24 Mean change in fasting self-monitored blood glucose (SMBG) from baseline to Week 12 and Week 24
Mean change in 8-point SMBG From baseline to Week 12 and Week 24 Mean change in 8-point SMBG from baseline to Week 12 and Week 24
Proportion of patients achieving HbA1c target of <7.0% At Weeks 12 and 24 Proportion of patients achieving HbA1c target of \<7.0% at Week 12 and Week 24
Proportion of patients achieving HbA1c target of <7.0% without hypoglycemia event At Weeks 12 and 24 Proportion of patients achieving HbA1c target of \<7.0% without hypoglycemia event during the last 4 weeks of treatment
Number of hypoglycemic events per patient-year Up to 28 weeks Proportion of patients achieving HbA1c improvement of at least 0.3% without nocturnal hypoglycemia From baseline to Week 24 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
Proportion of patients with any improvement in HbA1c From baseline to Week 24 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
Trial Locations
- Locations (11)
Investigational Site Number 076011
🇧🇷Ribeirão Preto, Brazil
Investigational Site Number 076002
🇧🇷Goiânia, Brazil
Investigational Site Number 076006
🇧🇷São José dos Campos, Brazil
Investigational Site Number 076004
🇧🇷Porto Alegre, Brazil
Investigational Site Number 076013
🇧🇷Campinas, Brazil
Investigational Site Number 076016
🇧🇷Curitiba, Brazil
Investigational Site Number 076007
🇧🇷Curitiba, Brazil
Investigational Site Number 076015
🇧🇷São Paulo, Brazil
Investigational Site Number 076012
🇧🇷São Paulo, Brazil
Investigational Site Number 076001
🇧🇷SãO Paulo, Brazil
Investigational Site Number 076005
🇧🇷Fortaleza, Brazil