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

ID: NCT03406000
Status: Recruiting
Phase: Phase 4
Start Date: February 19, 2018
First Submitted: January 15, 2018
Last Updated: February 21, 2018
Results: N/A
Organization: Sanofi
Sponsors & Collaborators: Sanofi
Location: Brazil
Conditions: Type I Diabetes Mellitus
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Study Description

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.
Condition or disease Intervention/treatment Phase

Type I Diabetes Mellitus

Drug: INSULIN GLARGINE (U300)
Other Names
Toujeo, HOE901
Phase 4

Tracking Information

First Submitted DateJanuary 15, 2018
Last Update Posted DateFebruary 21, 2018
Actual Start DateFebruary 19, 2018
Anticipated Completion DateJanuary 01, 2019
Actual Primary Completion DateJanuary 01, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Mean change in HbA1c [Time Frame: From baseline to Week 24]

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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Mean change in HbA1c [Time Frame: From baseline to Week 12]

    Mean HbA1c change from baseline to Week 12

  • Mean change in fasting plasma glucose (FPG) [Time Frame: From baseline to Week 12 and Week 24]

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

  • Mean change in fasting SMBG [Time Frame: 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 [Time Frame: 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% [Time Frame: 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 [Time Frame: At Weeks 12 and 24]

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

  • Proportion of patients achieving HbA1c improvement of at least 0.3% without nocturnal hypoglycemia [Time Frame: 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 [Time Frame: 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

  • Proportion of patients with no deterioration in HbA1c [Time Frame: From baseline to Week 24]

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

  • Proportion of patients with no deterioration in HbA1c [Time Frame: 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

  • Adverse events (AEs) [Time Frame: Up to 28 weeks]

    Number of adverse events and serious adverse events

  • Mean change in body weight [Time Frame: From baseline to Week 12 and Week 24]

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

  • Mean change in daily insulin doses [Time Frame: From baseline to Week 24]

    Insulin glargine (U300) dose: Mean change in daily insulin doses (basal, prandial, total) 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]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitlePhase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL
Official TitleA 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
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.

Study TypeInterventional
Study PhasePhase 4
Estimated Enrollment
123
Allocation
Not Available
Interventional Model
Single Group Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Type I Diabetes Mellitus
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: INSULIN GLARGINE (U300)

Pharmaceutical form: Solution for Injection Route of administration: Subcutaneous injection

Other Names
Toujeo, HOE901
Study Groups/Cohorts
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.

Study Arms
Experimental 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.
Drug : INSULIN GLARGINE (U300)
Pharmaceutical form: Solution for Injection Route of administration: Subcutaneous injection

Arm Intervention/Treatment
Experimental 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.
Drug : INSULIN GLARGINE (U300)

Recruitment Information

Recruitment Status:Recruiting
Enrollment123
Completion DateJanuary 01, 2019
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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Brazil

Administrative Information

NCT Number:NCT03406000
Other Study ID Numbers
GLARGL08200
U1111-1186-2485
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Sanofi
Collaborators
Not Available
Investigators
Study Director
Clinical Sciences & Operations
Sanofi