Back to resultsA Clinical Efficacy and Safety Study of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period (INITIATION)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Insulin glargine 300 U/ml
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Adult patients (age≥18 years) who diagnosed with type 2 diabetes
Patients who should initiate Insulin glargine U300 treatment following local label and guideline at investigator's discretion, including:
- insulin naive patients (no current or previous insulin used during the last year prior to screening except for a maximum 10 days in relation to acute illness or surgery, etc.) uncontrolled (HbA1c between 7.5% and 11.0%) at screening visit on stable dose treatment with ≤ 2 OADs (metformin, sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinide, α-glucosidase inhibitor) within 8 weeks prior to screening, at least one of which must be on maximum tolerated dose, or
- patients uncontrolled (HbA1c between 7.5% and 11.0%) at screening visit with other basal insulin, or
- patients controlled with other basal insulin but experienced frequent hypoglycemia or with increased hypoglycemia risk at investigator's discretion
- Patients who treated with basal insulin must have a stable dose of antidiabetic drugs (dose change no more than ±20% vs. the dose on screening visit for basal insulin) within 8 weeks prior to screening
Exclusion Criteria:
- Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or at 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
- Use of any product containing short or rapid acting insulin in the last 3 months prior to screening (unless used for ≤10 days in relation to hospitalization or an acute illness)
- Use of oral anti-diabetic drugs other than those allowed and listed in the inclusion criteria, Glucagon-like peptide-1 (GLP-1) receptor agonists, or any investigational agent (drug, biologic, device) within 3 months prior to screening visit
- Use of systemic glucocorticoids (excluding topical application or inhaled forms) for two weeks or more within 8 weeks prior to the time of screening
- Known hypersensitivity / intolerance to insulin glargine or any of its excipients
- 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.
Sites / Locations
- Investigational Sites
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Insulin glargine 300 U/ml
Arm Description
Insulin glargine 300 U/ml once daily for 24 weeks. Participants may continue for an additional 12 week extension period or switch to other anti-diabetic treatment, insulin dose will be adjusted according to the recommended dose titration algorithm
Outcomes
Primary Outcome Measures
Mean change in HbA1c from baseline to week 24
Secondary Outcome Measures
Mean change in HbA1c from baseline to week 12 and week 36
Percentage of participants achieving HbA1c target <7%
Percentage of participants achieving HbA1c target <7% without hypoglycemic events
Mean change in Fasting Plasma Glucose (FPG) from baseline to week 12, 24 and 36
Mean change in fasting Self-Monitored Blood Glucose (SMBG) from baseline to week 12 and week 24
Mean change in of 7-points SMBG per time point from baseline to week 12 and week 24
Mean change in Insulin glargine U300 dose from baseline to week 12, 24 and 36
Number of participants experiencing hypoglycemia from baseline to week 12, 24 and 36
Number of hypoglycemic events per patient-year
Number of participants with adverse events
Mean change in body weight from baseline to Week 12 and Week 24
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05002933
Brief Title
A Clinical Efficacy and Safety Study of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period
Acronym
INITIATION
Official Title
A 6-month, Multicenter, Prospective, Single-arm, Open-label, Phase IV Study Evaluating the Clinical Efficacy and Safety of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
February 24, 2023 (Actual)
Study Completion Date
February 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective, interventional, single arm, multicenter, phase 4 study to evaluate the clinical efficacy and safety of initiating Insulin glargine U300 in insulin-naive patients or switching from any other basal insulin to Insulin glargine U300 in insulin pre-treated patients with uncontrolled T2DM.
Detailed Description
Maximum study duration per participant will be approximately 37 weeks per patient: up to 1 week screening period, 24 weeks insulin glargine U300 treatment period and 12 weeks observational extension period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
570 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin glargine 300 U/ml
Arm Type
Experimental
Arm Description
Insulin glargine 300 U/ml once daily for 24 weeks. Participants may continue for an additional 12 week extension period or switch to other anti-diabetic treatment, insulin dose will be adjusted according to the recommended dose titration algorithm
Intervention Type
Drug
Intervention Name(s)
Insulin glargine 300 U/ml
Other Intervention Name(s)
HOE901 Toujeo
Intervention Description
Solution for injection Subcutaneous injection
Primary Outcome Measure Information:
Title
Mean change in HbA1c from baseline to week 24
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Mean change in HbA1c from baseline to week 12 and week 36
Time Frame
Baseline to Week 12 and 36
Title
Percentage of participants achieving HbA1c target <7%
Time Frame
at Week 12, 24 and 36
Title
Percentage of participants achieving HbA1c target <7% without hypoglycemic events
Time Frame
at Week 12 and 24
Title
Mean change in Fasting Plasma Glucose (FPG) from baseline to week 12, 24 and 36
Time Frame
Baseline to Week 12, 24 and 36
Title
Mean change in fasting Self-Monitored Blood Glucose (SMBG) from baseline to week 12 and week 24
Time Frame
Baseline to Week 12 and 24
Title
Mean change in of 7-points SMBG per time point from baseline to week 12 and week 24
Time Frame
Baseline to Week 12 and 24
Title
Mean change in Insulin glargine U300 dose from baseline to week 12, 24 and 36
Time Frame
Baseline to Week 12, 24 and 36
Title
Number of participants experiencing hypoglycemia from baseline to week 12, 24 and 36
Time Frame
Baseline to Week 12, 24 and 36
Title
Number of hypoglycemic events per patient-year
Time Frame
Baseline to Week 12, 24 and 36
Title
Number of participants with adverse events
Time Frame
Baseline to Week 24 and 36
Title
Mean change in body weight from baseline to Week 12 and Week 24
Time Frame
Baseline to Week 12 and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients (age≥18 years) who diagnosed with type 2 diabetes
Patients who should initiate Insulin glargine U300 treatment following local label and guideline at investigator's discretion, including:
insulin naive patients (no current or previous insulin used during the last year prior to screening except for a maximum 10 days in relation to acute illness or surgery, etc.) uncontrolled (HbA1c between 7.5% and 11.0%) at screening visit on stable dose treatment with ≤ 2 OADs (metformin, sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinide, α-glucosidase inhibitor) within 8 weeks prior to screening, at least one of which must be on maximum tolerated dose, or
patients uncontrolled (HbA1c between 7.5% and 11.0%) at screening visit with other basal insulin, or
patients controlled with other basal insulin but experienced frequent hypoglycemia or with increased hypoglycemia risk at investigator's discretion
Patients who treated with basal insulin must have a stable dose of antidiabetic drugs (dose change no more than ±20% vs. the dose on screening visit for basal insulin) within 8 weeks prior to screening
Exclusion Criteria:
Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or at 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
Use of any product containing short or rapid acting insulin in the last 3 months prior to screening (unless used for ≤10 days in relation to hospitalization or an acute illness)
Use of oral anti-diabetic drugs other than those allowed and listed in the inclusion criteria, Glucagon-like peptide-1 (GLP-1) receptor agonists, or any investigational agent (drug, biologic, device) within 3 months prior to screening visit
Use of systemic glucocorticoids (excluding topical application or inhaled forms) for two weeks or more within 8 weeks prior to the time of screening
Known hypersensitivity / intolerance to insulin glargine or any of its excipients
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.
Facility Information:
Facility Name
Investigational Sites
City
China
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Learn more about this trial
A Clinical Efficacy and Safety Study of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period
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