A National, Multicenter, Prospective, Interventional, Open-label, Single-arm, 24-Week Phase IV Study to Evaluate the Effectiveness and Safety of Initiation and Titration of Insulin Glargine U300 in Insulin-naïve Patients With T2DM Inadequately Controlled on OAD Treatment in Turkey
Overview
- Phase
- Phase 4
- Intervention
- INSULIN GLARGINE (U300)
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Sanofi
- Enrollment
- 112
- Primary Endpoint
- Mean change from baseline in HbA1c
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Primary Objective:
To assess the mean change in HbA1c (glycated haemoglobin).
Secondary Objectives:
To evaluate the efficacy and safety of the titration of insulin glargine U300 in terms of:
- Targeted HbA1c;
- Targeted fasting self- monitoring blood glucose (SMBG);
- Hypoglycemic events;
- Adverse events;
- Quality of life assessment by DTSQs (Diabetes Treatment Satisfaction Questionnaire status) and DTSQc (Diabetes Treatment Satisfaction Questionnaire change);
- Blood glucose fluctuation by using continuous glucose monitoring system (CGMS) in subgroup patients.
Detailed Description
The total study duration per patient will be 27 weeks (2 weeks of screening, 24 weeks on treatment, and 1 week follow-up period).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Insulin glargine (U300)
Insulin glargine (U300) will be administered daily through subcutaneous injection, and thereafter, dose will be titrated weekly (preferably 3-4 days) as needed. Background non-insulin anti-diabetic drugs approved for use in combination with insulin according to local labelling, will be permitted, with the exception of Thiazolidinediones (TZDs), which must be stopped at the time of basal insulin initiation.
Intervention: INSULIN GLARGINE (U300)
Insulin glargine (U300)
Insulin glargine (U300) will be administered daily through subcutaneous injection, and thereafter, dose will be titrated weekly (preferably 3-4 days) as needed. Background non-insulin anti-diabetic drugs approved for use in combination with insulin according to local labelling, will be permitted, with the exception of Thiazolidinediones (TZDs), which must be stopped at the time of basal insulin initiation.
Intervention: metformin
Insulin glargine (U300)
Insulin glargine (U300) will be administered daily through subcutaneous injection, and thereafter, dose will be titrated weekly (preferably 3-4 days) as needed. Background non-insulin anti-diabetic drugs approved for use in combination with insulin according to local labelling, will be permitted, with the exception of Thiazolidinediones (TZDs), which must be stopped at the time of basal insulin initiation.
Intervention: sulfonylurea
Insulin glargine (U300)
Insulin glargine (U300) will be administered daily through subcutaneous injection, and thereafter, dose will be titrated weekly (preferably 3-4 days) as needed. Background non-insulin anti-diabetic drugs approved for use in combination with insulin according to local labelling, will be permitted, with the exception of Thiazolidinediones (TZDs), which must be stopped at the time of basal insulin initiation.
Intervention: meglitinides
Insulin glargine (U300)
Insulin glargine (U300) will be administered daily through subcutaneous injection, and thereafter, dose will be titrated weekly (preferably 3-4 days) as needed. Background non-insulin anti-diabetic drugs approved for use in combination with insulin according to local labelling, will be permitted, with the exception of Thiazolidinediones (TZDs), which must be stopped at the time of basal insulin initiation.
Intervention: thiazolidinediones
Insulin glargine (U300)
Insulin glargine (U300) will be administered daily through subcutaneous injection, and thereafter, dose will be titrated weekly (preferably 3-4 days) as needed. Background non-insulin anti-diabetic drugs approved for use in combination with insulin according to local labelling, will be permitted, with the exception of Thiazolidinediones (TZDs), which must be stopped at the time of basal insulin initiation.
Intervention: alpha-glucosidase inhibitors
Insulin glargine (U300)
Insulin glargine (U300) will be administered daily through subcutaneous injection, and thereafter, dose will be titrated weekly (preferably 3-4 days) as needed. Background non-insulin anti-diabetic drugs approved for use in combination with insulin according to local labelling, will be permitted, with the exception of Thiazolidinediones (TZDs), which must be stopped at the time of basal insulin initiation.
Intervention: GLP1 Receptor Agonist
Insulin glargine (U300)
Insulin glargine (U300) will be administered daily through subcutaneous injection, and thereafter, dose will be titrated weekly (preferably 3-4 days) as needed. Background non-insulin anti-diabetic drugs approved for use in combination with insulin according to local labelling, will be permitted, with the exception of Thiazolidinediones (TZDs), which must be stopped at the time of basal insulin initiation.
Intervention: Dipeptidyl peptidase-IV (DPP-IV) inhibitors
Insulin glargine (U300)
Insulin glargine (U300) will be administered daily through subcutaneous injection, and thereafter, dose will be titrated weekly (preferably 3-4 days) as needed. Background non-insulin anti-diabetic drugs approved for use in combination with insulin according to local labelling, will be permitted, with the exception of Thiazolidinediones (TZDs), which must be stopped at the time of basal insulin initiation.
Intervention: Sodium-glucose transport-2 (SGLT-2) inhibitors
Outcomes
Primary Outcomes
Mean change from baseline in HbA1c
Time Frame: Baseline, Week 24
Secondary Outcomes
- Mean change from baseline in HbA1c(Baseline, Week 12)
- Percentage of patients achieving targeted fasting self-monitored blood glucose (SMBG) without experiencing severe and/or confirmed hypoglycemia ≤70mg/dL and <54 mg/dL(At Weeks 12 and 24)
- Percentage of patients reaching targeted fasting SMBG (80-130 mg/dL)(At Weeks 12 and 24)
- Duration to reach target pre-breakfast SMBG(Baseline, Week 24)
- Mean change from baseline in SMBG(Baseline, Weeks 12, and 24)
- Mean change from baseline in Diabetes Treatment Satisfaction Questionnaire (DTSO) scores(Baseline, Week 24)
- Mean change from baseline in fasting plasma glucose (FPG)(Baseline, Weeks 12, and 24)