Back to resultsA Study to Evaluate the Effectiveness and Safety Initiation and Titration of Insulin Glargine (U300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus (T2DM) Controlled on Oral Antidiabetic Drug Treatment in Turkey (EASE)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
INSULIN GLARGINE (U300)
metformin
sulfonylurea
meglitinides
thiazolidinediones
alpha-glucosidase inhibitors
GLP1 Receptor Agonist
Dipeptidyl peptidase-IV (DPP-IV) inhibitors
Sodium-glucose transport-2 (SGLT-2) inhibitors
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion criteria :
- Adult patients with type 2 diabetes mellitus (≥18 years of age).
- Type 2 diabetes mellitus diagnosis ≥1 year.
- Treated with ≥1 oral antidiabetics (±glucagon like peptid-1 (GLP-1) analogue) without insulin, for at least 6 months and HbA1c level between 8-11% (insulin-naïve).
- Stable antidiabetic treatment for at least 3 months.
- Willingness to adherence to treatment and titration (including self-injection, self- monitoring blood glucose [SMBG]).
- Signed informed consent obtained.
Exclusion criteria:
- Age <18 years old.
- Type 1 diabetes mellitus.
- Having secondary type 2 diabetes mellitus.
- Use of any insulin therapy including premix, basal plus/basal bolus regimen from the diagnosis.
- History of hypoglycemia unawareness.
- Known hypersensitivity/intolerance to insulin glargine or any of its excipients.
- Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol.
- Use of systemic glucocorticoids for two weeks or more within 12 weeks prior to the time of screening.
- Pregnant or lactating women.
- 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
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Insulin glargine (U300)
Arm Description
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.
Outcomes
Primary Outcome Measures
Mean change from baseline in HbA1c
Secondary Outcome Measures
Percentage of patients achieving targeted fasting self-monitored blood glucose (SMBG) without experiencing severe and/or confirmed hypoglycemia ≤70mg/dL and <54 mg/dL
Percentage of patients reaching targeted fasting SMBG (80-130 mg/dL)
Duration to reach target pre-breakfast SMBG
Mean change from baseline in HbA1c
Mean change from baseline in SMBG
Mean change from baseline in fasting plasma glucose (FPG)
Mean change from baseline in Diabetes Treatment Satisfaction Questionnaire (DTSO) scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02954692
Brief Title
A Study to Evaluate the Effectiveness and Safety Initiation and Titration of Insulin Glargine (U300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus (T2DM) Controlled on Oral Antidiabetic Drug Treatment in Turkey
Acronym
EASE
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 30, 2016 (undefined)
Primary Completion Date
December 22, 2017 (Actual)
Study Completion Date
December 22, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin glargine (U300)
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
INSULIN GLARGINE (U300)
Other Intervention Name(s)
HOE901
Intervention Description
Pharmaceutical form: pen for injection
Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
Pharmaceutical form: tablet
Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
sulfonylurea
Intervention Description
Pharmaceutical form: tablet
Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
meglitinides
Intervention Description
Pharmaceutical form: tablet
Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
thiazolidinediones
Intervention Description
Pharmaceutical form: tablet
Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
alpha-glucosidase inhibitors
Intervention Description
Pharmaceutical form: tablet
Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
GLP1 Receptor Agonist
Intervention Description
Pharmaceutical form: pen for injection
Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Dipeptidyl peptidase-IV (DPP-IV) inhibitors
Intervention Description
Pharmaceutical form: tablet
Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Sodium-glucose transport-2 (SGLT-2) inhibitors
Intervention Description
Pharmaceutical form: tablet
Route of administration: oral
Primary Outcome Measure Information:
Title
Mean change from baseline in HbA1c
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Percentage of patients achieving targeted fasting self-monitored blood glucose (SMBG) without experiencing severe and/or confirmed hypoglycemia ≤70mg/dL and <54 mg/dL
Time Frame
At Weeks 12 and 24
Title
Percentage of patients reaching targeted fasting SMBG (80-130 mg/dL)
Time Frame
At Weeks 12 and 24
Title
Duration to reach target pre-breakfast SMBG
Time Frame
Baseline, Week 24
Title
Mean change from baseline in HbA1c
Time Frame
Baseline, Week 12
Title
Mean change from baseline in SMBG
Time Frame
Baseline, Weeks 12, and 24
Title
Mean change from baseline in fasting plasma glucose (FPG)
Time Frame
Baseline, Weeks 12, and 24
Title
Mean change from baseline in Diabetes Treatment Satisfaction Questionnaire (DTSO) scores
Time Frame
Baseline, Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :
Adult patients with type 2 diabetes mellitus (≥18 years of age).
Type 2 diabetes mellitus diagnosis ≥1 year.
Treated with ≥1 oral antidiabetics (±glucagon like peptid-1 (GLP-1) analogue) without insulin, for at least 6 months and HbA1c level between 8-11% (insulin-naïve).
Stable antidiabetic treatment for at least 3 months.
Willingness to adherence to treatment and titration (including self-injection, self- monitoring blood glucose [SMBG]).
Signed informed consent obtained.
Exclusion criteria:
Age <18 years old.
Type 1 diabetes mellitus.
Having secondary type 2 diabetes mellitus.
Use of any insulin therapy including premix, basal plus/basal bolus regimen from the diagnosis.
History of hypoglycemia unawareness.
Known hypersensitivity/intolerance to insulin glargine or any of its excipients.
Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol.
Use of systemic glucocorticoids for two weeks or more within 12 weeks prior to the time of screening.
Pregnant or lactating women.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
City
Turkey
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Effectiveness and Safety Initiation and Titration of Insulin Glargine (U300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus (T2DM) Controlled on Oral Antidiabetic Drug Treatment in Turkey
We'll reach out to this number within 24 hrs