Repeated Dose Study With a New Insulin Glargine Formulation and Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
insulin glargine (HOE901)
insulin glargine- new formulation (HOE901)
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
Eligibility Criteria
Inclusion criteria :
- Japanese patients with Type 1 Diabetes Mellitus (T1DM) on treatment with basal-bolus insulin;
Exclusion criteria:
- Age < 20 years at written informed consent;
- HbA1c < 6.5% or > 10.0% at screening
- Diabetes mellitus (DM) other than T1DM;
- Body Mass Index (BMI) > 35.0 kg/m2 at screening visit
- Any contraindication to use of insulin glargine as defined in the Japanese Package Insert
- Hypoglycemia unawareness or history of metabolic acidosis, including hospitalization for diabetic ketoacidosis during the 24 weeks prior to screening visit
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Investigational Site Number 392001
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sequence 1
Sequence 2
Arm Description
Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal
Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal
Outcomes
Primary Outcome Measures
Change in 24-hour blood glucose profile measured by continuous glucose monitoring
Secondary Outcome Measures
Hypoglycemia categorized by the definition of American Diabetes Association
Change in fasting plasma glucose from baseline to each treatment end by treatment
Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment
Change in HbA1c from baseline to each treatment end by treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01676233
Brief Title
Repeated Dose Study With a New Insulin Glargine Formulation and Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus
Official Title
A Randomized, Open-label, 2-treatment Crossover Study of a New Formulation of Insulin Glargine Comparing to Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus on Treatment With Basal-bolus Insulin
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (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 compare the 24-hour glycemic profile in continuous glucose monitoring (CGM) between a new formulation of insulin glargine and Lantus at steady state
Secondary Objectives:
To compare the change of Fasting plasma glucose (FPG), Self-monitoring plasma glucose (SMPG) and Postprandial Plasma Glucose (PPG) between the 2 treatments;
To compare the efficacy of the 2 treatments on glycemic control in glycemic parameters (1,5-anhydroglucitol and hemoglobin A1c (glycosylated hemoglobin; HbA1c));
To compare the occurrence of hypoglycemia between the 2 treatments;
To assess the safety and tolerability of a new formulation of insulin glargine.
Detailed Description
66 days
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal
Intervention Type
Drug
Intervention Name(s)
insulin glargine (HOE901)
Intervention Description
Pharmaceutical form: solution Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
insulin glargine- new formulation (HOE901)
Intervention Description
Pharmaceutical form: solution Route of administration: subcutaneous
Primary Outcome Measure Information:
Title
Change in 24-hour blood glucose profile measured by continuous glucose monitoring
Time Frame
Baseline, Day 28, Day 56
Secondary Outcome Measure Information:
Title
Hypoglycemia categorized by the definition of American Diabetes Association
Time Frame
Up to Day 56
Title
Change in fasting plasma glucose from baseline to each treatment end by treatment
Time Frame
Baseline, Day 28, Day 56
Title
Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment
Time Frame
Baseline, Day 28, Day 56
Title
Change in HbA1c from baseline to each treatment end by treatment
Time Frame
Baseline, Day 28, Day 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :
Japanese patients with Type 1 Diabetes Mellitus (T1DM) on treatment with basal-bolus insulin;
Exclusion criteria:
Age < 20 years at written informed consent;
HbA1c < 6.5% or > 10.0% at screening
Diabetes mellitus (DM) other than T1DM;
Body Mass Index (BMI) > 35.0 kg/m2 at screening visit
Any contraindication to use of insulin glargine as defined in the Japanese Package Insert
Hypoglycemia unawareness or history of metabolic acidosis, including hospitalization for diabetic ketoacidosis during the 24 weeks prior to screening visit
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:
Facility Name
Investigational Site Number 392001
City
Kumamoto-Shi
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
26055218
Citation
Jinnouchi H, Koyama M, Amano A, Takahashi Y, Yoshida A, Hieshima K, Sugiyama S, Kurinami N, Jinnouchi T, Becker R. Continuous Glucose Monitoring During Basal-Bolus Therapy Using Insulin Glargine 300 U mL(-1) and Glargine 100 U mL (-1) in Japanese People with Type 1 Diabetes Mellitus: A Crossover Pilot Study. Diabetes Ther. 2015 Jun;6(2):143-52. doi: 10.1007/s13300-015-0115-1. Epub 2015 Jun 9.
Results Reference
derived
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Repeated Dose Study With a New Insulin Glargine Formulation and Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus
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