- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01689129
Comparison of a New Formulation of Insulin Glargine With Lantus® in Japanese Patients With Type 1 Diabetes Mellitus (EDITION JP I)
A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period
Primary Objective:
To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at month 6 [week 26]) in japanese patients with type 1 diabetes mellitus
Secondary Objectives:
To compare a new formulation of insulin glargine and Lantus in terms of change in fasting plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose (SMPG) profile.
To compare a new formulation of insulin glargine and Lantus in terms of occurrence of hypoglycemia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The duration of study will consist of:
- Up to 2-week screening period;
- 6-month open-label comparative efficacy and safety treatment period;
- 6-month open-label comparative safety extension period;
- 4-week post-treatment safety follow-up period
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Amagasaki-Shi, Japan
- Investigational Site Number 392119
-
Chuo-Ku, Japan
- Investigational Site Number 392106
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Chuo-Ku, Japan
- Investigational Site Number 392107
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Ebina-Shi, Japan
- Investigational Site Number 392110
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Higashiosaka-Shi, Japan
- Investigational Site Number 392115
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Izumisano-Shi, Japan
- Investigational Site Number 392117
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Kamakura-Shi, Japan
- Investigational Site Number 392109
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Koriyama-Shi, Japan
- Investigational Site Number 392101
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Kurashiki-Shi, Japan
- Investigational Site Number 392121
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Nagoya-Shi, Japan
- Investigational Site Number 392112
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Nishinomiya-Shi, Japan
- Investigational Site Number 392120
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Osaka-Shi, Japan
- Investigational Site Number 392113
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Osaka-Shi, Japan
- Investigational Site Number 392116
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Osaka-Shi, Japan
- Investigational Site Number 392118
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Shinjuku-Ku, Japan
- Investigational Site Number 392104
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Shinjuku-Ku, Japan
- Investigational Site Number 392105
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Shizuoka-Shi, Japan
- Investigational Site Number 392111
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Takatsuki-Shi, Japan
- Investigational Site Number 392114
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Tokushima-Shi, Japan
- Investigational Site Number 392122
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Tomioka-Shi, Japan
- Investigational Site Number 392103
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Ushiku-Shi, Japan
- Investigational Site Number 392102
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Yokohama-Shi, Japan
- Investigational Site Number 392108
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Patients with type 1 diabetes mellitus
Exclusion criteria:
- Age < 18 years at screening visit;
- HbA1c < 7.0 % or > 10.0 % (national glycohemoglobin standardization program [NGSP] value) at screening visit;
- Patients less than 1 year before screening visit on any basal plus mealtime insulin;
- Patients not on stable insulin dose (±20% total basal insulin dose) in the last 30 days prior to screening visit;
- Patients using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime rapid-insulin analogue in the last 3 months before screening visit;
- Use of an insulin pump in the last 6 months before screening visit and/or plan to switch to insulin pump in next 12 months;
- Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit;
- Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eq, laser, surgical treatment or injectable drugs) during the study period.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: New formulation of insulin glargine
once daily in the evening on-top of mealtime insulin
|
Pharmaceutical form: solution Route of administration: subcutaneous
|
Active Comparator: Lantus (insulin glargine)
once daily in the evening on-top of mealtime insulin
|
Pharmaceutical form: solution Route of administration: subcutaneous
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in HbA1c
Time Frame: baseline, 6 months
|
baseline, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of HbA1c responders (HbA1c < 7%; < 6.5%)
Time Frame: up to 6 months
|
up to 6 months
|
Change from baseline in FPG
Time Frame: baseline, 6 months
|
baseline, 6 months
|
Change from baseline in pre-basal insulin injection SMPG
Time Frame: baseline, 6 months
|
baseline, 6 months
|
Change from baseline in 8-point SMPG profiles
Time Frame: baseline, 6 months
|
baseline, 6 months
|
Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values)
Time Frame: baseline, 6 months
|
baseline, 6 months
|
Change from baseline in variability of plasma glucose profile
Time Frame: baseline, 6 months
|
baseline, 6 months
|
Change from baseline in daily basal insulin dose
Time Frame: baseline, 6 months
|
baseline, 6 months
|
Number of Patients with various types of Hypoglycemia Events
Time Frame: up to 6 months
|
up to 6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFC12449
- U1111-1130-3513 (Other Identifier: UTN)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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