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Comparison of a New Formulation of Insulin Glargine With Lantus® in Japanese Patients With Type 1 Diabetes Mellitus (EDITION JP I)

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Insulin glargine new formulation (HOE901)
Insulin glargine (HOE901) (Lantus)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 392119
  • Investigational Site Number 392106
  • Investigational Site Number 392107
  • Investigational Site Number 392110
  • Investigational Site Number 392115
  • Investigational Site Number 392117
  • Investigational Site Number 392109
  • Investigational Site Number 392101
  • Investigational Site Number 392121
  • Investigational Site Number 392112
  • Investigational Site Number 392120
  • Investigational Site Number 392113
  • Investigational Site Number 392116
  • Investigational Site Number 392118
  • Investigational Site Number 392104
  • Investigational Site Number 392105
  • Investigational Site Number 392111
  • Investigational Site Number 392114
  • Investigational Site Number 392122
  • Investigational Site Number 392103
  • Investigational Site Number 392102
  • Investigational Site Number 392108

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

New formulation of insulin glargine

Lantus (insulin glargine)

Arm Description

once daily in the evening on-top of mealtime insulin

once daily in the evening on-top of mealtime insulin

Outcomes

Primary Outcome Measures

Change from baseline in HbA1c

Secondary Outcome Measures

Percentage of HbA1c responders (HbA1c < 7%; < 6.5%)
Change from baseline in FPG
Change from baseline in pre-basal insulin injection SMPG
Change from baseline in 8-point SMPG profiles
Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values)
Change from baseline in variability of plasma glucose profile
Change from baseline in daily basal insulin dose
Number of Patients with various types of Hypoglycemia Events

Full Information

First Posted
September 14, 2012
Last Updated
June 6, 2014
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01689129
Brief Title
Comparison of a New Formulation of Insulin Glargine With Lantus® in Japanese Patients With Type 1 Diabetes Mellitus
Acronym
EDITION JP I
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
April 2014 (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 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
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

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 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
243 (Actual)

8. Arms, Groups, and Interventions

Arm Title
New formulation of insulin glargine
Arm Type
Experimental
Arm Description
once daily in the evening on-top of mealtime insulin
Arm Title
Lantus (insulin glargine)
Arm Type
Active Comparator
Arm Description
once daily in the evening on-top of mealtime insulin
Intervention Type
Drug
Intervention Name(s)
Insulin glargine new formulation (HOE901)
Intervention Description
Pharmaceutical form: solution Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Insulin glargine (HOE901) (Lantus)
Other Intervention Name(s)
Lantus
Intervention Description
Pharmaceutical form: solution Route of administration: subcutaneous
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c
Time Frame
baseline, 6 months
Secondary Outcome Measure Information:
Title
Percentage of HbA1c responders (HbA1c < 7%; < 6.5%)
Time Frame
up to 6 months
Title
Change from baseline in FPG
Time Frame
baseline, 6 months
Title
Change from baseline in pre-basal insulin injection SMPG
Time Frame
baseline, 6 months
Title
Change from baseline in 8-point SMPG profiles
Time Frame
baseline, 6 months
Title
Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values)
Time Frame
baseline, 6 months
Title
Change from baseline in variability of plasma glucose profile
Time Frame
baseline, 6 months
Title
Change from baseline in daily basal insulin dose
Time Frame
baseline, 6 months
Title
Number of Patients with various types of Hypoglycemia Events
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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 392119
City
Amagasaki-Shi
Country
Japan
Facility Name
Investigational Site Number 392106
City
Chuo-Ku
Country
Japan
Facility Name
Investigational Site Number 392107
City
Chuo-Ku
Country
Japan
Facility Name
Investigational Site Number 392110
City
Ebina-Shi
Country
Japan
Facility Name
Investigational Site Number 392115
City
Higashiosaka-Shi
Country
Japan
Facility Name
Investigational Site Number 392117
City
Izumisano-Shi
Country
Japan
Facility Name
Investigational Site Number 392109
City
Kamakura-Shi
Country
Japan
Facility Name
Investigational Site Number 392101
City
Koriyama-Shi
Country
Japan
Facility Name
Investigational Site Number 392121
City
Kurashiki-Shi
Country
Japan
Facility Name
Investigational Site Number 392112
City
Nagoya-Shi
Country
Japan
Facility Name
Investigational Site Number 392120
City
Nishinomiya-Shi
Country
Japan
Facility Name
Investigational Site Number 392113
City
Osaka-Shi
Country
Japan
Facility Name
Investigational Site Number 392116
City
Osaka-Shi
Country
Japan
Facility Name
Investigational Site Number 392118
City
Osaka-Shi
Country
Japan
Facility Name
Investigational Site Number 392104
City
Shinjuku-Ku
Country
Japan
Facility Name
Investigational Site Number 392105
City
Shinjuku-Ku
Country
Japan
Facility Name
Investigational Site Number 392111
City
Shizuoka-Shi
Country
Japan
Facility Name
Investigational Site Number 392114
City
Takatsuki-Shi
Country
Japan
Facility Name
Investigational Site Number 392122
City
Tokushima-Shi
Country
Japan
Facility Name
Investigational Site Number 392103
City
Tomioka-Shi
Country
Japan
Facility Name
Investigational Site Number 392102
City
Ushiku-Shi
Country
Japan
Facility Name
Investigational Site Number 392108
City
Yokohama-Shi
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
26662964
Citation
Matsuhisa M, Koyama M, Cheng X, Takahashi Y, Riddle MC, Bolli GB, Hirose T; EDITION JP 1 study group. New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese adults with type 1 diabetes using basal and mealtime insulin: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 1). Diabetes Obes Metab. 2016 Apr;18(4):375-83. doi: 10.1111/dom.12619. Epub 2016 Feb 1.
Results Reference
derived

Learn more about this trial

Comparison of a New Formulation of Insulin Glargine With Lantus® in Japanese Patients With Type 1 Diabetes Mellitus

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