Type 1 Diabetes Mellitus Clinical Trial
— EDITION JP IOfficial 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
Verified date | June 2014 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Interventional |
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
Status | Completed |
Enrollment | 243 |
Est. completion date | April 2014 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Investigational Site Number 392119 | Amagasaki-Shi | |
Japan | Investigational Site Number 392106 | Chuo-Ku | |
Japan | Investigational Site Number 392107 | Chuo-Ku | |
Japan | Investigational Site Number 392110 | Ebina-Shi | |
Japan | Investigational Site Number 392115 | Higashiosaka-Shi | |
Japan | Investigational Site Number 392117 | Izumisano-Shi | |
Japan | Investigational Site Number 392109 | Kamakura-Shi | |
Japan | Investigational Site Number 392101 | Koriyama-Shi | |
Japan | Investigational Site Number 392121 | Kurashiki-Shi | |
Japan | Investigational Site Number 392112 | Nagoya-Shi | |
Japan | Investigational Site Number 392120 | Nishinomiya-Shi | |
Japan | Investigational Site Number 392113 | Osaka-Shi | |
Japan | Investigational Site Number 392116 | Osaka-Shi | |
Japan | Investigational Site Number 392118 | Osaka-Shi | |
Japan | Investigational Site Number 392104 | Shinjuku-Ku | |
Japan | Investigational Site Number 392105 | Shinjuku-Ku | |
Japan | Investigational Site Number 392111 | Shizuoka-Shi | |
Japan | Investigational Site Number 392114 | Takatsuki-Shi | |
Japan | Investigational Site Number 392122 | Tokushima-Shi | |
Japan | Investigational Site Number 392103 | Tomioka-Shi | |
Japan | Investigational Site Number 392102 | Ushiku-Shi | |
Japan | Investigational Site Number 392108 | Yokohama-Shi |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in HbA1c | baseline, 6 months | No | |
Secondary | Percentage of HbA1c responders (HbA1c < 7%; < 6.5%) | up to 6 months | No | |
Secondary | Change from baseline in FPG | baseline, 6 months | No | |
Secondary | Change from baseline in pre-basal insulin injection SMPG | baseline, 6 months | No | |
Secondary | Change from baseline in 8-point SMPG profiles | baseline, 6 months | No | |
Secondary | Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values) | baseline, 6 months | No | |
Secondary | Change from baseline in variability of plasma glucose profile | baseline, 6 months | No | |
Secondary | Change from baseline in daily basal insulin dose | baseline, 6 months | No | |
Secondary | Number of Patients with various types of Hypoglycemia Events | up to 6 months | No |
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