Clinical trial NCT01689129: Comparison of a New Formulation of Insulin Glargine With Lantus® in Japanese Patients With Type 1 Diabetes Mellitus
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-09-21
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Change from baseline in HbA1c
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Percentage of HbA1c responders (HbA1c < 7%; < 6.5%)
timeFrame: up to 6 months
measure: Change from baseline in FPG
timeFrame: baseline, 6 months
measure: Change from baseline in pre-basal insulin injection SMPG
timeFrame: baseline, 6 months
measure: Change from baseline in 8-point SMPG profiles
timeFrame: baseline, 6 months
measure: Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values)
timeFrame: baseline, 6 months
measure: Change from baseline in variability of plasma glucose profile
timeFrame: baseline, 6 months
measure: Change from baseline in daily basal insulin dose
timeFrame: baseline, 6 months
measure: Number of Patients with various types of Hypoglycemia Events
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Amagasaki-Shi
country: Japan
facility: Investigational Site Number 392119
city: Chuo-Ku
country: Japan
facility: Investigational Site Number 392106
city: Chuo-Ku
country: Japan
facility: Investigational Site Number 392107
city: Ebina-Shi
country: Japan
facility: Investigational Site Number 392110
city: Higashiosaka-Shi
country: Japan
facility: Investigational Site Number 392115
city: Izumisano-Shi
country: Japan
facility: Investigational Site Number 392117
city: Kamakura-Shi
country: Japan
facility: Investigational Site Number 392109
city: Koriyama-Shi
country: Japan
facility: Investigational Site Number 392101
city: Kurashiki-Shi
country: Japan
facility: Investigational Site Number 392121
city: Nagoya-Shi
country: Japan
facility: Investigational Site Number 392112
city: Nishinomiya-Shi
country: Japan
facility: Investigational Site Number 392120
city: Osaka-Shi
country: Japan
facility: Investigational Site Number 392113
city: Osaka-Shi
country: Japan
facility: Investigational Site Number 392116
city: Osaka-Shi
country: Japan
facility: Investigational Site Number 392118
city: Shinjuku-Ku
country: Japan
facility: Investigational Site Number 392104
city: Shinjuku-Ku
country: Japan
facility: Investigational Site Number 392105
city: Shizuoka-Shi
country: Japan
facility: Investigational Site Number 392111
city: Takatsuki-Shi
country: Japan
facility: Investigational Site Number 392114
city: Tokushima-Shi
country: Japan
facility: Investigational Site Number 392122
city: Tomioka-Shi
country: Japan
facility: Investigational Site Number 392103
city: Ushiku-Shi
country: Japan
facility: Investigational Site Number 392102
city: Yokohama-Shi
country: Japan
facility: Investigational Site Number 392108
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
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.