Comparison of a New Formulation of Insulin Glargine With Lantus® in Japanese Patients With Type 1 Diabetes Mellitus
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 1 Diabetes Mellitus
Intervention: Insulin glargine new formulation (HOE901) (Drug); Insulin glargine (HOE901) (Lantus) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change from baseline in HbA1c
Secondary outcome: 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
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
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, Japan
Additional Information
Starting date: September 2012
Last updated: June 6, 2014
|
