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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

Page last updated: August 23, 2015

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