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Comparison of a New Formulation of Insulin Glargine With Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Japanese Patients With Type 2 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 2 Diabetes Mellitus

Intervention: Insulin glargine new formulation (HOE901) (Drug); Insulin glargine (HOE901) (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 2 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 Both in Combination With Oral Antihyperglycemic Drug(s) in Japanese Patients With Type 2 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 : o Patients with type 2 diabetes mellitus diagnosed for at least 1 year at the time of screening visit treated with basal insulin in combination with oral antihyperglycemic drugs (OADs) for at least 6 months before screening visit; Exclusion criteria:

- Age < 18 years at screening visit;

- BMI(body mass index) ≥ 35 kg/m2 at screening visit;

- HbA1c < 7. 0% or > 10% (national glycohemoglobin standardization program [NGSP] value)

at screening visit;

- Diabetes other than type 2 diabetes mellitus;

- Patients on self-monitoring of blood glucose less than 6 months before screening

visit;

- Patients using pre-mix insulins, insulin detemir at 2 times or more a day, or GLP 1

receptor agonists in the last 3 months before screening visit;

- Patients using mealtime insulin (rapid-acting insulin analogue and short-acting

insulin) for more than 10 days in the last 3 months before screening visit;

- Use of insulin pump in the last 6 months before screening visit;

- Initiation of new glucose-lowering medications and/or weight loss drugs in the last 3

months before screening visit;

- 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 (eg, 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 392226, Amagasaki-Shi, Japan

Investigational Site Number 392218, Chigasaki-Shi, Japan

Investigational Site Number 392212, Chiyoda-Ku, Japan

Investigational Site Number 392209, Chuo-Ku, Japan

Investigational Site Number 392210, Chuo-Ku, Japan

Investigational Site Number 392208, Chuoh-Ku, Japan

Investigational Site Number 392217, Ebina-Shi, Japan

Investigational Site Number 392216, Fujisawa-Shi, Japan

Investigational Site Number 392222, Higashiosaka-Shi, Japan

Investigational Site Number 392223, Izumisano-Shi, Japan

Investigational Site Number 392215, Kamakura-Shi, Japan

Investigational Site Number 392225, Kashiwara-Shi, Japan

Investigational Site Number 392205, Kawagoe-Shi, Japan

Investigational Site Number 392204, Kawaguchi-Shi, Japan

Investigational Site Number 392206, Kisarazu-Shi, Japan

Investigational Site Number 392201, Koriyama-Shi, Japan

Investigational Site Number 392228, Kurashiki-Shi, Japan

Investigational Site Number 392229, Matsuyama-Shi, Japan

Investigational Site Number 392230, Matsuyama-Shi, Japan

Investigational Site Number 392211, Mitaka-Shi, Japan

Investigational Site Number 392220, Nagoya-Shi, Japan

Investigational Site Number 392227, Nishinomiya-Shi, Japan

Investigational Site Number 392203, Ogawa-Machi, Hikigun, Japan

Investigational Site Number 392231, Okawa-Shi, Japan

Investigational Site Number 392224, Osaka-Shi, Japan

Investigational Site Number 392207, Shinjuku-Ku, Japan

Investigational Site Number 392219, Shizuoka-Shi, Japan

Investigational Site Number 392221, Takatsuki-Shi, Japan

Investigational Site Number 392202, Ushiku-Shi, Japan

Investigational Site Number 392213, Yokohama-Shi, Japan

Investigational Site Number 392214, Yokohama-Shi, Japan

Additional Information

Starting date: September 2012
Last updated: June 4, 2014

Page last updated: August 23, 2015

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