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Clinical Trial Details

Trial ID: L5439
Source ID: NCT01689142
Associated Drug: Insulin Glargine New Formulation (Hoe901)
Title: 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
Acronym: EDITION JP II
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Insulin glargine new formulation (HOE901)|DRUG: Insulin glargine (HOE901)
Outcome Measures: Primary: Change from baseline in HbA1c, baseline, 6 months | Secondary: Percentage of HbA1c responders (HbA1c < 7%; < 6.5%), up to 6 months|Change from baseline in FPG, baseline, 6 months|Change from baseline in pre-basal insulin injection SMPG, baseline, 6 months|Change from baseline in 8-point SMPG profiles, baseline, 6 months|Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values), baseline, 6 months|Change from baseline in variability of plasma glucose profile, baseline, 6 months|Change from baseline in daily basal insulin dose, baseline, 6 months|Number of patients with various types of hypoglycemia events, up to 6 months
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 240
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-09
Completion Date: 2014-06
Results First Posted:
Last Update Posted: 2014-06-05
Locations: 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
URL: https://clinicaltrials.gov/show/NCT01689142

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress