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
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Insulin glargine (HOE901)Drug: Insulin glargine new formulation (HOE901)
- Registration Number
- NCT01689142
- Lead Sponsor
- Sanofi
- 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 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
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lantus (insulin glargine) Insulin glargine (HOE901) once daily in the evening on-top of OADs New formulation of insulin glargine Insulin glargine new formulation (HOE901) once daily in the evening on-top of oral antihyperglycemic drug (OADs)
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c baseline, 6 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (31)
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
Scroll for more (21 remaining)Investigational Site Number 392226🇯🇵Amagasaki-Shi, Japan