TOFO Insulin Combination Trial
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT02201004
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objectives:
To assess the effects of tofogliflozin on glycemic control in comparison to placebo as an add-on treatment to insulin treatment in terms of glycated hemoglobin (HbA1c) reduction over a period of 16 weeks in patients with type 2 diabetes mellitus.
To assess the safety of tofogliflozin in combination with insulin treatment throughout 52 weeks.
Secondary Objectives:
To assess the effects of tofogliflozin in comparison to placebo on:
* Body weight
* Fasting plasma glucose (FPG)
* Postprandial plasma glucose (PPG) To assess the long term safety and tolerability of tofogliflozin.
- Detailed Description
The total study duration from screening for a patient can be approximately up to 1 year, including a screening period of 2 weeks, double-blinded placebo controlled treatment period of 16 weeks, an open-labeled extension period of 36 weeks, and a follow-up period of 3 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 211
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tofogliflozin insulin Tofogliflozin administered once daily for 52 weeks. Insulin administered as base treatment. placebo insulin Placebo administered once daily for 16 weeks. After 16-weeks, Tofogliflozin administered once daily for 36 weeks. Insulin administered as base treatment. placebo placebo Placebo administered once daily for 16 weeks. After 16-weeks, Tofogliflozin administered once daily for 36 weeks. Insulin administered as base treatment. tofogliflozin TOFOGLIFLOZIN CSG452 Tofogliflozin administered once daily for 52 weeks. Insulin administered as base treatment. placebo TOFOGLIFLOZIN CSG452 Placebo administered once daily for 16 weeks. After 16-weeks, Tofogliflozin administered once daily for 36 weeks. Insulin administered as base treatment.
- Primary Outcome Measures
Name Time Method Change in HbA1c from baseline 16 weeks after first intake of investigational product
- Secondary Outcome Measures
Name Time Method Change of Body Weight (BW) from baseline 16 weeks after first intake of investigational product Change of FPG from baseline 16 weeks after first intake of investigational product Change of PPG from baseline 16 weeks after first intake of investigational product Number of subjects with adverse events Up to 52 weeks from the first intake of investigational medicinal product
Trial Locations
- Locations (30)
Investigational Site Number 392-004
🇯🇵Koga-shi, Japan
Investigational Site Number 392-016
🇯🇵Sendai-shi, Japan
Investigational Site Number 392-007
🇯🇵Atsugi-shi, Japan
Investigational Site Number 392-026
🇯🇵Chuoh-ku, Japan
Investigational Site Number 392-021
🇯🇵Fukuoka-shi, Japan
Investigational Site Number 392-028
🇯🇵Adachi-ku, Japan
Investigational Site Number 392-002
🇯🇵Ichihara-shi, Japan
Investigational Site Number 392-012
🇯🇵Iruma-shi, Japan
Investigational Site Number 392-027
🇯🇵Kobe-shi, Japan
Investigational Site Number 392-003
🇯🇵Kawaguchi-shi, Japan
Investigational Site Number 392-014
🇯🇵Kitakyusyu-shi, Japan
Investigational Site Number 392-001
🇯🇵Kyoto-shi, Japan
Investigational Site Number 392-019
🇯🇵Kurume-shi, Japan
Investigational Site Number 392-022
🇯🇵Kunitachi-shi, Japan
Investigational Site Number 392-006
🇯🇵Matsudo-shi, Japan
Investigational Site Number 392-024
🇯🇵Kyoto-shi, Japan
Investigational Site Number 392-030
🇯🇵Musashino-shi, Japan
Investigational Site Number 392-029
🇯🇵Okayama-shi, Japan
Investigational Site Number 392-008
🇯🇵Mito-shi, Japan
Investigational Site Number 392-017
🇯🇵Otsu-shi, Japan
Investigational Site Number 392-011
🇯🇵Sagamihara-shi, Japan
Investigational Site Number 392-010
🇯🇵Sapporo-shi, Japan
Investigational Site Number 392-018
🇯🇵Shinjuku-ku, Japan
Investigational Site Number 392-005
🇯🇵Shizuoka-shi, Japan
Investigational Site Number 392-031
🇯🇵Suita-shi, Japan
Investigational Site Number 392-015
🇯🇵Sumida-ku, Japan
Investigational Site Number 392-023
🇯🇵Sunto-gun, Japan
Investigational Site Number 392-013
🇯🇵Tokorozawa-shi, Japan
Investigational Site Number 392-025
🇯🇵Yokohama-shi, Japan
Investigational Site Number 392-020
🇯🇵Sakai-shi, Japan