Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-01-04 @ 5:58 AM
Study NCT ID:
NCT02201004
Status:
COMPLETED
Last Update Posted:
2017-10-11
First Post:
2014-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TOFO Insulin Combination Trial
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Randomized, Double Blind Placebo Controlled 2-Arm Parallel Group, Multicenter Study With A 16-Week Treatment Assessing The Efficacy And Safety, And 52-Week Long Term Safety Including 36-Week Open Label Extension Of Tofogliflozin With Insulin Treatment In Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1159-5316 | None | UTN | View |