TOFO Insulin Combination Trial

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201004
• Other study ID #: TOFOGL07061
• Secondary ID: U1111-1159-5316
• Status: Completed
• Phase: Phase 4
• First received: July 23, 2014
• Last updated: October 10, 2017
• Start date: June 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: October 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion criteria:

• Patients aged 20-75 years old with type 2 diabetes mellitus (T2DM).

• Hemoglobin A1c =7.5% - =10.5% and FPG =220 mg/dL.

• Basal bolus (BB), Bolus, Premix, Basal supported oral therapy (BOT) regimens used for more than 12 weeks before screening.

• Stable dose (-/+20%) of insulin and no change in the dose of oral hypoglycemic agents for more than 12 weeks before screening.

• Only Dipeptidyl peptidase-4 inhibitor is allowed for basal supported oral therapy (BOT) regimen.

• Body mass index (BMI) =18.5 kg/m^2 and <35.0 kg/m^2.

• No change of antihypertensive, anti-hypercholesterolemia and uric acid lowering drug 4 weeks before screening.

Exclusion criteria:

• Type 1 diabetes mellitus.

• Pregnancy or lactation.

• Severely uncontrolled glycemic situation.

• History of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening.

• History of myocardial infarction, stroke, or heart failure requiring hospitalization or drug or alcohol abuse within the previous 6 months.

• A measured serum creatinine level greater than 2.0 mg/dL for men and 1.5 mg/dL for women.

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =2.5 times the upper limit of the reference range at the central laboratory test facility.

• Has previously received treatment with the investigational product.

• Has received treatment with another investigational product or non-approved drug within 3 months before tests for provisional enrolment.

• Corticosteroid therapy for 14 or more days in total within 8 weeks before tests for provisional enrolment (excluding those used for localized effects, such as drugs for topical [skin] application, eye drops and sprays).

• Patients who are frequently experiencing orthostatic hypotension.

• Required a change in the dosing regimen for the following drugs within 4 weeks before tests for provisional enrolment:

• Lipid-lowering drug

• Antihypertensive drug

• Thyroid hormone preparation

• Uric acid lowering drug

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• TOFOGLIFLOZIN CSG452
Pharmaceutical form:tablet Route of administration: oral
• insulin
Pharmaceutical form:solution Route of administration: subcutaneous
• placebo
Pharmaceutical form:tablet Route of administration: oral

Locations

Country	Name	City	State
Japan	Investigational Site Number 392-028	Adachi-ku
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 392-002	Ichihara-shi
Japan	Investigational Site Number 392-012	Iruma-shi
Japan	Investigational Site Number 392-003	Kawaguchi-shi
Japan	Investigational Site Number 392-014	Kitakyusyu-shi
Japan	Investigational Site Number 392-027	Kobe-shi
Japan	Investigational Site Number 392-004	Koga-shi
Japan	Investigational Site Number 392-022	Kunitachi-shi
Japan	Investigational Site Number 392-019	Kurume-shi
Japan	Investigational Site Number 392-001	Kyoto-shi
Japan	Investigational Site Number 392-024	Kyoto-shi
Japan	Investigational Site Number 392-006	Matsudo-shi
Japan	Investigational Site Number 392-008	Mito-shi
Japan	Investigational Site Number 392-030	Musashino-shi
Japan	Investigational Site Number 392-029	Okayama-shi
Japan	Investigational Site Number 392-017	Otsu-shi
Japan	Investigational Site Number 392-011	Sagamihara-shi
Japan	Investigational Site Number 392-020	Sakai-shi
Japan	Investigational Site Number 392-010	Sapporo-shi
Japan	Investigational Site Number 392-016	Sendai-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

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Kowa Company, Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Terauchi Y, Tamura M, Senda M, Gunji R, Kaku K. Efficacy and safety of tofogliflozin in Japanese patients with type 2 diabetes mellitus with inadequate glycaemic control on insulin therapy (J-STEP/INS): Results of a 16-week randomized, double-blind, place — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from baseline		16 weeks after first intake of investigational product
Secondary	Change of Body Weight (BW) from baseline		16 weeks after first intake of investigational product
Secondary	Change of FPG from baseline		16 weeks after first intake of investigational product
Secondary	Change of PPG from baseline		16 weeks after first intake of investigational product
Secondary	Number of subjects with adverse events		Up to 52 weeks from the first intake of investigational medicinal product