Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatments tofogliflozin csg452, insulin, placebo
Phase phase 4
Sponsor Sanofi
Collaborator Kowa Company, Ltd.
Start date June 2014
End date January 2016
Trial size 210 participants
Trial identifier NCT02201004, TOFOGL07061, U1111-1159-5316

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Tofogliflozin administered once daily for 52 weeks. Insulin administered as base treatment.
tofogliflozin csg452 Apleway
Pharmaceutical form:tablet Route of administration: oral
insulin
Pharmaceutical form:solution Route of administration: subcutaneous
(Placebo Comparator)
Placebo administered once daily for 16 weeks. After 16-weeks, Tofogliflozin administered once daily for 36 weeks. Insulin administered as base treatment.
tofogliflozin csg452 Apleway
Pharmaceutical form:tablet Route of administration: oral
insulin
Pharmaceutical form:solution Route of administration: subcutaneous
placebo
Pharmaceutical form:tablet Route of administration: oral

Primary Outcomes

Measure
Change in HbA1c from baseline
time frame: 16 weeks after first intake of investigational product

Secondary Outcomes

Measure
Change of Body Weight (BW) from baseline
time frame: 16 weeks after first intake of investigational product
Change of FPG from baseline
time frame: 16 weeks after first intake of investigational product
Change of PPG from baseline
time frame: 16 weeks after first intake of investigational product
Number of subjects with adverse events
time frame: Up to 52 weeks from the first intake of investigational medicinal product

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Sanofi.