Tofogliflozin GLP-1 Analogue Combination Trial

Type 2 Diabetes Mellitus Clinical Trial

Official title:

An Open-Label, Multicenter Study to Evaluate 52-Week Long-Term Safety, Tolerability and Efficacy of Tofogliflozin With Glucagon-like Peptide-1(GLP-1) Analogue Treatment In Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02537834
• Other study ID #: DEBT02
• Secondary ID: TOFOGL07279
• Status: Completed
• Phase: Phase 4
• Start date: August 2015
• Est. completion date: October 2017

Study information

• Verified date: November 2020
• Source: Kowa Company, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An open-label, multicenter study to evaluate 52-week long-term safety, tolerability and efficacy of Tofogliflozin with GLP-1 analogue treatment in type 2 diabetes mellitus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• The subject aged from 20 to 75 years old with type 2 diabetes mellitus(T2DM)

• The subject with hemoglobin A1c ?7.5% - <10.5 %

• The subject who has been receiving a stable dose and regimen of GLP-1 analogue over 8 weeks before Screening test

Exclusion Criteria:

• The subject with type 1 diabetes mellitus

• The subject with Pregnancy or lactation

• The subject with Fasting Plasma Glucose ? 270 mg/dl

• The subject with history of metabolic acidosis, including diabetic ketoacidosis ,within 1 year prior to screening

• The subject with myocardial infarction, stroke, or heart failure requiring hospitalization or drug or alcohol abuse within the previous 6 months

• The subject with serum creatinine level greater than 2.0 mg/dL for men and 1.5 mg/dL for women

• The subject with aspartate aminotransferase(AST) or alanine aminotransferase(ALT) ? 2.5 times the upper limit of the reference range at the central laboratory test facility

• The subject has received treatment with another investigational product or non-approved drug 3 months before screening

• The subject with history of Tofogliflozin therapy

• The subject with estimated glomerular filtration rate of <30 mL/min/1.73 m^2

• The subject who frequently experiencing orthostatic hypotension

• The subject systolic blood pressure of ? 180 or mmHg of diastolic blood pressure of ? 100 mmHg

• The subject required a change in the dosing regiment for the following drugs within 4 weeks before screening : Lipid-lowering drug , Antihypertensive drug, Thyroid hormone drug , Uric acid lowering drug

Related Conditions & MeSH terms

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

Intervention

Drug:
• Tofogliflozin

• GLP-1 analogue

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kowa Company, Ltd.	Sanofi

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Terauchi Y, Fujiwara H, Kurihara Y, Suganami H, Tamura M, Senda M, Gunji R, Kaku K. Long-term safety and efficacy of the sodium-glucose cotransporter 2 inhibitor, tofogliflozin, added on glucagon-like peptide-1 receptor agonist in Japanese patients with t — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability Assessed by Adverse Event and Adverse Drug Reaction		baseline and Week 52
Primary	Change from Baseline in HbA1c at 52 weeks		Week 52
Secondary	Change in Fasting plasma glucose		baseline and week 52
Secondary	Change in Body Weight		baseline and week 52
Secondary	Change in Blood pressure		baseline and week 52
Secondary	Change in Uric Acid		baseline and week 52
Secondary	Change in Total cholesterol		baseline and week 52
Secondary	Change in HDL-C		baseline and week 52
Secondary	Change in LDL-C		baseline and week 52
Secondary	Change in non HDL-C		baseline and week 52
Secondary	Change in Free Fatty Acid		baseline and week 52

External Links

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