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Tofogliflozin GLP-1 Analogue Combination Trial

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Tofogliflozin

GLP-1 analogue

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tofogliflozin ＋GLP-1 analogue

Arm Description

Tofogliflozin administered once daily for 52 weeks. GLP-1 analogue administered as base treatment.

Outcomes

Primary Outcome Measures

Safety and Tolerability Assessed by Adverse Event and Adverse Drug Reaction

Change from Baseline in HbA1c at 52 weeks

Secondary Outcome Measures

Change in Fasting plasma glucose

Change in Body Weight

Change in Blood pressure

Change in Uric Acid

Change in Total cholesterol

Change in HDL-C

Change in LDL-C

Change in non HDL-C

Change in Free Fatty Acid

Full Information

NCT ID

NCT02537834

First Posted

August 25, 2015

Last Updated

November 15, 2020

Sponsor

Kowa Company, Ltd.

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT02537834

Brief Title

Tofogliflozin GLP-1 Analogue Combination 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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

August 2015 (undefined)

Primary Completion Date

July 2017 (Actual)

Study Completion Date

October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kowa Company, Ltd.

Collaborators

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tofogliflozin ＋GLP-1 analogue

Arm Type

Experimental

Arm Description

Tofogliflozin administered once daily for 52 weeks. GLP-1 analogue administered as base treatment.

Intervention Type

Drug

Intervention Name(s)

Tofogliflozin

Other Intervention Name(s)

DEBERZA, APLEWAY

Intervention Type

Drug

Intervention Name(s)

GLP-1 analogue

Primary Outcome Measure Information:

Title

Safety and Tolerability Assessed by Adverse Event and Adverse Drug Reaction

Time Frame

baseline and Week 52

Title

Change from Baseline in HbA1c at 52 weeks

Time Frame

Week 52

Secondary Outcome Measure Information:

Title

Change in Fasting plasma glucose

Time Frame

baseline and week 52

Title

Change in Body Weight

Time Frame

baseline and week 52

Title

Change in Blood pressure

Time Frame

baseline and week 52

Title

Change in Uric Acid

Time Frame

baseline and week 52

Title

Change in Total cholesterol

Time Frame

baseline and week 52

Title

Change in HDL-C

Time Frame

baseline and week 52

Title

Change in LDL-C

Time Frame

baseline and week 52

Title

Change in non HDL-C

Time Frame

baseline and week 52

Title

Change in Free Fatty Acid

Time Frame

baseline and week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

City

Atsuta-ku

State/Province

Aichi

ZIP/Postal Code

456-0058

Country

Japan

City

Minato-ku

State/Province

Aichi

ZIP/Postal Code

455-0018

Country

Japan

City

Kisarazu

State/Province

Chiba

ZIP/Postal Code

292-0038

Country

Japan

City

Annaka

State/Province

Gunma

ZIP/Postal Code

379-0116

Country

Japan

City

Naka

State/Province

Ibaraki

ZIP/Postal Code

311-0113

Country

Japan

City

Sagamihara

State/Province

Kanagawa

ZIP/Postal Code

252-0302

Country

Japan

City

Kasaoka

State/Province

Okayama

ZIP/Postal Code

714-0043

Country

Japan

City

Shimono

State/Province

Tochigi

ZIP/Postal Code

329-0433

Country

Japan

City

Adachi-ku

State/Province

Tokyo

ZIP/Postal Code

123-0845

Country

Japan

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

103-0027

Country

Japan

City

Mitaka

State/Province

Tokyo

ZIP/Postal Code

181-0013

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

31033218

Citation

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 type 2 diabetes mellitus: A 52-week open-label, multicenter, post-marketing clinical study. J Diabetes Investig. 2019 Nov;10(6):1518-1526. doi: 10.1111/jdi.13066. Epub 2019 May 28.

Results Reference

result

Links:

URL

https://pubmed.ncbi.nlm.nih.gov/31033218/

Description

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Tofogliflozin GLP-1 Analogue Combination Trial

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