Tofogliflozin GLP-1 Analogue Combination Trial

NCT02537834 | Completed Phase 4

• 2 other identifiers: DEBT02TOFOGL07279
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 11

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability Assessed by Adverse Event and Adverse Drug Reaction

  baseline and Week 52

• Change from Baseline in HbA1c at 52 weeks

  Week 52

Secondary Outcomes (9)

• Change in Fasting plasma glucose

  baseline and week 52

• Change in Body Weight

  baseline and week 52

• Change in Blood pressure

  baseline and week 52

• Change in Uric Acid

  baseline and week 52

• Change in Total cholesterol

  baseline and week 52

Study Arms (1)

Tofogliflozin ＋GLP-1 analogue

EXPERIMENTAL

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

Drug: Tofogliflozin; Drug: GLP-1 analogue

Interventions

Tofogliflozin DRUG

Also known as: DEBERZA, APLEWAY

Tofogliflozin ＋GLP-1 analogue

GLP-1 analogue DRUG

Tofogliflozin ＋GLP-1 analogue

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kowa Company, Ltd.: lead
• Sanofi: collaborator

Study Sites (11)

Unknown Facility

Atsuta-ku, Aichi-ken, 456-0058, Japan

Location

Unknown Facility

Minato-ku, Aichi-ken, 455-0018, Japan

Location

Unknown Facility

Kisarazu, Chiba, 292-0038, Japan

Location

Unknown Facility

Annaka, Gunma, 379-0116, Japan

Location

Unknown Facility

Naka, Ibaraki, 311-0113, Japan

Location

Unknown Facility

Sagamihara, Kanagawa, 252-0302, Japan

Location

Unknown Facility

Kasaoka, Okayama-ken, 714-0043, Japan

Location

Unknown Facility

Shimono, Tochigi, 329-0433, Japan

Location

Unknown Facility

Adachi-ku, Tokyo, 123-0845, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, 103-0027, Japan

Location

Unknown Facility

Mitaka, Tokyo, 181-0013, Japan

Location

Related 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 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.

  PMID: 31033218 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: September 2, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

JP (11)