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Tofogliflozin GLP-1 Analogue Combination Trial

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ClinicalTrials.gov Identifier: NCT02537834
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : November 27, 2017
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Kowa Company, Ltd.

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Tofogliflozin Drug: GLP-1 analogue Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tofogliflozin +GLP-1 analogue
Tofogliflozin administered once daily for 52 weeks. GLP-1 analogue administered as base treatment.
Drug: Tofogliflozin
Other Names:
  • DEBERZA
  • APLEWAY

Drug: GLP-1 analogue



Primary Outcome Measures :
  1. Safety and Tolerability Assessed by Adverse Event and Adverse Drug Reaction [ Time Frame: baseline and Week 52 ]
  2. Change from Baseline in HbA1c at 52 weeks [ Time Frame: Week 52 ]

Secondary Outcome Measures :
  1. Change in Fasting plasma glucose [ Time Frame: baseline and week 52 ]
  2. Change in Body Weight [ Time Frame: baseline and week 52 ]
  3. Change in Blood pressure [ Time Frame: baseline and week 52 ]
  4. Change in Uric Acid [ Time Frame: baseline and week 52 ]
  5. Change in Total cholesterol [ Time Frame: baseline and week 52 ]
  6. Change in HDL-C [ Time Frame: baseline and week 52 ]
  7. Change in LDL-C [ Time Frame: baseline and week 52 ]
  8. Change in non HDL-C [ Time Frame: baseline and week 52 ]
  9. Change in Free Fatty Acid [ Time Frame: baseline and week 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537834


Locations
Japan
Atsuta-ku, Aichi, Japan, 456-0058
Minato-ku, Aichi, Japan, 455-0018
Kisarazu, Chiba, Japan, 292-0038
Annaka, Gunma, Japan, 379-0116
Naka, Ibaraki, Japan, 311-0113
Sagamihara, Kanagawa, Japan, 252-0302
Kasaoka, Okayama, Japan, 714-0043
Shimono, Tochigi, Japan, 329-0433
Adachi-ku, Tokyo, Japan, 123-0845
Chuo-ku, Tokyo, Japan, 103-0027
Mitaka, Tokyo, Japan, 181-0013
Sponsors and Collaborators
Kowa Company, Ltd.
Sanofi

Responsible Party: Kowa Company, Ltd.
ClinicalTrials.gov Identifier: NCT02537834     History of Changes
Other Study ID Numbers: DEBT02
TOFOGL07279 ( Other Identifier: Sanofi )
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: June 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon-Like Peptide 1
Glucagon
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents