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Type 2 Diabetes MellitusPhase 4NCT02537834

Tofogliflozin GLP-1 Analogue Combination Trial

A Phase 4 study testing Tofogliflozin and GLP-1 analogue in people with Type 2 Diabetes Mellitus, run by Kowa Company, Ltd. at 11 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Tofogliflozin and GLP-1 analogue
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
11 sitesJapan
Study dates
Aug 2015to Oct 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Japan11 sites

  • Study site

    Adachi-ku, Tokyo, 123-0845

  • Study site

    Annaka, Gunma, 379-0116

  • Study site

    Atsuta-ku, Aichi-ken, 456-0058

  • Study site

    Chuo-ku, Tokyo, 103-0027

  • Study site

    Kasaoka, Okayama-ken, 714-0043

  • Study site

    Kisarazu, Chiba, 292-0038

  • Study site

    Minato-ku, Aichi-ken, 455-0018

  • Study site

    Mitaka, Tokyo, 181-0013

  • Study site

    Naka, Ibaraki, 311-0113

  • Study site

    Sagamihara, Kanagawa, 252-0302

  • Study site

    Shimono, Tochigi, 329-0433

Other trials in Japan

About this study

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

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.

Being tested
Tofogliflozin, GLP-1 analogue
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TofogliflozinDrug

    Also called DEBERZA, APLEWAY

  • GLP-1 analogueDrug

Study groups in NCT02537834
Study groupRoleWhat they receive
Tofogliflozin ＋GLP-1 analogueExperimentalTofogliflozin administered once daily for 52 weeks. GLP-1 analogue administered as base treatment.
Receives: Drug: Tofogliflozin; Drug: GLP-1 analogue

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability Assessed by Adverse Event and Adverse Drug Reaction

    Measured: baseline and Week 52

  2. Change from Baseline in HbA1c at 52 weeks

    Measured: Week 52

Secondary outcomes (9)

  1. Change in Fasting plasma glucose

    Measured: baseline and week 52

  2. Change in Body Weight

    Measured: baseline and week 52

  3. Change in Blood pressure

    Measured: baseline and week 52

  4. Change in Uric Acid

    Measured: baseline and week 52

  5. Change in Total cholesterol

    Measured: baseline and week 52

  6. Change in HDL-C

    Measured: baseline and week 52

  7. Change in LDL-C

    Measured: baseline and week 52

  8. Change in non HDL-C

    Measured: baseline and week 52

  9. Change in Free Fatty Acid

    Measured: baseline and week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionJul 2017
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02537834
Sponsor's protocol ID
DEBT02
Other IDs
TOFOGL07279
Status last verified
Nov 2020
First submitted
25 Aug 2015
Last updated
17 Nov 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31033218

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tofogliflozin and GLP-1 analogue in people with Type 2 Diabetes Mellitus, run by Kowa Company, Ltd. at 11 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability Assessed by Adverse Event and Adverse Drug Reaction (time frame: baseline and Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02537834, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020; AzTrials last refreshed its copy on 6 Nov 2026.

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