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New diabetes pill shows promise in early trial

NCT ID NCT01022112

Disease control Sponsor: Tanabe Pharma Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tested an experimental oral drug called TA-7284 in 383 adults with type 2 diabetes. The drug works by helping the kidneys remove extra sugar through urine. Researchers compared four different doses of TA-7284 against a placebo to see how well it lowers blood sugar and whether it is safe. The study is already completed, and results will help decide if larger trials are warranted.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TA-7284 (an SGLT2 inhibitor drug taken by mouth)
What this could lead to
If successful, this could lead to a new oral medication to help people with type 2 diabetes better control their blood sugar levels.
What could go wrong
This is an early Phase 2 dose-ranging study, so results may not confirm effectiveness or safety. The drug may cause side effects or fail to outperform placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

383 people

The number who actually took part.

Start date

Nov 2009

Finished

Sep 2010

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged from 20 to 80 years inclusive on the day of informed consent; * Patients who was diagnosed with type 2 diabetes mellitus at least 3 months before the start of the run-in period; * Patients with HbA1c of ≥6.5% and ≤9.5% (according to the Japan Diabetic Society \[JDS\] criteria) on the start day of the run-in period; Exclusion Criteria: * Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, Cushing's syndrome, etc.); * Past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage III or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy); * Fasting blood glucose of \>270 mg/dL on the start day of the run-in period or at Week 2 of the run-in period; * eGFR of \<60 mL/min/1.73 m2 on the start day of the run-in period; * Systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg on the start or end day of the run-in period; * History of myocardial infarction, unstable angina, or cerebrovascular disorder within 3 months before the start of the run-in period; * Concurrent serious (e.g., requiring inpatient hospitalization or surgical intervention) renal or hepatic disease; * Past or current history of malignant tumor; however, this criterion shall not apply to those who have been free of relapse for at least 5 years even with a history of malignant tumor. * Past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms; * Pregnant women, lactating mothers, or women of childbearing potential; * Any condition that subjects are assessed to be ineligible by the investigator (sub investigator).

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes mellitus

Contacts and locations

Locations

  • Research site

    Chugoku, Japan

  • Research site

    Kanto, Japan

  • Research site

    Kinki, Japan

  • Research site

    Kyushu, Japan

  • Research site

    Shikoku, Japan

  • Research site

    Tōhoku, Japan

More trials for these conditions

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