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New combo pill plus insulin shows promise for type 2 diabetes

NCT ID NCT02081599

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding the diabetes pill teneligliptin to insulin helps people with type 2 diabetes control their blood sugar better. 148 Japanese adults who were already on a stable insulin dose took either teneligliptin or a placebo for 16 weeks, with an extension up to 52 weeks. The main goal was to see if HbA1c (a measure of average blood sugar) improved more with the combination.

What this could mean

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

Active substance
Teneligliptin (a diabetes pill that helps lower blood sugar)
What this could lead to
If it works, this could offer a new combination option for people with type 2 diabetes who need better blood sugar control despite using insulin.
What could go wrong
This is a completed Phase 4 study in a specific population (Japanese patients), so results may not apply to other groups. Adding another drug also raises the chance of side effects like low blood sugar.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

148 people

The number who actually took part.

Start date

Jan 2014

Finished

Jan 2016

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 years and older

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: * Patients who has been receiving a stable dose and regimen of insulin over 12 weeks before administration of investigational drug * Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug * Patients whose HbA1c is between 7.5% and 10.5% * Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug. Exclusion Criteria: * Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc) * Patients who are accepting treatments of arrhythmias * Patients with serious diabetic complications * Patients who are the excessive alcohol addicts * Patients with severe hepatic disorder or severe renal disorder. * Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

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Conditions

The condition(s) this trial relates to.

Insulin Resistance 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

  • Investigational site

    Chuo-ku, Tokyo, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.