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New combo therapy may help newly diagnosed diabetics go Drug-Free for a year

NCT ID NCT01471808

Disease control Sponsor: Sun Yat-sen University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested whether adding oral diabetes drugs (metformin/pioglitazone or sitagliptin) to a short-term insulin pump can improve long-term blood sugar control and help newly diagnosed type 2 diabetes patients achieve remission. 264 participants who were newly diagnosed, not on any diabetes medication, and had moderate to high blood sugar were enrolled. The main goal was to see how many could maintain normal blood sugar without medication for one year after the short intensive treatment.

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

264 people

The number who actually took part.

Start date

Oct 2011

Finished

Dec 2018

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

25 to 65 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: * newly diagnosed type 2 diabetes * fasting blood glucose (FBG) level ranging from 7.0～16.7 mmol/L * body mass index (BMI) ranging from21～35kg/m2 * Antihyperglycaemic and antihyperlipidemic medication-naive patients Exclusion Criteria: * having any severe acute or chronic diabetic complications * renal dysfunction, blood creatinine≥150µmol/L * blood aminotransferase level rising up(more than 2 times of the upper normal limit of ALT) * • Any severe cardiac disease including congestive cardiac failure, unstable angina or myocardial infarct in 12 months * chronic or acute pancreatic disease * severe systematic diseases or malignant tumor * female patients incline to be pregnant * being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs * poor compliance

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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.

Diabetes mellitus type 2

More trials for these conditions

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