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Researchers investigate adding diabetes pills to insulin for type 1 diabetes

NCT ID NCT07415226

Knowledge-focused Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Source: ClinicalTrials.gov ↗

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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The trial has finished. Results may not be published yet.
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Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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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

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

Summary

This study will look back at medical records of 500 Chinese adults with type 1 diabetes to see if adding glucose-lowering pills to insulin helps control blood sugar better than insulin alone. The main goal is to check changes in HbA1c (average blood sugar over 2-3 months) and how much insulin patients need. It is an observational study, meaning researchers will not give any treatments but will analyze existing data.

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.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

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.

Who is studied

The study population consists of Chinese adult patients with type 1 diabetes mellitus (T1DM) who met the predefined eligibility criteria, enrolled from January 2013 to June 2024. The population is divided into two cohorts: the study cohort (T1DM patients who first used oral GLDs as adjuvant therapy to insulin) and the control cohort (T1DM patients who maintained insulin monotherapy). All participants had an HbA1c level of ≥ 7% at baseline, were ≥ 18 years old, had at least one recorded HbA1c value before treatment initiation, and maintained the required medication regimen for at least 3 months. Patients with DKA, severe comorbidities, stress hyperglycemia, or incomplete medical records were excluded. This study population is representative of real-world T1DM patients with poor long-term blood glucose control who require adjuvant GLDs or maintain insulin monotherapy, ensuring the external validity of the study results.

Ages

18 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: 1. The research group consists of T1DM patients who first used oral hypoglycemic drugs from January 2013 to June 2024 and had a glycated hemoglobin level of \>= 7%; The control group consisted of T1DM patients who maintained only insulin treatment regimen and had glycated hemoglobin \>= 7%; 2. Age \>= 18 years old; 3. At least one recorded HbA1c value before the start of treatment; 4. Maintain medication regimen as needed from baseline to at least 3 months; 5. Record the first glycated hemoglobin value after treatment. Exclusion Criteria: 1. The patient had already used hypoglycemic drugs as an adjunct to insulin therapy before admission; 2. DKA、 Serious infection, perioperative status, severe trauma, pregnancy, patient's past or current involvement in interventional clinical research； 3. The standard for determining stress hyperglycemia by the supervising physician; 4. Patients who have no medication records or have not followed the treatment plan formulated by the doctor.

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

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

Type 1 diabetes mellitus

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

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More trials for these conditions

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