Type 1 Diabetes MellitusNCT07415226
Glucose-lowering Drugs as an Adjunct to Insulin Therapy in Chinese Patients With Type 1 Diabetes
An observational study of Type 1 Diabetes Mellitus, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
To assess the real-world impact of glucose-lowering drugs (GLDs) as an adjunct to insulin in Chinese patients with type 1 diabetes (T1DM). Does glucose-lowering drugs (GLDs) as an adjunct to insulin improve clinical outcomes in Chinese patients with type 1 diabetes (T1DM) when used long-term in real-world practice? Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- GLD+insulin group
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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%;
- Age >= 18 years old;
- At least one recorded HbA1c value before the start of treatment;
- Maintain medication regimen as needed from baseline to at least 3 months;
- Record the first glycated hemoglobin value after treatment.
Who cannot join
- The patient had already used hypoglycemic drugs as an adjunct to insulin therapy before admission;
- DKA、 Serious infection, perioperative status, severe trauma, pregnancy, patient's past or current involvement in interventional clinical research；
- The standard for determining stress hyperglycemia by the supervising physician;
- Patients who have no medication records or have not followed the treatment plan formulated by the doctor.
About this study
Official title: Effectiveness and Safety of Glucose-lowering Drugs as an Adjunct to Insulin Therapy in Chinese Patients With Type 1 Diabetes: a Retrospective, Observational Study
To assess the real-world impact of glucose-lowering drugs (GLDs) as an adjunct to insulin in Chinese patients with type 1 diabetes (T1DM).
Does glucose-lowering drugs (GLDs) as an adjunct to insulin improve clinical outcomes in Chinese patients with type 1 diabetes (T1DM) when used long-term in real-world practice?
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- GLD+insulin group
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLD+insulin groupDrug
The glucose-lowering drugs included in the analysis were metformin, acarbose and DPP-4i alone or in combination with other agents.
| Study group | Role | What they receive |
|---|---|---|
| GLD+insulin group | Patients with insulin and additional glucose-lowering drugs to treat type 1 diabetes were identified as adjuvant medication users (GLD+insulin group). Receives: Drug: GLD+insulin group | |
| insulin-only group | Patients who did not use glucose-lowering drugs (GLDs) as an adjunct to treat type 1 diabetes in the datasets were identified as insulin-only users (insulin-only group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
The primary outcome measure is glycated hemoglobin (HbA1c), which reflects the average blood glucose level of Chinese patients with type 1 diabetes mellitus (T1DM) over the past 2-3 months. HbA1c levels will be measured using a standardized clinical detection method at the baseline and follow-up visits of the study, to evaluate the long-term blood glucose control effect of insulin plus GLDs combined therapy compared with insulin monotherapy in real-world practice.
Measured: Baseline to 3 months, 6 months, 12 months
Secondary outcomes (1)
Absolute and relative insulin doses
Measured: Baseline to 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chenyang Shi, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415226
- Sponsor's protocol ID
- CCTR-2025C26
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Glucose-lowering Drugs as an Adjunct to Insulin Therapy in Chinese Patients With Type 1 Diabetes: a Retrospective, Observational Study
- ClinicalTrials.gov ID
- NCT07415226
- Acronym / sponsor ID
- CCTR-2025C26
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the real-world impact of glucose-lowering drugs (GLDs) as an adjunct to insulin in Chinese patients with type 1 diabetes (T1DM).
Does glucose-lowering drugs (GLDs) as an adjunct to insulin improve clinical outcomes in Chinese patients with type 1 diabetes (T1DM) when used long-term in real-world practice?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLD+insulin group | – | Drug: GLD+insulin groupPatients with insulin and additional glucose-lowering drugs to treat type 1 diabetes were identified as adjuvant medication users (GLD+insulin group). |
| insulin-only group | – | –Patients who did not use glucose-lowering drugs (GLDs) as an adjunct to treat type 1 diabetes in the datasets were identified as insulin-only users (insulin-only group) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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%;
- Age >= 18 years old;
- At least one recorded HbA1c value before the start of treatment;
- Maintain medication regimen as needed from baseline to at least 3 months;
- Record the first glycated hemoglobin value after treatment.
Key exclusion criteria (4 listed)
- The patient had already used hypoglycemic drugs as an adjunct to insulin therapy before admission;
- DKA、 Serious infection, perioperative status, severe trauma, pregnancy, patient's past or current involvement in interventional clinical research；
- The standard for determining stress hyperglycemia by the supervising physician;
- Patients who have no medication records or have not followed the treatment plan formulated by the doctor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLD+insulin groupThe glucose-lowering drugs included in the analysis were metformin, acarbose and DPP-4i alone or in combination with other agents. | Drug | GLD+insulin group |
Primary outcome
HbA1c
Time frame: Baseline to 3 months, 6 months, 12 months
The primary outcome measure is glycated hemoglobin (HbA1c), which reflects the average blood glucose level of Chinese patients with type 1 diabetes mellitus (T1DM) over the past 2-3 months. HbA1c levels will be measured using a standardized clinical detection method at the baseline and follow-up visits of the study, to evaluate the long-term blood glucose control effect of insulin plus GLDs combined therapy compared with insulin monotherapy in real-world practice.
1 secondary outcome
Absolute and relative insulin doses
Time frame: Baseline to 3 months, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
HbA1c (time frame: Baseline to 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2026.