Type 2 Diabetes MellitusPhase 3NCT06825182
Current Status of Islet Alpha Cell Function in Patients with Type 2 Diabetes
A Phase 3 study testing Outpatient newly diagnosed type 2 diabetes subjects and Inpatient newly diagnosed type 2 diabetes subjects in people with Type 2 Diabetes Mellitus, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
By detecting the fasting and postprandial 120-minute glucose, insulin (Insulin, INS), C-peptide (C-peptide, Cp), glucagon (GCG) levels in newly diagnosed type 2 diabetes patients, or the 0-minute, 30-minute, 120-minute glucose, INS, Cp, GCG levels during the Oral Glucose Tolerance Test (OGTT), and examining the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Outpatient newly diagnosed type 2 diabetes subjects and Inpatient newly diagnosed type 2 diabetes subjects
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 2024to 31 Dec 2025
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to participate voluntarily and able to sign the Informed Consent Form before the trial;
- Newly diagnosed patients with type 2 diabetes, aged 18 years or older, meeting the WHO 1999 diagnostic criteria;
- Subjects who are capable and willing to maintain a regular diet and exercise regimen.
Who cannot join
- Patients who are allergic to GLP-1RA or have a BMI less than 24 kg/m^2;
- History of using blood sugar-lowering medications;
- Estimated glomerular filtration rate (eGFR) less than 30 ml/(min*1.73 m^2);
- History of drug abuse or alcohol dependence within the past 5 years;
- Patients with poor compliance and irregular diet and exercise;
- History of diagnosed pancreatitis, pancreatic tumor, medullary thyroid carcinoma, or diabetic retinopathy stage IV or higher;
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- Patients who have used systemic glucocorticoid therapy within the past 3 months;
- Presence of infection or stress within the past four weeks;
- Any other significant condition or comorbidity judged by the researcher, such as severe cardiopulmonary disease, endocrine disorders, neurological disorders, tumors, other pancreatic diseases, mental illness, history of alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hostital
Nanjing, Jiangsu, 210000
Ma Jian Hua, Doctor, +8618951670116, majianhua196503@126.com
About this study
Official title: Survey on the Current Status of Islet Alpha Cell Function in Patients with Type 2 Diabetes and Interventional Study of GLP-1RA: a Multicenter, Prospective Study
By detecting the fasting and postprandial 120-minute glucose, insulin (Insulin, INS), C-peptide (C-peptide, Cp), glucagon (GCG) levels in newly diagnosed type 2 diabetes patients, or the 0-minute, 30-minute, 120-minute glucose, INS, Cp, GCG levels during the Oral Glucose Tolerance Test (OGTT), and examining the glucose, INS, Cp, GCG levels during hypoglycemia, the current status of islet alpha cell function in diabetic patients is observed. Type 2 diabetes patients willing to participate are treated with GLP-1RA for 3 months, and then retested for fasting and postprandial 120-minute glucose, INS, Cp, GCG, or the 0-minute, 30-minute, 120-minute glucose, INS, Cp, GCG during OGTT, as well as the counter-regulatory hormone levels during hypoglycemia, to assess the improvement of islet alpha cell function by GLP-1RA.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Outpatient newly diagnosed type 2 diabetes subjects, Inpatient newly diagnosed type 2 diabetes subjects
- Keywords
- Islet Alpha Cell Function, Glucagon-Like Peptide-1 Receptor Agonists (GLP1-RA)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient newly diagnosed type 2 diabetes subjectsDrug
Outpatient newly diagnosed type 2 diabetes subjects, who have signed the informed consent form, meet the inclusion and exclusion criteria, and have their demographic data collected, including height, weight, systolic and diastolic blood pressure, and calculation of the body mass index (BMI) = weight/height^2 (kg/m^2). Fasting and postprandial 120-minute glucose, insulin (INS), C-peptide (Cp), and glucagon (GCG) levels are measured, or an Oral Glucose Tolerance Test (OGTT) is performed, measuring glucose, INS, Cp, GCG at 0, 30, and 120 minutes, and renal function and HbA1c are tested, with eGFR calculated. Type 2 diabetes patients are treated with GLP-1RA for three months, and then the aforementioned indicators are retested to complete the study.
Inpatient newly diagnosed type 2 diabetes subjectsDrug
Demographic data are collected. Fasting and postprandial 120-minute glucose, insulin (INS), C-peptide (Cp), and glucagon (GCG) levels are measured, or an Oral Glucose Tolerance Test (OGTT) is conducted, measuring glucose, INS, Cp, GCG at 0, 30, and 120 minutes, and renal function and HbA1c are tested. During hospitalization, if hypoglycemic symptoms occur or peripheral blood glucose or continuous glucose monitoring is ≤3.9 mmol/L, immediate venous blood is drawn for glucose, GCG, adrenocorticotropic hormone (ACTH), cortisol (Cor), growth hormone (GH), and Cp testing. Patients are treated with GLP-1RA for three months, then the aforementioned indicators are retested to complete the study and hypoglycemia (including hypoglycemic clamp and hypoglycemia tests) is assessed for glucose and GCG, with additional tests for ACTH, Cor, GH, and Cp if conditions permit, to complete the study.
| Study group | Role | What they receive |
|---|---|---|
| Loxenatide | Other | Not described Receives: Drug: Outpatient newly diagnosed type 2 diabetes subjects; Drug: Inpatient newly diagnosed type 2 diabetes subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucagon levels
Compare the glucagon levels in diabetic subjects during hyperglycemia and hypoglycemia, and the changes in GCG after 3 months of GLP-1RA treatment
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start7 Nov 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825182
- Sponsor's protocol ID
- KY20240514-11
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on the Current Status of Islet Alpha Cell Function in Patients with Type 2 Diabetes and Interventional Study of GLP-1RA: a Multicenter, Prospective Study
- ClinicalTrials.gov ID
- NCT06825182
- Acronym / sponsor ID
- KY20240514-11
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Islet Alpha Cell Function, Glucagon-Like Peptide-1 Receptor Agonists (GLP1-RA)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Feb 2025 (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.
By detecting the fasting and postprandial 120-minute glucose, insulin (Insulin, INS), C-peptide (C-peptide, Cp), glucagon (GCG) levels in newly diagnosed type 2 diabetes patients, or the 0-minute, 30-minute, 120-minute glucose, INS, Cp, GCG levels during the Oral Glucose Tolerance Test (OGTT), and examining the glucose, INS, Cp, GCG levels during hypoglycemia, the current status of islet alpha cell function in diabetic patients is observed. Type 2 diabetes patients willing to participate are treated with GLP-1RA for 3 months, and then retested for fasting and postprandial 120-minute glucose, INS, Cp, GCG, or the 0-minute, 30-minute, 120-minute glucose, INS, Cp, GCG during OGTT, as well as the counter-regulatory hormone levels during hypoglycemia, to assess the improvement of islet alpha cell function by GLP-1RA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Loxenatide | Other | Drug: Outpatient newly diagnosed type 2 diabetes subjects, Drug: Inpatient newly diagnosed type 2 diabetes subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to participate voluntarily and able to sign the Informed Consent Form before the trial;
- Newly diagnosed patients with type 2 diabetes, aged 18 years or older, meeting the WHO 1999 diagnostic criteria;
- Subjects who are capable and willing to maintain a regular diet and exercise regimen.
Key exclusion criteria (9 listed)
- Patients who are allergic to GLP-1RA or have a BMI less than 24 kg/m^2;
- History of using blood sugar-lowering medications;
- Estimated glomerular filtration rate (eGFR) less than 30 ml/(min*1.73 m^2);
- History of drug abuse or alcohol dependence within the past 5 years;
- Patients with poor compliance and irregular diet and exercise;
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 |
|---|---|---|
| Outpatient newly diagnosed type 2 diabetes subjectsOutpatient newly diagnosed type 2 diabetes subjects, who have signed the informed consent form, meet the inclusion and exclusion criteria, and have their demographic data collected, including height, weight, systolic and diastolic blood pressure, and calculation of the body mass index (BMI) = weight/height^2 (kg/m^2). Fasting and postprandial 120-minute glucose, insulin (INS), C-peptide (Cp), and glucagon (GCG) levels are measured, or an Oral Glucose Tolerance Test (OGTT) is performed, measuring glucose, INS, Cp, GCG at 0, 30, and 120 minutes, and renal function and HbA1c are tested, with eGFR calculated. Type 2 diabetes patients are treated with GLP-1RA for three months, and then the aforementioned indicators are retested to complete the study. | Drug | Loxenatide |
| Inpatient newly diagnosed type 2 diabetes subjectsDemographic data are collected. Fasting and postprandial 120-minute glucose, insulin (INS), C-peptide (Cp), and glucagon (GCG) levels are measured, or an Oral Glucose Tolerance Test (OGTT) is conducted, measuring glucose, INS, Cp, GCG at 0, 30, and 120 minutes, and renal function and HbA1c are tested. During hospitalization, if hypoglycemic symptoms occur or peripheral blood glucose or continuous glucose monitoring is ≤3.9 mmol/L, immediate venous blood is drawn for glucose, GCG, adrenocorticotropic hormone (ACTH), cortisol (Cor), growth hormone (GH), and Cp testing. Patients are treated with GLP-1RA for three months, then the aforementioned indicators are retested to complete the study and hypoglycemia (including hypoglycemic clamp and hypoglycemia tests) is assessed for glucose and GCG, with additional tests for ACTH, Cor, GH, and Cp if conditions permit, to complete the study. | Drug | Loxenatide |
Primary outcome
Glucagon levels
Time frame: 19 months
Compare the glucagon levels in diabetic subjects during hyperglycemia and hypoglycemia, and the changes in GCG after 3 months of GLP-1RA treatment
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 13 Feb 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Outpatient newly diagnosed type 2 diabetes subjects and Inpatient newly diagnosed type 2 diabetes subjects in people with Type 2 Diabetes Mellitus, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jianhua Ma, professor (18951670116, majianhua196503@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucagon levels (time frame: 19 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 13 Feb 2025.