BridgeMD
New treatment option for Type 2 Diabetes Mellitus
Official title Current Status of Islet Alpha Cell Function in Patients with Type 2 Diabetes
ClinicalTrials.gov ID: NCT06825182
What this study is testing
What is Outpatient newly diagnosed type 2 diabetes subjects?
Outpatient newly diagnosed type 2 diabetes subjects is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for type 2 diabetes mellitus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
- people who are capable and willing to maintain a regular diet and exercise regimen.
You likely can't join if
- 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;
See the full eligibility criteria
- 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;
- people who are capable and willing to maintain a regular diet and exercise regimen.
- 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;
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.