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Compares treatment options for Type 2 Diabetic Patients
Official title Comparing the Efficacy and Safety Between Continuous Subcutaneous Beinaglutide and CSII for Newly Diagnosed T2DM Patients
ClinicalTrials.gov ID: NCT03987308
What this study is testing
What is Beinaglutide?
Beinaglutide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for type 2 diabetic patients.
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
- The efficacy, safety and post-treatment disease control will be compared between groups of continuous subcutaneous Beinaglutide infusion and continuous subcutaneous insulin infusion (CSII) in adult patients with newly diagnosed type 2 diabetes.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age 18 to 70 years (inclusive) at enrollment, regardless of gender.
- Voluntary signing of the informed consent form.
- Newly diagnosed type 2 diabetes mellitus patients, diagnosed according to the WHO 1999 criteria, with a disease duration ≤1 year.
- HbA1c between 7.5% and 10.0%.
- BMI between 24 kg/m² and 42 kg/m².
You likely can't join if
- Patients with type 1 diabetes or other types of diabetes.
- History of obstructive intestinal diseases or potential complications: people with post-abdominal surgery or peritoneal infection-related intestinal...
- History of pancreatitis.
- Family history of medullary thyroid carcinoma.
- History of malignant tumors.
- ALT, AST \>3 times the upper limit of normal, and/or total bilirubin \>2 times the upper limit of normal.
See the full eligibility criteria
- Age 18 to 70 years (inclusive) at enrollment, regardless of gender.
- Voluntary signing of the informed consent form.
- Newly diagnosed type 2 diabetes mellitus patients, diagnosed according to the WHO 1999 criteria, with a disease duration ≤1 year.
- HbA1c between 7.5% and 10.0%.
- BMI between 24 kg/m² and 42 kg/m².
- people who have not taken antidiabetic medications or have used oral antidiabetic medications for less than 3 months and have discontinued for more than 1 month (calculated from the date of signing the informed consent...
- people with reproductive potential (including male people whose partners have reproductive potential) agree to use effective contraception during the study and for 1 month after study completion.
- Patients with type 1 diabetes or other types of diabetes.
- History of obstructive intestinal diseases or potential complications: people with post-abdominal surgery or peritoneal infection-related intestinal adhesions, intestinal obstruction sequelae; people with intestinal...
- History of pancreatitis.
- Family history of medullary thyroid carcinoma.
- History of malignant tumors.
- ALT, AST \>3 times the upper limit of normal, and/or total bilirubin \>2 times the upper limit of normal.
- Moderate to severe renal insufficiency (eGFR \<60 ml/min/1.73m²).
- Triglycerides ≥5.0 mmol/L.
- Multiple endocrine neoplasia type 2 (MEN 2).
- Participation in any pre-marketing drug study within 3 months.
- Use or expected use of systemic corticosteroids, immunosuppressants, or cytotoxic drugs during the study period.
- History of diabetic ketoacidosis or non-ketotic hyperosmolar coma within 6 months prior to screening.
- Blood pressure exceeding the following criteria (untreated or treated): systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg.
- History of any of the following cardiovascular diseases within 3 months prior to screening: acute myocardial infarction, New York Heart Association functional class III/IV heart failure or left ventricular ejection...
- Allergy to binaclotide or any component of the study drug, or allergy to insulin or any component of the insulin used in the study.
- Presence of other severe diseases that may interfere with the study, as judged by the investigator.
- Pregnant or breastfeeding women.
- Poor compliance, as judged by the investigator, and inability to complete the study as required.
- Inability to undergo continuous pump infusion: people allergic to subcutaneous infusion tubes or adhesive tape; people unwilling to have long-term subcutaneous infusion tubes or continuous pump use; people with...
- Any other factors deemed unsuitable for participation in the study by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Harbin, Heilongjiang, China
- Nanjing, Jiangsu, China
- Xuzhou, Jiangsu, China
- Changchun, Jilin, China
- Xi'an, Shaanxi, China
- Luzhou, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Beijing, China
- Harbin, China
- Zhengzhou, 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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Harbin, Heilongjiang, China; Nanjing, Jiangsu, China; Xuzhou, Jiangsu, China; Changchun, Jilin, China and 6 more location(s). 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.