Investigating the effects of polyethylene glycol Losenatide on type 2 diabetes
Nanjing First Hospital, Nanjing Medical University
PHASE4 · Nanjing First Hospital, Nanjing Medical University · NCT05611684
This study is testing if a new diabetes medication called polyethylene glycol Losenatide can help people with type 2 diabetes improve their blood sugar, lose weight, and feel healthier over 12 weeks.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 480 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nanjing First Hospital, Nanjing Medical University (other) |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05611684 on ClinicalTrials.gov |
What this trial studies
This study examines the impact of polyethylene glycol Losenatide on various health factors in patients with type 2 diabetes over a 12-week period. It aims to identify the factors that influence the drug's efficacy, focusing on changes in body fat, insulin resistance, weight, blood sugar levels, and blood lipid profiles. Patients will be categorized based on their reduction in HbA1c levels, allowing for a detailed analysis of clinical characteristics and laboratory indicators. The findings are intended to enhance evidence-based treatment strategies for diabetes management.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with type 2 diabetes who have not achieved adequate blood glucose control despite diet and exercise.
Not a fit: Patients who have recently used certain diabetes medications or have specific contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with type 2 diabetes, enhancing their blood sugar control and overall health.
How similar studies have performed: While there have been studies on GLP-1 receptor agonists, the specific use of polyethylene glycol Losenatide in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Type 2 diabetes was diagnosed according to World Health Organization(WHO) classification or other locally applicable diagnostic criteria. * At least 8 weeks of simple diet control and physical exercise before screening; Type 2 diabetes patients with stable hypoglycemic drug treatment and insufficient blood glucose control within 8 weeks before screening. * HbA1c≥7.5%. * Body mass index (BMI) \> 24kg /m2. * Subjects agreed to maintain scientific diet and exercise habits throughout the study, regularly conduct self blood glucose monitoring (SMBG) and make records. * Willing to sign the written informed consent and abide by the research protocol. Exclusion Criteria: * Any of the following drugs or treatments were used within one year before screening: GLP-1RA, GLP-1 analogues, DPP-4 inhibitors or any other incretin analogues. * Long term (more than 7 consecutive days) intravenous administration, oral administration and intra-articular administration of corticosteroids received within 2 months prior to visit 1. * Used drugs with weight control effect or performed surgery that may lead to unstable weight within 2 months before screening, or is currently in the weight loss plan and not in the maintenance stage. * History of acute and chronic pancreatitis; History of myeloid C-cell carcinoma, MEN 2A or 2B syndrome, or related family history. * Clinically significant abnormal gastric emptying. * Any organ system tumors that have been treated or not treated within 5 years prior to visit 1. * Have received coronary angioplasty, coronary stent implantation, and coronary artery bypass surgery within 6 months prior to visit 1, and have experienced negligent compensatory heart failure (NYHA class III and IV of New York Heart Association), stroke or transient ischemic attack, unstable angina, myocardial infarction, and persistent and clinically significant arrhythmia. * Acute metabolic complications occurred within 6 months prior to visit 1. * Before screening, any laboratory test index meets the following standards: glutamic pyruvic transaminase\>2.5 times or glutamic oxaloacetic transaminase\>2.5 times; eGFR\<45ml\\/min\\/1.73m2； Fasting triglyceride\>5.64mmol /L.
Where this trial is running
Nanjing, Jiangsu
- Jianhua Ma — Nanjing, Jiangsu, China (RECRUITING)
Study contacts
- Study coordinator: Jianhua Ma, Doctor
- Email: majianhua196503@126.com
- Phone: +8618951670116
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type2 Diabetes Mellitus