Clinical trial NCT05611684: The Influencing Factors of 12 Week Efficacy of Polyethylene Glycol Losenatide in Type 2 Diabetes Patients
Official title: Nanjing First Hospital, Nanjing Medical University
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Type2 Diabetes Mellitus
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The effect of polyethylene glycol Losenatide on body fat, insulin resistance, weight, blood sugar, blood lipid, stomach volume and other factors in patients with type 2 diabetes through 12 week follow-up, and explore the factors affecting the efficacy, so as to provide more evidence-based medical basis for drug treatment and benefit patients.

Detailed description: The aim of the study is to investigate the factors influencing the efficacy of 12 week treatment with polyethylene glycol Losenatide in type 2 diabetes patients on the basis of diet and exercise. With the 12 week decrease of HbA1c\<0.4% from the baseline as the cut-off value, the patients were divided into HbA1c decrease\<0.4% group and HbA1c decrease ≥ 0.4% group. The clinical characteristics, laboratory indicators, blood glucose fluctuation of subgroups and gene spectrum differences between the groups were analyzed to provide reference for clinical accurate drug use.

Eligibility 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.

Primary outcomes:
measure: blood sugar changes
timeFrame: 12 weeks
measure: blood lipid changes
timeFrame: 12 weeks
Secondary outcomes:
measure: Body composition analysis
timeFrame: 12 weeks
measure: Inflammation factors
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jianhua Ma
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Jianhua Ma, Doctor
role: STUDY_DIRECTOR
References: