Current partner codePEPTIDESDE
NCT05990374·Not applicable·INTERVENTIONAL

Therapeutic Effects and Effects on Body Fat of GLP-1 Receptor Agonists in Patients With Type 2 Diabetes for 1-4 Years

Status

Unknown

Phase

Not applicable

Enrollment

100

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

The efficacy of long-term treatment with different GLP-1RA (Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc.) was evaluated through 1-4 years of follow-up, and the effects of long-term treatment on blood glucose and body fat of patients.

Full detailed description

At present, there has been no evaluation on the efficacy of long-term treatment of different GLP-1RA (Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc.), and the effects of long-term treatment on patients' blood glucose and body fat. This study intends to follow up for 1-4 years. To observe the effects of different GLP-1RA on body fat, insulin resistance, body weight, blood glucose, blood lipids, stomach volume, etc., in patients with type 2 diabetes, and explore the factors affecting the efficacy, so as to provide more evidence-based medical evidence for drug treatment and benefit patients.

Interventions

Treatment arms and agents.

DRUG

Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc

The study compared patients taking different types of GLP-1(Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc) with taking placebo.

Timeline

From registration to results.

  1. First posted

    Aug 14, 2023

  2. Study start

    Aug 1, 2023

  3. Primary completion

    Jan 1, 2024

  4. Study completion

    Jan 1, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Aug 14, 2023

Outcomes

What the study measures.

Primary outcomes

Effects of different GLP-1 on blood glucose

Time frame · 1,2,3,4 year

The changes of blood glucose fluctuation after treatment

Secondary outcomes

Effects of different GLP-1 on body fat mass

Time frame · 1,2,3,4 year

The changes of body fat mass after treatment

Eligibility

Who can take part.

Minimum age
Not reported
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: 1. Diagnosed type 2 diabetes according to the 1999 WHO standards; 2. received at least 8 weeks of simple diet control and physical exercise before screening; Patients with type 2 diabetes who were treated with stable hypoglycemic drugs and had inadequate glycemic control within 8 weeks prior to screening; 3. HbA1c≥7.5%; 4. BMI\>24kg/m2; 5. Subjects agree to maintain a scientific diet and exercise habits throughout the study, and regularly self-monitor and record blood sugar (SMBG); 6. Be willing to sign written informed consent and comply with the study protocol Exclusion Criteria: 1. Use of any of the following drugs or treatments in the 3 months prior to screening: treatment with GLP-1RA, GLP-1 analogue, DPP-4 inhibitor, or any other incretin analogue; 2. Long-term (more than 7 consecutive days) intravenous administration, oral administration, or intra-articular administration of corticosteroids within 2 months prior to screening; 3. Use of weight control drugs or surgery that can lead to weight instability within 2 months before screening, or are currently in a weight loss program and not in the maintenance stage: 4. History of acute and chronic pancreatitis; A history of medullary C-cell carcinoma, MEN (multiple endocrine tumors) 2A or 2B syndrome, or related family history; 5. Clinically significant gastric emptying abnormalities; 6. tumors of any organ system that have been treated or not treated in the 5 years prior to screening; 7. had received coronary angioplasty, coronary stenting, or coronary artery bypass within 6 months before screening. Negligent compensatory heart failure (NYHA rating III and IV), stroke or transient ischemic attack, unstable angina, myocardial infarction, persistent and clinically significant arrhythmia; 8. Acute metabolic complications occurred within 6 months before screening; 9. Before screening, any of the laboratory test indicators meet the following criteria: glutamic-pyrugenic transaminase \>2.5 times or ASpartate transaminase \>2.5 times; eGFR \<45ml/min/1.73m2; Fasting glycerin tricol \>5.64mmol/L.

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Nanjing First Hospital, Nanjing Medical Univesity

Nanjing, China

Related trials

More studies on Dulaglutide.

Related PeptideStat pages

Put the record in context.

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