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

Primary Purpose

Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosed type 2 diabetes according to the 1999 WHO standards; 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; HbA1c≥7.5%; BMI>24kg/m2; Subjects agree to maintain a scientific diet and exercise habits throughout the study, and regularly self-monitor and record blood sugar (SMBG); Be willing to sign written informed consent and comply with the study protocol Exclusion Criteria: 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; Long-term (more than 7 consecutive days) intravenous administration, oral administration, or intra-articular administration of corticosteroids within 2 months prior to screening; 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: 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; Clinically significant gastric emptying abnormalities; tumors of any organ system that have been treated or not treated in the 5 years prior to screening; 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; Acute metabolic complications occurred within 6 months before screening; 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.

Sites / Locations

  • Nanjing First Hospital, Nanjing Medical UnivesityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Dulaglutide

semaglutide

Loseenatide

tirzepatide

elbenatide

original treatment

placebo

Arm Description

Once a week, subcutaneous injection

Once a week, subcutaneous injection

Once a week, subcutaneous injection

Once a week, subcutaneous injection

Once a week, subcutaneous injection

Once a week, subcutaneous injection

The patients will be treated according to the original protocol

Outcomes

Primary Outcome Measures

Effects of different GLP-1 on blood glucose
The changes of blood glucose fluctuation after treatment

Secondary Outcome Measures

Effects of different GLP-1 on body fat mass
The changes of body fat mass after treatment

Full Information

First Posted
July 6, 2023
Last Updated
August 6, 2023
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05990374
Brief Title
Therapeutic Effects and Effects on Body Fat of GLP-1 Receptor Agonists in Patients With Type 2 Diabetes for 1-4 Years
Official Title
Therapeutic Effects and Effects on Body Fat of GLP-1 Receptor Agonists in Patients With Type 2 Diabetes for 1-4 Years
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dulaglutide
Arm Type
Active Comparator
Arm Description
Once a week, subcutaneous injection
Arm Title
semaglutide
Arm Type
Active Comparator
Arm Description
Once a week, subcutaneous injection
Arm Title
Loseenatide
Arm Type
Active Comparator
Arm Description
Once a week, subcutaneous injection
Arm Title
tirzepatide
Arm Type
Active Comparator
Arm Description
Once a week, subcutaneous injection
Arm Title
elbenatide
Arm Type
Active Comparator
Arm Description
Once a week, subcutaneous injection
Arm Title
original treatment
Arm Type
Active Comparator
Arm Description
Once a week, subcutaneous injection
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
The patients will be treated according to the original protocol
Intervention Type
Drug
Intervention Name(s)
Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc
Intervention Description
The study compared patients taking different types of GLP-1(Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc) with taking placebo.
Primary Outcome Measure Information:
Title
Effects of different GLP-1 on blood glucose
Description
The changes of blood glucose fluctuation after treatment
Time Frame
1,2,3,4 year
Secondary Outcome Measure Information:
Title
Effects of different GLP-1 on body fat mass
Description
The changes of body fat mass after treatment
Time Frame
1,2,3,4 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed type 2 diabetes according to the 1999 WHO standards; 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; HbA1c≥7.5%; BMI>24kg/m2; Subjects agree to maintain a scientific diet and exercise habits throughout the study, and regularly self-monitor and record blood sugar (SMBG); Be willing to sign written informed consent and comply with the study protocol Exclusion Criteria: 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; Long-term (more than 7 consecutive days) intravenous administration, oral administration, or intra-articular administration of corticosteroids within 2 months prior to screening; 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: 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; Clinically significant gastric emptying abnormalities; tumors of any organ system that have been treated or not treated in the 5 years prior to screening; 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; Acute metabolic complications occurred within 6 months before screening; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bingli Liu
Phone
+86 15366110069
Email
lxmxjtu@sina.com
Facility Information:
Facility Name
Nanjing First Hospital, Nanjing Medical Univesity
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Ma, Professor

12. IPD Sharing Statement

Learn more about this trial

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

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