Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial.
Richard E Pratley, Vanita R Aroda, Ildiko Lingvay...
https://pubmed.ncbi.nlm.nih.gov/29397376Actively Recruiting
Age: 18Years +
All Genders
ID06686134
Comprehensive Clinical Evaluation Study of GLP-1RA for Type 2 Diabetes in Adults
Led by LI YAN · Updated on 2024-11-13
492
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of glucagon-like peptide-1 receptor agonists (GLP-1RAs) for treating adults with type 2 diabetes mellitus (T2DM). The study aims to identify the most effective GLP-1RA drugs and assess their performance across six areas: safety, effectiveness, cost, innovation, appropriateness, and accessibility. The goal is to support medical institutions in safely and rationally using these drugs while reducing risks for patients. This observational study involves patients treated with liraglutide, dulaglutide, polyethylene glycol losenatide, or semaglutide. Researchers collect detailed patient information, including demographics, lifestyle habits, hospitalization details, diabetic complications, and medication use during hospital stays. Follow-ups occur at the end of the 4th, 8th, 12th, and 16th weeks of treatment via telephone to track medication adherence, effectiveness, safety, and any adverse reactions. Participants provide data on weight, blood sugar control (including HbA1c), lipid levels, kidney and liver function, blood and urine tests, and thyroid function at admission and discharge. Medication use and adverse drug reactions are carefully recorded and assessed. The main outcomes measured are weight reduction and HbA1c compliance at multiple time points, along with safety, medication adherence, changes in lipid levels, blood sugar fluctuations, adverse reactions, and treatment costs over 12 weeks.
CONDITIONS
Brief Title
Comprehensive Clinical Evaluation Study of GLP-1RA
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes
- No study drug used in the last three months
- Currently on hypoglycemic programs including investigational drugs
- Age 18 years or older
- Complete demographic data, disease history, course records, laboratory tests, and drug use information
- Signed informed consent
You will not qualify if you...
- Persistent influenza, autoimmune disease, or other metabolic diseases
- Significant gastrointestinal diseases, gastrointestinal resection, or malabsorption syndrome
- Use of diet drugs, glucocorticoids, or drugs affecting gastrointestinal motility
- Severe liver or kidney function impairment or malignant tumors
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for collection of demographic data, disease history, laboratory tests, and drug use information
Monitoring
Duration - Up to the time of discharge during hospitalization
Participants receiving GLP-1RA medications are observed with collection of hospitalization information including clinical measurements, laboratory test results, medication status, and adverse drug reactions.
Data collected during hospitalization
Long-term Monitoring
Duration - 12 weeks
Participants are followed up by telephone to assess medication adherence, efficacy, safety, and adverse reactions after starting GLP-1RA treatment.
Telephone follow-up at 4, 8, 12, and 16 weeks after starting medication
Trial Site Locations
Total: 1 location
1
Yan Li
Jinan, China
Actively Recruiting
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Research Team
D
Dong Zhonghua The First Affiliated Hospital of Shandong First Medical Univer, master
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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