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Glucagon-like peptide-1 receptor agonist
Liraglutide for Type 2 Diabetes
Phase 4
Waitlist Available
Led By Ajaykumar D Rao, MD
Research Sponsored by Temple University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Drug Has Already Been Approved
Summary
This trial tests if Liraglutide can reduce stress in fat tissue and improve health in obese patients with type 2 diabetes. The medication helps control blood sugar and appetite, potentially offering better management for these patients. Liraglutide is used for weight management and glycemic control in patients with type 2 diabetes.
Who is the study for?
This trial is for obese adults aged 18-75 with type 2 diabetes, a BMI of 27-35, and HbA1c levels between 7-10%. They should be managing their diabetes with exercise, diet, metformin or similar medications. Those with certain medical conditions like medullary thyroid cancer or pancreatitis cannot join.
What is being tested?
The study aims to see if Liraglutide can reduce ER stress in fat tissue of diabetic patients. It's a single blind test where half the participants first get Liraglutide then a placebo, while the other half start with placebo followed by Liraglutide.
What are the potential side effects?
Possible side effects of Liraglutide include digestive issues like nausea and diarrhea, low blood sugar levels (hypoglycemia), allergic reactions, pancreatitis and changes in heart rate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Body Weight Changes
Secondary study objectives
Beta cell function
Body composition
Body weight
+3 moreSide effects data
From 2017 Phase 4 trial • 100 Patients • NCT0201474029%
nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Liraglutide
Metformin
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LiraglutideExperimental Treatment1 Intervention
Liraglutide will be started first with 0.6 mg/d for 1 week, then increased to 1.2 mg/d from week 2 to week 12, followed by 1.8 mg/d from week 12 to week 24.
Group II: PlaceboPlacebo Group1 Intervention
Subjects will receive placebo for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liraglutide
FDA approved
Find a Location
Who is running the clinical trial?
Temple UniversityLead Sponsor
316 Previous Clinical Trials
89,254 Total Patients Enrolled
Ajaykumar D Rao, MDPrincipal InvestigatorTemple University