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Exercise + Liraglutide for Type 2 Diabetes (ZQL007 Trial)

Phase 4
Recruiting
Led By Zhenqi Liu, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21-60
Never on GLP-1RA (eg: exenatide, liraglutide) or DPP4I (eg: Sitaglipton)
Must not have
Family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome
BMI >35
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial is testing whether exercise, liraglutide, or a combination of the two can improve cardiac and muscle function in people with type 2 diabetes.

Who is the study for?
This trial is for adults aged 21-60 with Type 2 diabetes who have an A1C level of ≤8.5% and haven't used GLP-1RA or DPP4I medications. Participants should be on a stable dose of oral diabetes drugs for over four months, not taking insulin, non-smokers, with controlled blood pressure and BMI under 35. They must not have certain heart, lung, liver or kidney diseases, specific family cancer histories, vascular diseases or be pregnant.
What is being tested?
The study aims to see if exercise alone, the drug Liraglutide alone, or both combined can improve blood vessel function and insulin sensitivity in people with Type 2 diabetes. Participants will be randomly assigned to one of three groups and evaluated before and after the 16-week intervention period.
What are the potential side effects?
Liraglutide may cause nausea, diarrhea, vomiting; rare cases include pancreatitis or allergic reactions. Exercise is generally safe but could lead to muscle strain or injury especially if done improperly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 60 years old.
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I have never taken GLP-1RA or DPP4I medications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My family has a history of thyroid cancer or genetic syndromes affecting multiple glands.
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My BMI is over 35.
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I have a history of heart, lung, liver, or kidney disease.
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I am currently taking insulin.
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I have a history of heart attack, stroke, or poor blood circulation.
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My doctor will check for abnormal heart or lung connections during my exam.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Microvascular Blood Volume - change from baseline
Secondary study objectives
Augmentation Index - change from baseline
Flow Mediated Dilation - change from baseline
Insulin Sensitivity-Change from baseline
+2 more

Side effects data

From 2017 Phase 4 trial • 100 Patients • NCT02014740
29%
nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Liraglutide
Metformin

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Liraglutide aloneExperimental Treatment1 Intervention
16 weeks of treatment
Group II: Exercise AloneExperimental Treatment1 Intervention
16 weeks of treatment
Group III: Exercise + LiraglutideExperimental Treatment2 Interventions
16 weeks of treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liraglutide
2013
Completed Phase 4
~2680

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
785 Previous Clinical Trials
1,316,386 Total Patients Enrolled
5 Trials studying Diabetes
1,288 Patients Enrolled for Diabetes
American Diabetes AssociationOTHER
146 Previous Clinical Trials
101,619 Total Patients Enrolled
17 Trials studying Diabetes
1,664 Patients Enrolled for Diabetes
National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,172,560 Total Patients Enrolled
25 Trials studying Diabetes
64,177 Patients Enrolled for Diabetes
Zhenqi Liu, MDPrincipal Investigator - University of Virginia, Department of Endocrinoolgy
UVA-HealthSouth Rehabilitation Hospital, University of Virginia Medical Center
Hunan Medical University (Medical School)
University Of Va Medical Center (Residency)
3 Previous Clinical Trials
116 Total Patients Enrolled

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT03883412 — Phase 4
Diabetes Research Study Groups: Exercise + Liraglutide, Liraglutide alone, Exercise Alone
Diabetes Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT03883412 — Phase 4
Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT03883412 — Phase 4
~4 spots leftby Jun 2025
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