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

Patients with established type 2 diabetes

BMI 27-35

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upbaseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

All Individual Drugs Already Approved

Study Summary

This trial will test whether Liraglutide decreases ER stress and adipose tissue in obese patients with type 2 diabetes.

Eligible Conditions

Type 2 Diabetes

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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You have been diagnosed with type 2 diabetes.

Select...

Your body mass index (BMI) is between 27 and 35.

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You are currently taking certain medications for managing diabetes, such as exercise, diet, metformin, alpha glucosidase inhibitors (up to half of the maximum dose), or pioglitazone (up to 30 mg per day).

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Body Weight Changes

Secondary outcome measures

Beta cell function

Body composition

Body weight

+3 more

Side effects data

From 2017 Phase 4 trial • 100 Patients • NCT02014740

29%

nausea

100%

80%

60%

40%

20%

Study treatment Arm

Liraglutide

Metformin

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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.

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

0 / 3Eligibility criteria met

Find a site

Who is running the clinical trial?

Temple UniversityLead Sponsor

282 Previous Clinical Trials

80,699 Total Patients Enrolled

Ajaykumar D Rao, MDPrincipal Investigator

Temple University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are potential applications for Liraglutide?

"Liraglutide has multiple applications, including treating exercise and managing conditions such as inadequate control on monotherapy, cardiovascular risk reduction, and cardiovascular disease (CVD)."

Answered by AI

Is the minimum age requirement for participating in this experiment greater than fifty-five?

"To enter the trial, participants must abide by a certain age range: 18 and 75. There are 198 studies available for those under 18 years old and 1128 for people over 65."

Answered by AI

How many individuals are included in the current clinical trial?

"This medical trial is not currently recruiting. Originally posted on May 1st 2014, the study was recently amended on July 27th 2022. It may be beneficial to research other available trials: there are presently 1440 studies seeking diabetic patients and 35 clinicals involving liraglutide with open recruitment slots."

Answered by AI

What qualifications must potential participants satisfy in order to be included in the trial?

"To be considered for enrollment in this study, applicants must suffer from diabetes mellitus and possess an age between the ages of 18 to 75. Approximately 12 candidates will be chosen."

Answered by AI

To what extent could Liraglutide pose a risk to people?

"Considering the Phase 4 status of this particular pharmaceutical intervention, our team has assigned a score of 3 to liraglutide's safety."

Answered by AI

Is it possible to enroll in this trial at present?

"According to clinicaltrials.gov, this trial is not currently enrolling patients. It was initially published on May 1st 2014 and its latest update happened in July 2022. Despite that fact, there are still 1475 other research studies actively recruiting participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Liraglutide on ER Stress in Obese Patients With Type 2 Diabetes

2014. "Effects of Liraglutide on ER Stress in Obese Patients With Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02344186.