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GLP-1 Receptor Agonist

Metformin for Type 2 Diabetes

Phase 1 & 2
Waitlist Available
Led By Stephanie T Chung, M.D.
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks
Awards & highlights

Study Summary

This trial is testing whether using liraglutide and metformin are better than just metformin for decreasing excess sugar produced by the liver in African-American youth with type 2 diabetes.

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Absolute Gluconeogenesis From Baseline to 12 Weeks
Secondary outcome measures
Change in GIP AUC During OGTT and Meal Absorption
Change in GLP-1 Area Under the Curve Concentrations (AUC) During OGTT and Meal Absorption
Change in Glucose Production Rate From Baseline to 12 Weeks
+5 more

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Squamous cell carcinoma of the tongue
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Metformin and liraglutideExperimental Treatment2 Interventions
Standard release metformin (500 mg tablets) and liraglutide (0.6mg) were initiated and titrated to maximum dose of metformin 1000 mg twice daily, and liraglutide 1.8 mg daily over 3 weeks and continued for 12 weeks
Group II: MetforminActive Control1 Intervention
Standard release metformin (500 mg tablets) was initiated and titrated to maximum dose of metformin 1000 mg twice daily over 3 weeks and continued for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liraglutide
2013
Completed Phase 4
~2680
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

Children's National Medical Center (CNMC)UNKNOWN
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,359 Previous Clinical Trials
4,315,270 Total Patients Enrolled
Children's National Research InstituteOTHER
211 Previous Clinical Trials
208,133 Total Patients Enrolled

Frequently Asked Questions

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

What other research has been conducted concerning the efficacy of Metformin?

"Metformin was initially studied in 2002 at George Washington University, and since then 1330 trials have been concluded. At present there are 202 active studies of this medication, a large portion of which take place in Bethesda, Maryland."

Answered by AI

Is enrollment still feasible for this clinical trial?

"Affirmative, the clinicaltrial.gov information reveals that this research project is actively enrolling participants. It was first uploaded on May 9th 2017 and most recently revised on August 30th 2022. A total of 102 people need to be enrolled at two different sites for the trial's success."

Answered by AI

What is the aggregate size of the cohort participating in this trial?

"Affirmative, the publicly available data on clinicaltrials.gov shows that this medical trial is actively recruiting as of August 30th 2022. This study was first published in May 9th 2017 and seeks 102 patients to be recruited from two different sites."

Answered by AI

Am I eligible to join this experiment?

"Eligibility criteria for this medical trial mandate that patients must have type 2 diabetes mellitus and be aged between 12 to 25. 102 participants are sought in total."

Answered by AI

What are the usual applications of Metformin?

"Typically prescribed to manage type 1 diabetes, metformin can be an effective treatment for a range of other illnesses including cardiovascular disease, diabetic ketoacidosis and polycystic ovarian syndrome."

Answered by AI

Are participants of any age invited to join this research experiment?

"This trial is specifically targeting patients within the age bracket of 12 and 25."

Answered by AI

Are there any known adverse effects of taking Metformin?

"Given that this investigation is in its first stage, there is sparse evidence indicating the efficacy and safety of Metformin. Consequently, our team at Power gave it a score of 1 on the scale from one to three."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Title: Therapeutic Targets in African-American Youth With Type 2 Diabetes
2017. "Title: Therapeutic Targets in African-American Youth With Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02960659.
~3 spots leftby Apr 2025
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