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Leptin Analog

Metreleptin for Insulin Resistance

Phase 2

Waitlist Available

Led By Rebecca J Brown, 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

Diabetic symptoms with a random plasma glucose >= 200 mg/dL

Clinically significant, severe insulin resistance caused by a known or suspected defect in the insulin receptor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change at month 12 from baseline

Awards & highlights

Study Summary

This trial is testing whether metreleptin, a medication used to treat patients with leptin deficiency, will improve glycemia control in patients with genetic defects of the insulin receptor. The primary endpoint is hemoglobin A1c and the trial will enroll 20 patients at the NIH Clinical Center.

Who is the study for?

This trial is for males and females over the age of 5 with severe insulin resistance due to insulin receptor mutations. Participants must have diabetes as defined by ADA criteria, with fasting insulin >30 micro U/ml or glucose levels indicating diabetes. Pregnant women, those not using birth control, or with certain infections like HIV are excluded.Check my eligibility

What is being tested?

The study tests if metreleptin therapy (0.2 mg/kg/day) can improve blood sugar control in patients with genetic defects in the insulin receptor over a year. It's an open-label study at NIH Clinical Center focusing on changes in Hemoglobin A1c and other blood sugar markers.See study design

What are the potential side effects?

Potential side effects of metreleptin may include allergic reactions (especially in those sensitive to E. Coli proteins), weight loss, headaches, abdominal pain, and low blood sugar events.

Eligibility Criteria

Inclusion Criteria

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

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I have diabetes symptoms and my blood sugar level is 200 mg/dL or higher.

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I have severe insulin resistance due to issues with my insulin receptor.

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I have been diagnosed with diabetes according to the ADA guidelines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change at month 12 from baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change at month 12 from baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and change at month 12 from baseline 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 HbA1C

Secondary outcome measures

Change in Fasting Blood Glucose

Change in Fasting Insulin Level

Side effects data

From 2015 Phase 2 trial • 103 Patients • NCT00025883

15%

Musculoskeletal pain

12%

Weight loss

10%

Hypoglycemia

Nausea

Abdominal pain

Infection

Fatigue

tumor, benign

Anemia

Anxiety

Diarrhea

Insomnia

Constipation

Depression

Headache

Joins pain

Decreased appetite

Iron deficiency

Pneumonia

Exacerbations of heart failure

Group B streptococcus bacteremia

Abdominal pain requiring hospitalization

Osteomyelitis

Acute exacerbation of pancreatitis

Ovarian cyst requiring bilateral oophorectomy and total abdominal hysterectomy

Cellulitis

Miscarriage

Severe acute bronchitis

100%

80%

60%

40%

20%

Study treatment Arm

Metreleptin

Trial Design

1Treatment groups

Experimental Treatment

Group I: Leptin TreatmentExperimental Treatment1 Intervention

300 mg of study drug administered via subcutaneous (SC) injections.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metreleptin

2001

Completed Phase 2

~170

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor

2,357 Previous Clinical Trials

4,315,175 Total Patients Enrolled

Rebecca J Brown, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

10 Previous Clinical Trials

1,544 Total Patients Enrolled

Media Library

Insulin Resistance Syndrome Research Study Groups: Leptin Treatment

Frequently Asked Questions

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

Are there any vacancies open for prospective participants in this trial?

"Unfortunately, this medical trial is not actively recruiting patients as per data hosted on clinicaltrials.gov; the study was initially posted in August of 2003 and last modified on April 7th 2022. However, there are 168 other trials that presently seek participants."

Answered by AI

Has Metreleptin been sanctioned by the FDA?

"Metreleptin was assessed with a rating of 2 because while there is preliminary evidence of safety, efficacy has yet to be demonstrated."

Answered by AI

What is the highest capacity for individuals involved in this experiment?

"This medical trial is not accepting new participants at this time. It was posted on August 21st 2003 and its data most recently updated April 7th 2022. For individuals looking for other studies, 163 trials are currently recruiting patients suffering from Insulin Resistance while 5 trials offer enrolment to those dealing with Metreleptin-related issues."

Answered by AI

Are there any antecedent experiments examining the efficacy of Metreleptin?

"At this time, there are 5 ongoing Metreleptin trials with 2 of them in the third phase. Most studies take place in Bethesda, Maryland but other sites across America have opened clinical investigations as well."

Answered by AI

Recent research and studies

The Journal of Clinical Endocrinology & MetabolismJournal

Metreleptin Improves Blood Glucose in Patients with Insulin Receptor Mutations

Brown, Rebecca J., Elaine Cochran, and Phillip Gorden. 2013. “Metreleptin Improves Blood Glucose in Patients with Insulin Receptor Mutations”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/jc.2013-2317.

Journal of Clinical InvestigationJournal

Free Fatty Acid Processing Diverges in Human Pathologic Insulin Resistance Conditions

Sekizkardes, Hilal, Stephanie Therese Chung, Shaji Chacko, Morey W. Haymond, Megan Startzell, Mary Walter, Peter J. Walter, Marissa Lightbourne, and Rebecca J. Brown. 2020. “Free Fatty Acid Processing Diverges in Human Pathologic Insulin Resistance Conditions”. Journal of Clinical Investigation. American Society for Clinical Investigation. doi:10.1172/jci135431.

The Journal of Clinical Endocrinology & MetabolismJournal

Long-term Effects of Metreleptin in Rabson-mendenhall Syndrome on Glycemia, Growth, and Kidney Function

Okawa, Marinna C, Elaine Cochran, Marissa Lightbourne, and Rebecca J Brown. 2021. “Long-term Effects of Metreleptin in Rabson-mendenhall Syndrome on Glycemia, Growth, and Kidney Function”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/clinem/dgab782.

clinicaltrials.govStudy