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NCT02960659 · ClinicalTrials.gov registry record · Phase 1
Title: Therapeutic Targets in African-American Youth With Type 2 Diabetes
A Phase 1 study of Type 2 Diabetes, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT02960659: Completed Phase 1 study of Type 2 Diabetes, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT02960659 is a Phase 1 study of Type 2 Diabetes that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 24 participants, below the 1,103-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02960659, a Phase 1 study of Type 2 Diabetes, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: The pill metformin treats diabetes. But it does not work for all youth, especially African-Americans. The injectable Liraglutide treats type 2 diabetes in adults. Researchers want to understand how these drugs work and if they decrease excess sugar made by the liver in youth with type 2 diabetes. Objective: To test if 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. Eligibility: African-Americans ages 12-25 with type 2 diabetes Design: Visit 1: Participants will be screened with medical history, physical exam, and blood and urine tests. Participants will stop taking diabetes medicines for 1 week. They will learn how to check blood sugars at home twice a day. Visit 2: Overnight at the clinic. Participants will have: Vital signs taken. Pregnancy test. A thin plastic tube (IV catheter) be inserted in each forearm by needle. Blood drawn several times after drinking a sweet drink. X-ray of total body fat. Urine and stool collected. Breath tests while wearing a clear hood for up to 45 minutes. For several hours, participants can have only water. At 4 a.m. they will get sugar and fat with nonradioactive isotopes in one IV. Blood will be collected. Every 30 minutes from 9 a.m. to 2 p.m., they will drink small amounts of a shake and have blood drawn. Participants will be randomly assigned to take either both study drugs daily or just metformin daily. Visits 3-4: Participants will bring their blood sugar records and have blood tests. Visit 5, after 3 months: Repeat of visit 2....
Conditions Studied
Interventions
- DRUG Metformin
- DRUG Liraglutide
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-05-09 |
| Est. Completion | 2022-05-20 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02960659
The ClinicalTrials.gov registry entry for NCT02960659 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,103-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (98% lower). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Metformin is the first listed.
NCT02960659 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02960659 about?
NCT02960659 is a clinical study titled "Title: Therapeutic Targets in African-American Youth With Type 2 Diabetes". Background: The pill metformin treats diabetes. But it does not work for all youth, especially African-Americans. The injectable Liraglutide treats type 2 diabetes in adults. Researchers want to understand how these drugs work and if they decrease excess sugar made by the liver in youth with type 2...
What is the current status of trial NCT02960659?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2017-05-09. Estimated completion is 2022-05-20.
What conditions does trial NCT02960659 study?
This clinical trial studies the following conditions: Type 2 Diabetes.
What interventions are being tested in trial NCT02960659?
The interventions under investigation include: Metformin (DRUG), Liraglutide (DRUG).
Who is sponsoring clinical trial NCT02960659?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02960659 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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