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NCT03540758 · ClinicalTrials.gov registry record · Phase 2

Regulation of Endogenous Glucose Production by Central KATP Channels

A Phase 2 study of Type 2 Diabetes Mellitus and Glucose Metabolism Disorders, sponsored by Meredith Hawkins.

Recruiting
Registry status
Phase 2
Development phase
100
Enrollment target
1
Study location

NCT03540758: Recruiting Phase 2 study of Type 2 Diabetes Mellitus and Glucose Metabolism Disorders, sponsored by Meredith Hawkins.

NCT03540758 is a Phase 2 study of Type 2 Diabetes Mellitus and Glucose Metabolism Disorders that is actively recruiting participants, run by Meredith Hawkins. The registered enrollment target is 100 participants, below the 2,959-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03540758, a Phase 2 study of Type 2 Diabetes Mellitus and Glucose Metabolism Disorders, is actively recruiting participants, sponsored by Meredith Hawkins.

RECRUITING
Registry status
Phase 2
Development phase
100 participants
Enrollment target
1
Study location

Study Summary

Type 2 diabetes (T2D) affects the ability of the body to process glucose (sugar). Under fasting conditions, the liver is able to make sugar to maintain glucose levels in an important process called endogenous glucose production (EGP). Previous studies suggest that the central nervous system (CNS), including the brain, helps to regulate levels of glucose in the body by communicating with the liver. This process can be impaired in people with type 2 diabetes, and can contribute to the high level of glucose seen in these individuals. The purpose of this study is to understand how activating control centers of the brain with a medication called diazoxide can affect how much glucose (sugar) is made by the liver. This is particularly important for people with diabetes who have very high production of glucose, which in turn can lead to diabetes complications.

Primary Outcome

Rates of EGP (a measure of the body's production of sugar) will be measured using analysis of blood samples taken throughout the pancreatic clamp procedure under various treatment conditions (e.g., placebo, diazoxide, nicotinic acid, nicotinic acid/diazoxide), by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar). Measurement of blood glucose concentrations will either be performed with a Precision Xceed Pro glucometer or an Analox glucose analyzer

Interventions

  • DRUG Placebo
  • DRUG Diazoxide
  • DRUG Nicotinic acid

Study Locations (1)

New York

  • Albert Einstein College of Medicine - The Bronx

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2018-08-01
Est. Completion 2027-04
Phase Phase 2
Meredith Hawkins

3 total trials

What NCT03540758 shows while recruiting

NCT03540758 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 2,959-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (97% lower).

The record links to 3 conditions, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT03540758 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT03540758 about?

NCT03540758 is a clinical study titled "Regulation of Endogenous Glucose Production by Central KATP Channels". Type 2 diabetes (T2D) affects the ability of the body to process glucose (sugar). Under fasting conditions, the liver is able to make sugar to maintain glucose levels in an important process called endogenous glucose production (EGP). Previous studies suggest that the central nervous system (CNS), i...

What is the current status of trial NCT03540758?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2018-08-01. Estimated completion is 2027-04.

What conditions does trial NCT03540758 study?

This clinical trial studies the following conditions: Type 2 Diabetes Mellitus, Glucose Metabolism Disorders, Glucose, High Blood.

What interventions are being tested in trial NCT03540758?

The interventions under investigation include: Placebo (DRUG), Diazoxide (DRUG), Nicotinic acid (DRUG).

Who is sponsoring clinical trial NCT03540758?

This trial is sponsored by Meredith Hawkins, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03540758 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Type 2 Diabetes Mellitus

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03540758's enrollment target sits among peer trials

100 51st of 130 higher than 76 of 130 other Type 2 Diabetes Mellitus trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03540758, the US trial registry maintained by the National Library of Medicine. NCT03540758 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.