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NCT00013910 · ClinicalTrials.gov registry record · Phase 1

NNC 90-1170 Mechanism of Action: A Double-Blind, Randomized, Single-Center, Placebo-Controlled, Crossover Study to Examine Beta-Cell Responsiveness to Graded Glucose Infusion in Subjects With Type 2 Diabetes

A Phase 1 study, sponsored by National Center for Research Resources (NCRR).

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT00013910 is a Phase 1 study that has completed, run by National Center for Research Resources (NCRR). The registered enrollment target is 30 participants.

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The verdict

NCT00013910, a Phase 1 study, has completed, sponsored by National Center for Research Resources (NCRR).

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

The purpose of this research study is to investigate the mechanism of action of a new investigational medication (drug), NNC 90-1170, which is being developed for the treatment of type 2 diabetes (adult onset type of diabetes. NNC 90-1170 is a modified form of a hormone, Glucagon-Like Peptide 1 (or GLP-1), which is important for controlling insulin levels. Insulin, another hormone, is also important for controlling blood glucose levels, which are higher than normal in people who have type 2 diabetes. This study will measure the effect of NNC 90-1170, active investigational drug, to cause insulin to be released from the pancreas in response to increasing blood glucose concentrations. These results will be compared to that of a group of healthy volunteers of similar age and body weight who do not have diabetes. Also, various other hormones and substances that are known to control blood sugar will be measured in blood samples that will be drawn. One dose of NNC 90-1170 will be given to subjects with type 2 diabetes only in this study, and the effects of this dose will be compared to a placebo (inactive substance that looks like the active drug). This is a crossover study, which means that subjects will be treated both with NNC 90-1170 and with placebo. The order in which subjects will receive the treatments will be determined by chance (randomly). The study will be conducted as a so-called "double-blind" study, meaning that neither subjects nor study doctors will know the order in which subjects will be given each treatment until the study is over. The study will include approximately 15 healthy volunteers and 15 volunteers with type 2 diabetes, and it will be conducted at 1 clinic (the University of Michigan Health System) in the United States.

Interventions

  • DRUG NNC 90-1170

Trial Details

FieldValue
Enrollment Target 30 participants
Phase Phase 1

What the Registry Record Tells You About NCT00013910

The ClinicalTrials.gov registry entry for NCT00013910 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Center for Research Resources (NCRR), which has 94 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which NNC 90-1170 is the first listed.

NCT00013910 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00013910 about?

NCT00013910 is a clinical study titled "NNC 90-1170 Mechanism of Action: A Double-Blind, Randomized, Single-Center, Placebo-Controlled, Crossover Study to Examine Beta-Cell Responsiveness to Graded Glucose Infusion in Subjects With Type 2 Diabetes". The purpose of this research study is to investigate the mechanism of action of a new investigational medication (drug), NNC 90-1170, which is being developed for the treatment of type 2 diabetes (adult onset type of diabetes. NNC 90-1170 is a modified form of a hormone, Glucagon-Like Peptide 1 (or...

What is the current status of trial NCT00013910?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants.

What interventions are being tested in trial NCT00013910?

The interventions under investigation include: NNC 90-1170 (DRUG).

Who is sponsoring clinical trial NCT00013910?

This trial is sponsored by National Center for Research Resources (NCRR), which has 94 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.