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NCT02148250 · ClinicalTrials.gov registry record · Phase 2

PK/PD Study of U-500 Regular Insulin

A Phase 2 study, sponsored by University of Minnesota.

Completed
Registry status
Phase 2
Development phase
17
Enrollment target

NCT02148250 is a Phase 2 study that has completed, run by University of Minnesota. The registered enrollment target is 17 participants.

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The verdict

NCT02148250, a Phase 2 study, has completed, sponsored by University of Minnesota.

COMPLETED
Registry status
Phase 2
Development phase
17 participants
Enrollment target

Study Summary

The purpose of this study is to learn more about how U500 regular insulin can be effectively be used to treat type 2 diabetes. Most insulin treated patients with type 2 diabetes take U100 insulin, but if they require large doses (such as \>150 units a day) they may experience pain at this site of injection and the absorption of the insulin is unpredictable, thereby leading to poor glucose control. To overcome these problems, doctors sometimes switch to a more concentrated form of insulin called U500 insulin. U500 is five times as concentrated as U100 insulin and therefore delivers an equivalent dose of insulin in much lesser volume. However, how to best use U-500 insulin is not certain. The investigators are not really sure how long a given dose is effective in patients who require large doses (\>150 units of U100 insulin), so are not sure of how often the drug should be administered. In this study, the investigators will determine how effective two different doses of U-500 regular insulin (100 U and 200 U) are in lowering blood sugar and how long these two doses last. This information will help doctors develop better treatment plans for patients with type 2 diabetes.

Interventions

  • DRUG U-500 insulin, 100 syringe units
  • DRUG U-500 insulin, 200 syringe units

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2015-07
Est. Completion 2017-12
Phase Phase 2

Sponsor

University of Minnesota

966 total trials

What the Registry Record Tells You About NCT02148250

The ClinicalTrials.gov registry entry for NCT02148250 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which U-500 insulin, 100 syringe units is the first listed.

NCT02148250 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02148250 about?

NCT02148250 is a clinical study titled "PK/PD Study of U-500 Regular Insulin". The purpose of this study is to learn more about how U500 regular insulin can be effectively be used to treat type 2 diabetes. Most insulin treated patients with type 2 diabetes take U100 insulin, but if they require large doses (such as \>150 units a day) they may experience pain at this site of in...

What is the current status of trial NCT02148250?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2015-07. Estimated completion is 2017-12.

What interventions are being tested in trial NCT02148250?

The interventions under investigation include: U-500 insulin, 100 syringe units (DRUG), U-500 insulin, 200 syringe units (DRUG).

Who is sponsoring clinical trial NCT02148250?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

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

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.