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NCT02324309 · ClinicalTrials.gov registry record · Phase 1

BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500 Post-Meal Glucose Control in Patients With Severe Insulin Resistance

A Phase 1 study, sponsored by Biodel.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT02324309: Completed Phase 1 study, sponsored by Biodel.

NCT02324309 is a Phase 1 study that has completed, run by Biodel. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02324309, a Phase 1 study, has completed, sponsored by Biodel.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

The study is designed to compare meal time glucose control associated with BIOD-531, a rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500 in patients with diabetes and severe insulin resistance.

Interventions

  • DRUG Humulin R U-500
  • DRUG BIOD-531
  • DRUG Humalog Mix 75/25

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2014-05
Phase Phase 1
Biodel

6 total trials

What the finished NCT02324309 record still lists

NCT02324309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 3 interventions - of which Humulin R U-500 is the first listed.

NCT02324309 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02324309 about?

NCT02324309 is a clinical study titled "BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500 Post-Meal Glucose Control in Patients With Severe Insulin Resistance". The study is designed to compare meal time glucose control associated with BIOD-531, a rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500 in patients with diabetes and severe insulin resistance.

What is the current status of trial NCT02324309?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2014-05.

What interventions are being tested in trial NCT02324309?

The interventions under investigation include: Humulin R U-500 (DRUG), BIOD-531 (DRUG), Humalog Mix 75/25 (DRUG).

Who is sponsoring clinical trial NCT02324309?

This trial is sponsored by Biodel, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02324309's enrollment target sits among peer trials

12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT02324309, the US trial registry maintained by the National Library of Medicine. NCT02324309 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.