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NCT00916357 · ClinicalTrials.gov registry record · Phase 2
Liquid Meal Study With Insulin Lispro With/Without Recombinant Human Hyaluronidase PH20 (rHuPH20) and Regular Human Insulin With rHuPH20 to Compare Pharmacokinetics, Postprandial Glycemic Response, and Optimal Insulin Dose in Participants With Type 2 Diabetes Mellitus (T2DM)
A Phase 2 study of Diabetes Mellitus, Type 2, sponsored by Halozyme Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT00916357 is a Phase 2 study of Diabetes Mellitus, Type 2 that has completed, run by Halozyme Therapeutics. The registered enrollment target is 23 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00916357, a Phase 2 study of Diabetes Mellitus, Type 2, has completed, sponsored by Halozyme Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-center, Phase 2, randomized, double-blind, 3-way crossover meal study in participants with Type 2 Diabetes Mellitus (T2DM) to determine the optimum dose and compare the pharmacokinetics (PK) and postprandial glycemic response of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), and Humulin-R + rHuPH20 administered subcutaneously.
Conditions Studied
Interventions
- DRUG Humalog
- DRUG Humulin-R
- DRUG Recombinant human hyaluronidase PH20 (rHuPH20)
Study Locations (1)
California
- Profil Institute for Clinical Research, Inc. - Chula Vista
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2009-07 |
| Est. Completion | 2009-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00916357
The ClinicalTrials.gov registry entry for NCT00916357 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The listed sponsor is Halozyme Therapeutics, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 3 interventions - of which Humalog is the first listed.
NCT00916357 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT00916357 about?
NCT00916357 is a clinical study titled "Liquid Meal Study With Insulin Lispro With/Without Recombinant Human Hyaluronidase PH20 (rHuPH20) and Regular Human Insulin With rHuPH20 to Compare Pharmacokinetics, Postprandial Glycemic Response, and Optimal Insulin Dose in Participants With Type 2 Diabetes Mellitus (T2DM)". This is a single-center, Phase 2, randomized, double-blind, 3-way crossover meal study in participants with Type 2 Diabetes Mellitus (T2DM) to determine the optimum dose and compare the pharmacokinetics (PK) and postprandial glycemic response of Humalog alone, Humalog + recombinant human hyaluronida...
What is the current status of trial NCT00916357?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2009-07. Estimated completion is 2009-11.
What conditions does trial NCT00916357 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT00916357?
The interventions under investigation include: Humalog (DRUG), Humulin-R (DRUG), Recombinant human hyaluronidase PH20 (rHuPH20) (DRUG).
Who is sponsoring clinical trial NCT00916357?
This trial is sponsored by Halozyme Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00916357 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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