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NCT01194245 · ClinicalTrials.gov registry record · Phase 2
Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus
A Phase 2 study, sponsored by Halozyme Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 135
- Enrollment target
NCT01194245: Completed Phase 2 study, sponsored by Halozyme Therapeutics.
NCT01194245 is a Phase 2 study that has completed, run by Halozyme Therapeutics. The registered enrollment target is 135 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01194245, a Phase 2 study, has completed, sponsored by Halozyme Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 135 participants
- Enrollment target
Study Summary
The purpose of the study is to compare Humalog (Insulin lispro)-recombinant human hyaluronidase (rHuPH20) or Novolog (Insulin aspart)-rHuPH20 to Humalog (Insulin lispro) for the treatment of Type 1 Diabetes Mellitus (T1DM) in basal-bolus therapy.
Primary Outcome
Glycosylated hemoglobin A1C (HBA1c) levels were measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). Least Squares (LS) means were calculated from mixed effects linear models with treatment (Lispro, Aspart), recombinant human hyaluronidase PH20 (rHuPH20; yes, no), and treatment sequence as fixed effects a
Interventions
- DRUG Insulin aspart
- DRUG Insulin glargine
- DRUG Insulin lispro
- DRUG Insulin glulisine
- DRUG recombinant human hyaluronidase PH20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2010-08 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
What the finished NCT01194245 record still lists
NCT01194245 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Insulin aspart is the first listed.
NCT01194245 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01194245 about?
NCT01194245 is a clinical study titled "Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus". The purpose of the study is to compare Humalog (Insulin lispro)-recombinant human hyaluronidase (rHuPH20) or Novolog (Insulin aspart)-rHuPH20 to Humalog (Insulin lispro) for the treatment of Type 1 Diabetes Mellitus (T1DM) in basal-bolus therapy.
What is the current status of trial NCT01194245?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 135 participants. The study started on 2010-08. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01194245?
The interventions under investigation include: Insulin aspart (DRUG), Insulin glargine (DRUG), Insulin lispro (DRUG), Insulin glulisine (DRUG), recombinant human hyaluronidase PH20 (DRUG).
Who is sponsoring clinical trial NCT01194245?
This trial is sponsored by Halozyme Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01194245's enrollment target sits among peer trials
135 532nd of 2000 higher than 1,464 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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