Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus
Public ClinicalTrials.gov record NCT01194245. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II, Randomized, Double Blind, 2-Way Crossover Safety and Efficacy Study of Subcutaneously Injected Prandial Insulins: Lispro-PH20 or Aspart-PH20 Compared to Insulin Lispro (Humalog®) in Patients With Type 1 Diabetes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01194245
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 135 participants
Conditions and interventions
Conditions
Interventions
- Insulin lispro Drug
- recombinant human hyaluronidase PH20 Drug
- Insulin aspart Drug
- Insulin glulisine Drug
- Insulin glargine Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2010 (Type not available)
- Primary completion
- Aug 2011 (Actual)
- Completion
- Aug 2011 (Actual)
- Last update posted
- Feb 26, 2019
2010 – 2011
United States locations
- U.S. sites
- 19
- U.S. states
- 13
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AMCR Institute, Inc. | Escondido | California | 92026 | — |
| Scripps Whittier Diabetes Institute | La Jolla | California | 92037 | — |
| Mills-Peninsula Health Services | San Mateo | California | 94401 | — |
| Barbara Davis Center for Childhood Diabetes | Aurora | Colorado | 80045 | — |
| Center for Diabetes and Endocrine Care | Hollywood | Florida | 33021 | — |
| Diabetes Research Institute | Miami | Florida | 33136 | — |
| Rocky Mountain Diabetes and Osteoporosis Center | Idaho Falls | Idaho | 83404 | — |
| Mid-America Diabetes Associates | Wichita | Kansas | 67211 | — |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | — |
| Medstar Research Institute | Hyattsville | Maryland | 20782 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| International Diabetes Center | Minneapolis | Minnesota | 55416 | — |
| Mercury Street Medical | Butte | Montana | 59701 | — |
| Desert Endocrinology | Henderson | Nevada | 89052 | — |
| UT Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | — |
| Texas Diabetes and Endocrinology | Round Rock | Texas | 78681 | — |
| Cetero Research-San Antonio | San Antonio | Texas | 78229 | — |
| West Olympia Internal Medicine | Olympia | Washington | 98502 | — |
| University of Washington School of Medicine | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01194245, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 26, 2019 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01194245 live on ClinicalTrials.gov.