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NCT01848990 · ClinicalTrials.gov registry record · Phase 4
CONSISTENT 1: Metabolic and Safety Outcomes of Hylenex Recombinant (Hyaluronidase Human Injection) Preadministered at CSII Infusion Site in Participants With Type 1 Diabetes Mellitus (T1DM)
A Phase 4 study of Type 1 Diabetes Mellitus, sponsored by Halozyme Therapeutics.
- Completed
- Registry status
- Phase 4
- Development phase
- 456
- Enrollment target
- 20
- Study locations
NCT01848990: Completed Phase 4 study of Type 1 Diabetes Mellitus, sponsored by Halozyme Therapeutics.
NCT01848990 is a Phase 4 study of Type 1 Diabetes Mellitus that has completed, run by Halozyme Therapeutics. The registered enrollment target is 456 participants, above the 168-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (171% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01848990, a Phase 4 study of Type 1 Diabetes Mellitus, has completed, sponsored by Halozyme Therapeutics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 456 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objectives of this study are to compare the difference in glycosylated hemoglobin (HbA1c) from baseline to Month 6 using Hylenex recombinant preadministration in continuous subcutaneous insulin infusion (CSII) versus standard CSII and to evaluate the safety of Hylenex recombinant preadministration, including local tolerability, adverse events, and hypo- and hyperglycemia rates.
Primary Outcome
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Conditions Studied
Interventions
- DRUG Insulin aspart
- DRUG Commercial Hylenex® recombinant (hyaluronidase human injection)
- DRUG Precommercial Hylenex recombinant (hyaluronidase human injection)
- DRUG Insulin lispro
- DRUG Insulin glulisine
Study Locations (20)
California
- For additional information regarding investigative sites for this trial, call (858) 794-8889 8 AM to 5 PM Mon-Fri Pacific Standard Time - Concord
- For additional information regarding investigative sites for this trial, call (858) 794-8889 8 AM to 5 PM Mon-Fri Pacific Standard Time - Encino
- For additional information regarding investigative sites for this trial, call (858) 794-8889 8 AM to 5 PM Mon-Fri Pacific Standard Time - Escondido
- For additional information regarding investigative sites for this trial, call (858) 794-8889 8 AM to 5 PM Mon-Fri Pacific Standard Time - Greenbrae
- For additional information regarding investigative sites for this trial, call (858) 794-8889 8 AM to 5 PM Mon-Fri Pacific Standard Time - La Jolla
- For additional information regarding investigative sites for this trial, call (858) 794-8889 8 AM to 5 PM Mon-Fri Pacific Standard Time - San Mateo
Florida
- For additional information regarding investigative sites for this trial, call (858) 794-8889 8 AM to 5 PM Mon-Fri Pacific Standard Time - Hollywood
- For additional information regarding investigative sites for this trial, call (858) 794-8889 8 AM to 5 PM Mon-Fri Pacific Standard Time - Miami
- For additional information regarding investigative sites for this trial, call (858) 794-8889 8 AM to 5 PM Mon-Fri Pacific Standard Time - Miami
Georgia
- For additional information regarding investigative sites for this trial, call (858) 794-8889 8 AM to 5 PM Mon-Fri Pacific Standard Time - Atlanta
- For additional information regarding investigative sites for this trial, call (858) 794-8889 8 AM to 5 PM Mon-Fri Pacific Standard Time - Roswell
Maryland
- For additional information regarding investigative sites for this trial, call (858) 794-8889 8 AM to 5 PM Mon-Fri Pacific Standard Time - Hyattsville
- For additional information regarding investigative sites for this trial, call (858) 794-8889 8 AM to 5 PM Mon-Fri Pacific Standard Time - Rockville
Colorado
- For additional information regarding investigative sites for this trial, call (858) 794-8889 8 AM to 5 PM Mon-Fri Pacific Standard Time - Aurora
Idaho
- For additional information regarding investigative sites for this trial, call (858) 794-8889 8 AM to 5 PM Mon-Fri Pacific Standard Time - Idaho Falls
Iowa
- For additional information regarding investigative sites for this trial, call (858) 794-8889 8 AM to 5 PM Mon-Fri Pacific Standard Time - Des Moines
Kansas
- For additional information regarding investigative sites for this trial, call (858) 794-8889 8 AM to 5 PM Mon-Fri Pacific Standard Time - Wichita
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 456 participants |
| Start Date | 2013-03 |
| Est. Completion | 2014-09 |
| Phase | Phase 4 |
What the finished NCT01848990 record still lists
NCT01848990 is an interventional study that assigns participants to a tested intervention. The registered 456 participants enrollment target is mid-sized for trials with a published cap, above the 168-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (171% higher).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 5 interventions - of which Insulin aspart is the first listed.
NCT01848990 names 20 study sites across 11 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01848990 about?
NCT01848990 is a clinical study titled "CONSISTENT 1: Metabolic and Safety Outcomes of Hylenex Recombinant (Hyaluronidase Human Injection) Preadministered at CSII Infusion Site in Participants With Type 1 Diabetes Mellitus (T1DM)". The primary objectives of this study are to compare the difference in glycosylated hemoglobin (HbA1c) from baseline to Month 6 using Hylenex recombinant preadministration in continuous subcutaneous insulin infusion (CSII) versus standard CSII and to evaluate the safety of Hylenex recombinant preadmi...
What is the current status of trial NCT01848990?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 456 participants. The study started on 2013-03. Estimated completion is 2014-09.
What conditions does trial NCT01848990 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT01848990?
The interventions under investigation include: Insulin aspart (DRUG), Commercial Hylenex® recombinant (hyaluronidase human injection) (DRUG), Precommercial Hylenex recombinant (hyaluronidase human injection) (DRUG), Insulin lispro (DRUG), Insulin glulisine (DRUG).
Who is sponsoring clinical trial NCT01848990?
This trial is sponsored by Halozyme Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01848990 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01848990's enrollment target sits among peer trials
456 9th of 112 higher than 104 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus 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.
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