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NCT01194258 · ClinicalTrials.gov registry record · Phase 2
Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus
A Phase 2 study of Diabetes Mellitus Type II, sponsored by Halozyme Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 132
- Enrollment target
- 20
- Study locations
NCT01194258: Completed Phase 2 study of Diabetes Mellitus Type II, sponsored by Halozyme Therapeutics.
NCT01194258 is a Phase 2 study of Diabetes Mellitus Type II that has completed, run by Halozyme Therapeutics. The registered enrollment target is 132 participants, below the 221-participant average among 7 other Diabetes Mellitus Type II trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01194258, a Phase 2 study of Diabetes Mellitus Type II, has completed, sponsored by Halozyme Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 132 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study was to compare Humalog (insulin lispro)-recombinant human hyaluronidase PH20 (rHuPH20) or Novolog (insulin aspart)-rHuPH20 to insulin lispro for the treatment of Type 2 diabetes mellitus (T2DM) in basal-bolus therapy.
Primary Outcome
Change in glycosylated hemoglobin A1C (HbA1C) from baseline (Week 0) to end of treatment period (Week 12 and Week 24) is presented. Data are presented by combined treatment group (Lispro-recombinant human hyaluronidase PH20 (PH20) + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both groups). Least squares (LS) means were calculated from linear contrasts of mixed effects linear models with treatment (Lispro, Aspart), PH20 (yes, no), and treatment sequence as fixed e
Conditions Studied
Interventions
- DRUG Insulin aspart
- DRUG Insulin glargine
- DRUG Insulin lispro
- DRUG Insulin glulisine
- DRUG Recombinant human hyaluronidase PH20
Study Locations (20)
California
- John Muir Physician Network Clinical Research Center - Concord
- Medical Group of Encino - Encino
- AMCR Institute, Inc. - Escondido
- Marin Endocrine Care and Research - Greenbrae
- Mills-Peninsula Health Services - San Mateo
Florida
- Center for Diabetes and Endocrine Care - Hollywood
- Diabetes Research Institute - Miami
- Baptist Diabetes Associates - Miami
Texas
- UT Southwestern Medical Center at Dallas - Dallas
- Texas Diabetes and Endocrinology - Round Rock
- Cetero Research-San Antonio - San Antonio
Idaho
- Rocky Mountain Diabetes and Osteoporosis Center - Idaho Falls
Kansas
- Mid-America Diabetes Associates - Wichita
Louisiana
- Tulane University Health Sciences Center - New Orleans
Maryland
- Medstar Research Institute - Hyattsville
Michigan
- Henry Ford Health System - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2010-08 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
What the finished NCT01194258 record still lists
NCT01194258 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 221-participant average among 7 other Diabetes Mellitus Type II trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Diabetes Mellitus Type II appearing as the primary indexed condition, and to 5 interventions - of which Insulin aspart is the first listed.
NCT01194258 names 20 study sites across 12 states, led by California, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT01194258 about?
NCT01194258 is a clinical study titled "Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus". The purpose of the study was to compare Humalog (insulin lispro)-recombinant human hyaluronidase PH20 (rHuPH20) or Novolog (insulin aspart)-rHuPH20 to insulin lispro for the treatment of Type 2 diabetes mellitus (T2DM) in basal-bolus therapy.
What is the current status of trial NCT01194258?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2010-08. Estimated completion is 2011-08.
What conditions does trial NCT01194258 study?
This clinical trial studies the following conditions: Diabetes Mellitus Type II.
What interventions are being tested in trial NCT01194258?
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 NCT01194258?
This trial is sponsored by Halozyme Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01194258 being conducted?
This trial has 20 study locations across California, Florida, Idaho, Kansas, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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