A Pharmacokinetic and Glucodynamic Study of Subcutaneously Administered Insulin Analogs With rHuPH20 Compared to Insulin Analogs Alone

Completed · Phase 1

Conditions studied: Healthy

In brief

This is a single-center, Phase 1, randomized, double-blind, 6-way crossover study to determine insulin pharmacokinetics, insulin glucodynamics, safety, and tolerability of subcutaneously administered dose(s) of insulin lispro + recombinant human hyaluronidase PH20 (rHuPH20), insulin lispro alone, insulin glulisine + rHuPH20, insulin glulisine alone, insulin aspart + rHuPH20, and insulin aspart alone.

Key facts

Study ID: NCT00979875
Run by: Halozyme Therapeutics
People needed: 14
Starts: 2009-09-01
Expected to finish: 2010-05-01
Last updated by the study team: 2014-07-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Healthy participants between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities).
Body mass index (BMI) between 18-27 kilograms per meter squared (kg/m\^2), inclusive.
Total body weight >65 kilograms (kg) (143 pounds [lb]) for men and >46 kg (101 lb) for women.
Decision making capacity and willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including adequate venous access.
Vital signs (blood pressure [BP], pulse rate, body temperature) within normal range or, if out of range, assessed by the Principal Investigator as not clinically significant.
Fasting blood glucose level <100 milligrams per deciliter (mg/dL) at screening.
A negative serum pregnancy test (if female of childbearing potential).
Female participants of childbearing potential must agree to practice effective birth control or abstinence currently and agree to continue to do so for the duration of their time on study.
Signed, written institutional review board (IRB)-approved informed consent.

You may not qualify if…

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, oncologic, or neurologic (to include history of seizures) disease; hypoglycemic episodes; intercurrent illness (such as influenza); or allergic disease (including severe drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Clinical significance to be determined by the Principal Investigator.
As judged by the investigator, clinically significant findings in routine laboratory data. (Anemia with hematocrit less than 33% at screening is specifically exclusionary.)
Known history of diabetes mellitus (type 1 or type 2) or gestational diabetes.
Known allergy to hyaluronidase or any other ingredient in the study drug.
Positive human immunodeficiency virus (HIV) 1, hepatitis B, or hepatitis C antibody test.
History or evidence of alcohol or drug abuse.
History or evidence of use of any tobacco- or nicotine-containing product within 6 months prior to screening and a screening qualitative urine nicotine test.
Use of drugs that may interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action or glucose utilization.
Blood donation or high volume phlebotomy, for example, >100 milliliters (mL), within 56 days before dosing.
Participation in a study of any investigational drug or device 30 days before enrollment in this study.
The participant is unfit for the study in the opinion of the investigator.
Women who are pregnant or breast-feeding.

Where it is running

Profil Institute for Clinical Research, Inc. — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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