Safety Study of Subcutaneously Injected Prandial INSULIN-PH20 NP Compared to Insulin Analog Injection in Patients With Type 1 Diabetes Mellitus
This trial is active, not recruiting.
|Condition||diabetes mellitus, type 1|
|Treatments||insulin lispro injection, insulin-ph20|
|Start date||May 2009|
|End date||February 2010|
|Trial size||40 participants|
|Trial identifier||NCT00883558, HALO-117-203|
Insulin lispro is approved by the FDA for the treatment of diabetes mellitus. Recombinant human hyaluronidase (rHuPH20) is approved by the FDA as an aid to the absorption and dispersion of other injectable drugs. In this study, rHuPH20 combined with regular human insulin (INSULIN-PH20 NP) will be compared to insulin lispro with respect to absorption and action of insulin.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Aurora, CO||Barbara Davis Center for Childhood Diabetes||no longer recruiting|
|Miami, FL||Diabetes Research Institute||no longer recruiting|
|Detroit, MI||Henry Ford Health System||no longer recruiting|
|Butte, MT||Mercury Street Medical||no longer recruiting|
|Durham, NC||UNC Diabetes Care Center/Highgate Specialty Center||no longer recruiting|
|Cleveland, OH||Cleveland Clinic||no longer recruiting|
|Austin, TX||Texas Diabetes and Endocrinology||no longer recruiting|
|Olympia, WA||West Olympia Internal Medicine||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||crossover assignment|
To test for non-inferiority of INSULIN-PH20 NP as compared to insulin lispro with respect to 8-point glucose profiles over 3 days during the second to last week of each treatment cycle, with specific reference to glycemic excursions.
time frame: 3 months
Male or female participants from 18 years up to 65 years old.
Inclusion Criteria: - Male or female of age 18 to 65 years, inclusive. Females of child-bearing potential must use a standard and effective means of birth control for the duration of the study. - Patients with Type 1 diabetes mellitus (per WHO criteria) treated with insulin for ≥24 months. - Patients who use an insulin infusion pump for basal insulin administration must be on the device for at least 90 days prior to screening. - BMI 18.0 to 35.0 kg/m², inclusive. - HbA1c (glycosylated hemoglobin A1c) ≤7.5 % based on central laboratory screening results. - Fasting C-peptide <0.6 ng/mL. - Patient should be in good general health based on medical history and physical examination, without medical conditions that might prevent the completion of study drug injections and assessments required in this protocol. Exclusion Criteria: - Known or suspected allergy to any component of any of the study drugs in this study. - Previous enrollment in this study. Patients who fail the Screening visit may attempt to rescreen into the study. - A patient who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator. - As judged by the Investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including a history of arrhythmia or conduction delays on ECG), hepatic, neurological, renal, genitourinary, or hematological systems. - As judged by the Investigator, uncontrolled hypertension (diastolic blood pressure ≥ 100 mmHg and/or systolic blood pressure ≥ 160 mmHg after 5 minutes in the supine position). Three attempts may be performed to measure blood pressure. - History of any illness or disease that in the opinion of the Investigator might confound the results of the study or pose additional risk in administering the study drugs to the patient. - As judged by the Investigator, clinically significant findings in routine laboratory data. - Use of drugs (such as steroids) that may interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia. - Recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or hypoglycemic unawareness, as judged by the Investigator. - Current addiction to alcohol or substances of abuse as determined by the Investigator. - Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, intra-uterine device [IUD], oral or injectable contraceptives, or barrier methods). - Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation in this study. - Receipt of any investigational drug within 4 weeks of Screening. - Any condition (intrinsic or extrinsic) that in the judgment of the Investigator will interfere with study participation or evaluation of data. Examples would include: renal insufficiency (serum creatinine >1.5 mg/dL for males or >1.4 mg/dL for females), congestive heart failure required medication treatment, cardiac disease with New York Heart Association Functional Capacity III/IV.
|Official title||A Phase II, Randomized, Open Label, 2-Way Crossover, Safety Study of Subcutaneously Injected Prandial INSULIN-PH20 NP Compared to Insulin Analog Injection in Patients With Type 1 Diabetes|
|Description||The purpose of this study is to compare the safety of INSULIN-PH20 NP vs. insulin lispro alone. The safety and tolerability of INSULIN-PH20 will be studied and compared to insulin lispro. The study drugs will be administered by subcutaneous (under the skin) injection.|
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