A Prospective, Randomized, Double-blind, Placebo Controlled Study to Assess the Impact of ORMD-0801 (Insulin Capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus Type 1
- Sponsor
- Oramed, Ltd.
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Total, Basal, and Bolus Exogenous Insulin Requirements
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This will be a prospective, randomized, double-blind, placebo controlled study. Patients with established Type 1 diabetes will be eligible for entry into the study. Eligible patients will be screened and those who fulfill all inclusion/exclusion criteria will be admitted to the inpatient unit no fewer than 2 days and no more than 7 days after Screening. Patients will report to the inpatient unit at 6 a.m. and outfitted with a continuous glucose monitoring (CGM) device. Patients will be given standardized meals and snacks for the duration of their inpatient visit.
Detailed Description
For the first 3 days, patients will be dosed with placebo 45 minutes prior to each of the day's 3 meals to establish baseline insulin requirements. Patients will be dosed with exogenous insulin according to their normal sliding scale and each patient's daily insulin requirement will be documented. The average daily insulin requirements during the 3 day run-in period will constitute the patient's baseline insulin level. Following the 3 day run-in, the CGM device will be detached, its data download, and the patient refitted with the CGM with a fresh cannula for continued monitoring during the 7-day treatment period. Patients will be randomized 2:1 to receive ORMD-0801 or placebo for the 7-day double-blind treatment period.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and Females age 18 to 55 years old, inclusive.
- •Patients must be willing and able to sign informed consent.
- •Documented history of Type 1 Diabetes for at least 6 months
- •Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urinary screening test following admission to the inpatient unit
Exclusion Criteria
- •Presence of any clinically significant endocrine disease according to the Investigator (euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least six weeks prior to Screening)
- •Fasting plasma glucose \>260 mg/dL at the end of run-in
- •Evidence of unawareness of hypoglycemia with a documented plasma glucose ≤50 mg/dL in the absence of symptoms of hypoglycemia
- •Presence of any clinically significant condition that might interfere with the evaluation of study medication (i.e., significant renal, hepatic, gastrointestinal (GI), cardiovascular (CV), immune disease).
- •Presence or history of cancer within the past five years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer
- •Laboratory abnormalities at screening including:
- •Positive pregnancy test in females of childbearing potential (at screening and Day -3 of Visit 2)
- •Abnormal serum thyrotropin (TSH) levels \>1.5X upper limit of normal (ULN)
- •Positive test for hepatitis B surface antigen and/or hepatitis C antibody
- •Positive test for HIV
Outcomes
Primary Outcomes
Change From Baseline in Total, Basal, and Bolus Exogenous Insulin Requirements
Time Frame: Baseline:Run-In Average (run in days 1-7), and treatment (day 6 and day 7)
Change from baseline (Run-in Average) to treatment days 6 and 7 (average of day 6 and 7) in exogenous insulin requirements in patients treated with ORMD-0801 compared to patients treated with placebo.
Secondary Outcomes
- Mean Nighttime, Daytime, and Fasting Glucose Levels(last two days (day 6 and day 7, averaged))