A Phase 1/2 interventional study of Human Insulin and Oral Placebo in Type 1 Diabetes, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 2 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-20.
Sponsored by University of Colorado, Denver · Phase 1/2, Interventional, and Prevention
A dose with proven drug bioavailability to the immune system for use in a phase II/III primary T1DM (type 1 diabetes) vaccination trial (POINT study) in genetically at risk subjects.
Study Design Randomized, placebo-controlled, double-blind/double-masked, multi-center, dose escalation primary intervention pilot study.
Accrual Objective 25 (3:2 randomization to active and control arms)
The objective of this study is to determine the feasibility, safety and bioavailability of oral insulin in children with high genetic risk for T1DM in a dose escalation primary intervention pilot study.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 25 is below the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 319 are open to participants now.
Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Children aged 2 years to 7 years who:
None of the following HLA DR or DQB1 alleles:
Exclusion Criteria:
Oral Insulin at 2.5 mg, 7.5 mg, 22.5 mg, or 67.5 mg per day
Drug: Human Insulin
Oral Placebo
Other: Oral Placebo
Drug pages: Insulin, Regular, Human · Insulin
There is a study drug dose increase once during the study. The dose increase will occur 6 months after entering into the study. A total of 6 children will be included at each dose (3 children will not have received insulin prior to entering the study and 3 children will have received a lower dose of insulin for 6 months). Further dose increases or more frequent dose increases in individual children will not be performed during Pre-POINT. Escalation will occur in both treatment and placebo group so that participants and study investigators will remain blinded to treatment throughout the study. First dose (2.5 mg oral insulin/day) Second dose (7.5 mg oral insulin/day) Third dose (22.5 mg oral insulin/day) Fourth dose (67.5 mg oral insulin/day)
Also known as: Oral Insulin
Oral Placebo is given orally daily
Change in Blood Glucose Levels
Evaluation for hypoglycemia will be measured prior to administration of the insulin (baseline), then at 30, 60, and 120 minutes after administration of the insulin.
Time frame: Day 1
Daily Evaluation of Blood Glucose Levels
Blood glucose will be measured 60 minutes after the administration of the Insulin.
Time frame: Days 2 through 7
Evaluation of Blood Glucose Levels
After treatment day 7, Insulin will be administered and measured on a monthly basis.
Time frame: Measured 60 minutes after oral insulin dosing, every day during each 4th week, as long as the subject is given oral insulin.
Change in Total IgE and IgE.
Allergy/intolerance to the study drug evaluated with total IgE and IgE antibodies to insulin at 2 weeks, 3 months, 6 months, then every 6 months thereafter, as well as monitored through self-reporting by families. Parents/guardians will be educated on and instructed to look out for possible allergic reactions to insulin.
Time frame: 2 weeks, 3 months, 6 months
T-cell responses related to potential immune response to Insulin
T-cell responses e.g. antibody and cell mediated immune results will be evaluated the day of administration then at 15 days, 3 and 6 months, and every 6 months of treatment, and will be reported directly to the Data Coordinating Center.
Time frame: Day 1, 15 days, 3 and 6 months.
Plan to share: Yes
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Insulin, Regular, Human · Insulin
University of Colorado, Denver →