A Euglycemic Insulin Clamp Study in Type 1 Diabetic Patients With Oral Insulin (ORAMED)
1 other identifier
interventional
11
1 country
1
Brief Summary
ORAMED has developed an oral insulin that, in preliminary studies, has shown promise. In the present study investigators will perform a pharmacodynamic/pharmacokinetic study to evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 12, 2015
CompletedFirst Posted
Study publicly available on registry
August 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedResults Posted
Study results publicly available
March 21, 2019
CompletedMarch 21, 2019
May 1, 2017
2.2 years
August 12, 2015
October 2, 2018
March 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hepatic Glucose Production (Co-primary Outcome)
Tritiated glucose infusion during procedures (Baseline and every 30 minutes during procedures) Calculated from plasma(mg/kg-minute). Averaged every 30 minutes.
Participants will be followed during the procedures, until all 3 procedures are completed, an average of 1 month
Secondary Outcomes (4)
Plasma Insulin Concentrations
Participants will be followed during the procedures, until all 3 procedures are completed, an average of 1 month
Plasma Glucose Concentrations
Participants will be followed during the procedures, until all 3 procedures are completed, an average of 1 month
Plasma Glucagon Concentrations
Participants will be followed during the procedures, until all 3 procedures are completed, an average of 1 month
Plasma Free Fatty Acid Concentrations
Participants will be followed during the procedures, until all 3 procedures are completed, an average of 1 month
Study Arms (3)
ORAMED ORMD-0801 capsules- 2x8mg 1st; 3x8mg 2nd, 1x16mg 3rd
EXPERIMENTALTwo 8 mg ORAMED capsules containing insulin then 3X8mg ORAMED capsules containing insulin, second study then 1X16mg ORAMED capsules containing insulin, third study
ORAMED ORMD-0801 capsules- 3x8mg 1st, 1x16mg 2nd, 2x8mg 3rd
EXPERIMENTALThree 8mg ORAMED capsules containing insulin then 1X16mg ORAMED capsules containing insulin, second study then 2X8mg ORAMED capsules containing insulin, third study
ORAMED ORMD-0801 capsules-1x16mg 1st, 2x8mg 2nd, 3x8mg 3rd
EXPERIMENTALOne 16mg ORAMED capsule containing insulin then 2X8mg ORAMED capsule containing insulin, second study then 3X8mg ORAMED capsule containing insulin, third study
Interventions
Participants who receive this intervention first, then receive either ORMD-0801- 3x8mg or 1x16mg dose after a 3 day to 4 week interval. Participants receiving this drug as the second drug intervention will then receive the third intervention after a 3 day to 4 week interval. ORMD-0801 capsules are an oral insulin that has shown promise in preliminary studies. Investigators will evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients.
Participants who receive this intervention first, then receive either ORMD-0801- 2x8mg or 1x16mg dose after a 3 day to 4 week interval. Participants receiving this drug as the second drug intervention will then receive the third intervention after a 3 day to 4 week interval. ORMD-0801 capsules are an oral insulin that has shown promise in preliminary studies. Investigators will evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients.
Participants who receive this intervention first, then receive either ORMD-0801- 2x8mg or 3x8mg dose after a 3 day to 4 week interval. Participants receiving this drug as the second drug intervention will then receive the third intervention after a 3 day to 4 week interval. ORMD-0801 capsules are an oral insulin that has shown promise in preliminary studies. Investigators will evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients.
Eligibility Criteria
You may qualify if:
- Must be between 18 and 70 years of age
- Must have type 1 diabetes
- Must be in good general health by routine history and physical exam
- A1c \<10.0%
- BMI = 18-40 kg/m2
- On no medications known to affect glucose metabolism other than insulin
- Hematocrit ≥ 34 vol%
- Liver Function Tests \< 3 x Upper Normal Limit
- Plasma creatinine \< 1.8 mg/dl
You may not qualify if:
- Under 18 years of age and over 70 years of age
- Does not have type 1 diabetes
- A1c \> 10.0%
- BMI \< 18 or \> 40 kg.m2
- On medications known to affect glucose metabolism other than insulin
- Hematocrit ≤ 34 vol%
- Liver Function Tests \>3 x Upper Normal Limit
- Plasma creatinine \> 1.8 mg/dl
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Related Publications (3)
Polonsky WH, Fisher L, Guzman S, Villa-Caballero L, Edelman SV. Psychological insulin resistance in patients with type 2 diabetes: the scope of the problem. Diabetes Care. 2005 Oct;28(10):2543-5. doi: 10.2337/diacare.28.10.2543. No abstract available.
PMID: 16186296BACKGROUNDDeFronzo RA, Ferrannini E, Simonson DC. Fasting hyperglycemia in non-insulin-dependent diabetes mellitus: contributions of excessive hepatic glucose production and impaired tissue glucose uptake. Metabolism. 1989 Apr;38(4):387-95. doi: 10.1016/0026-0495(89)90129-7.
PMID: 2657323BACKGROUNDSTEELE R. Influences of glucose loading and of injected insulin on hepatic glucose output. Ann N Y Acad Sci. 1959 Sep 25;82:420-30. doi: 10.1111/j.1749-6632.1959.tb44923.x. No abstract available.
PMID: 13833973BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Curtis Triplitt, PharmD
- Organization
- University of Texas Health San Antonio
Study Officials
- PRINCIPAL INVESTIGATOR
Ralph A DeFronzo, MD
University of Texas
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2015
First Posted
August 31, 2015
Study Start
January 1, 2015
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
March 21, 2019
Results First Posted
March 21, 2019
Record last verified: 2017-05