A Euglycemic Insulin Clamp Study in Type 1 Diabetic Patients With Oral Insulin (ORAMED)

Completed · Phase 2

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT02535715

Run by

The University of Texas Health Science Center at San Antonio

People needed

11

Starts

2015-01-01

Expected to finish

2017-04-01

Last updated by the study team

2019-03-21

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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