ovel oral insulin for diabetes.
Phase 1
- Conditions
- Nutritional, Metabolic, Endocrine
- Registration Number
- PACTR202008660051554
- Lead Sponsor
- Prof. Mostafa Hamad
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Patients with age from 19 to 64 years.
Patients who suffer from type II diabetes.
Patients with HbA1c more than 8.0%.
Patients under insulin treatment with or without oral anti-diabetic in the form of metformin.
Patients with BMI from 20 to 45.
Exclusion Criteria
Patients who are known to have gastroparesis.
Patients with a of gastro-intestinal (GI) surgery thought to significantly affect upper GI functions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference between the test drug and placebo regarding fasting plasma glucose (FPG) level (significant difference).<br>;The difference between test drug and placebo regarding plasma glucose level after a standard meal; usually breakfast (significant difference).;The difference between the test drug and placebo regarding average blood glucose (mean of seven measurements obtained before and after each meal and at bedtime) (significant difference).;The difference between the test drug and placebo regarding fasting plasma insulin level. (significant difference)
- Secondary Outcome Measures
Name Time Method The proportion of patients who achieved treatment goal in reducing the FPG greater than 20 mg/dL during the treatment period in comparison to the placebo period.;The number of patients receiving hyperglycemic rescue for the tratment period versus placebo versus.;The number of incidents of hyperglycemic rescue for the treatment period versus the placebo period.;The difference in the time-to-hyperglycemic rescue between test drug and placebo.;The number of hypoglycemic attacks in the treatment period.;Safety and tolerability of the treatment will be assessed including GI adverse events, hypoglycemic events and potential allergic reaction.<br>