Novel oral insulin for diabetes.

Novel oral insulin formulation for treatment of diabetic patients: An exploratory clinical study of a new route of administration

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

PACTR

Registry ID

PACTR202008660051554

Enrollment

Registered

2020-08-31

Start date

2020-10-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional, Metabolic, Endocrine

Interventions

Treatment of diabetic patients by a novel oral insulin formulation

placebo

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Patients who are known to have gastroparesis. Patients with a of gastro-intestinal (GI) surgery thought to significantly affect upper GI functions.

Design outcomes

Primary

Measure	Time frame
The difference between the test drug and placebo regarding fasting plasma glucose (FPG) level (significant difference). ;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)	—

Measure

Time frame

The difference between the test drug and placebo regarding fasting plasma glucose (FPG) level (significant difference). ;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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Egypt

Contacts

Public ContactTahra Sherif

Assiut University

tahrasherif@yahoo.com+201227446166

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026