Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202008660051554 Date of Approval: 31/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Novel oral insulin for diabetes.
Official scientific title Novel oral insulin formulation for treatment of diabetic patients: An exploratory clinical study of a new route of administration
Brief summary describing the background and objectives of the trial Diabetes is a world-wide health problem. A large list of drugs is currently in use to treat diabetes ranging from insulin to several groups of parenteral and oral anti-diabetics. Insulin is the ideal therapy, however, it can only be administered by injection. "Oral" insulin formulation have been sought for since the discovery of Insulin about a century ago. In 2017, two of the current authors; Elsabahy and Hamad, applied for an international patent for an "oral delivery platform" that could be used for oral administration of drug molecules that are already used by injection including protein molecules as insulin. In 12-2018, the application was published in WIPO journal under the title of "prolonged oral delivery platform" including extensive pre-clinical in-vivo animal testing for safety and efficacy. This clinical trial is testing the novel oral insulin under the code-name of "EN-I-010" which was recently formulated by EgyNano Pharma company in Egypt. This is a trial of "reformulation" of an already in-use drug which is insulin. We are just changing its route of administration from Subcutaneous to Oral. The trial is considered an "Exploratory clinical trials" (sometimes known as Phase 0 clinical trial) which is de facto first-in-human study. The objective of this exploratory clinical trial is to help decide either continuation or suspension of this novel drug. This could be achieved through short-term evaluation of pharmacokinetics and pharmacodynamics of the tested drug.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) ORIN
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2020
Actual trial start date 01/10/2020
Anticipated date of last follow up 31/03/2021
Actual Last follow-up date 31/03/2021
Anticipated target sample size (number of participants) 10
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Treatment of diabetic patients by a novel oral insulin formulation Single dose of the oral capsule containing 20 IU/Kg of insulin glargine. The dose will be given just once for each patient during the study. Just single dose given once for each patient during the study. This study is an exploratory clinical trial with a reformulated already approved drug (insulin glargine) This study is a prospective, open -label, substitute, single arm, non-randomized, crossover, placebo-controlled study The study will comprise three study periods, namely washout, placebo and treatment periods. The washout period will have a duration equal to at least five times the half life of the original insulin used by the patient (if mixture of insulin is used the duration is calculated for the insulin with longer action). The placebo period extends for a maximum of three days. The treatment period extends for a maximum of four days. At any time of the study, patients who meet the criteria of hyperglycemic rescue or hypoglycemic rescue (according to the predefined fasting plasma glucose [FPG]) will be given the needed rescue treatment as defined below. also, any patient who fulfills the withdrawal criteria (as described below) will be withdrawn from the study 10
Control Group placebo No antidiabetic treatment maximum 3 days This study is an exploratory clinical trial with a reformulated already approved drug (insulin glargine) This study is a prospective, open -label, substitute, single arm, non-randomized, crossover, placebo-controlled study The study will comprise three study periods, namely washout, placebo and treatment periods. The washout period will have a duration equal to at least five times the half life of the original insulin used by the patient (if mixture of insulin is used the duration is calculated for the insulin with longer action). The placebo period extends for a maximum of three days. The treatment period extends for a maximum of four days. At any time of the study, patients who meet the criteria of hyperglycemic rescue or hypoglycemic rescue (according to the predefined fasting plasma glucose [FPG]) will be given the needed rescue treatment as defined below. also, any patient who fulfills the withdrawal criteria (as described below) will be withdrawn from the study 10 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. Patients who are known to have gastroparesis. Patients with a of gastro-intestinal (GI) surgery thought to significantly affect upper GI functions. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 64 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/07/2020 The Medical Ethics Committee of the Faculty of Medicine Assiut University
Ethics Committee Address
Street address City Postal code Country
Assiut University Campus, Faculty of Medicine Assiut 71515 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The difference between the test drug and placebo regarding fasting plasma glucose (FPG) level (significant difference). Blood sample for blood glucose level taken immediately before breakfast
Primary Outcome The difference between test drug and placebo regarding plasma glucose level after a standard meal; usually breakfast (significant difference). Blood sample for plasma glucose level taken two hours after the standard breakfast
Primary Outcome 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). Blood sample for plasma glucose level taken before and after each meal and at bed time
Primary Outcome The difference between the test drug and placebo regarding fasting plasma insulin level. (significant difference) Blood sample for plasma insulin level taken before breakfast
Secondary Outcome 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. Assess all the blood samples taken for the primary outcomes.
Secondary Outcome The number of patients receiving hyperglycemic rescue for the tratment period versus placebo versus. Assess all the blood samples taken for the primary outcomes
Secondary Outcome The number of incidents of hyperglycemic rescue for the treatment period versus the placebo period. Assess all blood samples taken for the primary outcomes.
Secondary Outcome The difference in the time-to-hyperglycemic rescue between test drug and placebo. Calculate time from the beginning of the respective period till the occurrence of the hyperglycemic incident.
Secondary Outcome The number of hypoglycemic attacks in the treatment period. Assess the blood samples and the clinical manifestation of hypoglycemia during the treatment period.
Secondary Outcome Safety and tolerability of the treatment will be assessed including GI adverse events, hypoglycemic events and potential allergic reaction. Assess blood samples and clinical manifestations of any adverse events during the treatment period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nile Hospital Maamoon Street 11 Assiut 71151 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
EgyNano Pharma Company Galaa Street 25 Assiut 71151 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof. Mostafa Hamad Department of General Surgery, Faculty of Medicine, Assiut University Campus Assiut 71515 Egypt Individual
Secondary Sponsor EgyNano Pharma Company Galaa Street 25 Assiut 71151 Egypt Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Prof. Mahmoud Elsabahy Prof. of Pharmaceuticals, Faculty of Pharmacy, Assiut university Campus Assiut 71515 Egypt
Prof. Mohammed Zein El Din Hafez Prof. of Internal Medicine, Faculty of Medicine, Assiut University Campus Assiut 71515 Egypt
Prof. Tahra Sherif Prof. of Clinical Pathology, Faculty of Medicine, Assiut University Campus Assiut 71515 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Hamad mostafa_hamad@yahoo.com +20881222438186 Department of General Surgery, Faculty of Medicine, Assiut University Campus
City Postal code Country Position/Affiliation
Assiut 71515 Egypt Assiut University
Role Name Email Phone Street address
Public Enquiries Tahra Sherif tahrasherif@yahoo.com +201227446166 Department of Clinical Pathology, Faculty of Medicine, Assiut University Campus
City Postal code Country Position/Affiliation
Assiut Egypt Assiut University
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Elsabahy mahmoud.elsabahy@gmail.com +201000607466 department of Pharmaceuticals, Faculty of Pharmacy, Assiut University Campus
City Postal code Country Position/Affiliation
Assiut 71515 Egypt Assiut University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data will be available after deidentification. Informed Consent Form,Study Protocol immediately after publication and for 5 years The data will be available for researchers who provide a methodologically sound proposal to achieve aims in that approved proposal. Proposal should be directed to mostafa_hamad@yahoo.com.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information