A Study Evaluating the Bioavailability of Oral Insulin (N11005)

Research on Clinical Application of New Therapies for Diabetes and Its Complications and Related Translational Medicine Research

The objective of this study was to preliminarily verify whether the oral insulin N11005 is a prandial insulin by assessing the PK, PD, and safety profiles of N11005.

Study Overview

• Status: Completed
• Conditions: PK, PD, and Safety
• Intervention / Treatment: Drug: N11005; Drug: Novolin R

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 1) Volunteer to participate in the trial and sign an informed consent form; 2) 18-45 years old (including 18 and 45 years old) healthy male subjects (without heart, liver, kidney, digestive tract, neurological diseases, and metabolic abnormalities in the 4 weeks before screening; No abnormal clinically significant vital signs results, physical examination results, laboratory examination results and electrocardiogram examination results judged by the investigator at the time of screening); 3) BMI (body mass index): between 19-24 Kg/m2, including 19 and 24 Kg/m2; 4) Normal glucose tolerance (fasting plasma glucose [FPG] <6.1 mmol/L, and oral glucose tolerance test [OGTT] 2-hour postprandial blood glucose <7.8 mmol/L); 5) No family history of diabetes, obesity, etc.; 6) Insulin secretion function is normal (confirmed by insulin release test (IRT) judged by the investigator); 7) There is no planned parenthood during the study period, and it is agreed to use reliable contraceptive measures during the study period until 4 weeks after the last administration of the study drug; 8) Be able to communicate well with researchers and complete research in accordance with research regulations.

Exclusion Criteria:

• 1). Those who have serious systemic diseases, infectious diseases or mental disorders; 2). The results of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, syphilis test are positive; 3). Those who have used any prescription drugs, Chinese herbal medicines and/or over-the-counter drugs (except for subjects with occasional and restricted use of paracetamol) and health products (except routine vitamin supplements) within 2 weeks before screening; 4). Those who donated more than 400 mL of blood within 3 months before screening; 5). Severe smokers (25 or more cigarettes per day); 6). Alcoholics (drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), or those who have a positive alcohol breath test result; 7). Those who have a history of drug abuse or have a positive urine test for illegal drugs; 8). Those who are known or suspected to be allergic to insulin and/or its excipients; 9). Those who have participated in other clinical trials within 3 months before screening, or plan to participate in other clinical trials during the trial period or within 1 month after the end of the trial; 10). Those who have any food allergies or have special dietary requirements and cannot follow a unified diet; 11). Those who have undergone gastrointestinal surgery before screening, or have a history of gastric obstruction or impaired gastrointestinal motility; 12). Those who are using gastric mucosal protective agents during screening; 13). Those who are deemed unsuitable to participate in this trial after the researcher's evaluation;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: T group	Drug: N11005; oral insulin N11005, 300IU, p.o.
ACTIVE_COMPARATOR: R group	Drug: Novolin R; reference preparation Novolin R, 0.1 IU/Kg, i.h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	the peak concentration	Pre-dose, 5,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300, 330,360,420,480 minutes；
AUC 0-8 h	the AUC for insulin from time zero to 8 hours	Pre-dose, 5,10,20,30,45,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300, 330,360,420,480 minutes；
AUCGIR,0-8 h		Pre-dose, 0-8 hours
GIRmax		Pre-dose, 0-8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	time to Cmax	Pre-dose, 5,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300,330,360,420,480 minutes；
AUC 0-2 h	the AUC for insulin from time zero to 2 hours	Pre-dose, 5,10,20,30,40,50,60,75,90,105,120 minutes
the elimination half-life (t1/2) of serum insulin		Pre-dose, 5,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300, 330,360,420,480 minutes；
the AUC for insulin from time zero to 4 h		Pre-dose, 5,10,20,30,40,50,60,75,90,105,120,150,180,210,240 minutes
the AUC for insulin from time zero to infinite time		Pre-dose, 5,10,20,30,45,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300, 330,360,420,480 minutes；
AUCGIR，0-2 h		Pre-dose, 0-2 hours
AUCGIR，0-4 h		Pre-dose, 0-4 hours
tGIRmax		Pre-dose, 0-8 hours

Collaborators and Investigators

• Sponsor: Beijing Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 10, 2019
• Primary Completion (ACTUAL): August 14, 2020
• Study Completion (ACTUAL): August 14, 2020

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (ACTUAL): July 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 12013-P-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No