Study to Evaluate the Safety and Efficacy of Oral Insulin Formulation in Type 2 Diabetes Mellitus Subjects

NCT06473662 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: Diabetology Ltd
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study was to compare the pharmacodynamic properties of different doses of regular human insulin administered in capsule form twice daily in a randomised twelve-week open-label trial.

Conditions

Type 2 Diabetes Treated With Insulin

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change in HbA1c Relative to Baseline at Start of Study

  12 weeks

Secondary Outcomes (3)

• Change in Fasting Plasma Glucose

  12 weeks

• Change in Post-Prandial Glucose

  12 weeks

• Changes in Triglycerides

  12 weeks

Study Arms (3)

75iu

EXPERIMENTAL

Capsule containing 75iu recombinant human insulin administered two times per day

Drug: Oral insulin

150iu

EXPERIMENTAL

Capsule containing 150iu recombinant human insulin administered two times per day

Drug: Oral insulin

300iu

EXPERIMENTAL

Capsule containing 300iu recombinant human insulin administered two times per day

Drug: Oral insulin

Interventions

Oral insulin DRUG

Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper

150iu; 300iu; 75iu

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female aged 35 to 60 years (both inclusive)
• Type 2 diabetes mellitus diagnosed \< 2 years prior to enrolment
• Glycated haemoglobin level ≥ 7% and ≤ 9.5%
• On stable oral monotherapy with metformin hydrochloride (1000 mg to 2500 mg/day) and regular diet and exercise regimen at least 12 weeks prior to enrolment
• Body mass index between 18 to 30 kg/m2
• Ability to perform capillary blood glucose measurements
• Willing to provide informed and written consent for the clinical trial
• Able to comply with all requirements of clinical trial protocol

You may not qualify if:

• Subject with history or evidence of hypersensitivity to insulin or metformin hydrochloride or its excipients
• Suffering from type 1 diabetes mellitus
• Received treatment with sulphonylureas or alpha-glucosidase inhibitors, Glucagonlike peptide-1 (GLP-1) receptor agonists or Sodium-glucose co-transporter 2 (SGLT2) inhibitors or meglitinides or pramlintide or thiazolidinediones within 3 months prior to enrolment
• Previously treated with insulin within 3 months prior to enrolment
• History of episodes of hypoglycaemia during 3 months prior to enrolment.
• Reduced awareness of hypoglycaemia or inability to identify and tackle hypoglycaemic episodes
• History of substantial weight loss defined as 5% decrease in body weight within the last 6 months
• Medical history of unstable angina within 1 year prior to enrolment
• History of tobacco or nicotine more than two packs/day within 3 months prior to enrolment
• Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within 1 year prior to enrolment) of drug or alcohol abuse or dependence. (Note: Alcohol abuse includes heavy alcohol intake as defined by \>3 drinks per day or \>14 drinks per week, or binge drinking).
• History of gastrointestinal disorders which may potentially interfere with absorption of the investigational product
• Treatment with systemic corticosteroids or with inhalational corticosteroids (Beclomethasone or budesonide) within the 3 months prior to enrolment
• Likelihood of requiring treatment during the study period with prohibited medications mentioned (as defined in this clinical trial protocol)
• Female subject who is pregnant, lactating or planning pregnancy during the trial
• Female subject of childbearing age who is not willing to use adequate method of contraception during the study period

Sponsors & Collaborators

• Roger New: lead

Study Sites (1)

Diabetology

London, NW1 0NH, United Kingdom

Location

MeSH Terms

Interventions

Insulin

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Roger New
• Organization: Diabetology Ltd

rn@diabetology.co.uk

07818068012

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Scientific Officer

Model Details: A randomised twelve-week open-label study.

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: October 22, 2018
• Primary Completion: July 11, 2020
• Study Completion: July 11, 2020
• Last Updated: February 6, 2025
• Results First Posted: February 6, 2025

Record last verified: 2025-02

Locations

GB (1)