Type 2 Diabetes Treated With InsulinPhase 2NCT06473662

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

A Phase 2 study testing Oral insulin in people with Type 2 Diabetes Treated With Insulin, run by Roger New at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 35 to 60 years
Conditions the study is for: Type 2 Diabetes Treated With Insulin
What is being tested?: Oral insulin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 153 participants
Where: 1 siteUnited Kingdom
Study dates: 22 Oct 2018to 11 Jul 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Show all 28Show fewer

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
Life expectancy of less than 6 months from screening
Elective surgery or any other surgical procedure/s requiring general anaesthesia during the clinical trial
Has participated in another research trial within 12 weeks prior to screening
History of diabetic ketoacidosis requiring hospitalization within 6 months prior to enrolment, case of proliferative retinopathy or advanced neuropathy
Subject having any of the following laboratory results at screening
Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2
Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) >3 times of upper limit normal
Blood urea nitrogen (BUN) > 30 mg/dL
Subject who has a positive serology for hepatitis B virus (HBV) or hepatitis C (HCV) or human immunodeficiency virus (HIV) infections at screening
Subject who has undergone pancreatectomy or pancreas islet transplant or renal transplant
Subject receiving or has received any immunomodulation medications within 1 year prior to enrolment
Subject with history or evidence of diabetic complications (e.g. diabetic retinopathy, diabetic neuropathy, or diabetic nephropathy, etc.), cardiac disorders, or any other systemic complication due to diabetes, which in the opinion of the Investigator signifies subjects' ineligibility for the trial
Has any concurrent disease or medical/surgical condition, which required treatment of more than 3 months and which in the opinion of the Investigator does not allow participation of the subject in this study

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Diabetology
London, NW1 0NH

Other trials in United Kingdom

About this study

Official title: A Phase 2b, Open-label Randomized Comparative Study to Evaluate the Safety and Efficacy of Oral Insulin Formulation in Type 2 Diabetes Mellitus Subjects Uncontrolled With Metformin Hydrochloride Treatment

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
Being tested: Oral insulin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06473662
Study group	Role	What they receive
75iu	Experimental	Capsule containing 75iu recombinant human insulin administered two times per day Receives: Drug: Oral insulin
150iu	Experimental	Capsule containing 150iu recombinant human insulin administered two times per day Receives: Drug: Oral insulin
300iu	Experimental	Capsule containing 300iu recombinant human insulin administered two times per day Receives: Drug: Oral insulin

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in HbA1c
Change in HbA1c Relative to Baseline at Start of Study
Measured: 12 weeks

Secondary outcomes (3)

Change in Fasting Plasma Glucose
Change in Fasting Plasma Glucose Relative to Baseline at Start of Study
Measured: 12 weeks
Change in Post-Prandial Glucose
Change in Post-Prandial Glucose Relative to Baseline at Start of study
Measured: 12 weeks
Changes in Triglycerides
Change in Triglycerides Relative to Baseline at Start of Study
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Oct 201811 Jul 2020

First posted25 Jun 2024
Study start22 Oct 2018
Primary completion11 Jul 2020
Study completion11 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes Treated With InsulinStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A randomised twelve-week open-label study.
Masking: None (open label)
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06473662
Sponsor's protocol ID: Diabetology Ltd
Status last verified: Feb 2025
First submitted: 19 Jun 2024
Last updated: 6 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Not yet recruitingPhase 3
A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
Diabetes Mellitus, Type 2
Not yet recruiting
Physiologic Insulin Resensitization (PIR) Treatment in Patients With a Diagnosis of Type 2 Diabetes Mellitus (T2DM)
Type 2 Diabetes Mellitus
Not yet recruiting
Transitioning Recently Admitted Patients With Non-Insulin and Insulin-treated Type 2 Diabetes to Innovative Glucose Monitoring
Type 2 Diabetes

All Type 2 Diabetes Treated With Insulin trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2b, Open-label Randomized Comparative Study to Evaluate the Safety and Efficacy of Oral Insulin Formulation in Type 2 Diabetes Mellitus Subjects Uncontrolled With Metformin Hydrochloride Treatment
ClinicalTrials.gov ID: NCT06473662
Acronym / sponsor ID: Diabetology Ltd
Conditions: Type 2 Diabetes Treated With Insulin
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: Roger NewIndustry (pharma, biotech, devices)
Study start: 22 Oct 2018 (actual)
Primary completion: 11 Jul 2020 (actual)
Study completion: 11 Jul 2020 (actual)
First posted: 25 Jun 2024 (actual)
Results: Posted 6 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: A randomised twelve-week open-label study.

Arm	Type	Receives
75iu	Experimental	Drug: Oral insulinCapsule containing 75iu recombinant human insulin administered two times per day
150iu	Experimental	Drug: Oral insulinCapsule containing 150iu recombinant human insulin administered two times per day
300iu	Experimental	Drug: Oral insulinCapsule containing 300iu recombinant human insulin administered two times per day

Who may qualify

Ages: 35 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (28 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oral insulinCapsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper	Drug	150iu, 300iu, 75iu

Primary outcome

Change in HbA1c
Time frame: 12 weeks
Change in HbA1c Relative to Baseline at Start of Study

3 secondary outcomes

Change in Fasting Plasma Glucose
Time frame: 12 weeks
Change in Post-Prandial Glucose
Time frame: 12 weeks
Changes in Triglycerides
Time frame: 12 weeks

Results and safety

Results posted to the registry on 6 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
75iu	51	33
150iu	50	29
300iu	52	38

Primary outcome: Change in HbA1c

Time frame: 12 weeks. Mean (Standard Deviation). Unit: % of glycated haemoglobin

Measure	75iu n = 33	150iu n = 29	300iu n = 38
Value	-0.20 (1.06)	-0.53 (1.04)	-0.31 (1.04)

150iu: Mean Difference (Final Values): -0.53, p = 0.0039, t-test, 2 sided

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
75iu	0 of 33 (0%)	0 of 33 (0%)	0 of 33
150iu	0 of 29 (0%)	0 of 29 (0%)	0 of 29
300iu	0 of 38 (0%)	0 of 38 (0%)	0 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Type 2 Diabetes Treated With Insulin

Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Not yet recruitingPhase 3
A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
Diabetes Mellitus, Type 2
Not yet recruiting
Physiologic Insulin Resensitization (PIR) Treatment in Patients With a Diagnosis of Type 2 Diabetes Mellitus (T2DM)
Type 2 Diabetes Mellitus
Not yet recruiting
Transitioning Recently Admitted Patients With Non-Insulin and Insulin-treated Type 2 Diabetes to Innovative Glucose Monitoring
Type 2 Diabetes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oral insulin in people with Type 2 Diabetes Treated With Insulin, run by Roger New at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06473662.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.