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A dose escalating open label study in Type 1 diabetic subjects, to assess the pharmacodynamics activity of transbuccal human recombinant insulin compared to subcutaneous human insulin.

Phase 2
Completed
Conditions
Type 1 Diabetes Mellitus
Metabolic and Endocrine - Diabetes
Registration Number
ACTRN12615000495527
Lead Sponsor
Midatech Pharma Pty Ltd:
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
12
Inclusion Criteria

1. Age between 18 and 55 years
2. Body mass index (BMI) equal to or great than 18 kg/m2 and equal to or less than 30 kg/m2.
3. Diagnosis of T1DM made at least 2 years prior to study screening day, on an insulin pump or multiple insulin injections daily.
4. HbA1c at screening less than 10 percent.
5. Subject understands the study requirements and the treatment procedures, and is willing to comply with all specified follow-up evaluations, and provides written Informed Consent before any study-specific tests or procedures are performed.
6. Subject is C- peptide negative (less than 0.2 nmol/L) on screening.
7.Female subjects must be 1 year post-menopause, surgically sterile, or if sexually active, using an acceptable method of contraception to prevent pregnancy for the duration of the study (from the time they consent until 4 weeks after the last dose of the IP). Post menopause is defined as complete cessation of menstruation for 12 months.

Women of childbearing potential must have a negative urine pregnancy test at screening and at check-in (Day-1). Female subjects must not become pregnant during the study and so must be confirmed as surgically sterile (based on documented hysterectomy or bilateral tubal ligation),
Male partner sterilization (vasectomy with documentation of azoospermia), sexually inactive by abstinence or use following contraceptive methods from the time of the first dose of study treatment until at least 4 weeks after the final dose of study treatment.
- Abstinence: Sexual inactivity by abstinence must be consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception. Complete abstinence from sexual intercourse for 14 days prior to first dose of study treatment, through the dosing period, and for at least 4 weeks after the last dose of study treatment.

- Contraceptive Methods: Use of two of the following: Hormonal Contraceptives (oral, injectable, implant, patch, ring), Barrier Contraceptives (condom or diaphragm) or Intrauterine device.
8.Male subjects, if sexually active, must agree to use condoms during intercourse for the duration of the study and for 3 months after the last dose of study treatment. Male subjects must not donate sperm for the duration of the study period and for 3 months after the last dose of study treatment.

Exclusion Criteria

1. History of drug or alcohol abuse in the opinion of the Investigator.
2. History of severe or multiple allergies in the opinion of the Investigator.
3. Treatment with any investigational drug/device within 1 month or 5 half-lives of the IP (whichever is longer) prior to screening.
4. Progressive fatal disease.
5. History of significant cardiovascular, respiratory, gastrointestinal, hepatic, neurological, psychiatric and/or hematological disease defined at the discretion of the Investigator.
6. History or evidence of renal impairment of greater than Chronic Kidney Disease (CKD) stage 2.
7. Pregnant or lactating woman.
8. Lack of compliance or other similar reason that, according to Investigator, precludes satisfactory participation in the study.
9. History of Coronary Artery Bypass Graft (CABG), Myocardial Infarction (MI), active Ischemic heart disease, or Class II or greater congestive heart failure.
10. History of Cardiovascular Accident (CVA) or Transient Ischemic Accident (TIA).
11. Hypertension (blood pressure greater than 140/90 mm Hg) at screening (BP may be repeated up to 2 additional times after five minute semi supine rest period with the lowest BP taken as the measurement).
12. Low blood hemoglobin concentration equal to or less than 12 g/dL for female and equal to or less than 13 g/dL for male, at screening.
13. Psychological incompetence, whereby subject is assessed as being unable to provide information, consent, or comply with study requirements and procedures in the opinion of the Investigator.
14. Diminished skin integrity at the relevant injection sites in particular the abdomen.
15. Involved in or planned to participate in other studies that may interfere in data collection in the opinion of the Investigator.
16. Unstable blood glucose levels at the discretion of the Investigator.
17. Daily insulin requirements greater than 80 IU
18. Any significant secondary complications of diabetes including neuropathy, ketoacidosis, nephropathy, cardiovascular disease, stroke, and retinopathy as defined by the Investigator.
19. Experienced more than one episode of severe hypoglycemia in past 6 months requiring hospital intervention
20. Suffered more than one episode of Diabetic Ketoacidosis (DKA) in the past 6 months requiring hospital intervention.
21.Any other reason that, in the opinion of the Investigator, the volunteer is unsuitable to participate

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pharmacodynamic profile of Insulin Buccal Soluble Film (MSL-001) in comparison to subcutaneous administered human recombinant insulin (Humulin).[Blood Sampling will occur at (in minutes) :<br>-15, 0, 3, 5, 10, 15, 20, 25, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 420, 480, 540, 600, 660 and 720 for measurement of insulin and c-peptide. <br><br>Glucagon (blood) samples will be collected at -15, 0, 15, 30, 60, 90 and 120 min.<br><br>Primary Outcome Measures:<br><br>Glucose Infusion Rate (GIR) of four doses of transbuccal administered Insulin Buccal Soluble Film (5IU, 15IU, 20IU, and 60IU) vs. three doses (5IU, 10IU, 15IU) of subcutaneous human recombinant insulin (Humulin Registered Trademark) as measured by area under the curve (AUC):<br>-for 5IU and 15IU doses AUC(0-360) <br>-for 20IU and 60IU doses AUC(0-720) <br><br>(measure via blood glucose samples).]
Secondary Outcome Measures
NameTimeMethod
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