E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the safety of Capsulin To measure the effects of oral insulin on glucose control To compare 150IU and 300IU doses of Capsulin and control
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E.2.2 | Secondary objectives of the trial |
To confirm the kinetics of oral insulin To establish baseline glucose control
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects will be considered for entry into the study if they are: • Males or females. • Aged between 18-70 years (inclusive). • Have a body mass index (BMI) of 18-35kg/m2. • Signed informed consent. • Have a confirmed medical history of type 2 diabetes • Without major organ pathology (e.g. cardiac, immunological, psychiatric, endocrine or neurological disorders, cancer or other wasting diseases – (adequately treated actinic keratosis, or basal cell carcinoma [BCC], or carcinoma in situ [CIS] of the cervix are permitted). • A fasting blood glucose of less than 10 mmol/L • Taking stable appropriate oral antidiabetic medication for 3 months • Have completed study DBTY_000/Capsulin/1Mar more than 8 weeks before the start of the study.
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E.4 | Principal exclusion criteria |
• Presence of any clinically significant medical condition as determined by the Investigator. • Medically significant hypersensitivity or idiosyncratic reaction related to any medical product including vaccines. • History or evidence of drug abuse 1 year prior to enrolment. • Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method) • History or suspicion of inability to co-operate adequately. • Immunodeficiency or clinically autoimmune disease. • Positive breath alcohol and drug screen for drugs of abuse (methadone, cocaine, amphetamines, cannabinoids, and barbiturates). • Positive history of human immunodeficiency virus (HIV), and/or hepatitis B and/or hepatitis C. • Clinically relevant abnormal findings on routine physical examination. • Clinically significant out-of-range laboratory tests at screening including: urinalysis, serum creatinine, potassium, liver function tests (LFT), (>3 x upper limit of normal); absolute neutrophil count, platelet count, white blood cell count, electrolytes and blood haemoglobin. • Twelve-lead ECG recording with clinically relevant signs of pathology and conduction disturbances as judged by the investigator.
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E.5 End points |
E.5.1 | Primary end point(s) |
To measure the change in glucose infusion rate (GIR) in response to Capsulin |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |