E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 |
Determine the efficacy of DM-99 on changes in glucose and insulin when given a half hour prior to a meal tolerance test. |
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E.2.2 | Secondary objectives of the trial |
To determine the effect of the DM-99 on post-prandial markers:
Changes in triglycerides,Changes in free fatty acids,Changes in C-peptide,Changes in glucagon,Changes in lactate
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Diagnosed Type 2 diabetes for no less than 3 months prior to screening
• HbA1c between 7.5 – 8.9
• Drug naïve OR stable on no more than one anti-diabetic medication, limited exclusively to either sulfonylureas (SU) or metformin (Met) for a period of at least 8 weeks.
• Ability to give legal consent
• A willingness to participate in this study as judged by the subject giving informed consent
• A willingness to refrain from blood donation within 7 days prior to Visit 1 and throughout the trial
• A willingness to refrain from alcohol within 24 hours prior to any study visit
• Agree to follow caffeine restrictions during the study and agree to eat served standard and test meals
• Age 40-70
• If females, must be post-menopausal (12 consecutive months amenorrhea) or full oophorectomy (removal of both ovaries)
• Ability to consume a can of liquid Vanilla Boost within 2 minutes
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E.4 | Principal exclusion criteria |
• Use of any investigational drug or device, or participation in any drug study during or within 30 days prior to baseline (Visit 1)
• Use of ACE inhibitors (refer to Addendum 1 for list of drugs)
• Use of products containing Nicotine including cigarettes
• Significant digestive abnormalities such as malabsorption or chronic diarrhea
• Alcohol or drug abuse within the past year
• Insulin treatment
• On Hormone Replacement Therapy
• Positive HIV or hepatitis (B or C)
• Body mass index (BMI) > 39 kg/m2
• Any medical or psychiatric condition which would make the subject unsuitable to participate in a clinical study
• Any known hypersensitivity or allergy to kallikrein
• Concomitant use of any product containing kallikrein
• Any known lactose intolerant or allergic to dairy products
• Neoplasia
• Any known hypersensitivity or allergy to agglutinins and/or hemagglutinin
• Cerebral Vascular Events
• Intracranial Hypertension
• Severe Cardiac insufficiency or coronary insufficiency
• Acute or chronic inflammation of the genitals
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E.5 End points |
E.5.1 | Primary end point(s) |
A total of 20 subjects will be enrolled for the cross-over study. All subjects will receive the same dose of DM-99 or placebo taken a half hour prior to each meal tolerance test. Adminstration of DM-99 a half hour prior to a meal tolerance test will improve post-prandial markers. |
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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 | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |