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 | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012614 |
E.1.2 | Term | Diabetes mellitus NOS |
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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 |
Effect of DM-83 on Post-Prandial Glucose and Insulin Control
Determine the efficacy of DM-83 on changes in glucose and insulin when given one 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-83 on post-prandial markers:
Changes in triglycerides
Changes in free fatty acids
Changes in C-reactive protein
Changes in glucagon
Changes in lactate
Changes in plasma kallikrein
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The following criteria must be met for a subject to be entered into the study
•Diagnosed Type 2 diabetes for no less than 3 months prior to screening
•HbA1c between 7.5 – 8.9
•Drug naïve OR 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 standardized meals
•Age 40-70
•If female, must be post-menopausal (12 consecutive months amenorrhea) or full oophorectomy (removal of both ovaries)
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E.4 | Principal exclusion criteria |
A subject with any of the following complications will be excluded from the study. The exclusion criteria must be assessed prior to entering the subject to the active study period.
•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 any nitric oxide donating medications (refer to Addendum 1 for list of drugs)
•Significant digestive abnormalities such as malabsorption or chronic diarrhea
•Significant organ malfunction including (but not limited to): liver disease (2.5 x normal upper limit), pulmonary disease, ischemic heart disease, heart failure, stroke, peripheral vascular disease, vasomotor instability, hyperthyroidism, peptic ulcer, latent or active bronchial asthma, pronounced bradycardia or hypotension, epilepsy and parkinsonism, other serious or chronic illness or history of serious or chronic illness
•Any significant complications from diabetes such as: kidney damage (renal insufficiency, serum creatinine greater than 2mg/dL or 176.8 µmol/L), eye damage (proliferative retinopathy), diabetic neuropathy, coronary artery disease, or peripheral vascular disease.
•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 acetyl cysteine
•Concomitant use of any product containing acetyl cysteine or molsidomine
•Any known hypersensitivity or allergy to molsidomine.
•Subjects must not be lactose intolerant or allergic to dairy products
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E.5 End points |
E.5.1 | Primary end point(s) |
A dose of DM-83 (4 mg molsidomine, 600 mg ACC) when taken one hour prior to a meal tolerance test will reduce the mean post-prandial glucose and/or insulin measurement in a cohort of subjects. |
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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
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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 | 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 |