Diabetes MedDRA version: 9.1 Level: LLT Classification code 10012614 Term: Diabetes mellitus NOS
Conditions
Interventions
Trade Name: Molsidominum
Pharmaceutical Form: Tablet
INN or Proposed INN: molsidomina
Other descriptive name: N-(MORPHOLINO-3TETRAHYDRO-2,3,4,5 OXADIAZOLE-1,2,3YLIDENE-5)CARBAMATE D'ETHYLE
Concentrati
Sponsors
DiaMedica Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 ;Secondary Objective: 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 ;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. | — |
Countries
Poland
Outcome results
None listed