Cukrzyca
Conditions
Interventions
Trade Name: Padutin
Pharmaceutical Form: Coated tablet
INN or Proposed INN: kallicrein
Other descriptive name: kallidinogenase
Concentration unit: U unit(s)
Concentration type: equal
Concentration num
Sponsors
DiaMedica Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 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: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the efficacy of DM-99 on changes in glucose and insulin when given a half hour prior to a meal tolerance test.;Secondary Objective: 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 ;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. | — |
Countries
Poland
Outcome results
None listed