A study on the safety, tolerability and the effect of DM-199 on the body, a new agent for the treatment of Diabetes Mellitus Type 2, after single- and multiple dosing in healthy volunteers and Diabetes Mellitus Type 2 patients.
- Conditions
- Diabetes Mellitus type 2Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]MedDRA version: 16.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
- Registration Number
- EUCTR2013-000225-30-NL
- Lead Sponsor
- DiaMedica USA Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1.Status:Parts A and C: healthy subjects
Parts B and D: type 2 diabetes mellitus patients
2.Gender: Parts A, B, C and D: males and/or females;
in Parts A, B and C, females may be of childbearing or non childbearing potential;
in Part D, females must be of non-childbearing potential
3.Age: Parts A and C: 18 - 65 years, inclusive
Parts B and D: 18 - 75 years, inclusive
4.BMI: Parts A and C: 18.0 - 30.0 kg/m2
Parts B and D: 25.0 - 35.0 kg/m2 for Part B and 25.0 - 45.0 kg/m2 with a maximum body weight up to 165 kg for Part D; of eligible patients, those with a BMI =27 will preferably be included in order to match the demographics of the typical BMI observed in patients with well characterized type 2 diabetes mellitus in the United States of America
5.For females of non-childbearing potential: females must be either surgically sterilized or at least 1 year postmenopausal (amenorrhoea duration of at least 12 months) and have a negative pregnancy test at screening and each admission
6.For females of childbearing potential: females must be non-pregnant and non lactating, and have a negative serum pregnancy test at screening and each admission.
7.For females of child-bearing potential: willingness to use adequate contraception from screening until 90 days after the follow up visit. Adequate contraception is defined as using hormonal contraceptives combined with at least 1 of the following forms of contraception: an intrauterine device, a diaphragm or cervical cap, or a condom
8.For males: willingness to use adequate contraception from entry in the clinical research center until 90 days after the follow-up visit
9.Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, powerdrinks), grapefruit (juice) and tobacco products from 48 hours prior to entry in the clinical research center until discharge each period
10.Medical history without clinically significant abnormalities
11.Parts A and C: Resting supine blood pressure of 140/90 mmHg or lower and higher than 90/50 mmHg, and showing no clinically relevant deviations as judged by the Principal Investigator
12.Parts B and D: Resting supine blood pressure of 160/100 mmHg or lower and higher than 90/50 mmHg, and showing no clinically relevant deviations as judged by the Principal Investigator
13.Computerised (12-lead) ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Principal Investigator
14.All values for hematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the Principal Investigator.
15.Willing to sign the written Informed Consent Form (ICF
Additional Inclusion Criteria Specific to Type 2 Diabetes Mellitus Patients (Part B and Part D)
++ Diagnosed with type 2 diabetes mellitus
++ Taking a stable dose of one or more oral anti-diabetic medications, such as metformin, sulphonylurea or any other orally administered glucose lowering medication (except for thiazolidinediones) for at least 3 months prior to screening
++ Receiving no other chronic medications, including dietary supplements, that alter blood glucose control. Non-systemic steroids are permitted
++ The use (before and in the same dose during the study) of antihypertensives, (except angiotensin-converting-enzyme (ACE) inhibitors) and drugs to treat dyslipidaemia
1.Evidence of clinically relevant pathology
2.Mental handicap
3.History of relevant drug and/or food allergies
4.Smoking more than 5 cigarettes, 1 cigar or 1 pipe daily
5.Parts A to C: History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
Part D: history of drug addiction (including soft drugs like cannabis products); history of alcohol abuse within the year prior to the start of the study
6.Use of concomitant medication, except for acetaminophen (paracetamol), which is allowed up to 3 days before entry into the clinical research centre (after that time the use of a limited amount of acetaminophen is permitted after consultation with the Principal Investigator). Multivitamins and vitamin C are allowed up to 7 days before entry into the clinical research center. All other medication (including over the counter medication, health supplements, and herbal remedies such as St. John’s Wort extract) must have been stopped at least 14 days prior to entry into the clinical research center.
7.Participation in a drug study within 60 days prior to drug administration. Participation in more than 3 other drug studies (for men) / more than 2 other drug studies (for women) in the 10 months preceding the start of this study)
8.Donation or blood loss of more than 50 mL of blood within 60 days prior to drug administration. Donation of more than 1.5 litres of blood (for men) / more than 1.0 litres of blood (for women) in the 10 months preceding the start of this study.
9.Positive drug screen (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and alcohol)
10.Intake of more than 24 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
11.Positive screen on HBsAg, anti-HCV or anti-HIV 1/2
12.Illness within 7 days prior to (the first) drug administration
13.Serum creatinine > upper limit of the normal (ULN) range
Additional Exclusion Criteria Specific to Type 2 Diabetes Mellitus Patients (Part B and Part D)
14.The use of insulin and thiazolidinediones for type 2 diabetes mellitus 3 months prior to screening is not allowed.
15.History of diabetic ketoacidosis or hyperosmolar coma
16.Advanced diabetic complications, including neuropathy, nephropathy, retinopathy or other symptoms
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method