A DOUBLE-BLINDED, PLACEBO-CONTROLLED, SINGLE DOSE AND MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND PROOF OF CONCEPT OF DM-199 IN HEALTHY SUBJECTS AND PATIENTS WITH TYPE 2 DIABETES MELLITUS

Completed

Conditions: Type2 Diabetes Mellitus: bloodglucose.
10018424

Registration Number: NL-OMON40545

Lead Sponsor: DiaMedica Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 96

Inclusion Criteria

Age: Healthy subjects (Parts A and C): 18 - 65 years, inclusive
: Type 2 diabetes mellitus patients (Parts B and D): 18 - 75 years, inclusive ;Body Mass Index (BMI): Healthy subjects (Parts A and C): 18.0 - 30.0 kg/m2
: Type 2 diabetes mellitus patients (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.;Gender : Healthy males or females; for Part D females must be of non-childbearing potential (either surgically sterilized or at least 1 year post-menopausal)

Exclusion Criteria

Suffering from : hepatitis B. cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of the study. In case of donating blood or significant loss of blood within 60 days of the start of drug dosing.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety:<br /><br>Parts A, B, C and D: adverse events, vital signs (including supine and standing<br /><br>systolic and diastolic blood pressure, pulse, body temperature, respiratory<br /><br>rate), 12-lead ECG, clinical laboratory (including clinical chemistry,<br /><br>hematology, coagulation and urinalysis) tests, local tolerability at injection<br /><br>site and physical examination<br /><br>Part A: fasting and non-fasting serum glucose<br /><br>Parts B, C and D: fasting glucose using the glucometer (or determined by the<br /><br>clinical laboratory for Part D patients only when they are in the clinic)<br /><br>Parts C and D: anti-drug antibodies (ADA)<br /><br><br /><br>Pharmacokinetics: Parts A, B, C and D: plasma concentrations of DM-199 and PK<br /><br>parameters</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pharmacodynamics:<br /><br>Parts B and C: glucose (fasting and non-fasting), insulin, C-peptide, glucagon<br /><br>and GLP-1 (active and total); in Part B these will be measured as a response to<br /><br>a meal tolerance test (MTT)<br /><br>Parts C and D: analysis of immune cell populations (lymphocytes, B lymphocytes,<br /><br>T (helper/cytotoxic) lymphocytes, monocytes and natural killer cells)<br /><br>Part D: adiponectin, aldosterone, renin and lipid (total cholesterol, high<br /><br>density lipoprotein [HDL], low density lipoprotein [LDL], free fatty acids,<br /><br>triglycerides) concentrations<br /><br><br /><br>Proof of concept: Part D: glucose (fasting and non-fasting), insulin,<br /><br>C-peptide, glucagon and GLP-1 (active and total) as a response to an MTT,<br /><br>fasting glucose using the glucometer (or determined by the clinical laboratory<br /><br>for Part D patients only when they are in the clinic), fasting insulin,,<br /><br>fructosamine and HbA1c</p><br>