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

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 - DM-199 SAD, MAD and POC study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40545

Enrollment

Registered

2013-04-08

Start date

2013-04-15

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type2 Diabetes Mellitus: bloodglucose.

Interventions

Part A: Group 1: Period 1: a single sc dose of 0.015 mg/kg DM-199 (n=6) or matching placebo (n=3) Period 2: a single sc dose of 0.15 mg/kg DM-199 (n=6) or matching placebo (n=3) Period 3: a single

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)