Type 2 Diabetes mellitus MedDRA version: 21.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: NLY01
Product Code: NLY01
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: NLY01
Current Sponsor code: NLY01
Other descriptive name: PEGylated (Cys40) Exe
Sponsors
Neuraly, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed and dated informed consent obtained before any trial-related activities - Male or female subject with type 2 diabetes mellitus for at least one year - Age between 18 and 65 years, both inclusive - Treated with metformin for at least 3 months either alone or in combination with a second oral antidiabetic agent. - Willing to continue treatment with metformin at the same dose and frequency until Day 30 and (if applicable) to pause any treatment with a second oral antidiabetic agent from at least 7 days before dosing and until Day 35 - Body Mass Index (BMI) 22.0 to 35.0 kg/m^2, inclusive - HbA1c at screening between 7.0% and 9.0% (inclusive) for subjects treated with metformin alone or HbA1c at screening between 6.5% and 8.5% (inclusive) for subjects treated with metformin in combination with a second oral antidiabetic Agent - Considered generally healthy (apart from type 2 diabetes mellitus) upon completion of medical history and screening safety assessments, as judged by the Investigator 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 17 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: - Known or suspected hypersensitivity to the IMP or related products - Known contra-indication to exenatide - Established CV Disease - History of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months - Treated with insulin, GLP-1 receptor agonisits or oral antidiabetic drugs (OADs) other than those specified in the inclusion criterion 4 within 3 months prior to screening - Any prior exposure to an exenatide-based product (Byetta® and Bydureon®) - Men with non-pregnant partner(s) of childbearing potential not willing to use male contraception (condom) in addition to a highly effective contraceptive method until 90 days after dosing - Men with pregnant partner not willing to use male contraception (condom) until 90 days after dosing, in order to avoid exposure of the embryo/fetus to seminal fluid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To investigate the effect of a single subcutaneous injection of NLY01 at different dose-levels on pharmacodynamic (PD) parameters (24-hours insulin, glucagon, glucose profiles) in subjects with type 2 diabetes • To investigate the safety and tolerability of a single subcutaneous injection of NLY01 at different dose-levels in subjects with type 2 diabetes ;Secondary Objective: • To investigate the pharmacokinetic (PK) profile of a single subcutaneous injection of NLY01 at different dose-levels in subjects with type 2 diabetes • To investigate the effect of a single subcutaneous injection of NLY01 at different dose-levels on pharmacodynamic (PD) parameters (gastric emptying, weight, appetite) in subjects with type 2 diabetes • To investigate the PK/PD correlation and concentration/effect of a single subcutaneous injection of NLY01 at different dose-levels in subjects with type 2 diabetes ;Primary end point(s): Safety endpoints: • Adverse events (including nausea, vomiting, diarrhea, hypoglycemia, injection site reactions) PD endpoints: 1. Plasma glucose (PG): change of fasting PG, postprandial(PP) PG, PPPG excursions, and 24-hour PG 2. Serum insulin and plasma glucagon: change in 24-hour serum insulin and plasma glucagon concentrations ;Timepoint(s) of evaluation of this end point: Safety endpoints: Ongoing during the participation of a subject PD endpoints: 1. fasting, postprandial, excursions, after 24 hours 2. initially, after 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Safety Endpoints: Ongoing during the participation of a subject PD endpoints: as detailed in section E.5.2 PK endpoints: as detailed in section E.5.2;Secondary end point(s): Safety Endpoints: • Physical examination • Vital signs • Electrocardiogram • Safety laboratory parameters • NLY01 antibodies PD endpoints: • Body weight: change in body weight • Appetite: change in appetite assessed by electronic visual analog scale (eVAS) • Gastric emptying: paracetamol concentrations: change in maximum concentration of paracetamol (Cmax.par) and corresponding time to reach this level (Tmax.par) • Exploration of the time-course of the PD Response of NLY01, in terms of percentage of decrease in plasma glucose AUC versus Day -1 in comparison to the placebo group. The PD-time course will be compared to NLY01 serum levels time course PK endpoints: • Cmax: maximum NLY01 serum concentration after a single subcutaneous injection • tmax: time to reach maximum serum concentration after a single subcutaneous injection • AUCt: the area under the serum concentration time curve from injection to the last quantifiable point after a single subcutaneous injection • AUC0-35: the area under the serum concentration time curve from 0 to 35 days after a single subcutaneous injection • AUC0-168h: the area under the serum concentration time curve from 0 to 7 days after a single subcutaneous injection • ?z: the apparent elimination rate constant • t1/2:·the apparent elimination half-life • absorption rate constant (ka) | — |
Countries
Germany
Contacts
Public ContactTim Heise / Medical Monitor
Profil Institut für Stoffwechselforschung GmbH
Outcome results
None listed