A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NLY01 when Administered as a Single Dose in Subjects with Type 2 Diabetes

Phase 1

• Conditions: Type 2 Diabetes mellitus; MedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-000398-21-DE
• Lead Sponsor: euraly, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-12
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified