Diabetes Mellitus, Type 2, Type2 Diabetes
Conditions
Brief summary
This is a Phase 2a study designed to assess the effect of NLY01 in patients with type 2 diabetes. Patients will be monitored for safety, pharmacokinetics, and pharmacodynamic effects on glycemic control.
Interventions
DRUGNLY01
NLY01, a PEGylated form of the anti-diabetic peptide exenatide
DRUGPlacebo
normal saline
Sponsors
Neuraly, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subject with type 2 diabetes for at least one year * Willing to continue treatment with metformin at the same dose and frequency until and (if applicable) to pause any treatment with a second oral antidiabetic * Body Mass Index (BMI) 22.0 to 35.0 kg/m\^2,
Exclusion criteria
* History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. * Any history or presence of clinically relevant comorbidity (with the exception of conditions associated with diabetes mellitus), that may place the subject at increased risk as determined by the investigator * Any prior exposure to an exenatide-based product (BYETTA and BYDUREON) * History of gastroparesis * History of severe hypoglycemia in the past 6 months * If female, pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Treatment Emergent Adverse Events | 35 days | — |
| Number of Incidences of Adverse Events | 35 days | — |
| Plasma glucose | 24 hours | Change of fasting glucose profiles |
| Change in serum insulin | 24 hours | Change in 24 hour serum insulin |
| Change in plasma glucagon | 24 hours | Change in 24 hour plasma glucagon concentrations |
Countries
Germany
Outcome results
None listed