Back to resultsA Study With NLY01 in Subjects With Type 2 Diabetes
Primary Purpose
Type2 Diabetes, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
NLY01
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type2 Diabetes
Eligibility Criteria
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
Sites / Locations
- Profil Institute fur Stoffwechselforschung GmbH
- Profil Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
NLY01 (2.5 mg)
NLY01 (5.0 mg)
NLY01 (10 mg)
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with Treatment Emergent Adverse Events
Number of Incidences of Adverse Events
Plasma glucose
Change of fasting glucose profiles
Change in serum insulin
Change in 24 hour serum insulin
Change in plasma glucagon
Change in 24 hour plasma glucagon concentrations
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04159766
Brief Title
A Study With NLY01 in Subjects With Type 2 Diabetes
Official Title
A Phase 2a Dose-Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NLY01, a PEGylated Exenatide, When Administered as a Single Dose in Subjects With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 16, 2019 (Actual)
Primary Completion Date
December 4, 2020 (Actual)
Study Completion Date
December 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuraly, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NLY01 (2.5 mg)
Arm Type
Active Comparator
Arm Title
NLY01 (5.0 mg)
Arm Type
Active Comparator
Arm Title
NLY01 (10 mg)
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
NLY01
Intervention Description
NLY01, a PEGylated form of the anti-diabetic peptide exenatide
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
normal saline
Primary Outcome Measure Information:
Title
Number of participants with Treatment Emergent Adverse Events
Time Frame
35 days
Title
Number of Incidences of Adverse Events
Time Frame
35 days
Title
Plasma glucose
Description
Change of fasting glucose profiles
Time Frame
24 hours
Title
Change in serum insulin
Description
Change in 24 hour serum insulin
Time Frame
24 hours
Title
Change in plasma glucagon
Description
Change in 24 hour plasma glucagon concentrations
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Lee
Organizational Affiliation
Neuraly, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Profil Institute fur Stoffwechselforschung GmbH
City
Neuss
ZIP/Postal Code
D-41460
Country
Germany
Facility Name
Profil Institute
City
Neuss
ZIP/Postal Code
D-41460
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Study With NLY01 in Subjects With Type 2 Diabetes
We'll reach out to this number within 24 hrs