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Anti-diabetic agent

Dosing scheme A (NNC0519-0130) for Type 2 Diabetes

Phase 2
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week -2 to week 0) to week 22-24 and week 34-36, respectively
Awards & highlights

Study Summary

This trial will test a new medicine called NNC0519-0130 to see how well it can help people with type 2 diabetes lower their blood sugar and body weight. Participants will receive

Who is the study for?
This trial is for individuals with type 2 diabetes interested in testing a new medication, NNC0519-0130, which may help lower blood sugar and body weight. Participants will be randomly assigned to receive one of up to seven different doses or a placebo through weekly injections for about 40 weeks.Check my eligibility
What is being tested?
The study is testing the effectiveness of various doses of a new drug called NNC0519-0130 compared to a placebo in lowering blood sugar levels in people with type 2 diabetes. The medicine is administered via subcutaneous injections.See study design
What are the potential side effects?
Potential side effects are not specified here but generally could include reactions at the injection site, low blood sugar (hypoglycemia), nausea, fatigue, and possible allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week -2 to week 0) to week 22-24 and week 34-36, respectively
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week -2 to week 0) to week 22-24 and week 34-36, respectively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in Glycated haemoglobin (HbA1c)
Change in body weight
Change in fasting plasma glucose (FPG)
+10 more

Trial Design

11Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Dosing scheme E (NNC0519-0130)Experimental Treatment1 Intervention
Participants will receive NNC0519-0130 at 7 dose levels once weekly as s.c. injection in dose escalating manner.
Group II: Dosing scheme D (NNC0519-0130)Experimental Treatment1 Intervention
Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.
Group III: Dosing scheme C (NNC0519-0130)Experimental Treatment1 Intervention
Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.
Group IV: Dosing scheme B (NNC0519-0130)Experimental Treatment1 Intervention
Participants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as s.c. injection in dose escalating manner.
Group V: Dosing scheme A (NNC0519-0130)Experimental Treatment1 Intervention
Participants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as subcutaneous (s.c.) injection in dose escalating manner.
Group VI: Dosing scheme F (tirzepatide)Active Control1 Intervention
Participants will receive tirzepatide at 6 dose levels once weekly as s.c. injection in dose escalating manner.
Group VII: Dosing scheme A (Placebo)Placebo Group1 Intervention
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Group VIII: Dosing scheme B (Placebo)Placebo Group1 Intervention
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Group IX: Dosing scheme C (Placebo)Placebo Group1 Intervention
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Group X: Dosing scheme D (Placebo)Placebo Group1 Intervention
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Group XI: Dosing scheme E (Placebo)Placebo Group1 Intervention
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NNC0519-0130
2023
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,515 Previous Clinical Trials
2,415,071 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
107 Previous Clinical Trials
139,829 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently seeking participants for this study?

"As per the details on clinicaltrials.gov, recruitment for this particular research endeavor has ceased. The study was originally listed on March 18th, 2024 and its most recent update was made on March 16th, 2024. While this specific study is no longer enrolling participants, there are currently 1406 alternative studies open to accepting new patients at present."

Answered by AI

Are individuals who are older than 65 eligible to participate in this research study?

"Individuals aged between 18 and 75 years are qualified to enroll in this investigation. It is noteworthy that there exist a total of 191 studies dedicated to minors under the age of 18, as well as an additional 1093 trials focusing on patients over the age of 65."

Answered by AI

What safety profile does Dosing scheme D (NNC0519-0130) exhibit in individuals?

"Based on our evaluation at Power, the safety rating for Dosing regimen D (NNC0519-0130) is a 2. This assessment reflects that while there is existing data supporting its safety profile, evidence of efficacy remains lacking given the Phase 2 nature of the trial."

Answered by AI

In how many diverse venues is this experimental examination currently being conducted?

"At the moment, this research is ongoing at a total of 79 sites. These locations include Box Hill, Seoul, and Chiba among numerous others. Opting for the closest site to your residence can help reduce travel burdens once you are enrolled in the study."

Answered by AI

Who else is applying?

What site did they apply to?
International Research Associates, LLC_Miami
Centricity Research
Catalina Research Institute, LLC
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

SEEKING RX WITH MINIMAL TO NO SIDE AFFECTS. To research any additional medical treatment for the reversal if any of diabetes, and to make extra money.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes
2024. "A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06326047.
All > Pflugerville Tx > Greensboro
~192 spots leftby Nov 2024
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