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Plasmid
NNC0361-0041 for Type 1 Diabetes (TOPPLE T1D Trial)
Phase 1
Waitlist Available
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-45 years (both inclusive) at the time of signing informed consent
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
TOPPLE T1D Trial Summary
This trial is testing a new drug to see if it is safe and tolerated by people with Type 1 Diabetes. The trial is designed so that patients don't know if they are receiving the drug or a placebo, and the doses are given incrementally to test safety.
Who is the study for?
This trial is for adults aged 18-45 with Type 1 Diabetes diagnosed within the last 4 years. Participants must have certain levels of C-peptide, at least one diabetes-related autoantibody, and be up to date on immunizations including COVID-19 vaccines. Women should not be pregnant and agree to use contraception; men also need to use birth control.Check my eligibility
What is being tested?
The study tests a new drug called NNC0361-0041 given as weekly shots against a placebo in people with Type 1 Diabetes. It's randomized (people are put into groups by chance), double-blinded (neither participants nor researchers know who gets the real treatment), and doses increase over time.See study design
What are the potential side effects?
Specific side effects aren't listed, but the trial will monitor how safe and tolerable NNC0361-0041 is when taken in increasing doses compared to a placebo. This includes any adverse reactions or discomforts experienced.
TOPPLE T1D Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 45 years old.
TOPPLE T1D Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events
Secondary outcome measures
Change in the area under the plasma C-peptide concentration-time curve
TOPPLE T1D Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NNC0361-0041Experimental Treatment1 Intervention
Dosage form: 9 mg/ml Solution for injection Route of administration: Subcutaneous Initial dose/Unit dose strength(s)/Dosage level(s) in cohort 1: 1mg Additional doses in cohorts 2, 3, and 4: 5mg, 12.5mg and 25mg Dosing instructions: Once weekly on site
Group II: PlaceboPlacebo Group1 Intervention
Dosage form: Solution for injection Route of administration: Subcutaneous Dosing instructions: Once weekly on site
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,357 Previous Clinical Trials
4,315,138 Total Patients Enrolled
Novo Nordisk A/SIndustry Sponsor
1,513 Previous Clinical Trials
2,414,981 Total Patients Enrolled
Carla Greenbaum, MDStudy DirectorType 1 Diabetes TrialNet
10 Previous Clinical Trials
557 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer before.I am up to date on all my recommended vaccinations.I am between 18 and 45 years old.I am fully vaccinated against COVID-19, including all eligible boosters, at least two weeks before the study starts.I haven't had a live virus vaccine in the last 6 weeks or a killed vaccine in the last 4 weeks.It has been over 6 weeks since my last live vaccine.I have a long-term infection that is not just on my skin.I was diagnosed with Type 1 Diabetes less than 4 years ago.My BMI is 40 or higher.Your HbA1c level is less than 8.5% at the screening.I am not pregnant and will use effective birth control during the study.I have untreated hypothyroidism or active Graves' disease.I have received the flu shot at least 2 weeks before joining the study.You must have specific antibodies related to diabetes present in your body.My C-peptide levels are above 0.2 pmol/ml after a special diabetes test.You have HIV or Hepatitis B infection now or in the past.I use immunosuppressive drugs, but only apply them to my skin, nose, or eyes.It has been over 4 weeks since I received a vaccine (other than flu).I have not had symptoms of CMV or EBV lasting more than a week recently.I am willing to delay any live vaccines during and for 3 months after treatment.I am currently diagnosed with COVID-19.Your lab test results don't meet the requirements.You have had a serious reaction to a vaccine in the past.I have had tuberculosis in the past or currently, confirmed by a test or medical history.You have a current Hepatitis C infection.I currently have symptoms of an infection.I have taken diabetes medication that is not insulin in the last week.I am a man who will use birth control during and for 3 months after treatment.Your blood pressure while lying down is not between 90-139 for the top number or 50-89 for the bottom number. If you are nervous, they can check it again once.
Research Study Groups:
This trial has the following groups:- Group 1: NNC0361-0041
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Type 1 Diabetes Patient Testimony for trial: Trial Name: NCT04279613 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To whom is this research opportunity accessible?
"To qualify for this medical trial, applicants must be within the age range of 18 and 45 years old, as well as possess type 1 diabetes mellitus. A total of 48 participants will be accepted into the study."
Answered by AI
How many participants are there in this clinical experiment?
"The sponsor, Novo Nordisk A/S, has identified a need for 48 patients who meet the eligibility criteria to conduct this study. Recruitment efforts are taking place at medical centres such as University of Texas Southwestern Medical Center in Dallas and Vanderbilt Eskind Diabetes Centre in Nashville."
Answered by AI
Is this clinical trial open to people under the age of forty?
"This clinical study is exclusively for participants aged 18 to 45. Those under the age of consent have 156 other trials available, and those over 65 have 177 options."
Answered by AI
What has been revealed about the safety profile of NNC0361-0041?
"Due to there being limited evidence of safety and efficacy, our team has assigned NNC0361-0041 a score of 1 on the risk scale."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
California
Other
New York
How old are they?
18 - 65
What site did they apply to?
Barbara Davis Center at University of Colorado Anschutz Medical Campus
Emory Children's Center
Stanford University
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I want to help out and possibly be cured. I am interested on helping finds solutions for other Type 1 Diabetics.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
What is the drug and what is it supposed to do?
PatientReceived no prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Most responsive sites:
- Emory Children's Center: < 48 hours
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