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NCT07076199RECRUITINGIRB Ready

A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes

(ONWARDS 11)

Sponsored by Novo Nordisk A/S

Quick Self-Assessment

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Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.

Who Can Participate

Inclusion Criteria

Diagnosed with type 1 diabetes mellitus greater than or equal to (โ‰ฅ) 1 year before screening.
Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) โ‰ฅ 6 months before screening.
HbA1c from 7.0-10.0 percentage (%) (53.0-85.8 millimoles per mole (mmol/mol)), both inclusive, at screening confirmed by central laboratory analysis.
Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator's judgement.

Exclusion Criteria

Known or suspected hypersensitivity to study intervention(s) or related products.
Previous participation in this study. Participation is defined as signed informed consent.
Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
Exposure to an investigational medicinal product within 90 days or 5 half-li

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

877 participants

โšง

Gender

ALL

๐Ÿข

Sponsor

Novo Nordisk A/S

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Cullman

Alabama

Location available
View Cullman location page
RECRUITING

Concord

California

Location available
View Concord location page
RECRUITING

Escondido

California

Location available
View Escondido location page
RECRUITING

Fresno

California

Location available
View Fresno location page
RECRUITING

Fullerton

California

Location available
View Fullerton location page
RECRUITING

La Jolla

California

Location available
View La Jolla location page
RECRUITING

Loma Linda

California

Location available
View Loma Linda location page
NOT_YET_RECRUITING

Loma Linda

California

Location available
View Loma Linda location page
RECRUITING

Los Alamitos

California

Location available
View Los Alamitos location page

๐Ÿ“ And 91 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Type 1 Diabetes Treatment in Cullman?

Join others in Alabama exploring innovative treatment options through clinical research

Type 1 Diabetes Treatment Options in Cullman, Alabama

If you're searching for Type 1 Diabetes treatment in Cullman, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Cullman, Concord, Escondido and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Type 1 Diabetes. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 877 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Type 1 Diabetes?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Type 1 Diabetes

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Type 1 Diabetes Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07076199. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.