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Insulin

Insulin icodec for Diabetes

Phase 3
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-4 to 0) to week 22-26
Awards & highlights

Study Summary

This trial compares a new insulin called insulin icodec, which is taken once a week, to the already approved insulin glargine, which is taken once a day. The participants in the study

Who is the study for?
This trial is for adults with type 2 diabetes who are currently managing their condition with daily basal insulin. Participants should be interested in potentially switching to a new weekly insulin option.Check my eligibility
What is being tested?
The study compares two types of insulin: Insulin Icodec, which is taken once a week, and Insulin Glargine, which is taken daily. The goal is to see if the new weekly insulin can better control blood sugar levels than the daily one.See study design
What are the potential side effects?
Possible side effects may include low blood sugar (hypoglycemia), allergic reactions at the injection site, weight gain, swelling in arms or legs, and changes in potassium levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week -4 to 0) to week 22-26
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week -4 to 0) to week 22-26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in glycated hemoglobin (HbA1c)
Secondary outcome measures
Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction
Change in body weight
Change in time in range 3.9-10.0 millimoles per litre (mmol/L) (70-180 milligrams per decilitre (mg/dL))
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Insulin icodecExperimental Treatment2 Interventions
Participants will receive Insulin icodec subcutaneously once weekly.
Group II: Insulin glargine U100Active Control2 Interventions
Participants will receive Insulin glargine subcutaneously once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin icodec
2021
Completed Phase 3
~4140
Insulin glargine
2013
Completed Phase 4
~10810

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,515 Previous Clinical Trials
2,414,955 Total Patients Enrolled
646 Trials studying Diabetes
756,738 Patients Enrolled for Diabetes
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
107 Previous Clinical Trials
139,713 Total Patients Enrolled

Frequently Asked Questions

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

At how many different sites is this research study currently being conducted?

"The trial is conducted at Advanced Investigative Medicine, Inc. in Hawthorne, California; Cotton-Oneill Diabetes and Endocrinology Center in Topeka, Kansas; Trial Management Associates in Myrtle Beach, South carolina; along with an additional 68 sites across various locations."

Answered by AI

What are the safety considerations associated with Insulin icodec for individuals?

"Our assessment at Power rates the safety of Insulin icodec as a 3 on our scale, reflecting the robust evidence from both efficacy and safety data gathered throughout this Phase 3 trial."

Answered by AI

Are potential participants still able to enroll in this ongoing trial?

"As per clinicaltrials.gov, the current status of this study is not actively seeking new participants. The trial's initial posting was on April 19th, 2024, with the latest update on March 26th, 2024. Although recruitment for this specific study is paused, it's pertinent to note that there are currently 1391 other trials open for enrollment."

Answered by AI

Who else is applying?

What site did they apply to?
International Diabetes Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

General interest in replacing daily injections with weekly injections.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes
2024. "A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06340854.
All > Anaheim > Greensboro
~269 spots leftby May 2025
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