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Insulin
Weekly vs Daily Insulin for Type 2 Diabetes
Phase 3
Waitlist Available
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
No Placebo-Only Group
Pivotal Trial
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline (week -4 to 0) to week 22-26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week -4 to 0) to week 22-26
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in glycated hemoglobin (HbA1c)
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
~5430
Insulin glargine
2013
Completed Phase 4
~10810
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,560 Previous Clinical Trials
3,646,103 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
141 Previous Clinical Trials
1,355,509 Total Patients Enrolled