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Insulin

Weekly vs Daily Insulin for Type 2 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
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 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

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 more

Awards & 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
~4140
Insulin glargine
2013
Completed Phase 4
~10810

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,552 Previous Clinical Trials
2,444,656 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
133 Previous Clinical Trials
152,925 Total Patients Enrolled
~168 spots leftby May 2025
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