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Combination Product

IcoSema for Type 2 Diabetes (COMBINE 1 Trial)

Verified Trial
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
Are you 18 years or older?
Is your HbA1c between 7% and 10%?
Timeline
Screening 3 days
Treatment Varies
Follow Up 3 days
Awards & highlights

COMBINE 1 Trial Summary

This trial will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin icodec taken once a week in people with type 2 diabetes, in terms of blood sugar control.

Who is the study for?
This trial is for adults with type 2 diabetes who have been managing their condition for at least 6 months and have an HbA1c level between 7% and 10%. They should be using insulin once or twice daily. Pregnant or breastfeeding women, or those planning to become pregnant during the study, cannot participate.Check my eligibility
What is being tested?
The trial is testing IcoSema—a new weekly medication combining insulin icodec and semaglutide—against weekly insulin icodec alone. The goal is to see which one controls blood sugar better in people with type 2 diabetes over approximately a year of treatment involving injections with a pen device.See study design
What are the potential side effects?
Potential side effects may include typical reactions to insulin such as low blood sugar levels, injection site reactions, weight gain, tiredness, allergic reactions including skin rash or itching. Semaglutide can cause nausea, vomiting, diarrhea, abdominal pain and loss of appetite.

COMBINE 1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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Your average blood sugar level, as measured by HbA1c, should be between 7% and 10%.
Select...
I have had type 2 diabetes for at least 6 months.
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I use insulin once or twice daily.

COMBINE 1 Trial Timeline

Screening ~ 3 days
Treatment ~ Varies
Follow Up ~3 days
This trial's timeline: 3 days for screening, Varies for treatment, and 3 days 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 haemoglobin (HbA1c)
Secondary outcome measures
Change in body weight
Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)

COMBINE 1 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IcoSemaExperimental Treatment1 Intervention
Group II: Insulin icodecActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IcoSema
2021
Completed Phase 3
~700

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,513 Previous Clinical Trials
2,413,739 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
105 Previous Clinical Trials
138,499 Total Patients Enrolled

Media Library

IcoSema (Combination Product) Clinical Trial Eligibility Overview. Trial Name: NCT05352815 — Phase 3
Type 2 Diabetes Research Study Groups: Insulin icodec, IcoSema
Type 2 Diabetes Clinical Trial 2023: IcoSema Highlights & Side Effects. Trial Name: NCT05352815 — Phase 3
IcoSema (Combination Product) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05352815 — Phase 3
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05352815 — Phase 3

Frequently Asked Questions

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

Are clinical sites for this trial limited to the United States?

"63 different medical centres are participating in this trial, making it widely accessible to patients. Skokie, Boston and Fleming Island are a few of the places where patients can be enrolled, with other locations spread throughout the nation.Choosing a site that is close to your location can cut down on travel time and expenses."

Answered by AI

Could you please highlight the risks associated with IcoSema?

"There is enough evidence from past trials to support the safety of IcoSema, so it received a score of 3."

Answered by AI

Could you please share the total amount of people who have signed up for this clinical trial?

"That is correct, the online information on clinicaltrials.gov affirms that this study is still looking for participants. The trial was established on June 1st, 2022 and was last updated on November 4th, 2022. 1290 individuals are needed for the 63 different locations."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
Colorado
Other
Texas
Arizona
What site did they apply to?
Novo Nordisk Investigational Site
Other
How many prior treatments have patients received?
1
3+
2
0

What questions have other patients asked about this trial?

What is involved ? What do I have to do? How much time is required? How long will this trial last?
PatientReceived no prior treatments
Do you have an Arizona location?
PatientReceived no prior treatments

Why did patients apply to this trial?

I only use metformin. I saw an ad on Facebook. Help with Type 2 diabetes. Nothing I have tried is working.
PatientReceived 2+ prior treatments
It is real hard to keep my A1C low.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Phone Call
Average response time
  • < 2 Days
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 24 hours
  2. Elligo Novo Nordisk Investigational Site: < 24 hours
Recent research and studies
clinicaltrials.govStudy
A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec
2022. "A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05352815.
All > Diabetes Type 2
~455 spots leftby Apr 2025
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