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Combination Therapy
IcoSema for Type 2 Diabetes (COMBINE 4 Trial)
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 week 38 to week 40
Awards & highlights
COMBINE 4 Trial Summary
"This trial will compare a new medicine called IcoSema, which is a combination of insulin icodec and semaglutide taken once a week, to insulin glargine taken daily in
Who is the study for?
This trial is for people with type 2 diabetes whose blood sugar isn't well-controlled by oral medications. Participants will be randomly chosen to receive either the new weekly medicine IcoSema or daily insulin glargine. The study excludes specific details on eligibility criteria.Check my eligibility
What is being tested?
The effectiveness of a new once-weekly medication, IcoSema (a mix of insulin icodec and semaglutide), is being compared to the daily use of insulin glargine in controlling blood sugar levels over approximately 11 months.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include those common to diabetes treatments such as low blood sugar, injection site reactions, weight changes, and gastrointestinal issues.
COMBINE 4 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from week 38 to week 40
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 38 to week 40
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 Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction
Change in body weight
Change in fasting plasma glucose (FPG)
+7 moreCOMBINE 4 Trial Design
2Treatment groups
Experimental Treatment
Group I: Insulin glargineExperimental Treatment1 Intervention
Participants will receive once daily insulin glargine subcutaneously with or without oral anti diabetic drugs for 40 weeks.
Group II: IcoSemaExperimental Treatment1 Intervention
Participants will receive once weekly IcoSema subcutaneously with or without oral anti diabetic drugs for 40 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin glargine
2013
Completed Phase 4
~10810
IcoSema
2021
Completed Phase 3
~700
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,414,594 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
106 Previous Clinical Trials
139,352 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In how many medical institutions is this clinical examination currently being conducted?
"Elite Clinical Trials in Blackfoot, Idaho, Diab & Endo Assoc of Stark Co in Canton, Ohio, and Diabetes, Thyroid and Endocrine Centre in Jaipur, Rajasthan are among the 97 active sites open for patient enrollment."
Answered by AI
Are individuals currently able to apply and participate in this ongoing medical trial?
"Per the data on clinicaltrials.gov, recruitment for this trial is currently closed. This study was initially listed on 2/15/2024 and had its latest update on 2/13/2024. Although this specific trial is not accepting new participants presently, it's worth noting that there are approximately 1433 other trials actively enrolling subjects at present."
Answered by AI
Has IcoSema been granted approval by the FDA?
"Our team has rated the safety of IcoSema as 3 on a scale of 1 to 3, aligning with it being in Phase 3 where there is existing evidence supporting its effectiveness and repeated data backing its safety profile."
Answered by AI
Who else is applying?
What site did they apply to?
Desert Oasis Hlthcr Med Group
Endo Res Solutions Inc
Holston Medical Group
Other
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I've been in metformin for about a year and My A1c doesn't improve my BMI is between 35-38 my weight is 230 height 5'5 my cardiologist wants me to loose 50 lbs. I have coronary artery disease so I decided to contact the clinical research trials.
PatientReceived no prior treatments
I am on a weekly medication that mostly controls my blood glucose, but many times it is in a high range without any explanation. I would like to do this trial so that other medications can become available to diabetics that have a greater efficacy,.
PatientReceived 2+ prior treatments
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