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Combination Drug
IcoSema for Type 2 Diabetes (COMBINE 2 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline week 0 (v2) to week 57 (v56)
Awards & highlights
COMBINE 2 Trial Summary
This trial will compare the new medicine IcoSema, a combination of insulin icodec and semaglutide, to semaglutide in people with type 2 diabetes.
Who is the study for?
Adults with type 2 diabetes, BMI ≤40.0 kg/m^2, stable on certain diabetes meds for 90+ days, and HbA1c between 7.0-10.0%. Excludes those with recent severe heart failure or pancreatitis, uncontrolled diabetic eye disease, recent major cardiovascular events, pregnant/breastfeeding women or those planning pregnancy without effective contraception.Check my eligibility
What is being tested?
The trial is testing IcoSema—a new weekly injectable combo of insulin icodec and semaglutide—against the existing diabetes medication semaglutide alone. Participants will be randomly assigned to one of these treatments for about a year and monitored through clinic visits and calls.See study design
What are the potential side effects?
Potential side effects may include typical reactions at injection sites (like pain or swelling), low blood sugar levels (hypoglycemia), nausea, digestive issues due to insulin or GLP-1 receptor agonists in the medications being tested.
COMBINE 2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline week 0 (v2) to week 57 (v56)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline week 0 (v2) to week 57 (v56)
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
Change in fasting plasma glucose (FPG)
Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter)
+2 moreCOMBINE 2 Trial Design
2Treatment groups
Experimental Treatment
Group I: SemaglutideExperimental Treatment1 Intervention
Participants will get once weekly dose
Group II: IcoSemaExperimental Treatment1 Intervention
Participants will get once weekly dose
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
2,414,349 Total Patients Enrolled
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
44,440 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe chronic heart failure.You have been diagnosed with type 2 diabetes for at least 180 days before the screening.Your HbA1c level is between 7.0% and 10.0% as tested by the central laboratory at the time of screening.You have had pancreatitis in the last 180 days before screening.You have been taking a certain type of diabetes medicine called a GLP-1 receptor agonist at the same dose for at least 90 days before the study.You have a serious and uncontrolled eye condition related to diabetes that has been confirmed by an eye exam within the past 90 days.You have not used insulin before, unless it was for a short time (no more than 14 days) or for gestational diabetes.You have had diabetic ketoacidosis within the last 90 days.Your body mass index (BMI) is 40 or lower.You have had a heart attack, stroke, or been hospitalized for chest pain or a mini-stroke within the last 180 days.Your body mass index (BMI) is 40 or lower.You have taken medications for diabetes or obesity not allowed by the study in the last 90 days.You are male or female and at least 18 years old at the time of signing informed consent.You have been taking a specific type of diabetes medication at a stable dose for at least 90 days before the screening.You have been diagnosed with type 2 diabetes for at least 180 days before the screening.Your HbA1c level is between 7.0% and 10.0% when tested by the central laboratory at the screening.You have not used insulin before, unless it was for a short period of time (up to 14 days) before the study, or if you used insulin during pregnancy for gestational diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: IcoSema
- Group 2: Semaglutide
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05259033 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do many hospitals in the United States offer this type of clinical trial to patients?
"There are 53 clinical trial sites currently operational for this study, with locations in Albany, London, Philadelphia and other cities. If you're considering participating in this trial, it might be helpful to choose a location nearest to you to reduce travel time and costs."
Answered by AI
Is IcoSema deadly for human beings?
"IcoSema's safety is estimated to be a 3. This assessment comes from the fact that IcoSema is in Phase 3 of clinical trials. Consequently, there is existing data which supports both its efficacy and safety."
Answered by AI
How many people are allowed to enroll in this trial?
"Yes, according to the information available on clinicaltrials.gov, this trial is ongoing and currently looking for 680 participants at 53 different sites. The trial was first posted on April 11th, 2022 and most recently updated on November 3rd, 2022."
Answered by AI
Are there any vacancies in this clinical trial for new participants?
"That is correct. The most recent update on clinicaltrials.gov reveals that this trial, which was initially posted on April 11th, is still looking for 680 individuals to participate at 53 different sites."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Texas
Arizona
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Novo Nordisk Investigational Site
How many prior treatments have patients received?
2
0
1
Why did patients apply to this trial?
I can't seem to get meds on time. I am struggling to reduce my A1c. Would like some help.
PatientReceived no prior treatments
I am on jardiance but I don't believe it's really controlling my diabetes.
PatientReceived no prior treatments
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