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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
No Placebo-Only Group
Pivotal Trial
Summary
This trial will test a new weekly injection called IcoSema, which combines two drugs, in people with type 2 diabetes. The goal is to see if it controls blood sugar better than the existing drug, semaglutide. Participants will be randomly assigned to receive either IcoSema or semaglutide for several months.
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.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in glycated haemoglobin (HbA1c)
Secondary study objectives
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 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
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Type 2 Diabetes include insulin therapy and GLP-1 receptor agonists. Insulin, such as insulin icodec, helps regulate blood sugar by facilitating glucose uptake into cells, thereby lowering blood glucose levels.
GLP-1 receptor agonists, like semaglutide, increase insulin secretion and decrease glucagon release in response to meals, aiding in blood sugar control. These treatments are essential for Type 2 Diabetes patients as they address insulin resistance and impaired insulin secretion, helping to maintain better glycemic control and reduce the risk of complications.
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,549 Previous Clinical Trials
2,443,352 Total Patients Enrolled
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
57 Previous Clinical Trials
44,659 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
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