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Combination Product
IcoSema for Type 2 Diabetes
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 week 50 (v52) to week 52 (v54)
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. It aims to see if IcoSema can control blood sugar better than the current daily treatments. Participants will receive either IcoSema or the standard daily injections. The study will take place over several months, and participants will wear a sensor to monitor their blood sugar levels.
Eligible Conditions
- Type 2 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from week 50 (v52) to week 52 (v54)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 50 (v52) to week 52 (v54)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in HbA1c
Secondary study objectives
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction
Change in body weight
Change in fasting plasma glucose (FPG)
+7 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
Active Control
Group I: IcoSemaExperimental Treatment1 Intervention
Participants will receive once weekly subcutaneous (s.c) injections of IcoSema during the 52-week treatment period.
Group II: Insuling glargine/insulin aspartActive Control2 Interventions
Participants will receive subcutaneous (s.c) injections of insulin glargine once daily combined with 2-4 times daily injections of insulin aspart.
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
1,551 Previous Clinical Trials
2,444,227 Total Patients Enrolled
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
57 Previous Clinical Trials
44,686 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe chronic heart failure that is classified as Class IV by doctors.You have experienced frequent and severe low blood sugar episodes in the past year.You have had pancreatitis (an inflammation of the pancreas) within the past 180 days before the screening.
Research Study Groups:
This trial has the following groups:- Group 1: IcoSema
- Group 2: Insuling glargine/insulin aspart
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: NCT05013229 — Phase 3
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