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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

Study Summary

This trial will compare a new once-weekly combination insulin to daily insulin in people with type 2 diabetes, to see how well it controls blood sugar levels.

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 50 (v52) to week 52 (v54)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 50 (v52) to week 52 (v54) 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 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 more

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
1,503 Previous Clinical Trials
2,385,135 Total Patients Enrolled
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
44,441 Total Patients Enrolled

Media Library

IcoSema (Combination Product) Clinical Trial Eligibility Overview. Trial Name: NCT05013229 — Phase 3
Type 2 Diabetes Research Study Groups: IcoSema, Insuling glargine/insulin aspart
Type 2 Diabetes Clinical Trial 2023: IcoSema Highlights & Side Effects. Trial Name: NCT05013229 — Phase 3
IcoSema (Combination Product) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05013229 — Phase 3
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05013229 — Phase 3

Frequently Asked Questions

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

How many human subjects are included in this experiment?

"Correct, the clinical trial is still recruiting patients. 39 sites across the nation are looking for a total of 680 participants. The study was originally posted on 11/30/2021 and last updated on 11/7/2022 according to clinicaltrials.gov"

Answered by AI

For what conditions is IcoSema regularly prescribed?

"IcoSema can be used to manage hyperglycemia, type 2 diabetes mellitus, and help patients get active through exercise."

Answered by AI

Is IcoSema likely to lead to any adverse health effects?

"IcoSema's safety is estimated to be a 3. This rating comes from the fact that it is a Phase 3 trial, which suggests that not only does some data support efficacy, but multiple rounds of data support safety."

Answered by AI

Are the results of IcoSema backed by other scientific research?

"Currently, there are 29 different clinical trials evaluating the efficacy of IcoSema. Of these active studies, 7 have progressed to Phase 3 testing. The majority of these trials taking place in Baltimore, MD; however, 477 locations across the world are running similar investigations."

Answered by AI

Who else is applying?

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

Why did patients apply to this trial?

Saw an ad on Facebook.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long does this investigation last?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 48 hours
Average response time
  • < 2 Days
~209 spots leftby Mar 2025