IcoSema for Type 2 Diabetes

Novo Nordisk Investigational Site, Seri Manjung, Malaysia
Type 2 DiabetesIcoSema - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

Video Summary

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

1
Participants with Type 2 Diabetes
2
IcoSema
2
Insulin Icodec

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: From week 50 (V52) to week 52 (V54)

Week 52
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction
Change in HbA1c
Change in body weight
Change in fasting plasma glucose (FPG)
Week 57
Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter)
Number of severe hypoglycaemic episodes (level 3)
Week 52
Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
Week 52
Time in range 3.9 - 10.0 mmol/L (70 - 180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
Time spent less than 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
Time spent more than 10.0 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
Week 52
Insulin

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Participants with Type 2 Diabetes
3
IcoSema
3
Insulin Icodec

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

Insuling glargine/insulin aspart
1 of 2
IcoSema
1 of 2

Active Control

Experimental Treatment

680 Total Participants · 2 Treatment Groups

Primary Treatment: IcoSema · No Placebo Group · Phase 3

IcoSema
Drug
Experimental Group · 1 Intervention: IcoSema · Intervention Types: Drug
Insuling glargine/insulin aspartActiveComparator Group · 2 Interventions: Insulin glargine, insulin aspart · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from week 50 (v52) to week 52 (v54)

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,436 Previous Clinical Trials
2,331,378 Total Patients Enrolled
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
53,579 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Texas22.2%
Tennessee16.7%
Maryland11.1%
Other50.0%
How old are they?
65+37.5%
18 - 6562.5%
What site did they apply to?
Novo Nordisk Investigational Site50.0%
Other50.0%
What portion of applicants met pre-screening criteria?
Met criteria64.3%
Did not meet criteria35.7%
How many prior treatments have patients received?
050.0%
3+50.0%
Why did patients apply to this trial?
  • "Saw an ad on Facebook"
What questions have other patients asked about this trial?
  • "How long does this investigation last?"

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email100.0%
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 48 hours
References

Frequently Asked Questions

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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