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Insulin Icodec for Type 2 Diabetes

Novo Nordisk Investigational Site, Las Vegas, NV
Type 2 DiabetesInsulin Icodec - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test how well a weekly insulin injection and a small sensor inserted under the skin can control blood sugar in people with type 2 diabetes. Participants will have to wear the sensor and inject insulin for 8 months.

Eligible Conditions
  • Type 2 Diabetes

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
1
Treatment Arm
2
IcoSema

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: From initiation week 0 (Visit 3) to week 26 (Visit 26)

Week 26
Change in glycated haemoglobin (HbA1c)

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
2
Treatment Arm
3
IcoSema

Side Effects for

NPH With Corticosteroid
21%Hypoglycemia
This histogram enumerates side effects from a completed 2016 Phase 4 trial (NCT01970241) in the NPH With Corticosteroid ARM group. Side effects include: Hypoglycemia with 21%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1 Treatment Group

Insulin Icodec
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Insulin Icodec · No Placebo Group · Phase 3

Insulin Icodec
Drug
Experimental Group · 1 Intervention: Insulin Icodec · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin Icodec
2021
Completed Phase 3
~580

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from initiation week 0 (visit 3) to week 26 (visit 26)

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,436 Previous Clinical Trials
2,332,008 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
64 Previous Clinical Trials
81,382 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are taking at least half of the maximum approved dose, or an effective/tolerable dose, of antidiabetic medications including sulfonylureas, meglitinides (glinides), DPP-4 inhibitors, SGLT2 inhibitors, thiazolidinediones, alpha-glucosidase inhibitors and combinations of these drugs either orally or via injections.

Who else is applying?

What state do they live in?
Minnesota100.0%
What site did they apply to?
Novo Nordisk Investigational Site100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
How many prior treatments have patients received?
2100.0%
References

Frequently Asked Questions

Has the FDA endorsed Insulin Icodec?

"There is a history of clinical data that supports the safety profile of Insulin Icodec, which has earned it a score of 3." - Anonymous Online Contributor

Unverified Answer

Which areas are offering access to this research protocol?

"Currently, nine different sites are running this trial. Choosing a centre close to you is encouraged as it helps reduce the need for travel; these locations include Sacramento, Minneapolis and Las Vegas in addition to six other cities." - Anonymous Online Contributor

Unverified Answer

Are there still openings in this research study for participants?

"As indicated on clinicaltrials.gov, the posting for this study is no longer accepting patients. It was initially published on April 11th 2023 and most recently edited on April 9th 2023. However, there are numerous other trials that require participants; at current count 1423 studies have open recruitment." - 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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