Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Semaglutide (COMBINE 2)

NCT05259033 · View on ClinicalTrials.gov ↗

Study Summary

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to semaglutide taken once a week in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to semaglutide. Participants will either get IcoSema or semaglutide. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe semaglutide in many countries. Participants will get IcoSema or semaglutide, which they must inject once a week with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will have 18 clinic visits, 34 phone/video calls with the study doctor, and 4 contacts with the site that can either be clinic visits or phone/video calls. At 11 clinic visits participants will have blood samples taken. At 7 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

Conditions Studied

Interventions

  • DRUG IcoSema
  • DRUG Semaglutide 1 mg

Study Locations (20)

Florida

  • Northeast Research Institute — Fleming Island
  • Northeast Res Inst. Inc. — Jacksonville
  • Est Cst Inst for Rsrch,Jksnvil — Jacksonville
  • South Broward Research LLC — Miramar
  • Adult Medicine of Lake County, Inc. — Mt. Dora
  • Florida Inst For Clin Res — Orlando
  • Florida Institute For Clinical Research — Orlando
  • Oviedo Medical Research, LLC — Oviedo
  • Metabolic Research Institute Inc — West Palm Beach

California

  • John Muir Physicians Network — Concord
  • Velocity Clin Res Los Angeles — Los Angeles
  • Velocity Clin Res Wstlke — Los Angeles
  • Valley Clinical Trials, Inc. — Northridge
  • Premier Medical Center, Inc. — Toluca Lake

Arizona

  • Pri Med Grp dba/Gil Ctr Fam — Gilbert
  • Clinical Research Institute of Arizona — Sun City West

Alabama

  • Univ of AL at Birmingham_BRM — Birmingham

Georgia

  • Javara/Privia Med Grp GA,LLC — Albany

Hawaii

  • East West Med Res Inst — Honolulu

Idaho

  • Saltzer Medical Group Research — Nampa

Trial Details

FieldValue
Enrollment Target 683 participants
Start Date 2022-04-11
Est. Completion 2024-01-16
Phase Phase 3

Sponsor

Novo Nordisk A/S

189 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05259033

The ClinicalTrials.gov registry entry for NCT05259033 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 683 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 189 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions — of which IcoSema is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05259033 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05259033 about?

NCT05259033 is a clinical study titled "A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Semaglutide (COMBINE 2)". This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to semaglutide taken once a week in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared ...

What is the current status of trial NCT05259033?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 683 participants. The study started on 2022-04-11. Estimated completion is 2024-01-16.

What conditions does trial NCT05259033 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 2. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05259033?

The interventions under investigation include: IcoSema (DRUG), Semaglutide 1 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05259033?

This trial is sponsored by Novo Nordisk A/S, which has 189 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05259033 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial