Trials Sponsors Conditions Drugs Pricing

Conditions

Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

Change in HbA1c

Secondary Outcomes (15)

Change in body weight
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
Weekly insulin dose (total)
Change in DTSQs total treatment satisfaction
Change in HbA1c
+10 more secondary outcomes

Interventions

Ryzodeg 100 units/mL FlexTouch solution for injection in pre-filled penType not reported

IcoSema 700 U/mL + 2 mg/mL PDS290Type not reported

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female
Age 18 years or above at the time of signing the informed consent.
Diagnosed with T2D ≥ 180 days before screening.

Sponsors & Collaborators

Novo Nordisk A/S
Industrylead

Study Sites (9)

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji

Warsaw, 02-507, Poland

Edward Franek+48502652566 edward.franek@pimmswia.gov.pl

Velocity Nova Sp. z o.o.

Staszow, 28-200, Poland

Katarzyna Wawrzyniec-Lis+48533330827 kwawrzyniec@velocityclinical.com

Zdrowie Osteo-Medic S.C. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik

Białystok, 15-351, Poland

Katarzyna Wasilewska

Central Study Contacts

EU Submission Hub

+4544448888 EUSUBHUB@novonordisk.com

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

August 21, 2025

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2025-521150-42-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-11-01 06:30:29 UTC

Documents

K1_PL_NN1535-8377 Recruitment arrangements_Polish_For Publication

A research study to see how weekly IcoSema controls blood sugar levels when compared with daily insulin degludec/insulin aspart (IDegAsp) in people with poorly controlled type 2 diabetes (COMBINE 5)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations