A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Once-daily Basal Insulin With or Without Metformin

Last updated: April 7, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Not Recruiting

Phase

3

Condition

Diabetes And Hypertension

Diabetes Prevention

Diabetes Mellitus, Type 2

Treatment

Cagrilintide

Semaglutide

Placebo

Clinical Study ID

NCT06323161
NN9388-7637
U1111-1283-0754
2022-502679-43
  • Ages > 18
  • All Genders

Study Summary

This study will look at how much CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participant will get either CagriSema or "dummy" medicine and which treatment they get is decided by chance. Participant will take the study medicine together with their current diabetes medicine (once-daily insulin with or without metformin). For each participant, the study will last for about one year.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female (sex at birth).

  • Age 18 years or above at the time of signing the informed consent.

  • Diagnosed with type 2 diabetes mellitus ≥180 days before screening.

  • On stable once-daily dose of basal insulin (minimum of 0.25 units per kilogram perday (U/kg/day) or 20 U/day) alone or in combination with metformin (at effective ormaximum tolerated dose as judged by the investigator) for 90 days prior toscreening.

  • Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole [mmol/mol]) (both inclusive) as determined by central laboratory at screening.

  • Body Mass Index (BMI) greater than or equal to 25 kilogram per square meter (kg/m^2)at screening. BMI will be calculated in the electronic case report form (eCRF) basedon height and body weight at screening.

Exclusion

Exclusion Criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is ofchildbearing potential and not using a highly effective contraceptive method.

  • Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) as determined bycentral laboratory at screening.

  • Treatment with any medication for the indication of diabetes or obesity other thanstated in the inclusion criteria within 90 days before screening.

  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verifiedby an eye examination performed within 90 days before screening or in the periodbetween screening and randomisation. Pharmacological pupil-dilation is a requirementunless using a digital fundus photography camera specified for non-dilatedexamination.

  • Known hypoglycaemia unawareness as indicated by the investigator according toClarke's questionnaire question 8.

  • Recurrent severe hypoglycaemic episodes within the last year as judged by theinvestigator.

Study Design

Total Participants: 270
Treatment Group(s): 3
Primary Treatment: Cagrilintide
Phase: 3
Study Start date:
March 26, 2024
Estimated Completion Date:
October 24, 2025

Connect with a study center

  • Chinese People's Liberation Army General Hospital

    Beijing, Beijing 100853
    China

    Site Not Available

  • Chinese People's Liberation Army General Hospital-Endocrinology

    Beijing, Beijing 100853
    China

    Site Not Available

  • Huaihe Hospital of Henan University

    Kaifeng, Henan 475000
    China

    Site Not Available

  • Huaihe Hospital of Henan University-Endocrinology

    Kaifeng, Henan 475000
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

    Nanjing, Jiangsu 210011
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University_Nanjing

    Nanjing, Jiangsu 210011
    China

    Site Not Available

  • The Affiliated Hospital of Jiangsu University-Endocrinology

    Zhenjiang, Jiangsu 212001
    China

    Site Not Available

  • The Affiliated Hospital of Jiangsu University_Zhenjiang

    Zhenjiang, Jiangsu 212001
    China

    Site Not Available

  • Jinan Central Hospital

    Ji'nan, Shandong 250013
    China

    Site Not Available

  • Shanghai Pudong New Area People's Hospital

    Shanghai, Shanghai 201200
    China

    Site Not Available

  • Shanghai Pudong New Area People's Hospital-Endocrinology

    Shanghai, Shanghai 201200
    China

    Site Not Available

  • Manda Memorial Hospital

    Sapporo-shi, Hokkaido, Hokkaido, Japan 060-0062
    Japan

    Site Not Available

  • Tsuruma Kaneshiro Diabetes Clinic

    Yamato-shi, Kanagawa 242-0004
    Japan

    Site Not Available

  • Kumanomae Nishimura Internal Medical Clinic

    Arakawa-ku, Tokyo, 116-0012
    Japan

    Site Not Available

  • Akaicho Clinic

    Chiba-shi, Chiba, 260-0804
    Japan

    Site Not Available

  • Futata Tetsuhiro Clinic Meinohama

    Fukuoka-shi, Fukuoka, 819-0006
    Japan

    Site Not Available

  • Kunisaki Makoto Clinic

    Fukuoka-shi, Fukuoka, 819-0168
    Japan

    Site Not Available

  • Sasaki Hospital Internal Medicine

    Hokkaido, 062-0007
    Japan

    Active - Recruiting

  • Sasaki Internal Medicine

    Hokkaido, 062-0007
    Japan

    Site Not Available

  • Naka Kinen Clinic

    Ibaraki, 311-0113
    Japan

    Site Not Available

  • H.E.C Science Clinic

    Kanagawa, 235-0045
    Japan

    Site Not Available

  • Kyoto University Hospital

    Kyoto-shi, Kyoto, 606-8507
    Japan

    Site Not Available

  • Minami Akatsuka Clinic

    Mito-shi, Ibaraki, 311-4153
    Japan

    Site Not Available

  • Fukuwa Clinic

    Tokyo, 104-0031
    Japan

    Site Not Available

  • Kato Clinic of Internal Medicine

    Tokyo, 125-0054
    Japan

    Site Not Available

  • Tokyo-Eki Center-building Clinic

    Tokyo, 103-0027
    Japan

    Site Not Available

  • Healthcare centre Zvezdara

    Belgrade, RS 11050
    Serbia

    Site Not Available

  • Healthcare centre Kragujevac

    Kragujevac, RS 34000
    Serbia

    Site Not Available

  • Healthcare centre Nis

    Nis, RS 18000
    Serbia

    Site Not Available

  • University Clinical Centre Nis

    Nis, RS 18 000
    Serbia

    Site Not Available

  • Policlinic for diabetes

    Zajecar, 19000
    Serbia

    Site Not Available

  • MOMED, s.r.o

    Kralovsky Chlmec, 077 01
    Slovakia

    Site Not Available

  • DIA - KONTROL s.r.o.

    Levice, 93401
    Slovakia

    Site Not Available

  • SIN AZUCAR s.r.o.

    Malacky, 901 01
    Slovakia

    Site Not Available

  • ENRIN, s.r.o.

    Rimavska Sobota, 979 01
    Slovakia

    Site Not Available

  • LUDIA, s.r.o.

    Spisska Nova Ves, 05201
    Slovakia

    Site Not Available

  • Oraderumaz (Pty) Ltd

    Bloemfontein, Free State 9301
    South Africa

    Site Not Available

  • Vuyo Clinical Research

    Bloemfontein, Free State 9323
    South Africa

    Site Not Available

  • Lenasia Clinical Trial Centre

    Lenasia, Gauteng 1827
    South Africa

    Site Not Available

  • Clinical Trial Systems (CTC)

    Pretoria, Gauteng 0186
    South Africa

    Site Not Available

  • Prinshof Medical Campus

    Pretoria, Gauteng 0002
    South Africa

    Site Not Available

  • Ashmed Medi-Centre

    Cape Town, Western Cape 7760
    South Africa

    Site Not Available

  • Valley Clinical Trials, Inc.

    Northridge, California 91325
    United States

    Site Not Available

  • Bioclinical Research Alliance

    Miami, Florida 33155
    United States

    Site Not Available

  • Solaris Clinical Research

    Meridian, Idaho 83646
    United States

    Site Not Available

  • Iowa Diab & Endo Res Center

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Alliance for Multispec Res

    Newton, Kansas 67114
    United States

    Site Not Available

  • Elite Research Center

    Flint, Michigan 48532
    United States

    Site Not Available

  • Palm Research Center Inc.

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27517
    United States

    Site Not Available

  • Clinical Research Associates

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Velocity Clinical Res-Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • PlanIt Research, PLLC

    Houston, Texas 77079
    United States

    Site Not Available

  • Synergy Groups Medical

    Houston, Texas 77061
    United States

    Site Not Available

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Site Not Available

  • TPMG Clinical Research

    Newport News, Virginia 23606
    United States

    Site Not Available

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