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: November 26, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetes And Hypertension

Diabetes Prevention

Diabetes Mellitus, Type 2

Treatment

Semaglutide

Placebo

Cagrilintide

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: 274
Treatment Group(s): 3
Primary Treatment: Semaglutide
Phase: 3
Study Start date:
March 26, 2024
Estimated Completion Date:
October 23, 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

  • Chinese People's Liberation Army General Hospital-Endocrinology

    Beijing 1816670, Beijing Municipality 2038349 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

  • Huaihe Hospital of Henan University

    Kaifeng 1804879, Henan 1808520 475000
    China

    Site Not Available

  • Huaihe Hospital of Henan University-Endocrinology

    Kaifeng 1804879, Henan 1808520 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

  • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

    Nanjing 1799962, Jiangsu 1806260 210011
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University_Nanjing

    Nanjing 1799962, Jiangsu 1806260 210011
    China

    Site Not Available

  • The Affiliated Hospital of Jiangsu University-Endocrinology

    Zhenjiang 1784642, Jiangsu 1806260 212001
    China

    Site Not Available

  • Jinan Central Hospital

    Ji'nan, Shandong 1796328 250013
    China

    Site Not Available

  • Jinan Central Hospital Affiliated to Shandong University

    Ji'nan, Shandong 1796328 250013
    China

    Site Not Available

  • Jinan Central Hospital Affiliated to Shandong University

    Jinan 1805753, Shandong 1796328 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

  • Shanghai Pudong New Area People's Hospital-Endocrinology

    Shanghai 1796236, Shanghai Municipality 1796231 201200
    China

    Site Not Available

  • Manda Memorial Hospital

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

    Site Not Available

  • Manda Memorial Hospital_Internal Medicine

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

    Site Not Available

  • Manda Memorial Hospital_Internal Medicine

    Sapporo-shi, Hokkaido 2128295, Hokkaido, Japan 060-0062
    Japan

    Site Not Available

  • Tsuruma Kaneshiro Diabetes Clinic

    Yamato-shi, Kanagawa 1860291 242-0004
    Japan

    Site Not Available

  • Kumanomae Nishimura Internal Medical Clinic

    Arakawa-ku, Tokyo, 116-0012
    Japan

    Site Not Available

  • Kumanomae Nishimura Internal Medical Clinic

    Arakawa-ku, Tokyo 1850147, 116-0012
    Japan

    Site Not Available

  • Kumanomae Nishimura Naika Clinic_Internal Medicine

    Arakawa-ku, Tokyo 1850147, 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

  • Futata Tetsuhiro Clinic Meinohama_Internal medicine

    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

  • Naka Kinen Clinic_Internal medicine

    Ibaraki, 311-0113
    Japan

    Site Not Available

  • Naka Kinen Clinic_Internal medicine

    Ibaraki 1862033, 311-0113
    Japan

    Site Not Available

  • H.E.C Science Clinic

    Kanagawa, 235-0045
    Japan

    Site Not Available

  • H.E.C Science Clinic

    Kanagawa 1860292, 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

  • Fukuwa Clinic_Internal Medicine

    Tokyo, 104-0031
    Japan

    Site Not Available

  • Kato Clinic of Internal Medicine

    Tokyo, 125-0054
    Japan

    Site Not Available

  • Kato Clinic of Internal Medicine_Internal Medicine

    Tokyo, 125-0054
    Japan

    Site Not Available

  • Tokyo-Eki Center-building Clinic

    Tokyo, 103-0027
    Japan

    Site Not Available

  • Tokyo-Eki Center-building Clinic_Internal Medicine

    Tokyo, 103-0027
    Japan

    Site Not Available

  • Fukuwa Clinic_Internal Medicine

    Tokyo 1850147, 104-0031
    Japan

    Site Not Available

  • Kato Clinic of Internal Medicine_Internal Medicine

    Tokyo 1850147, 125-0054
    Japan

    Site Not Available

  • Tokyo-Eki Center-building Clinic

    Tokyo 1850147, 103-0027
    Japan

    Site Not Available

  • Tokyo-Eki Center-building Clinic_Internal Medicine

    Tokyo 1850147, 103-0027
    Japan

    Site Not Available

  • Healthcare centre Zvezdara

    Belgrade, RS 11050
    Serbia

    Site Not Available

  • Healthcare centre Zvezdara

    Belgrade 792680, RS 11050
    Serbia

    Site Not Available

  • Healthcare centre Kragujevac

    Kragujevac, RS 34000
    Serbia

    Site Not Available

  • Healthcare centre Kragujevac

    Kragujevac 789128, 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

  • Healthcare centre Nis

    Niš 787657, RS 18000
    Serbia

    Site Not Available

  • University Clinical Centre Nis

    Niš 787657, RS 18 000
    Serbia

    Site Not Available

  • Policlinic for diabetes

    Zajecar, 19000
    Serbia

    Site Not Available

  • Policlinic for diabetes

    Zaječar 784024, 19000
    Serbia

    Site Not Available

  • MOMED, s.r.o

    Kralovsky Chlmec, 077 01
    Slovakia

    Site Not Available

  • MOMED, s.r.o

    Kráľovský Chlmec 724411, 077 01
    Slovakia

    Site Not Available

  • DIA - KONTROL s.r.o.

    Levice, 93401
    Slovakia

    Site Not Available

  • DIA - KONTROL s.r.o.

    Levice 3059101, 93401
    Slovakia

    Site Not Available

  • SIN AZUCAR s.r.o.

    Malacky, 901 01
    Slovakia

    Site Not Available

  • SIN AZUCAR s.r.o.

    Malacky 3058897, 901 01
    Slovakia

    Site Not Available

  • ENRIN, s.r.o.

    Rimavska Sobota, 979 01
    Slovakia

    Site Not Available

  • ENRIN, s.r.o.

    Rimavská Sobota 723736, 979 01
    Slovakia

    Site Not Available

  • LUDIA, s.r.o.

    Spisska Nova Ves, 05201
    Slovakia

    Site Not Available

  • LUDIA, s. r. o.

    Spišská Nová Ves 723526, 05201
    Slovakia

    Site Not Available

  • LUDIA, s.r.o.

    Spišská Nová Ves 723526, 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

  • Oraderumaz (Pty) Ltd

    Bloemfontein 1018725, Free State 967573 9301
    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

  • Lenasia Clinical Trial Centre

    Lenasia 983199, Gauteng 1085594 1827
    South Africa

    Site Not Available

  • Clinical Trial Systems (CTC)

    Pretoria 964137, Gauteng 1085594 0186
    South Africa

    Site Not Available

  • Prinshof Medical Campus

    Pretoria 964137, Gauteng 1085594 0002
    South Africa

    Site Not Available

  • Ashmed Medi-Centre

    Cape Town, Western Cape 7760
    South Africa

    Site Not Available

  • Ashmed Medi-Centre

    Cape Town 3369157, Western Cape 1085599 7760
    South Africa

    Site Not Available

  • Valley Clinical Trials, Inc.

    Northridge, California 91325
    United States

    Site Not Available

  • Valley Clinical Trials, Inc.

    Northridge 5377985, California 5332921 91325
    United States

    Site Not Available

  • Bioclinical Research Alliance

    Miami, Florida 33155
    United States

    Site Not Available

  • Bioclinical Research Alliance

    Miami 4164138, Florida 4155751 33155
    United States

    Site Not Available

  • Solaris Clinical Research

    Meridian, Idaho 83646
    United States

    Site Not Available

  • Solaris Clinical Research

    Meridian 5600685, Idaho 5596512 83646
    United States

    Site Not Available

  • Iowa Diab & Endo Res Center

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Iowa Diab & Endo Res Center

    West Des Moines 4881346, Iowa 4862182 50266
    United States

    Site Not Available

  • Alliance for Multispec Res

    Newton, Kansas 67114
    United States

    Site Not Available

  • Alliance for Multispec Res

    Newton 4276248, Kansas 4273857 67114
    United States

    Site Not Available

  • Elite Research Center

    Flint, Michigan 48532
    United States

    Site Not Available

  • Elite Research Center

    Flint 4992982, Michigan 5001836 48532
    United States

    Site Not Available

  • Palm Research Center Inc.

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Palm Research Center Inc.

    Las Vegas 5506956, Nevada 5509151 89128
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill 4460162, North Carolina 4482348 27614
    United States

    Site Not Available

  • Clinical Research Associates

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Clinical Research Associates

    Nashville 4644585, Tennessee 4662168 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

  • Velocity Clinical Res-Dallas

    Dallas 4684888, Texas 4736286 75230
    United States

    Site Not Available

  • PlanIt Research, PLLC

    Houston 4699066, Texas 4736286 77079
    United States

    Site Not Available

  • Synergy Groups Medical

    Houston 4699066, Texas 4736286 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

  • Manassas Clinical Research Center

    Manassas 4771401, Virginia 6254928 20110
    United States

    Site Not Available

  • TPMG Clinical Research

    Newport News 4776024, Virginia 6254928 23606
    United States

    Site Not Available

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