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

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT06323161

Run by

Novo Nordisk A/S

People needed

274

Starts

2024-03-26

Expected to finish

2025-10-23

Last updated by the study team

2025-11-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 per day (U/kg/day) or 20 U/day) alone or in combination with metformin (at effective or maximum tolerated dose as judged by the investigator) for 90 days prior to screening.
• 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) based on height and body weight at screening.

You may not qualify if…

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
• Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening.
• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
• Known hypoglycaemia unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
• Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.

Where it is running

• Bioclinical Research Alliance — Miami, Florida, United States
• Solaris Clinical Research — Meridian, Idaho, United States
• Iowa Diab & Endo Res Center — West Des Moines, Iowa, United States
• Alliance for Multispec Res — Newton, Kansas, United States
• Elite Research Center — Flint, Michigan, United States
• Palm Research Center Inc. — Las Vegas, Nevada, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Clinical Research Associates — Nashville, Tennessee, United States
• Velocity Clinical Res-Dallas — Dallas, Texas, United States
• Synergy Groups Medical — Houston, Texas, United States
• PlanIt Research, PLLC — Houston, Texas, United States
• Manassas Clinical Research Center — Manassas, Virginia, United States
• TPMG Clinical Research — Newport News, Virginia, United States
• Chinese People's Liberation Army General Hospital-Endocrinology — Beijing, Beijing Municipality, China
• Huaihe Hospital of Henan University-Endocrinology — Kaifeng, Henan, China
• Huaihe Hospital of Henan University — Kaifeng, Henan, China
• The Second Affiliated Hospital of Nanjing Medical University-Endocrinology — Nanjing, Jiangsu, China
• The Second Affiliated Hospital of Nanjing Medical University_Nanjing — Nanjing, Jiangsu, China
• The Affiliated Hospital of Jiangsu University-Endocrinology — Zhenjiang, Jiangsu, China
• Jinan Central Hospital — Ji'nan, Shandong, China
• Jinan Central Hospital Affiliated to Shandong University — Jinan, Shandong, China
• Shanghai Pudong New Area People's Hospital-Endocrinology — Shanghai, Shanghai Municipality, China
• Manda Memorial Hospital_Internal Medicine — Sapporo-shi, Hokkaido, Hokkaido, Japan, Japan
• Tsuruma Kaneshiro Diabetes Clinic — Yamato-shi, Kanagawa, Japan
• Valley Clinical Trials, Inc. — Northridge, California, United States

Full record on ClinicalTrials.gov

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