Type 2 Diabetes
Conditions
Brief summary
This study will look at how well 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 medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.
Interventions
DRUGCagrilintide
Cagrilintide will be administered subcutaneously.
DRUGSemaglutide
Semaglutide will be administered subcutaneously.
DRUGTirzepatide
Tirzepatide will be administered subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 ≥ 180 days before screening. * Stable daily dose(s) ≥ 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without an sodium-glucose co-transporter-2 (SGLT2) inhibitor. * HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening. * Body mass index (BMI) of ≥ 30.0 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.
Exclusion criteria
* 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 \< 30 milliliter 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. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) | From baseline (week 0) to end of treatment (week 68) | Measured in percentage (%)-points. |
| Relative change in body weight | From baseline (week 0) to end of treatment (week 68) | Measured in percentage (%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | From baseline (week 0) to end of treatment (week 68) | Measured in %-points. |
| Change in fasting plasma glucose (FPG) | From baseline (week 0) to end of treatment (week 68) | Measured in millimoles per liter (mmol/L). |
| Achievement of HbA1c target values of less than (<) 7.0% (<53 millimole per mole [mmol/mol]) | At end of treatment (week 68) | Count of participant |
| Achievement of HbA1c target values of less than or equal to (≤) 6.5% (≤ 48 mmol/mol) | From baseline (week 0) to end of treatment (week 68) | Count of participant |
| Achievement of greater than or equal to (≥) 5% weight reduction | From baseline (week 0) to end of treatment (week 68) | Count of participant |
| Achievement of ≥ 10% weight reduction | From baseline (week 0) to end of treatment (week 68) | Count of participant |
| Achievement of ≥ 15 % weight reduction | From baseline (week 0) to end of treatment (week 68) | Count of participant |
| Achievement of ≥ 20 % weight reduction | From baseline (week 0) to end of treatment (week 68) | Count of participant |
| Change in systolic blood pressure | From baseline (week 0) to end of treatment (week 68) | Measured in millimeters of mercury(mmHg). |
| Change in diastolic blood pressure | From baseline (week 0) to end of treatment (week 68) | Measured in mmHg. |
| Change in waist circumference | From baseline (week 0) to end of treatment (week 68) | Measured in centimeter (cm). |
| Ratio to baseline in lipids: Total cholesterol | From baseline (week 0) to end of treatment (week 68) | Measured in ratio. |
| Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol | From baseline (week 0) to end of treatment (week 68) | Measured in ratio. |
| Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol | From baseline (week 0) to end of treatment (week 68) | Measured in ratio. |
| Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol | From baseline (week 0) to end of treatment (week 68) | Measured in ratio. |
| Ratio to baseline in lipids: Triglycerides | From baseline (week 0) to end of treatment (week 68) | Measured in ratio. |
| Ratio to baseline in lipids: non-HDL cholesterol | From baseline (week 0) to end of treatment (week 68) | Measured in ratio. |
| Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | From baseline (week 0) to end of treatment (week 68) | The SF-36 v2 will be used to measure differences in quality of life and mental wellbeing. The scores 0-100 (where higher scores indicated a better quality of life and mental wellbeing) from the SF-36 will be converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 United States general population. Measured as score on a scale. |
| Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) version 3 | From baseline (week 0) to end of treatment (week 68) | IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Composite scores (score range): Physical composite (0-100), Psychosocial composite (0-100), Physical Function composite (0-100). Total score (0-100). Higher scores indicate better level of functioning. |
| Number of Treatment-emergent Adverse Events (TEAEs) | From baseline (week 0) to end of study (week 74) | Count of events |
| Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (<54 milligram per deciliter [mg/dL]), confirmed by blood glucose meter) | From baseline (week 0) to end of study (week 74) | Count of episodes |
| Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold | From baseline (week 0) to end of study (week 74) | Count of episodes |
Countries
Argentina, Australia, Canada, Colombia, India, South Africa, Taiwan, United States
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed