Type 2 Diabetes
Conditions
Brief 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.
Interventions
DRUGCagrilintide
Participants will receive once-weekly cagrilintide subcutaneously.
DRUGSemaglutide
Participants will receive once-weekly semaglutide subcutaneously.
DRUGPlacebo
Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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 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.
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 (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycated Haemoglobin (HbA1c) | From baseline (week 0) to end of treatment (week 40) | Measured in percentage (%)- points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieve ≥5% Body Weight Reduction | From baseline (week 0) to end of treatment (week 40) | Measured as count of participants. |
| Number of Participants Who Achieve ≥20% Body Weight Reduction | From baseline (week 0) to end of treatment (week 40) | Measured as count of participants. |
| Change in Waist Circumference | From baseline (week 0) to end of treatment (week 40) | Measured in centimeter (cm). |
| Change in Systolic Blood Pressure (SBP) | From baseline (week 0) to end of treatment (week 40) | Measured in millimeter of mercury (mmHg). |
| Change in Diastolic Blood Pressure (DBP) | From baseline (week 0) to end of treatment (week 40) | Measured in mmHg. |
| Ratio to Baseline in High Sensitivity C-reactive Protein (hsCRP) | From baseline (week 0) to end of treatment (week 40) | Measured in ratio. |
| Ratio to Baseline in Lipids: Non-high Density Lipoprotein (Non-HDL) Cholesterol | From baseline (week 0) to end of treatment (week 40) | Measured in ratio. |
| Ratio to Baseline in Lipids: Triglycerides | From baseline (week 0) to end of treatment (week 40) | Measured in ratio. |
| Ratio to Baseline in Lipids: Low-Density Lipoprotein (LDL) Cholesterol | From baseline (week 0) to end of treatment (week 40) | Measured in ratio. |
| Ratio to Baseline in Lipids: Very Low-Density Lipoprotein (VLDL) cholesterol | From baseline (week 0) to end of treatment (week 40) | Measured in ratio. |
| Ratio to Baseline in Lipids: HDL Cholesterol | From baseline (week 0) to end of treatment (week 40) | Measured in ratio. |
| Ratio to Baseline in Lipids: Total Cholesterol | From baseline (week 0) to end of treatment (week 40) | Measured in ratio. |
| Ratio to Baseline in Lipids: Free Fatty Acids | From baseline (week 0) to end of treatment (week 40) | Measured in ratio. |
| Relative Change in Body Weight | From baseline (week 0) to end of treatment (week 40) | Measured in percentage (%). |
| Number of Participants Who Achieve Greater than or Equal to (≥) 10% Body Weight Reduction | From baseline (week 0) to end of treatment (week 40) | Measured as count of participants. |
| Number of Participants Who Achieve ≥15% Body Weight Reduction | From baseline (week 0) to end of treatment (week 40) | Measured as count of participants. |
| Number of Participants Who Achieve HbA1c Target Values of Less than (<) 7.0% (<53 millimole per mole [mmol/mol]) | At end of treatment (week 40) | Measured as count of participants. |
| Number of Participants Who Achieve HbA1c Target Values of Less than or Equal to (≤) 6.5% (≤48 mmol/mol) | At end of treatment (week 40) | Measured as count of participants. |
| Change in Fasting Plasma Glucose (FPG) | From baseline (week 0) to end of treatment (week 40) | Measured as millimole per liter (mmol/L). |
| Change in Insulin Dose | From baseline (week 0) to end of treatment (week 40) | Measured in units (u). |
| Number of Participants Who Achieve Insulin Dose Equal to (=) 0 Units | At end of treatment (week 40) | Measured as count of participants. |
| Change in Short Form-36 Version 2.0 Health Survey (SF-36v2): Vitality score | From baseline (week 0) to end of treatment (week 40) | Measured as score points. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The vitality score range is from 25.6 to 69.1. |
| Change in SF-36v2: Physical Component Summary Score | From baseline (week 0) to end of treatment (week 40) | Measured as score points. SF-36v2 Acute measures HRQoL. The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The score range for physical component summary is 6.1 to 79.7. |
| Change in SF-36v2: Mental Component Summary Core | From baseline (week 0) to end of treatment (week 40) | Measured as score points. SF-36v2 Acute measures HRQoL. The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The score range for mental component summary score is -3.8 to 78.7. |
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score | From baseline (week 0) to end of treatment (week 40) | Measured as score points. DTSQs measures treatment satisfaction and diabetes-specific quality of life. The measure consists of 8 items yielding 1 global score and 2 single item scores. Higher scores on the global score indicate greater satisfaction with treatment. Lower scores on the single-item scores indicate BG levels closer to the ideal, while higher scores indicate problems. Single-item scores (score range): Perceived frequency of hyperglycaemia (0-6), Perceived frequency of hypoglycaemia (0-6). Global score (score range): Total Treatment Satisfaction (0-36). |
| Ratio to Baseline in Leptin | From baseline (week 0) to end of treatment (week 40) | Measured in ratio. |
| Ratio to Baseline in Soluble Leptin Receptor | From baseline (week 0) to end of treatment (week 40) | Measured in ratio. |
| Number of Treatment Emergent Adverse Events (TEAEs) | From baseline (week 0) to end of treatment +7 weeks (week 47) | Measured as count of events. |
| Number of Clinically Significant Hypoglycaemic Episodes (level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose Meter) | From baseline (week 0) to end of treatment +7 weeks (week 47) | Measured as count of episodes. |
| Change in 7-point Self-measured Plasma Glucose (SMPG) Profiles: Mean 7-point profile and Mean postprandial increment (over all meals) | From baseline (week 0) to end of treatment (week 40) | Measured in mmol/L. |
| Number of Clinically Significant Hypoglycaemic Episodes (level 3) | From baseline (week 0) to end of treatment +7 weeks (week 47) | Measured as count of episodes. Hypoglycaemic episodes (level 3) is hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold. |
Countries
China, Japan, Serbia, Slovakia, South Africa, United States
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed