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 Diet and Exercise

Novo Nordisk A/S189 enrolled

Overview

This study will look at how much CagriSema helps participants 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. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

189

Conditions

Type 2 Diabetes

Interventions

CagrilintideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female * Age 18 years or above at the time of signing the informed consent * Diagnosed with type 2 diabetes \>=30 days before screening * HbA1c 7.0-9.5 percent (53-80 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening * Body mass index (BMI) \>=23 kilograms 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 less than 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 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 * History of use of any injectable therapy for diabetes or obesity. 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 a fundus 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

Locations (50)

Nat Res Inst Huntington Park

Huntington Park, California, United States

Valley Clinical Trials, Inc.

Northridge, California, United States

Southern California Dermatology

Santa Ana, California, United States

Encore Medical Research LLC

Hollywood, Florida, United States

Headlands Research Orlando

Orlando, Florida, United States

Outcomes

Primary Outcomes

Change in glycated haemoglobin (HbA1c)

Measured as percentage (%)-points.

Time frame: From baseline (week 0) to end of treatment (week 40)

Secondary Outcomes

Relative change in body weight

Measured in %.

Time frame: From baseline (week 0) to end of treatment (week 40)

Number of participants who achieve greater than or equal to (>=) 10% body weight reduction

Measured as count of participants.

Time frame: From baseline (week 0) to end of treatment (week 40)

Number of participants who achieve >=15% body weight reduction

Measured as count of participants.

Time frame: From baseline (week 0) to end of treatment (week 40)

Number of participants who achieve HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol])

Measured as count of participants.

Time frame: At end of treatment (week 40)

Number of participants who achieve HbA1c target values of less than or equal to (<=) 6.5% (<= 48 mmol/mol)

Measured as count of participants.

Time frame: At end of treatment (week 40)

Change in Fasting Plasma Glucose (FPG)

Measured in millimoles per liter (mmol/L).

Time frame: From baseline (week 0) to end of treatment (week 40)

Number of participants who achieve >=5% body weight reduction

Measured as count of participants.

Time frame: From baseline (week 0) to end of treatment (week 40)

Number of participants who achieve >=20% body weight reduction

Measured as count of participants.

Time frame: From baseline (week 0) to end of treatment (week 40)

Change in waist circumference

Measured in centimeters (cm).

Time frame: From baseline (week 0) to end of treatment (week 40)

Change in systolic blood pressure (SBP)

Measured in millimeters of mercury (mmHg).

Time frame: From baseline (week 0) to end of treatment (week 40)

Change in diastolic blood pressure (DBP)

Measured in mmHg.

Time frame: From baseline (week 0) to end of treatment (week 40)

Ratio to baseline in high sensitivity C-reactive protein (hsCRP)

Measured as ratio.

Time frame: From baseline (week 0) to end of treatment (week 40)

Ratio to baseline in lipids: Total cholesterol

Measured as ratio.

Time frame: From baseline (week 0) to end of treatment (week 40)

Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol

Measured as ratio.

Time frame: From baseline (week 0) to end of treatment (week 40)

Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol

Measured as ratio.

Time frame: From baseline (week 0) to end of treatment (week 40)

Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol

Measured as ratio.

Time frame: From baseline (week 0) to end of treatment (week 40)

Ratio to baseline in lipids: Triglycerides

Measured as ratio.

Time frame: From baseline (week 0) to end of treatment (week 40)

Ratio to baseline in lipids: Free fatty acids

Measured as ratio.

Time frame: From baseline (week 0) to end of treatment (week 40)

Ratio to baseline in lipids: Non-HDL cholesterol

Measured as ratio.

Time frame: From baseline (week 0) to end of treatment (week 40)

Number of participants who achieve type 2 diabetes (T2D) remission (HbA1c <6.5% and no antidiabetic medication)

Measured as count of participants.

Time frame: At end of study (week 52)

Ratio to baseline in oral glucose tolerance test (OGTT) based oral glucose disposition index (DIo)

Measured as ratio.

Time frame: From baseline (week 0) to end of treatment (week 40)

Change in experienced level of energy as measured by the SF-36v2 Health Survey Acute (SF-36v2) Vitality score

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.

Time frame: From baseline (week 0) to end of treatment (week 40)

Change in SF-36v2 score: Physical Component Summary score

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.

Time frame: From baseline (week 0) to end of treatment (week 40)

Change in SF-36v2 score: Mental Component Summary score

Time frame: From baseline (week 0) to end of treatment (week 40)

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score

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).

Time frame: From baseline (week 0) to end of treatment (week 40)

Change in leptin

Measured in nanograms per milliliter (ng/mL).

Time frame: From baseline (week 0) to end of treatment (week 40)

Change in soluble leptin receptor

Measured in ng/mL.

Time frame: From baseline (week 0) to end of treatment (week 40)

Number of Treatment Emergent Adverse Events (TEAEs)

Measured as count of events.

Time frame: From baseline (week 0) to end of treatment +7 weeks (week 47)

Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose (BG) meter

Measured as count of episodes.

Time frame: From baseline (week 0) to end of treatment +7 weeks (week 47)

Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold

Measured as count of episodes.

Time frame: From baseline (week 0) to end of treatment + 7 weeks (week 47)