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

Novo Nordisk A/S274 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

274

Conditions

Type 2 Diabetes

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (61)

Valley Research

Fresno, California, United States

Valley Clinical Trials, Inc.

Northridge, California, United States

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

Outcomes

Primary Outcomes

Change in Glycated Haemoglobin (HbA1c)

Measured in percentage (%)- points.

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

Secondary Outcomes

Relative Change in Body Weight

Measured in percentage (%).

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 millimole 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 as millimole per liter (mmol/L).

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

Change in Insulin Dose

Measured in units (u).

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

Number of Participants Who Achieve Insulin Dose Equal to (=) 0 Units

Measured as count of participants.

Time frame: At end of treatment (week 40)

Change in 7-point Self-measured Plasma Glucose (SMPG) Profiles: Mean 7-point profile and Mean postprandial increment (over all meals)

Measured in 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 centimeter (cm).

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

Change in Systolic Blood Pressure (SBP)

Measured in millimeter 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 in ratio.

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

Ratio to Baseline in Lipids: Non-high Density Lipoprotein (Non-HDL) Cholesterol

Measured in ratio.

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

Ratio to Baseline in Lipids: Triglycerides

Measured in ratio.

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

Ratio to Baseline in Lipids: Low-Density Lipoprotein (LDL) Cholesterol

Measured in 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 in ratio.

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

Ratio to Baseline in Lipids: HDL Cholesterol

Measured in ratio.

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

Ratio to Baseline in Lipids: Total Cholesterol

Measured in ratio.

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

Ratio to Baseline in Lipids: Free Fatty Acids

Measured in ratio.

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

Change in Short Form-36 Version 2.0 Health Survey (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: 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: Mental Component Summary Core

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)

Ratio to Baseline in Leptin

Measured in ratio.

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

Ratio to Baseline in Soluble Leptin Receptor

Measured in ratio.

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/L (54 mg/dL), Confirmed by Blood Glucose Meter)

Measured as count of episodes.

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

Number of Clinically Significant Hypoglycaemic Episodes (level 3)

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.

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