Clinical trial NCT06323161: 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
Official title: Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4 mg/2.4 mg and 1.0 mg/1.0 mg Once Weekly Versus Placebo in Participants With Type 2 Diabetes as Add on to Once-daily Basal Insulin With or Without Metformin
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-03-21
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Glycated Haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of treatment (week 40)
Secondary outcomes:
measure: Relative Change in Body Weight
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Number of Participants Who Achieve Greater than or Equal to (≥) 10% Body Weight Reduction
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Number of Participants Who Achieve ≥15% Body Weight Reduction
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Number of Participants Who Achieve HbA1c Target Values of Less than (<) 7.0% (<53 millimole per mole [mmol/mol])
timeFrame: At end of treatment (week 40)
measure: Number of Participants Who Achieve HbA1c Target Values of Less than or Equal to (≤) 6.5% (≤48 mmol/mol)
timeFrame: At end of treatment (week 40)
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Change in Insulin Dose
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Number of Participants Who Achieve Insulin Dose Equal to (=) 0 Units
timeFrame: At end of treatment (week 40)
measure: Change in 7-point Self-measured Plasma Glucose (SMPG) Profiles: Mean 7-point profile and Mean postprandial increment (over all meals)
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Number of Participants Who Achieve ≥5% Body Weight Reduction
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Number of Participants Who Achieve ≥20% Body Weight Reduction
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Change in Waist Circumference
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Change in Systolic Blood Pressure (SBP)
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Change in Diastolic Blood Pressure (DBP)
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Ratio to Baseline in High Sensitivity C-reactive Protein (hsCRP)
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Ratio to Baseline in Lipids: Non-high Density Lipoprotein (Non-HDL) Cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Ratio to Baseline in Lipids: Triglycerides
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Ratio to Baseline in Lipids: Low-Density Lipoprotein (LDL) Cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Ratio to Baseline in Lipids: Very Low-Density Lipoprotein (VLDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Ratio to Baseline in Lipids: HDL Cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Ratio to Baseline in Lipids: Total Cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Ratio to Baseline in Lipids: Free Fatty Acids
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Change in Short Form-36 Version 2.0 Health Survey (SF-36v2): Vitality score
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Change in SF-36v2: Physical Component Summary Score
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Change in SF-36v2: Mental Component Summary Core
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Ratio to Baseline in Leptin
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Ratio to Baseline in Soluble Leptin Receptor
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: From baseline (week 0) to end of treatment +7 weeks (week 47)
measure: Number of Clinically Significant Hypoglycaemic Episodes (level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose Meter)
timeFrame: From baseline (week 0) to end of treatment +7 weeks (week 47)
measure: Number of Clinically Significant Hypoglycaemic Episodes (level 3)
timeFrame: From baseline (week 0) to end of treatment +7 weeks (week 47)
Other outcomes:
Locations:
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Miami
country: United States
facility: Bioclinical Research Alliance
state: Florida
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: West Des Moines
country: United States
facility: Iowa Diab & Endo Res Center
state: Iowa
city: Flint
country: United States
facility: Elite Research Center
state: Michigan
city: Las Vegas
country: United States
facility: Palm Research Center Inc.
state: Nevada
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Nashville
country: United States
facility: Clinical Research Associates
state: Tennessee
city: Dallas
country: United States
facility: Velocity Clinical Res-Dallas
state: Texas
city: Houston
country: United States
facility: Synergy Groups Medical
state: Texas
city: Houston
country: United States
facility: PlanIt Research, PLLC
state: Texas
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Newport News
country: United States
facility: TPMG Clinical Research
state: Virginia
city: Beijing
country: China
facility: Chinese People's Liberation Army General Hospital-Endocrinology
state: Beijing
city: Kaifeng
country: China
facility: Huaihe Hospital of Henan University-Endocrinology
state: Henan
city: Kaifeng
country: China
facility: Huaihe Hospital of Henan University
state: Henan
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University_Nanjing
state: Jiangsu
city: Zhenjiang
country: China
facility: The Affiliated Hospital of Jiangsu University-Endocrinology
state: Jiangsu
city: Ji'nan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Sapporo-shi, Hokkaido
country: Japan
facility: Manda Memorial Hospital
state: Hokkaido, Japan
city: Yamato-shi
country: Japan
facility: Tsuruma Kaneshiro Diabetes Clinic
state: Kanagawa
city: Arakawa-ku, Tokyo
country: Japan
facility: Kumanomae Nishimura Internal Medical Clinic
city: Chiba-shi, Chiba
country: Japan
facility: Akaicho Clinic
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Futata Tetsuhiro Clinic Meinohama
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Kunisaki Makoto Clinic
city: Hokkaido
country: Japan
facility: Sasaki Internal Medicine
city: Ibaraki
country: Japan
facility: Naka Kinen Clinic
city: Kanagawa
country: Japan
facility: H.E.C Science Clinic
city: Kyoto-shi, Kyoto
country: Japan
facility: Kyoto University Hospital
city: Mito-shi, Ibaraki
country: Japan
facility: Minami Akatsuka Clinic
city: Tokyo
country: Japan
facility: Tokyo-Eki Center-building Clinic
city: Tokyo
country: Japan
facility: Fukuwa Clinic
city: Tokyo
country: Japan
facility: Kato Clinic of Internal Medicine
city: Belgrade
country: Serbia
facility: Healthcare centre Zvezdara
state: RS
city: Kragujevac
country: Serbia
facility: Healthcare centre Kragujevac
state: RS
city: Nis
country: Serbia
facility: University Clinical Centre Nis
state: RS
city: Nis
country: Serbia
facility: Healthcare centre Nis
state: RS
city: Zajecar
country: Serbia
facility: Policlinic for diabetes
city: Kralovsky Chlmec
country: Slovakia
facility: MOMED, s.r.o
city: Levice
country: Slovakia
facility: DIA - KONTROL s.r.o.
city: Malacky
country: Slovakia
facility: SIN AZUCAR s.r.o.
city: Rimavska Sobota
country: Slovakia
facility: ENRIN, s.r.o.
city: Spisska Nova Ves
country: Slovakia
facility: LUDIA, s.r.o.
city: Bloemfontein
country: South Africa
facility: Oraderumaz (Pty) Ltd
state: Free State
city: Lenasia
country: South Africa
facility: Lenasia Clinical Trial Centre
state: Gauteng
city: Pretoria
country: South Africa
facility: Prinshof Medical Campus
state: Gauteng
city: Pretoria
country: South Africa
facility: Clinical Trial Systems (CTC)
state: Gauteng
city: Cape Town
country: South Africa
facility: Ashmed Medi-Centre
state: Western Cape
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: