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
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT06323161
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 270
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CagriSema Dose 1 Cagrilintide Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 32 weeks. CagriSema Dose 2 Cagrilintide Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 16-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 24 weeks. CagriSema Dose 1 Semaglutide Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 32 weeks. CagriSema Dose 2 Semaglutide Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 16-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 24 weeks. Placebo Dose 1 Placebo Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 40 weeks. Placebo Dose 2 Placebo Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 40 weeks
- Primary Outcome Measures
Name Time Method Change in Glycated Haemoglobin (HbA1c) From baseline (week 0) to end of treatment (week 40) Measured in percentage (%)- points.
- Secondary Outcome Measures
Name Time Method Ratio to Baseline in Soluble Leptin Receptor 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 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 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.
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.
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.
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.
Trial Locations
- Locations (49)
Kumanomae Nishimura Internal Medical Clinic
🇯🇵Arakawa-ku, Tokyo, Japan
Akaicho Clinic
🇯🇵Chiba-shi, Chiba, Japan
Futata Tetsuhiro Clinic Meinohama
🇯🇵Fukuoka-shi, Fukuoka, Japan
Kunisaki Makoto Clinic
🇯🇵Fukuoka-shi, Fukuoka, Japan
Sasaki Internal Medicine
🇯🇵Hokkaido, Japan
Naka Kinen Clinic
🇯🇵Ibaraki, Japan
H.E.C Science Clinic
🇯🇵Kanagawa, Japan
Kyoto University Hospital
🇯🇵Kyoto-shi, Kyoto, Japan
Minami Akatsuka Clinic
🇯🇵Mito-shi, Ibaraki, Japan
PlanIt Research, PLLC
🇺🇸Houston, Texas, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, 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
Elite Research Center
🇺🇸Flint, Michigan, United States
Palm Research Center Inc.
🇺🇸Las Vegas, Nevada, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Clinical Research Associates
🇺🇸Nashville, Tennessee, United States
Velocity Clinical Res-Dallas
🇺🇸Dallas, Texas, United States
Synergy Groups Medical
🇺🇸Houston, Texas, United States
TPMG Clinical Research
🇺🇸Newport News, Virginia, United States
Chinese People's Liberation Army General Hospital-Endocrinology
🇨🇳Beijing, Beijing, China
Huaihe Hospital of Henan University-Endocrinology
🇨🇳Kaifeng, Henan, China
Huaihe Hospital of Henan University
🇨🇳Kaifeng, Henan, China
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University_Nanjing
🇨🇳Nanjing, Jiangsu, China
The Affiliated Hospital of Jiangsu University-Endocrinology
🇨🇳Zhenjiang, Jiangsu, China
Jinan Central Hospital
🇨🇳Ji'nan, Shandong, China
Manda Memorial Hospital
🇯🇵Sapporo-shi, Hokkaido, Hokkaido, Japan, Japan
Tsuruma Kaneshiro Diabetes Clinic
🇯🇵Yamato-shi, Kanagawa, Japan
Tokyo-Eki Center-building Clinic
🇯🇵Tokyo, Japan
Fukuwa Clinic
🇯🇵Tokyo, Japan
Kato Clinic of Internal Medicine
🇯🇵Tokyo, Japan
Healthcare centre Zvezdara
🇷🇸Belgrade, RS, Serbia
Healthcare centre Kragujevac
🇷🇸Kragujevac, RS, Serbia
University Clinical Centre Nis
🇷🇸Nis, RS, Serbia
Healthcare centre Nis
🇷🇸Nis, RS, Serbia
Policlinic for diabetes
🇷🇸Zajecar, Serbia
MOMED, s.r.o
🇸🇰Kralovsky Chlmec, Slovakia
DIA - KONTROL s.r.o.
🇸🇰Levice, Slovakia
SIN AZUCAR s.r.o.
🇸🇰Malacky, Slovakia
ENRIN, s.r.o.
🇸🇰Rimavska Sobota, Slovakia
LUDIA, s.r.o.
🇸🇰Spisska Nova Ves, Slovakia
Oraderumaz (Pty) Ltd
🇿🇦Bloemfontein, Free State, South Africa
Lenasia Clinical Trial Centre
🇿🇦Lenasia, Gauteng, South Africa
Prinshof Medical Campus
🇿🇦Pretoria, Gauteng, South Africa
Clinical Trial Systems (CTC)
🇿🇦Pretoria, Gauteng, South Africa
Ashmed Medi-Centre
🇿🇦Cape Town, Western Cape, South Africa