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Clinical Trial NCT06534411 (REIMAGINE 5) for Diabetes Mellitus, Type 2 is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both (REIMAGINE 5) Phase 3 1,023
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 1.0 mg/1.0 mg s.c. Once Weekly Versus Tirzepatide 5 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin, SGLT2 Inhibitor or Both
- REIMAGINE 5
- NN9388-7741
- U1111-1300-2590 (Other Identifier) (World Health Organization (WHO))
- 2023-509600-15 (Other Identifier) (European Medical Agency (EMA))
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalCagriSema Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every 4 weeks in a 8-week dose escalation period until target dose of CagriSema is achieved and maintained for 52 weeks. | Cagrilintide Participants will receive once-weekly cagrilintide subcutaneously. Semaglutide Participants will receive once-weekly semaglutide subcutaneously. |
ExperimentalTirzepatide Participants will receive once-weekly s.c injections of tirzepatide at escalating dose in a 4-week dose escalating period and maintained up to 56 weeks. | Tirzepatide Participants will receive once-weekly tirzepatide subcutaneously. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in Glycated Haemoglobin (HbA1c) | Measured in percentage points. | From baseline (week 0) to end of treatment (week 60) |
Relative Change in Body Weight | Measured in percentage (%). | From baseline (week 0) to end of treatment (week 60) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in HbA1c | Measured in percentage points. | From baseline (week 0) to end of treatment (week 60) |
Change in Fasting Plasma Glucose (FPG) | Measured as millimole per liter (mmol/L). | From baseline (week 0) to end of treatment (week 60) |
Number of Participants Who Achieve HbA1c Target Values of Less Than (<) 7.0 (Percent [%]) (< 53 millimole per mole [mmol/mol]) | Measured as count of participants. | At end of treatment (week 60) |
Number of Participants Who Achieve HbA1c Target Values of Less Than or Equal to (<=) 6.5% (<= 48 mmol/mol) | Measured as count of participants. | At end of treatment (week 60) |
Number of Participants Who Achieve Greater Than or Equal to (>=) 5% Weight Reduction | Measured as count of participants. | From baseline (week 0) to end of treatment (week 60) |
Number of Participants Who Achieve >= 10% Weight Reduction | Measured as count of participants. | From baseline (week 0) to end of treatment (week 60) |
Number of Participants Who Achieve >= 15% Weight Reduction | Measured as count of participants. | From baseline (week 0) to end of treatment (week 60) |
Number of Participants Who Achieve >= 20% Weight Reduction | Measured as count of participants. | From baseline (week 0) to end of treatment (week 60) |
Change in Systolic Blood Pressure (SBP) | Measured in millimeter of mercury (mmHg). | From baseline (week 0) to end of treatment (week 60) |
Change in Diastolic Blood Pressure (DBP) | Measured in mmHg. | From baseline (week 0) to end of treatment (week 60) |
Change in Waist Circumference | Measured in centimeter (cm). | From baseline (week 0) to end of treatment (week 60) |
Ratio to Baseline in Lipids: Total Cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 60) |
Ratio to Baseline in Lipids: High Density Lipoprotein (HDL) Cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 60) |
Ratio to Baseline in Lipids: Low Density Lipoprotein (LDL) Cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 60) |
Ratio to Baseline in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 60) |
Ratio to Baseline in Lipids: Triglycerides | Measured as ratio. | From baseline (week 0) to end of treatment (week 60) |
Ratio to Baseline in Lipids: Non-HDL cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 60) |
Change in Short Form (SF) -36v2 Score: Physical Component Summary 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, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Physical component summary scores ranges from 6.1 to 79.7 with higher scores indicating better functional health and well-being. | From baseline (week 0) to end of treatment (week 60) |
Change in SF-36v2 Score: Mental Component Summary 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, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Mental component summary scores ranges from -3.8 to 78.7 with higher scores indicating better functional health and well-being. | From baseline (week 0) to end of treatment (week 60) |
Change in SF-36v2 Score: Vitality Subscale | 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, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Vitality score ranges from 25.6 to 69.1 with higher scores indicating better functional health and well-being. | From baseline (week 0) to end of treatment (week 60) |
Change in Impact of Weight on Quality of Life Lite for Clinical Trials Version (IWQOL-Lite-CT) : Physical Function score | Measured as score points. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Physical functioning score ranges from 0 to 100, with higher scores reflecting better levels of functioning. | From baseline (week 0) to end of treatment (week 60) |
Change in IWQOL-Lite-CT: Total score | Measured as score points. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score ranges from 0 to 100, with higher scores reflecting better levels of functioning. | From baseline (week 0) to end of treatment (week 60) |
Number of Treatment Emergent Adverse Events (TEAEs) | Measured as count of events. | From baseline (week 0) to end of study (week 66) |
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (<54 Milligram per Deciliter [mg/dL]), Confirmed by Blood Glucose (BG) Meter | Measured as count of episodes. | From baseline (week 0) to end of study (week 66) |
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. | From baseline (week 0) to end of study (week 66) |
- 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 greater than or equal to (>=) 180 days before screening.
- Stable daily dose(s) >= 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator:
- Metformin
- sodium-glucose co-transporter 2 inhibitor (SGLT2i)
- Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mol \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening.
- Body mass index (BMI) >= 30 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 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 anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days is allowed.
- 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.
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