Phase 2
Completed N=92
Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes
Source: ClinicalTrials.gov NCT04982575 ↗Enrolled (actual)
92
Serious AEs
6.5%
Results posted
Jul 2023
Primary outcomePrimary: Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide) — -2.2; -1.9; -2.2; -2.0 Percentage of HbA1c — p=0.2284
Summary
This study looks at how well a new medicine called cagrilintide works together with semaglutide on blood sugar levels in people with type 2 diabetes compared to cagrilintide alone or semaglutide alone.
Before a new medicine can be prescribed to people it needs to be tested to see if it is safe and effective.
Participants will either get cagrilintide and semaglutide together or cagrilintide and a dummy medicine or semaglutide and a dummy medicine. Which treatment participants get is decided by chance.
A dummy medicine (placebo) looks like the study medicine but does not contain any active medicine. The dummy medicine is in the study to see if the study medicine works as expected.
Participants will get 2 injections per week on the same day. Participants will take the study medicine with a pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show how.
The study will last for about 39 weeks. Participants will have 12 visits at the clinic and 5 phone calls with the study doctor.
At 6 of the clinic visits participants must not eat and drink for 8 hours before the visit (water is allowed).
Women who can become pregnant cannot take part in this study. Only women that are surgically sterilised or post-menopausal are allowed to participate in this study Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide) |
-2.2; -1.9; -2.2; -2.0 | 0.2284 |
| SECONDARY Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide) |
-2.2; -0.8 | — |
| SECONDARY Percentage Change in Body Weight: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide) |
-14.7; -5.0 | — |
| SECONDARY Change in Body Weight (Kilogram): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide) |
-15.4; -5.3 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide) |
-3.4; -2.7 | — |
| SECONDARY CGM: Change in Mean Glucose: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide) |
-3.5; -1.0 | — |
| SECONDARY Percentage of Time Above Range (TAR) Greater Than 10.0 mmol/L (Greater Than 180 mg/dL) Measured Using CGM (Continuous Glucose Monitoring): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide) |
10.3; 30.9 | — |
| SECONDARY Percentage of Time in Range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) Measured Using CGM (Continuous Glucose Monitoring): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide) |
88.9; 68.9 | — |
| SECONDARY Number of Treatment Emergent Adverse Events (TEAEs) |
21; 24; 22 | — |
| SECONDARY Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0mmol/L (54mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3) |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Female of non-childbearing potential or male
- Age above or equal to 18 years at the time of signing informed consent
- Body mass index (BMI) greater than or equal to 27.0 kg/m^2
- Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
- Glycated haemoglobin (HbA1c) of 7.5-10.0% (58-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening
- Stable daily dose(s) ≥ 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at maximum tolerated or effective dose as judged by the investigator: metformin with or without Sodium-glucose co-transporter-2 (SGLT2) inhibitor
Exclusion Criteria
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days and prior insulin treatment for gestational diabetes are allowed
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 60 ml/min/1.73m^2 by central laboratory at screening
- 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
Data sourced from ClinicalTrials.gov (NCT04982575). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.