Across 89 unique European CTIS diabetes mellitus Phase II and Phase III trial protocols, safety and adverse-event measurement is the most common endpoint family, appearing in 49 trials (55.1%). HbA1c and glycaemic-control endpoints follow closely in 44 trials (49.4%), while body weight/BMI/waist endpoints appear in 32 trials (36.0%). Phase II trials are dominated by safety endpoints, whereas Phase III trials shift toward HbA1c, body weight, cardiometabolic risk, and patient-relevant long-term outcomes.
Safety/adverse-event endpoints appear in 49 of 89 trials (55.1%), narrowly ahead of HbA1c/glycaemic-control endpoints in 44 trials (49.4%). Body weight/BMI/waist endpoints appear in 32 trials (36.0%), reflecting the overlap between diabetes, obesity, and cardiometabolic trial strategies.
The European diabetes endpoint landscape is not purely glucose-centric. Safety and tolerability lead overall, while HbA1c remains the main metabolic anchor and weight-related endpoints are now frequent enough to form a third major endpoint pillar.
Safety/adverse events are the most common primary endpoint family, appearing as a primary endpoint in 18 of 89 trials (20.2%). HbA1c and body weight each appear as primary endpoints in 14 trials (15.7%), while HbA1c becomes the leading secondary endpoint family in 39 trials (43.8%). Exploratory/other endpoint fields are rare, appearing in 1 trial (1.1%).
| Endpoint family | Primary | Secondary | Exploratory / other |
|---|---|---|---|
| Safety / AE / tolerability | 18/89 20.2% | 37/89 41.6% | 0/89 0.0% |
| HbA1c / glycaemic control | 14/89 15.7% | 39/89 43.8% | 1/89 1.1% |
| Body weight / BMI / waist | 14/89 15.7% | 28/89 31.5% | 0/89 0.0% |
| C-peptide / beta-cell function | 9/89 10.1% | 21/89 23.6% | 0/89 0.0% |
| Diabetic retinopathy / vision | 9/89 10.1% | 9/89 10.1% | 0/89 0.0% |
| FPG / glucose tolerance | 8/89 9.0% | 23/89 25.8% | 0/89 0.0% |
Primary endpoints concentrate on safety, HbA1c, weight, beta-cell function, and diabetic eye outcomes. Secondary endpoints carry the broader metabolic burden, especially HbA1c, safety, weight, blood pressure, CGM, fasting glucose, quality of life, and C-peptide.
Phase II records are safety-heavy: safety/adverse-event endpoints appear in 32 of 45 Phase II records (71.1%). Phase III records shift toward clinical efficacy and cardiometabolic outcomes: HbA1c appears in 25 of 47 records (53.2%), body weight/BMI/waist in 19 (40.4%), and lipids/Lp(a) in 16 (34.0%).