Patient Baseline and Treatment Characteristics and Change in HbA1c
| . | GLP-1 RA . | DPP-4 . | ||
|---|---|---|---|---|
| . | RW (n = 221) . | RCTsa (n = 2,600) . | RW (n = 652) . | RCTsa (n = 1,889) . |
| Baseline patient characteristics | ||||
| Age (years), mean (SE) | 57 (0.71) | 56 (0.20) | 63 (0.46) | 56 (0.22) |
| Male sex, % (n) | 58 (127) | 53 (1,378) | 58 (378) | 53 (1,001) |
| White race, % (n) | 82 (181) | 68 (1,768) | 81 (525) | 77 (1,455) |
| HbA1c (%), mean (SE) | 8.34 (0.06) | 8.41 (0.02) | 8.15 (0.03) | 7.81 (0.02) |
| HbA1c (mmol/mol), mean (SE) | 67 (0.7) | 68 (0.25) | 66 (0.3) | 62 (0.35) |
| Any diabetes complications,b % (n) | 62 (136) | 15 (390)c | 62 (401) | 15 (283)c |
| Use of advanced type 2 diabetes therapy before index,d % (n) | 83 (184) | 50 (1,300) | 71 (460) | 7 (132) |
| Treatment characteristics during follow-up | ||||
| Adherent to index drug, % (n) | 29 (64)e | 95 (2,470)e | 37 (242) | 95 (1,795)f |
| Discontinued index drug, % (n) | 45 (100)g,h | 0 (0) | 40 (263)g,h | 0 (0) |
| Switched to another class of diabetes drug, % of patients who discontinued (n) | 44 (44) | — | 42 (110) | — |
| Did not discontinue index drug, % (n) | 55 (121)g,h | 100 (2,600) | 60 (389)g,h | 100 (1,889) |
| Added new diabetes medication and continued index therapy (e.g., rescue therapy), % of patients who did not discontinue (n) | 21 (26) | — | 29 (114) | — |
| Addition of other type 2 diabetes drug(s) after GLP-1 RA/DPP-4 initiation, % (n) | 32 (70)h | 0 (0)i | 34 (224)h | 0 (0)i |
| Change in HbA1c level ∼1 year after drug initiation | ||||
| Level difference (%), mean (95% CI) [range] | −0.52 (−0.66, −0.38) | −1.30 [−1.60, −0.84]j | −0.51 (−0.59, −0.43) | −0.68 [−0.90, −0.47]j |
| Level difference (mmol/mol), mean (95% CI) [range] | −6 (−16.3, −27.6) | −14 [−18, −9]j | −6 (−17.1, −28.2) | −8 [−10, −5]j |
| . | GLP-1 RA . | DPP-4 . | ||
|---|---|---|---|---|
| . | RW (n = 221) . | RCTsa (n = 2,600) . | RW (n = 652) . | RCTsa (n = 1,889) . |
| Baseline patient characteristics | ||||
| Age (years), mean (SE) | 57 (0.71) | 56 (0.20) | 63 (0.46) | 56 (0.22) |
| Male sex, % (n) | 58 (127) | 53 (1,378) | 58 (378) | 53 (1,001) |
| White race, % (n) | 82 (181) | 68 (1,768) | 81 (525) | 77 (1,455) |
| HbA1c (%), mean (SE) | 8.34 (0.06) | 8.41 (0.02) | 8.15 (0.03) | 7.81 (0.02) |
| HbA1c (mmol/mol), mean (SE) | 67 (0.7) | 68 (0.25) | 66 (0.3) | 62 (0.35) |
| Any diabetes complications,b % (n) | 62 (136) | 15 (390)c | 62 (401) | 15 (283)c |
| Use of advanced type 2 diabetes therapy before index,d % (n) | 83 (184) | 50 (1,300) | 71 (460) | 7 (132) |
| Treatment characteristics during follow-up | ||||
| Adherent to index drug, % (n) | 29 (64)e | 95 (2,470)e | 37 (242) | 95 (1,795)f |
| Discontinued index drug, % (n) | 45 (100)g,h | 0 (0) | 40 (263)g,h | 0 (0) |
| Switched to another class of diabetes drug, % of patients who discontinued (n) | 44 (44) | — | 42 (110) | — |
| Did not discontinue index drug, % (n) | 55 (121)g,h | 100 (2,600) | 60 (389)g,h | 100 (1,889) |
| Added new diabetes medication and continued index therapy (e.g., rescue therapy), % of patients who did not discontinue (n) | 21 (26) | — | 29 (114) | — |
| Addition of other type 2 diabetes drug(s) after GLP-1 RA/DPP-4 initiation, % (n) | 32 (70)h | 0 (0)i | 34 (224)h | 0 (0)i |
| Change in HbA1c level ∼1 year after drug initiation | ||||
| Level difference (%), mean (95% CI) [range] | −0.52 (−0.66, −0.38) | −1.30 [−1.60, −0.84]j | −0.51 (−0.59, −0.43) | −0.68 [−0.90, −0.47]j |
| Level difference (mmol/mol), mean (95% CI) [range] | −6 (−16.3, −27.6) | −14 [−18, −9]j | −6 (−17.1, −28.2) | −8 [−10, −5]j |
aInformation from seven GLP-1 RA and four DPP-4 trials was extracted. One GLP-1 RA trial was a head-to-head comparison against a DPP-4 agent (19). Data for both treatment arms were extracted.
bPatients were considered to have diabetes complications if their DCSI score was greater than 1 (22) and included the following seven categories of complications: cardiovascular disease, nephropathy, retinopathy, peripheral vascular disease, stroke, neuropathy, and metabolic.
cPatients in GLP-1 RA and DPP-4 trials were assumed to have a similar percentage of patients with any diabetes complications as to the percentage reported in one of the selected GLP-1 RA trials (25).
dUse of advanced diabetes medications was defined as equal to 1 if the patient was treated with any monotherapy or combination of type 2 diabetes drugs beyond metformin monotherapy and defined as equal to 0 if the patient was treated with metformin monotherapy during the baseline year.
eFor patients with multiple treatment measurements due to multiple weight measurements eligible for the study, PDC was weighted by the number of observations per patient.
fMedication adherence was not widely reported in RCTs and was assumed to be 95% based on information reported in the included RCTs (see Supplementary Table 1).
gDiscontinuation was defined by the absence of the index drug on hand for at least 30 days and until the second HbA1c measurement date.
hFor patients with multiple treatment measurements due to multiple HbA1c measurements eligible for the study, discontinuation and treatment augmentation associated with the latest observation of each patient were reported.
iBecause data after patients receive additional diabetes drugs (e.g., rescue therapy) are excluded from analyses of trial data, the addition of type 2 diabetes drugs post index in trial settings was assumed to be zero for the purpose of predicting change in HbA1c under typical trial conditions.
jOwing to the lack of individual patient-level data of RCTs, ranges of change in HbA1c were reported for GLP-1 RA and DPP-4 studies, respectively.