Diabetes & Metabolism Journal (original) (raw)

Table 1. Subject demographics and characteristics at baseline (safety analysis set)a

Values are presented as number (%) or mean±standard deviation.

BMI, body mass index; HbA1c, glycosylated hemoglobin; FBG, fasting blood glucose; T2DM, type 2 diabetes mellitus.

The safety analysis set (n=3,022) includes subjects from the effectiveness analysis set (n=2,368). The effectiveness set includes subjects whose HbA1c, FBG, or body weight data were collected at baseline,

The diagnosis date of T2DM for 19 subjects is the same date as starting date for dulaglutide,

Dyslipidaemia refers to the imbalance of lipids in the blood (low-density lipoprotein cholesterol, triglycerides, and high-density lipoprotein),

Hyperlipidaemia refers to high levels of lipids or fats in the blood (low-density lipoprotein cholesterol only),

Renal impairment, hepatic impairment, allergy definitions were not formally defined for this study, and were noted in the case report forms by the treating physician as part of routine clinical practice.

Table 2. Adverse events and adverse drug reactions and most common symptoms (n=3,022)

DM, diabetes mellitus.

Preferred term as defined by MedDRA 24.0 (MedDRA-K 24.0) for system organ class and investigations,

Serious adverse events included adverse events that resulted in death, required either inpatient hospitalization or the prolongation of hospitalization, were life-threatening (immediate risk of death), resulted in a persistent or significant disability/incapacity or resulted in a congenital anomaly/birth defect, or any adverse event that did not result in death or require inpatient hospitalization but was considered significant based on the investigator’s judgment,

The causal relationship between dulaglutide and this death was considered unlikely by the investigator.

Table 3. Occurrence of adverse events by baseline characteristics and other factors

Values are presented as number (%).

AE, adverse event; CI, confidence interval; BMI, body mass index; T2DM, type 2 diabetes mellitus.

Chi-square test,

Statistically significant,

Medical history was not formally defined for this study, and was noted in the case report forms by the treating physician as part of routine clinical practice.

Table 4. Baseline characteristics and other factors associated with occurrence of adverse events

CI, confidence interval; BMI, body mass index; T2DM, type 2 diabetes mellitus.

Logistic regression,

Statistically significant.

Table 5. Mixed model for repeated measures for change from baseline in HbA1c, FBG, and body weight (baseline follow-up visit, ±4 weeks)

HbA1c, glycosylated hemoglobin; FBG, fasting blood glucose; LS, least-square; SE, standard error; CI, confidence interval.

P values are tests from mixed model for repeated measure (MMRM),

MMRM model: change from baseline=β1×visit+β2×baseline HbA1c+β3×visit×baseline HbA1c,

Statistically significant,

MMRM model: change from baseline=β1×visit+β2×baseline FBG+β3×visit×baseline FBG,

MMRM model: change from baseline=β1×visit+β2×baseline weight+β3×visit×baseline weight.

Table 6. Baseline characteristics and other factors associated with achievement of HbA1c <6.5%

Response variable: achieved HbA1c <6.5% at last observation (yes/no).

HbA1c, glycosylated hemoglobin; CI, confidence interval; BMI, body mass index.

Logistic regression,

Statistically significant.