etes mellitus inadequately controlled (HbA1c between 7% and 10.5%) on diet and exercise participated in a randomized, double-blind, multi-center, 26-week, placebo-controlled study (NCT01958671) to eva luate the efficacy and safety of STEGLATRO monotherapy. These patients, who were either treatment naïve or not receiving any background antihyperglycemic treatment ≥8 weeks, entered a 2-week, single-blind, placebo run-in period and were randomized to placebo, STEGLATRO 5 mg, or STEGLATRO 15 mg, administered once daily.
At Week 26, treatment with STEGLATRO at 5 mg or 15 mg daily provided statistically significant reductions in HbA1c compared to placebo. STEGLATRO also resulted in a greater proportion of patients achieving an HbA1c <7% compared with placebo (see Table 4 and Figure 3).
Table 4: Results at Week 26 from a Placebo-Controlled Monotherapy Study of STEGLATRO in Patients with Type 2 Diabetes Mellitus*
Placebo
STEGLATRO 5 mg
STEGLATRO 15 mg
* N includes all randomized and treated patients with a baseline measurement of the outcome variable. At Week 26, the primary HbA1c endpoint was missing for 23%, 11%, and 16% of patients, and during the trial, rescue medication was initiated by 25%, 2%, and 3% of patients randomized to placebo, STEGLATRO 5 mg, and STEGLATRO 15 mg, respectively. Missing Week 26 measurements were imputed using multiple imputation with a mean equal to the baseline value of the patient. Results include measurements collected after initiation of rescue medication. For those patients who did not receive rescue medication and had values measured at 26 weeks, the mean changes from baseline for HbA1c were -0.1%, -0.8%, and -1.0% for placebo, STEGLATRO 5 mg, and STEGLATRO 15 mg, respectively. † Intent-to-treat analysis using ANCOVA adjusted for baseline value, prior antihyperglycemic medication, and baseline eGFR. ‡ p<0.001 compared to placebo.
HbA1c (%) N = 153 N = 155 N = 151
Baseline (mean) 8.1 8.2 8.4
Change from baseline (LS mean†) -0.2 -0.7 -0.8
Difference from placebo (LS mean†, 95% CI) -0.6‡ (-0.8, -0.4) -0.7‡ (-0.9, -0.4)
Patients [N (%)] with HbA1c <7% 26 (16.9) 47 (30.1) 59 (38.8)
FPG (mg/dL) N = 150 N = 151 N = 149
Baseline (mean) 180.2 180.9 179.1
Change from baseline (LS mean†) -11.6 -31.0 -36.4
Difference from placebo (LS mean†, 95% CI) -19.4‡ (-27.6, -11.2) -24.8‡ (-33.2, -16.4)
The mean baseline body weight was 94.2 kg, 94.0 kg, and 90.6 kg in the placebo, STEGLATRO 5 mg, and STEGLATRO 15 mg groups, respectively. The mean changes from baseline to Week 26 were -1.0 kg, -3.0 kg, and -3.1 kg in the placebo, STEGLATRO 5 mg, and STEGLATRO 15 mg groups, respectively. The difference from placebo (95% CI) for STEGLATRO 5 mg was -2.0 kg (-2.8, -1.2) and for STEGLATRO 15 mg was -2.1 kg (-2.9, -1.3).
* Data to the left of the vertical line are observed means (non-model-based) excluding values occurring post glycemic rescue. Data to the right of the vertical line represent the final Week 26 data, including all values regardless of use of glycemic rescue medication and use of study drug, with missing Week 26 values imputed using multipl
