Figure 3: HbA1c (%) Change Over Time in a 26-Week Placebo-Controlled Monotherapy Study of STEGLATRO in Patients with Type 2 Diabetes Mellitus* 

Figure 3 

 

14.3 Clinical Studies of Combination Therapy Use of STEGLATRO in Patients with Type 2 Diabetes Mellitus

 

Add-on Combination Therapy with Metformin 

 

A total of 621 patients with type 2 diabetes mellitus inadequately controlled (HbA1c between 7% and 10.5%) on metformin monotherapy (≥1,500 mg/day for ≥8 weeks) participated in a randomized, double-blind, multi-center, 26-week, placebo-controlled study (NCT02033889) to eva luate the efficacy and safety of STEGLATRO in combination with metformin. Patients entered a 2-week, single-blind, placebo run-in, and were randomized to placebo, STEGLATRO 5 mg, or STEGLATRO 15 mg administered once daily in addition to continuation of background metformin therapy.

 

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 to placebo (see Table 5).

 

 

Table 5: Results at Week 26 from a Placebo-Controlled Study for STEGLATRO Used in Combination with Metformin 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 12%, 6%, and 9% of patients, and during the trial, rescue medication was initiated by 18%, 3%, and 1% 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 -0.2%, -0.7%, 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, menopausal status and baseline eGFR. ‡ p<0.001 compared to placebo.  

 

HbA1c (%) N = 207 N = 205 N = 201 

  Baseline (mean) 8.2 8.1 8.1 

  Change from baseline (LS mean†) -0.2 -0.7 -0.9 

  Difference from placebo (LS mean†, 95% CI)  -0.5‡ (-0.7, -0.4) -0.7‡ (-0.9, -0.5) 

Patients [N (%)] with HbA1c <7% 38 (18.4) 74 (36.3) 87 (43.3) 

FPG (mg/dL)  N = 202 N = 199 N = 201 

  Baseline (mean) 169.1 168.1 167.9 

  Change from baseline (LS mean†) -8.7 -30.3 -40.9 

  Difference from placebo (LS mean†, 95% CI)  -21.6‡ (-27.8, -15.5) -32.3‡ (-38.5, -26.0)