Fiasp (Page 6 of 9)

14.4 Type 2 Diabetes — Adults

Study B (NCT01819129): FIASP added to basal insulin and oral antidiabetics in patients with Type 2 DM inadequately controlled at baseline on basal insulin and oral antidiabetics

The efficacy of FIASP was evaluated in a 26-week randomized, double-blind, active controlled, treat-to-target, multicenter, multinational, parallel group trial in 689 adult patients with type 2 diabetes who were inadequately controlled at baseline on basal insulin and oral antidiabetic therapy and had been on these therapies for at least 6 months. Patients were randomized to either mealtime FIASP or to mealtime NovoLog, both in combination with insulin glargine and metformin in a basal-bolus regimen. Mealtime FIASP or mealtime NovoLog was injected 0-2 minutes before the meal.

The mean age of the randomized subjects was 59.5 years and the mean duration of diabetes was 12.7 years. 49% were male, 81% were White, 6% were Black or African American, and 6% were Hispanic. The mean BMI was 31.2 kg/m2.

After 26 weeks of treatment, the treatment difference in HbA1c reduction from baseline between mealtime FIASP and mealtime NovoLog, both in combination with insulin glargine and metformin, met the pre-specified non-inferiority margin (0.4%). See Table 9. Insulin doses were similar among study arms at the end of the trial.

Table 9. Results from Study B: 26-Week Trial of Mealtime FIASP Compared to Mealtime NovoLog, Both used in Combination with Insulin Glargine and Metformin, in Adults with Type 2 Diabetes

MealtimeFIASP

+insulin glargine

+metformin

MealtimeNovoLog

+insulin glargine

+metformin

Number of subjects randomized (N)

345

344

HbA1c (%)

Baseline

8.0

7.9

Adjusted change from baseline

-1.38

-1.36

Estimated treatment difference
vs. NovoLog [95%CI]*

-0.02 [-0.15;0.10]

Baseline is based on the mean of the observed last available values prior to randomization.

* Tested for non-inferiority

Estimated treatment difference was calculated using mixed model for repeated measurements (MMRM).

11.9% of subjects on the Mealtime FIASP arm and 10.2% of subjects on the Mealtime NovoLog arm were missing the final HbA1c assessment.

Study C (NCT01850615): FIASP added to basal insulin and metformin in patients with Type 2 DM inadequately controlled at baseline on basal insulin and metformin

The efficacy of FIASP was evaluated in an 18-week randomized, open-label, parallel group trial in 236 adult patients with type 2 diabetes who were inadequately controlled on basal insulin and metformin therapy, either with or without other oral antidiabetic therapy, for at least 3 months. Patients were randomized to either mealtime FIASP in addition to basal insulin and metformin or to continuing basal insulin and metformin therapy without FIASP. The basal insulins used in both treatment arms were insulin glargine, insulin detemir or NPH. All patients were also required to be on ≥1000 mg metformin treatment at baseline.

The mean age of the trial population was 57.4 years and the mean duration of diabetes was 11.3 years. 48% were male, 70% were White, 4% were Black or African American, and 37% were Hispanic. The mean BMI was 30.8 kg/m2.

After 18 weeks of treatment, addition of FIASP to basal insulin and metformin statistically significantly reduced HbA1c compared to continuing basal insulin and metformin therapy without addition of FIASP (Table 10).

Table 10. Results from Study C: 18-Week Trial of Mealtime FIASP in Adults with Type 2 Diabetes Inadequately Controlled at Baseline on Basal Insulin and Metformin

FIASP + basal insulin + metformin

Basal insulin + metformin

Number of subjects randomized (N)

116

120

HbA1c (%)

Baseline

7.9

7.9

Adjusted change from baseline

-1.16

-0.22

Estimated treatment difference
vs. basal insulin+metformin [95%CI]

-0.94 [-1.17; -0.72]*

Proportion of patients Achieving HbA1c < 7% at Trial End

60.3%

18.3%

Baseline is based on the mean of the observed last available values prior to randomization.

* p<0.0001, 1-sided p-value evaluated at 2.5% level for superiority.

Estimated treatment difference was calculated using mixed model for repeated measurements (MMRM).

6.0% of subjects on the mealtime FIASP arm and 3.3% of subjects on the placebo arm were missing the final HbA1c assessment.

14.5 Type 1 Diabetes – Adult Continuous Subcutaneous Insulin Infusion (CSII)

Study D (NCT02825251): FIASP in Continuous Subcutaneous Insulin Infusion (CSII) in Adults with Type 1 DM

The efficacy and safety of FIASP vs. NovoLog in CSII in adult subjects with T1DM (N=472) was evaluated in a randomized, multicenter, multinational, active controlled, treat-to-target, parallel group trial with a 4-week run-in and a 16-week treatment period. Meal-time bolus insulin infusion was initiated 0-2 minutes before a meal.

The mean age of the randomized subjects was 43 years and the mean duration of diabetes was 24 years. 43% were male. 89% were Caucasian, 1% were Black or African American, 1% were Asian, and 3% were Hispanic. The mean BMI was 26.3 kg/m2.

After 16 weeks of treatment, the treatment difference in HbA1c reduction from baseline between FIASP and NovoLog was 0.10 with 95%CI [0.02, 0.18] (Table 11).

Table 11. Results from Study D: 16-Week Trial FIASP in Adults with Type 1 Diabetes

FIASP

NovoLog

Number of subjects randomized (N)

236

236

HbA1c (%)

Baseline

7.5

7.5

Adjusted change from baseline

-0.04

-0.14

Estimated treatment difference
FIASP vs. NovoLog [95%CI]*

0.10 [0.02; 0.18]

Proportion of patients Achieving HbA1c < 7% at Trial End

20.3%

23.3%

Baseline is based on the mean of the observed last available values prior to randomization.

* Tested for non-inferiority using a margin of 0.4%.

Estimated treatment difference was calculated using ANCOVA.

2.1% of subjects on the FIASP arm and 2.5% of subjects on the NovoLog arm were missing the final HbA1c assessment. Missing values were imputed using multiple imputation with a mean equal to the baseline value of the corresponding patient.

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