All the trial data says that isn't an issue. That said, I have no intention of using FIasp myself as the curves look so similar to existing RAA I cannot see much of a gain. My bet is that Novo Nordisk will give the insurers rebates to push FIasp as a replacement for RAA rather like Abbott is doing with the Libre, and Dexcom is doing with the G6.
What trial data? Point me to all the FIASP trials?
14 CLINICAL STUDIES
14.1 Overview of Clinical Studies
The efficacy of FIASP was evaluated in 3 randomized, active-controlled trials of 18 to 26 weeks duration. In total 1224 adult subjects were randomized to FIASP (N=763 with type 1 diabetes; N=461 with type 2 diabetes). In adult patients with type 1 diabetes, mealtime FIASP and postmeal FIASP led to non-inferior glycemic control compared to mealtime NovoLog, both in combination with insulin detemir. In adult patients with type 2 diabetes, mealtime FIASP provided non-inferior glycemic control compared to mealtime NovoLog, both in combination with metformin. In addition, mealtime FIASP in a basal-bolus regimen with metformin also provided statistically significant improvement in the overall glycemic control compared to basal insulin therapy alone with metformin in adult patients with type 2 diabetes.
14.2 Type 1 Diabetes - Adults
Study A (NCT01831765): FIASP added to insulin determir in patients with Type 1 DM inadequately controlled at baseline.
The efficacy of FIASP was evaluated in a 26-week, randomized, active controlled, treat-to target, multicenter trial in 1143 adult patients with type 1 diabetes inadequately controlled at baseline. Patients were randomized to either blinded mealtime FIASP (N=381), blinded mealtime NovoLog (N=380), or open-label postmeal FIASP (N=382), all in combination with once or twice daily insulin detemir. At randomization, patients were switched to FIASP on a unit to unit basis. Mealtime FIASP or NovoLog was injected 0-2 minutes before the meal, and postmeal FIASP was injected 20 minutes after the start of the meal.
The mean age of the randomized subjects was 44.4 years and mean duration of diabetes was 19.9 years. 59% were male, 93% were White, 2% were Black or African American, and 7% were Hispanic. The mean BMI was 26.7 kg/m2.
After 26 weeks of treatment, treatment difference in HbA1c reduction from baseline between mealtime FIASP compared to mealtime NovoLog, and the treatment difference between postmeal FIASP compared to mealtime NovoLog met the pre-specified non-inferiority margin
Reference ID: 4160518
(0.4%). See Table 6. Insulin doses were similar among study arms at baseline and at the end of the trial.
Table 6. Results from Study A: 26-Week Trial of Mealtime FIASP and Postmeal FIASP compared to Mealtime NovoLog Used in Combination with Insulin Detemir in Adults with Type 1 Diabetes
Mealtime FIASP
+ insulin detemir
Postmeal FIASP
+ insulin detemir
Mealtime
NovoLog
+ insulin detemir
Number of subjects randomized (N)
381
382
380
HbA1c (%)
Baseline (mean)
7.6
7.6
7.6
Adjusted mean change from baseline
-0.32
-0.13
-0.17
Estimated treatment difference vs. mealtime NovoLog [95% CI]*
-0.15 [-0.23;-0.07]
Estimated treatment difference vs. mealtime NovoLog [95% CI]*
0.04 [-0.04;0.12]
Baseline is based on the mean of the observed last available values prior to randomization.
*Tested for non-inferiority
7.6% of subjects on the Mealtime FIASP arm, 7.6% of subjects on the Postmeal FIASP arm, and 5.3% of subjects on the Mealtime NovoLog arm were missing the final HbA1c assessment.
14.3 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 7. Insulin doses were similar among study arms at the end of the trial.
Table 7. 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
Baseline is based on the mean of the observed last available values prior to randomization.
*Tested for non-inferiority
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 8).
Mealtime FIASP +insulin glargine +metformin
Mealtime
NovoLog +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]
Reference ID: 4160518
Reference ID: 4160518
Table 8. 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.
6.0% of subjects on the mealtime FIASP arm and 3.3% of subjects on the placebo arm were missing the final HbA1c assessment.
www.accessdata.fda.gov/drugsatfda_docs/label/2017/208751s000lbl.pdf======================================================================================================
onset 1 (Study A) Study Design1,2:
Population: Adults with type 1 diabetes.
Study Design: 26-week, randomized, active-controlled, treat-to-target, multicenter trial in 1143 adult patients with type 1 diabetes inadequately controlled at baseline who were on basal/bolus insulin therapy for at least 12 months. Patients were randomized to either blinded mealtime Fiasp® (n=381), blinded mealtime NovoLog® (n=380), or open-label postmeal Fiasp® (n=382), all in combination with once- or twice-daily insulin detemir. At randomization, patients were switched to Fiasp® on a unit-to-unit basis from their pretrial bolus insulin. Mealtime Fiasp® or NovoLog® was injected 0-2 minutes before the meal, and postmeal Fiasp® was injected 20 minutes after the start of the meal.
Primary endpoint: Change in A1C from baseline after 26 weeks of treatment. Noninferiority of Fiasp® (mealtime and postmeal dosing) to mealtime NovoLog® was confirmed.
onset 3 (Study C) Study Design11,3:
Population: Adults with type 2 diabetes.
Study Design: 18-week randomized, open-label, parallel group trial in 236 adult patients with type 2 diabetes who were inadequately controlled at baseline who were 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 (n=116) and metformin or to continuing basal insulin and metformin therapy without Fiasp® (n=120). 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. Mealtime Fiasp® was injected 0-2 minutes before the meal.
Primary endpoint: Change in A1C from baseline after 18 weeks of treatment. Superiority of Fiasp® when used in a basal/bolus regimen vs basal insulin was confirmed.
www.fiasppro.com/the-fiasp-story/efficacy-and-safety.html===============================================================================================================
the studies were easy to find, drman7.
the dr stands for David Richard?
Added: listening to videos, pharmaceutical companies can run as many trials as they want and they can publish the trials they want to publish.
Not all trials are published.
