Phase 3
Completed N=1,025
Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes
Diabetes · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT02500706 ↗
Enrolled (actual)
1,025
Serious AEs
5.3%
Results posted
Aug 2018
Primary outcomePrimary: Change From Baseline in HbA1c 26 Weeks After Randomisation — -0.12; 0.005; -0.09 percentage of HbA1c — p=<0.001
◆ Published Evidence
Established
54citations · ~7 / year
Fast-acting insulin aspart versus insulin aspart in the setting of insulin degludec-treated type 1 diabetes: Efficacy and safety from a randomized double-blind trial.
Summary
This trial is conducted in Asia, Europe and North America. The purpose is to confirm efficacy in terms of glycaemic control of treatment with mealtime faster-acting insulin aspart in combination with insulin degludec in adults with Type 1 Diabetes Mellitus.
Linked Publications (2)
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Fast-acting insulin aspart versus insulin aspart in the setting of insulin degludec-treated type 1 diabetes: Efficacy and safety from a randomized double-blind trial.
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Efficacy and Safety of Fast-Acting Insulin Aspart in People with Type 1 Diabetes Using Carbohydrate Counting: A Post Hoc Analysis of Two Randomised Controlled Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c 26 Weeks After Randomisation |
-0.12; 0.005; -0.09 | <0.001 sig |
| SECONDARY Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test) |
-1.13; 1.04; -0.15 | <0.001 sig |
| SECONDARY Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation |
0.22; -0.15; 0.22 | 0.924 |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation |
0.17; 0.44; 0.64 | — |
| SECONDARY Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation |
28.7; 28.2; 32.7; 71.3; 71.8; 67.3 | — |
| SECONDARY Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation |
25.7; 26.4; 30.4; 74.3; 73.6; 69.6 | — |
| SECONDARY Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation |
16.4; 17.9; 19.3; 83.6; 82.1; 80.7 | — |
| SECONDARY Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation |
-0.47; 1.31; 0.21; -1.05; 1.39; 0.20 | — |
| SECONDARY Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation |
-0.55; 0.94; -0.14; -1.13; 1.04; -0.15 | — |
| SECONDARY Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile |
-0.304; -0.231; -0.309 | — |
| SECONDARY Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) |
-0.83; -0.03; -0.31; -0.59; 0.06; -0.33 | — |
| SECONDARY Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) |
-1.14; 0.06; -0.30; -0.67; -0.08; -0.004 | — |
| SECONDARY Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Fluctuation in 7-9-7-point Profile |
0.876; 0.875; 0.890 | — |
| SECONDARY Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements |
0.14; 0.19; 0.45; 0.86; 0.93; 0.33 | — |
| SECONDARY Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L |
27.8; 19.9; 21.6; 72.2; 80.1; 78.4 | — |
| SECONDARY Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia |
24.6; 18.8; 20.5; 75.4; 81.2; 79.5 | — |
| SECONDARY Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia |
7.6; 4.7; 8.2; 92.4; 95.3; 91.8 | — |
| SECONDARY Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol) |
0.981; 0.998; 0.999; 1.025; 1.053; 1.062 | — |
| SECONDARY Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) |
25.5; 25.4; 26.6; 31.1; 30.5; 33.5 | — |
| SECONDARY Number of Treatment Emergent Adverse Events During 26 Weeks After Randomisation |
649; 656; 627 | — |
| SECONDARY Number of Treatment-emergent Injection Site Reactions During the 26 Weeks After Randomisation |
9; 12; 10 | — |
| SECONDARY Number of Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition During 26 Weeks After Randomisation: Overall |
15760; 16579; 16520 | — |
| SECONDARY Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) |
14570; 15379; 15257; 1190; 1200; 1263 | — |
| SECONDARY Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal |
624; 614; 459; 1314; 1470; 1224 | — |
| SECONDARY Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) |
97.4; 98.8; 97.7; 2.6; 0.9; 2.0 | — |
| SECONDARY Change From Baseline in Blood Pressure 26 Weeks After Randomisation |
0.5; 0.2; 0.8; 0.6; 1.4; 0.8 | — |
| SECONDARY Change From Baseline in Pulse 26 Weeks After Randomisation |
0.0; -0.7; 0.7 | — |
| SECONDARY Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation |
80.7; 81.8; 84.2; 19.3; 17.6; 15.8 | — |
| SECONDARY Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation |
65.8; 68.0; 69.3; 26.9; 23.5; 23.4 | — |
| SECONDARY Change From Baseline in Erythrocytes 26 Weeks After Randomisation |
-0.01; -0.03; -0.02 | — |
| SECONDARY Change From Baseline in Haematocrit 26 Weeks After Randomisation |
-0.48; -0.52; -0.57 | — |
| SECONDARY Change From Baseline in Haemoglobin 26 Weeks After Randomisation |
-0.04; -0.04; -0.05 | — |
| SECONDARY Change From Baseline in Leukocytes 26 Weeks After Randomisation |
-0.17; -0.03; -0.01 | — |
| SECONDARY Change From Baseline in Thrombocytes 26 Weeks After Randomisation |
-0.7; -2.0; -1.8 | — |
| SECONDARY Change From Baseline in Alanine Aminotransferase 26 Weeks After Randomisation |
1.3; 0.9; 0.6 | — |
| SECONDARY Change From Baseline in Albumin 26 Weeks After Randomisation |
-0.02; -0.05; -0.03 | — |
| SECONDARY Change From Baseline in Alkaline Phosphatase 26 Weeks After Randomisation |
2.1; 1.4; -0.2 | — |
| SECONDARY Change From Baseline in Aspartate Aminotransferase 26 Weeks After Randomisation |
-0.0; -0.1; -0.3 | — |
| SECONDARY Change From Baseline in Total Bilirubin 26 Weeks After Randomisation |
-0.1; -0.2; -0.2 | — |
| SECONDARY Change From Baseline in Potassium 26 Weeks After Randomisation |
0.01; 0.04; 0.04 | — |
| SECONDARY Change From Baseline in Creatinine 26 Weeks After Randomisation |
2.0; 1.8; 1.8 | — |
| SECONDARY Change From Baseline in Total Protein 26 Weeks After Randomisation |
0.03; 0.02; -0.02 | — |
| SECONDARY Change From Baseline in Urinary Albumin-to-creatinine Ratio 26 Weeks After Randomisation |
0.636; -0.379; 0.656 | — |
| SECONDARY Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation |
96.2; 97.1; 92.7; 0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation |
82.2; 79.5; 80.4; 0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation |
95.3; 93.3; 93.3; 0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation |
0.033; -0.027; -0.013; -0.972; -1.799; -1.427 | — |
| SECONDARY Change From Baseline in Body Weight 26 Weeks After Randomisation |
1.43; 1.14; 1.24 | — |
| SECONDARY Change From Baseline in Body Mass Index 26 Weeks After Randomisation |
0.49; 0.39; 0.43 | — |
Eligibility Criteria
Inclusion Criteria: - Male or female, age greater than or equal to 18 years ( for Japan and Taiwan: age greater than or equal to 20 years) at the time of signing informed consent - Type 1 Diabetes Mellitus (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) 12 months or more prior to screening - Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) - Currently treated with a basal insulin analogue for at least 4 months prior to screening (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory - Body Mass Index less than or equal to 35.0 kg/m^2 Exclusion Criteria: - Within the past 180 days any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack - Subjects presently classified as being in New York Heart Association (NYHA) Class IV Currently planned coronary, carotid or peripheral artery revascularisation - Diabetic ketoacidosis requiring hospitalisation within the last 180 days prior to screening (Visit 1) - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of three months before screening (Visit 1)
Data sourced from ClinicalTrials.gov (NCT02500706) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.