Phase 3
Completed N=1,091
Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes
Source: ClinicalTrials.gov NCT03268005 ↗Enrolled (actual)
1,091
Serious AEs
7.2%
Results posted
Mar 2020
Primary outcomePrimary: Change in Glycosylated Haemoglobin (HbA1c) — -0.15; -0.09 Percentage of HbA1c — p=0.310
◆ Published Evidence
Established
26citations · ~4 / year
A Randomized Trial Evaluating the Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec With or Without Metformin, in Adults With Type 2 Diabetes (ONSET 9).
Summary
The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe). Fast-acting insulin aspart will be tested to see how well it works and if it is safe. Participants will get either fast-acting insulin aspart or NovoRapid®/ NovoLog® - which treatment you get is decided by chance. Both medicines will be taken together with insulin degludec. Participants will need to take 1 injection 4 times every day (all insulins will be provided in pens). The study will last for about 8 months (34 weeks).
Linked Publications (2)
-
A Randomized Trial Evaluating the Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec With or Without Metformin, in Adults With Type 2 Diabetes (ONSET 9).
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Effective Overall Glycaemic Control with Fast-Acting Insulin Aspart Across Patients with Different Baseline Characteristics: A Post Hoc Analysis of the Onset 9 Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin (HbA1c) |
-0.15; -0.09 | 0.310 |
| SECONDARY Change From Baseline in 1-hour PPG Increment |
-0.43; 0.08 | — |
| SECONDARY Change From Baseline in 1,5-anhydroglucitol |
1.38; 0.89 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) |
0.56; 0.68 | — |
| SECONDARY Participants Who Achieved HbA1c <7.0% (53 mmol/L) (Yes/No) |
271; 282; 275; 263 | — |
| SECONDARY Participants Who Achieved HbA1c <7.0% (53 mmol/L) Without Severe Hypoglycaemia Episodes (Yes/No) |
265; 278; 281; 267 | — |
| SECONDARY Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test]) |
0.31; 0.55; 0.03; 0.68; 0.08; 0.61 | — |
| SECONDARY Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test) |
-0.13; -0.05; -0.43; 0.08; -0.37; 0.001 | — |
| SECONDARY Change From Baseline in Mean of the 7-9-7 Point Self-measured Plasma Glucose (SMPG) Profile |
-0.56; -0.50 | — |
| SECONDARY Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal) |
-0.38; -0.28; -0.78; -0.58; -1.04; -0.71 | — |
| SECONDARY Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal) |
-0.56; -0.42; -0.38; -0.23; -0.44; -0.10 | — |
| SECONDARY Change From Baseline of the 7-9-7 Point SMPG Profile: Fluctuation in 7-9-7 Point Profile |
0.82; 0.85 | — |
| SECONDARY Change From Baseline of the 7-9-7 Point SMPG Profile: Nocturnal SMPG Measurements |
0.70; 0.29; 1.30; 0.90; 0.66; 0.75 | — |
| SECONDARY Participants Who Achieved Overall PPG (1 Hour) <7.8 mmol/L (140 mg/dL) (Yes/No) |
186; 192; 360; 353 | — |
| SECONDARY Participants Who Achieved Overall PPG <7.8 mmol/L (140 mg/dL) Without Severe Hypoglycaemia Episodes (Yes/No) |
182; 190; 364; 355 | — |
| SECONDARY Total Bolus Insulin Dose: in Units/Day |
54.72; 53.38 | — |
| SECONDARY Total Bolus Insulin Dose: in Units/kg/Day |
0.57; 0.55 | — |
| SECONDARY Total Basal Insulin Dose: in Units/Day |
63.76; 62.25 | — |
| SECONDARY Total Basal Insulin Dose: in Units/kg/Day |
0.66; 0.64 | — |
| SECONDARY Individual Meal Insulin Dose: in Units |
16.27; 15.52; 18.51; 17.96; 19.88; 19.85 | — |
| SECONDARY Individual Meal Insulin Dose: in Units/kg |
0.17; 0.16; 0.19; 0.19; 0.21; 0.20 | — |
| SECONDARY Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) - Ratio to Baseline |
1.01; 1.00; 0.97; 0.98; 0.99; 0.99 | — |
| SECONDARY Number of Treatment Emergent Adverse Events |
667; 643 | — |
| SECONDARY Number of Treatment Emergent Injection Site Reactions |
3; 1 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall |
18; 14; 5038; 6165; 3761; 3681 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive) |
16; 12; 4703; 5700; 3617; 3484 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) |
2; 2; 335; 465; 144; 197 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal |
2; 0; 149; 148; 87; 80 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal |
2; 1; 465; 446; 201; 159 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal |
6; 9; 1627; 1882; 852; 744 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal |
4; 8; 1162; 1436; 651; 585 | — |
| SECONDARY Change From Baseline in Physical Examination |
459; 460; 79; 79; 6; 5 | — |
| SECONDARY Change From Baseline in Vital Signs: Systolic and Diastolic Blood Presure |
0.4; -1.2; -0.4; -0.7 | — |
| SECONDARY Change From Baseline in Vital Signs: Pulse |
0.5; 0.03 | — |
| SECONDARY Change From Baseline in Electrocardiogram (ECG) |
287; 270; 252; 264; 5; 10 | — |
| SECONDARY Change From Baseline in Fundoscopy/Fundus Photography |
225; 219; 287; 297; 32; 27 | — |
| SECONDARY Change From Baseline in Haematology - Haematocrit |
0.48; 0.35 | — |
| SECONDARY Change From Baseline in Haematology - Haemoglobin |
-0.02; -0.04 | — |
| SECONDARY Change From Baseline in Haematology - Leukocytes |
0.01; -0.01 | — |
| SECONDARY Change From Baseline in Haematology - Thrombocytes |
-0.9; -1.3 | — |
| SECONDARY Change From Baseline in Haematology - Erythrocytes |
-0.02; -0.04 | — |
| SECONDARY Change From Baseline in Biochemistry - Alanine Aminotransferase (ALT) |
-0.1; 3.1 | — |
| SECONDARY Change From Baseline in Biochemistry - Alkaline Phosphatase |
2.9; 2.2 | — |
| SECONDARY Change From Baseline in Biochemistry - Aspartate Aminotransferase (AST) |
-0.2; 2.2 | — |
| SECONDARY Change From Baseline in Biochemistry - Albumin |
0.02; 0.01 | — |
| SECONDARY Change From Baseline in Biochemistry - Creatinine |
0.1; 1.5 | — |
| SECONDARY Change From Baseline in Biochemistry - Potassium |
-0.001; 0.02 | — |
| SECONDARY Change From Baseline in Biochemistry - Sodium |
-0.6; -0.7 | — |
| SECONDARY Change From Baseline in Biochemistry - Total Bilirubin |
0.1; 0.1 | — |
| SECONDARY Change From Baseline in Biochemistry - Total Protein |
-0.01; -0.02 | — |
| SECONDARY Change From Baseline in Body Weight |
1.19; 1.12 | — |
| SECONDARY Change From Baseline in Body Mass Index (BMI) |
0.43; 0.40 | — |
Eligibility Criteria
Inclusion Criteria: - Male or female, age equal to or above 18 years at the time of signing informed consent. - Diagnosed with type 2 diabetes mellitus for 10 years or longer prior to screening (Visit 1). - Treated with a basal-bolus insulin regimen for 1 year or longer prior to the day of screening (Visit 1). A basal-bolus insulin regimen is defined as basal insulin once or twice daily and bolus insulin analogue taken with meals at least 3 times daily. Treatment with premixed insulin or soluble insulin combination is not considered a basal-bolus regimen. - Treated with or without oral antidiabetic drugs including extended release formulations. - HbA1c 7.0-10.0% (both inclusive) as assessed by central laboratory at screening (Visit 1). Exclusion Criteria: - Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening (Visit 1). - Subjects presently classified as being in New York Heart Association (NYHA) Class IV. - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening (Visit 1). - Treatment with injectable GLP-1 receptor agonists in a period of 90 days prior to screening (Visit 1). - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).
Data sourced from ClinicalTrials.gov (NCT03268005) 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.