NCT01819129: onset® 2

Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes

Completed Phase 3 Results posted Last updated 30 January 2019

What this trial tests

Phase 3 trial testing Faster-acting insulin aspart in Diabetes in 881 participants. Completed in 22 January 2015.

Timeline

9 September 2013

Primary endpoint
22 January 2015

22 January 2015

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	881
Start date	9 September 2013
Primary completion	22 January 2015
Estimated completion	22 January 2015
Sites	144 locations across Slovakia, Russia, Serbia, United Kingdom, Israel, Canada, Puerto Rico, Croatia

Drugs / interventions tested

• Faster-acting insulin aspart — full drug profile →
• Insulin aspart (INSULIN ASPART) — full drug profile →
• Insulin glargine (INSULIN GLARGINE) — full drug profile →

Conditions studied

• Diabetes — all drugs for Diabetes →
• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

18 and older, any sex, with Diabetes or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in HbA1c Primary · Week 0, Week 26

The primary endpoint was change from baseline in HbA1c after 26 weeks of randomized treatment. For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.

Baseline (week 0)

Group	Value	95% CI
Faster Aspart	7.96	± 0.68
NovoRapid	7.89	± 0.71

Week 26

Group	Value	95% CI
Faster Aspart	6.63	± 0.88
NovoRapid	6.59	± 0.84

Change From Baseline in 2-hour PPG Increment (Meal Test) Secondary · Week 0, week 26

For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.

Baseline (week 0)

Group	Value	95% CI
Faster Aspart	7.57	± 3.19
NovoRapid	7.34	± 3.12

Week 26

Group	Value	95% CI
Faster Aspart	4.55	± 3.13
NovoRapid	4.9	± 3.36

Number of Treatment Emergent Confirmed Hypoglycaemic Episodes Secondary · From Week 0 to Week 26.

A hypoglycaemic episode was defined as treatment-emergent if the onset of the episode was on or after the first day of exposure to randomized treatment and no later than 1 day after the last day of randomized treatment. A severe or blood glucose (BG) confirmed hypoglycaemic episode was an episode that was severe according to the American Diabetes Association (ADA) classification (an episode that required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with or without

Group	Value	95% CI
Faster Aspart	2857
NovoRapid	2692

Change From Baseline in Body Weight Secondary · Week 0, week 26

For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.

Baseline (week 0)

Group	Value	95% CI
Faster Aspart	89.0	± 16.9
NovoRapid	88.3	± 16.7

Week 26

Group	Value	95% CI
Faster Aspart	91.6	± 18.2
NovoRapid	90.8	± 17.7

Adverse events — posted to ClinicalTrials.gov

Time frame: All treatment-emergent adverse events (AEs) were collected from the date on or after the first day of exposure to randomized treatment until no later than 7 days after the last day of randomised treatment. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Faster Aspart

Serious: 15/341 (4%)

Deaths: —

NovoRapid

Serious: 24/341 (7%)

Deaths: —

Serious adverse events (37 terms)

Reaction	System	Faster Aspart	NovoRapid
Hypoglycaemia	Metabolism and nutrition disorders	—	—
Carotid artery stenosis	Nervous system disorders	—	—
Fall	Injury, poisoning and procedural complications	—	—
Transient ischaemic attack	Nervous system disorders	—	—
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Acute myocardial infarction	Cardiac disorders	—	—
Angina unstable	Cardiac disorders	—	—
Arteriogram coronary	Investigations	—	—
Aural polyp	Ear and labyrinth disorders	—	—
Bacteraemia	Infections and infestations	—	—
Cardiac myxoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Cardiomyopathy	Cardiac disorders	—	—
Carotid artery occlusion	Nervous system disorders	—	—
Cellulitis	Infections and infestations	—	—
Cholecystectomy	Surgical and medical procedures	—	—
Cholecystitis infective	Infections and infestations	—	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—	—
Colitis ischaemic	Gastrointestinal disorders	—	—
Coronary artery bypass	Surgical and medical procedures	—	—
Coronary artery occlusion	Cardiac disorders	—	—
Diabetic foot	Skin and subcutaneous tissue disorders	—	—
Gastric polyps	Gastrointestinal disorders	—	—
Hypertension	Vascular disorders	—	—
Inguinal hernia	Gastrointestinal disorders	—	—
Ischaemic stroke	Nervous system disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Faster Aspart	NovoRapid
Nasopharyngitis	Infections and infestations	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—

Most-reported serious reactions: Hypoglycaemia, Carotid artery stenosis, Fall, Transient ischaemic attack, Transitional cell carcinoma, Acute myocardial infarction, Angina unstable, Arteriogram coronary.

Data from ClinicalTrials.gov NCT01819129 adverse events section.

Sponsor's own description

This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare FIAsp (faster-acting insulin aspart) to insulin aspart, both in combination with insulin glargine and metformin in adults with type 2 diabetes.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mealtime fast-acting insulin aspart versus insulin aspart for controlling postprandial hyperglycaemia in people with insulin-resistant Type 2 diabetes.
   Bowering K, Harvey J, Kolaczynski JW, Snyder JW, et al · · 2019 · cited 7× · PMID 30466191 · DOI 10.1111/dme.13866
2. Prediction of Hypoglycemia From Continuous Glucose Monitoring in Insulin-Treated Patients With Type 2 Diabetes Using Transfer Learning on Type 1 Diabetes Data: A Deep Transfer Learning Approach.
   Thomsen HB, Jakobsen MM, Hecht-Pedersen N, Jensen MH, et al · · 2025 · cited 6× · PMID 38014538 · DOI 10.1177/19322968231215324
3. Abstracts of 52nd EASD Annual Meeting.
   · 2016 · cited 6× · PMID 27539147 · DOI 10.1007/s00125-016-4046-9
4. Bedtime Prediction of Nocturnal Hypoglycemia in Insulin-Treated Type 2 Diabetes Patients.
   Kronborg T, Hangaard S, Hejlesen O, Vestergaard P, et al · · 2024 · cited 5× · PMID 36514195 · DOI 10.1177/19322968221141736
5. Investigating the Association Between Baseline Characteristics (HbA1c and Body Mass Index) and Clinical Outcomes of Fast-Acting Insulin Aspart in People with Diabetes: A Post Hoc Analysis.
   Bowering K, Rodbard HW, Russell-Jones D, Bode B, et al · · 2019 · cited 3× · PMID 30547388 · DOI 10.1007/s13300-018-0553-7
6. Personalized Prediction of Change in Fasting Blood Glucose Following Basal Insulin Adjustment in People With Type 2 Diabetes: A Proof-of-Concept Study.
   Thomsen CHN, Kronborg T, Hangaard S, Vestergaard P, et al · · 2025 · cited 1× · PMID 37786283 · DOI 10.1177/19322968231201400
7. Prediction of People With Type 2 Diabetes Not Achieving HbA1c Target After Initiation of Fast-Acting Insulin Therapy: Using Machine Learning Framework on Clinical Trial Data.
   Stoltenberg CW, Hangaard S, Hejlesen O, Kronborg T, et al · · 2025 · PMID 39305031 · DOI 10.1177/19322968241280096