NCT02500706 (onset®8) is a Phase 3 clinical trial of Faster-acting insulin aspart in Diabetes, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT02500706?

NCT02500706 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT02500706?

Interventions in NCT02500706: Faster-acting insulin aspart, insulin aspart, insulin degludec.

What condition does NCT02500706 study?

NCT02500706 studies Diabetes, Diabetes Mellitus, Type 1.

Is NCT02500706 still recruiting?

NCT02500706 is currently completed. Last updated 12 June 2019.

Are results published for NCT02500706?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-06-12 · How we verify

NCT02500706: onset®8

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes

Completed Phase 3 Results posted Last updated 12 June 2019

What this trial tests

Phase 3 trial testing Faster-acting insulin aspart in Diabetes in 1,108 participants. Completed in 16 August 2017.

Timeline

4 May 2016

Primary endpoint
17 July 2017

16 August 2017

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	1,108
Start date	4 May 2016
Primary completion	17 July 2017
Estimated completion	16 August 2017
Sites	152 locations across Italy, Japan, Russia, Serbia, Austria, Taiwan, Germany, Israel

Drugs / interventions tested

Faster-acting insulin aspart — full drug profile →
insulin aspart (INSULIN ASPART) — full drug profile →
insulin degludec (INSULIN DEGLUDEC) — full drug profile →

Conditions studied

Diabetes — all drugs for Diabetes →
Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

18 and older, any sex, with Diabetes or Diabetes Mellitus, Type 1. 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 26 Weeks After Randomisation Primary · Week 0, week 26

Change from baseline (week 0) in HbA1c was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact.

Group	Value	95% CI
Faster Aspart (Meal)	-0.12	± 0.64
Faster Aspart (Post)	0.005	± 0.64
NovoRapid (Meal)	-0.09	± 0.65

Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test) Secondary · Week 0, week 26

The 1-hour PPG increment was analysed based on the laboratory-measured values in the meal test, and was derived using the 1-hour PPG measurement minus the pre-prandial plasma glucose (PG). The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Group	Value	95% CI
Faster Aspart (Meal)	-1.13	± 4.04
Faster Aspart (Post)	1.04	± 3.53
NovoRapid (Meal)	-0.15	± 3.78

Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation Secondary · Week 0, week 26

The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Group	Value	95% CI
Faster Aspart (Meal)	0.22	± 2.23
Faster Aspart (Post)	-0.15	± 2.10
NovoRapid (Meal)	0.22	± 2.25

Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation Secondary · Week 0, week 26

The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Group	Value	95% CI
Faster Aspart (Meal)	0.17	± 2.94
Faster Aspart (Post)	0.44	± 3.29
NovoRapid (Meal)	0.64	± 3.35

Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation Secondary · 26 weeks after randomisation

The percentage of subjects who achieved the HbA1c target of \<7.0% 26 weeks after randomisation. Subjects without an HbA1c measurement at week 26 were treated as non-responders.

Yes

Group	Value	95% CI
Faster Aspart (Meal)	28.7
Faster Aspart (Post)	28.2
NovoRapid (Meal)	32.7

Group	Value	95% CI
Faster Aspart (Meal)	71.3
Faster Aspart (Post)	71.8
NovoRapid (Meal)	67.3

Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation Secondary · 26 weeks after randomisation

The percentage of subjects who achieved the HbA1c target of \<7.0% without severe hypoglycaemia 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 were treated as non-responder

Yes

Group	Value	95% CI
Faster Aspart (Meal)	25.7
Faster Aspart (Post)	26.4
NovoRapid (Meal)	30.4

Group	Value	95% CI
Faster Aspart (Meal)	74.3
Faster Aspart (Post)	73.6
NovoRapid (Meal)	69.6

Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation Secondary · 26 weeks after randomisation

The percentage of subjects who achieved the HbA1c target of \<7.0% without severe hypoglycaemia and with minimal weight gain (defined as less than a 3% increase) 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects wit

Yes

Group	Value	95% CI
Faster Aspart (Meal)	16.4
Faster Aspart (Post)	17.9
NovoRapid (Meal)	19.3

Group	Value	95% CI
Faster Aspart (Meal)	83.6
Faster Aspart (Post)	82.1
NovoRapid (Meal)	80.7

Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation Secondary · Week 0, week 26

Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Change in PPG at 30 min

Group	Value	95% CI
Faster Aspart (Meal)	-0.47	± 3.58
Faster Aspart (Post)	1.31	± 3.52
NovoRapid (Meal)	0.21	± 3.78

Change in PPG at 1 hour

Group	Value	95% CI
Faster Aspart (Meal)	-1.05	± 4.56
Faster Aspart (Post)	1.39	± 4.44
NovoRapid (Meal)	0.20	± 4.52

Change in PPG at 2 hours

Group	Value	95% CI
Faster Aspart (Meal)	-0.41	± 5.17
Faster Aspart (Post)	0.80	± 5.38
NovoRapid (Meal)	0.33	± 5.51

Change in PPG at 3 hours

Group	Value	95% CI
Faster Aspart (Meal)	-0.12	± 5.20
Faster Aspart (Post)	0.93	± 5.06
NovoRapid (Meal)	0.51	± 5.33

Change in PPG at 4 hours

Group	Value	95% CI
Faster Aspart (Meal)	0.005	± 4.64
Faster Aspart (Post)	0.83	± 4.59
NovoRapid (Meal)	0.53	± 4.60

Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation Secondary · Week 0, week 26

Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The corresponding PPG increments were derived separately using each PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

Change in PPG increment at 30 min

Group	Value	95% CI
Faster Aspart (Meal)	-0.55	± 2.55
Faster Aspart (Post)	0.94	± 2.47
NovoRapid (Meal)	-0.14	± 2.63

Change in PPG increment at 1 hour

Group	Value	95% CI
Faster Aspart (Meal)	-1.13	± 4.04
Faster Aspart (Post)	1.04	± 3.53
NovoRapid (Meal)	-0.15	± 3.78

Change in PPG increment at 2 hours

Group	Value	95% CI
Faster Aspart (Meal)	-0.47	± 4.74
Faster Aspart (Post)	0.42	± 5.01
NovoRapid (Meal)	-0.01	± 5.15

Change in PPG increment at 3 hours

Group	Value	95% CI
Faster Aspart (Meal)	-0.20	± 4.89
Faster Aspart (Post)	0.55	± 4.95
NovoRapid (Meal)	0.11	± 5.32

Change in PPG increment at 4 hours

Group	Value	95% CI
Faster Aspart (Meal)	-0.10	± 4.47
Faster Aspart (Post)	0.45	± 4.44
NovoRapid (Meal)	0.16	± 4.63

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 Secondary · Week 0, week 26

The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. The mean of the 7-9-7-point profile was define

Group	Value	95% CI
Faster Aspart (Meal)	-0.304	± 1.928
Faster Aspart (Post)	-0.231	± 1.846
NovoRapid (Meal)	-0.309	± 2.060

Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) Secondary · Week 0, week 26

Change in PPG breakfast

Group	Value	95% CI
Faster Aspart (Meal)	-0.83	± 3.34
Faster Aspart (Post)	-0.03	± 3.30
NovoRapid (Meal)	-0.31	± 3.18

Change in PPG lunch

Group	Value	95% CI
Faster Aspart (Meal)	-0.59	± 3.04
Faster Aspart (Post)	0.06	± 2.98
NovoRapid (Meal)	-0.33	± 3.38

Change in PPG main evening meal

Group	Value	95% CI
Faster Aspart (Meal)	-0.53	± 3.55
Faster Aspart (Post)	-0.01	± 3.56
NovoRapid (Meal)	-0.14	± 3.22

Change in PPG all meals

Group	Value	95% CI
Faster Aspart (Meal)	-0.65	± 2.26
Faster Aspart (Post)	-0.004	± 2.19
NovoRapid (Meal)	-0.25	± 2.33

Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) Secondary · Week 0, week 26

Change in PPG increment breakfast

Group	Value	95% CI
Faster Aspart (Meal)	-1.14	± 3.64
Faster Aspart (Post)	0.06	± 3.51
NovoRapid (Meal)	-0.30	± 3.16

Change in PPG increment lunch

Group	Value	95% CI
Faster Aspart (Meal)	-0.67	± 3.20
Faster Aspart (Post)	-0.08	± 3.10
NovoRapid (Meal)	-0.004	± 3.31

Change in PPG increment main evening meal

Group	Value	95% CI
Faster Aspart (Meal)	-0.29	± 3.70
Faster Aspart (Post)	0.34	± 3.54
NovoRapid (Meal)	0.26	± 3.49

Change in PPG increment all meals

Group	Value	95% CI
Faster Aspart (Meal)	-0.72	± 2.06
Faster Aspart (Post)	0.08	± 1.98
NovoRapid (Meal)	-0.02	± 2.01

Adverse events — posted to ClinicalTrials.gov

Time frame: Week 0 to week 26 (+7 days). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Faster Aspart (Meal)

Serious: 20/342 (6%)

Deaths: 0/342

Faster Aspart (Post)

Serious: 17/341 (5%)

Deaths: 0/341

NovoRapid (Meal)

Serious: 17/342 (5%)

Deaths: 0/342

Serious adverse events (38 terms)

Reaction	System	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Hypoglycaemia	Metabolism and nutrition disorders	—	—	—
Hypoglycaemic unconsciousness	Nervous system disorders	—	—	—
Hypoglycaemic seizure	Nervous system disorders	—	—	—
Polyneuropathy	Nervous system disorders	—	—	—
Wrong drug administered	Injury, poisoning and procedural complications	—	—	—
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Blood glucose fluctuation	Investigations	—	—	—
Bursitis	Musculoskeletal and connective tissue disorders	—	—	—
Cellulitis	Infections and infestations	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—
Chest pain	General disorders	—	—	—
Cholecystitis	Hepatobiliary disorders	—	—	—
Collagen disorder	Musculoskeletal and connective tissue disorders	—	—	—
Depression	Psychiatric disorders	—	—	—
Diabetic metabolic decompensation	Metabolism and nutrition disorders	—	—	—
Diabetic neuropathy	Nervous system disorders	—	—	—
Diverticulitis	Infections and infestations	—	—	—
Extradural haematoma	Injury, poisoning and procedural complications	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—
Femoral neck fracture	Injury, poisoning and procedural complications	—	—	—
Forearm fracture	Injury, poisoning and procedural complications	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—
Haemorrhoid operation	Surgical and medical procedures	—	—	—
Hypoglycaemia unawareness	Metabolism and nutrition disorders	—	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	Faster Aspart (Meal)	Faster Aspart (Post)	NovoRapid (Meal)
Viral upper respiratory tract infection	Infections and infestations	—	—	—
Blood glucose decreased	Investigations	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Influenza	Infections and infestations	—	—	—

Most-reported serious reactions: Hypoglycaemia, Hypoglycaemic unconsciousness, Hypoglycaemic seizure, Polyneuropathy, Wrong drug administered, Bladder transitional cell carcinoma, Blood glucose fluctuation, Bursitis.

Data from ClinicalTrials.gov NCT02500706 adverse events section.

Sponsor's own description

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.

Publications & conference data

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

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.
Buse JB, Carlson AL, Komatsu M, Mosenzon O, et al · · 2018 · cited 38× · PMID 30259644 · DOI 10.1111/dom.13545
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.
Rose L, Kadowaki T, Pieber TR, Buchholtz K, et al · · 2019 · cited 3× · PMID 30949906 · DOI 10.1007/s13300-019-0608-4

Verify or expand the search:

Other trials of Faster-acting insulin aspart

Trials testing the same drug.

NCT03987802 — An Indian Post Marketing Study of Mealtime Insulin, Fiasp®, to Evaluate Its Safety and Effectiveness in Patients With Di · completed
NCT03268005 — Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/" · Phase 3 · completed
NCT03215498 — A Research Study of How Faster-acting Insulin Aspart Moves Into, Through, and Out of the Body and How it Works in the Bo · Phase 1 · completed
NCT02933853 — A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects Wit · Phase 1 · completed
NCT02825251 — Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® i · Phase 3 · completed

Other recruiting trials for Diabetes

Currently open trials in the same condition.

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Other Novo Nordisk A/S trials

Trials by the same sponsor.

NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes · Phase 2 · not yet recruiting
NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles · Phase 3 · not yet recruiting
NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02500706 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
Last refreshed: 12 June 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02500706.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing