Trial · NCT02500706
Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes
NCT02500706, Phase 3, Completed, Novo Nordisk A/S; results first posted 2018-08-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes. Trials, record NCT02500706. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02500706
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes
- NCT number
- NCT02500706
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,108 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Interventions
- Faster-acting insulin aspart, insulin aspart, insulin degludec
- First posted
- 2015-07-16
- Last updated
- 2019-06-12
- Other registries' IDs
- eudract:2015-001047-36
- Results first posted
- 2018-08-10
Source ClinicalTrials.gov
Registered outcomes49
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in HbA1c 26 Weeks After Randomisation | 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. |
| Secondary | Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test) | 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. |
| Secondary | Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation | 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. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation | 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. |
| Secondary | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation | 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. |
| Secondary | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation | 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-responders. |
| Secondary | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation | 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 without an HbA1c measurement at week 26 or without body weight measurement at week 26 were treated as non-responders. |
| Secondary | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation | 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. |
| Secondary | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation | 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. |
| 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 | 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 defined as the area under the curve profile divided by the measurement time, and was calculated using the linear trapezoidal technique. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 registered outcomesOutcomes49
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in HbA1c 26 Weeks After Randomisation | Week 0, week 26 | Analysis was based on FAS. Number of subjects analysed=subject with data available for HbA1c. | percentage of HbA1c | MEAN |
| SECONDARY | Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test) | Week 0, week 26 | Analysis was based on FAS. Number of subjects analysed=subject with data available for 1-hour PPG and pre-prandial PG. | mmol/L | MEAN |
| SECONDARY | Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation | Week 0, week 26 | Analysis was based on FAS. Number of subjects analysed=subject with data available for 1,5-anhydroglucitol. | ug/mL | MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation | Week 0, week 26 | Analysis was based on FAS. Number of subjects analysed=subject with data available for HbA1c. | mmol/L | MEAN |
| SECONDARY | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation | 26 weeks after randomisation | Analysis was based on FAS. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation | 26 weeks after randomisation | Analysis was based on FAS. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation | 26 weeks after randomisation | Analysis was based on FAS. | percentage of subjects | NUMBER |
| SECONDARY | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation | Week 0, week 26 | Analysis was based on FAS. Number of analysed=subject with data available for PPG at individual timepoints. | mmol/L | MEAN |
| SECONDARY | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation | Week 0, week 26 | Analysis was based on FAS. Number of analysed=subject with data available for PPG and pre-prandial PG at individual timepoints. | mmol/L | MEAN |
| 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 | Week 0, week 26 | Analysis was based on FAS. Number of analysed=subject with data available for 7-9-7 point profile. | mmol/L | MEAN |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 outcomesResults by group543
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in HbA1c 26 Weeks After Randomisation | Faster Aspart (Meal) | -0.12 | Standard Deviation 0.64 | percentage of HbA1c | |
| Change From Baseline in HbA1c 26 Weeks After Randomisation | Faster Aspart (Post) | 0.005 | Standard Deviation 0.64 | percentage of HbA1c | |
| Change From Baseline in HbA1c 26 Weeks After Randomisation | NovoRapid (Meal) | -0.09 | Standard Deviation 0.65 | percentage of HbA1c | |
| Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test) | Faster Aspart (Meal) | -1.13 | Standard Deviation 4.04 | mmol/L | |
| Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test) | Faster Aspart (Post) | 1.04 | Standard Deviation 3.53 | mmol/L | |
| Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test) | NovoRapid (Meal) | -0.15 | Standard Deviation 3.78 | mmol/L | |
| Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation | Faster Aspart (Meal) | 0.22 | Standard Deviation 2.23 | ug/mL | |
| Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation | Faster Aspart (Post) | -0.15 | Standard Deviation 2.10 | ug/mL | |
| Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation | NovoRapid (Meal) | 0.22 | Standard Deviation 2.25 | ug/mL | |
| Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation | Faster Aspart (Meal) | 0.17 | Standard Deviation 2.94 | mmol/L |
1 to 10 of 543Source ClinicalTrials.gov
See all 543 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Faster Aspart (Meal) | 342 | |
| Overall Study | STARTED | Faster Aspart (Post) | 341 | |
| Overall Study | STARTED | NovoRapid (Meal) | 342 | |
| Overall Study | Exposed | Faster Aspart (Meal) | 342 | |
| Overall Study | Exposed | Faster Aspart (Post) | 341 | |
| Overall Study | Exposed | NovoRapid (Meal) | 342 | |
| Overall Study | COMPLETED | Faster Aspart (Meal) | 338 | |
| Overall Study | COMPLETED | Faster Aspart (Post) | 334 | |
| Overall Study | COMPLETED | NovoRapid (Meal) | 335 | |
| Overall Study | NOT COMPLETED | Faster Aspart (Meal) | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events126
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood glucose decreased | Investigations | Faster Aspart (Meal) | 58 | 342 | 81 |
| other | Blood glucose decreased | Investigations | Faster Aspart (Post) | 67 | 341 | 83 |
| other | Blood glucose decreased | Investigations | NovoRapid (Meal) | 68 | 342 | 82 |
| other | Influenza | Infections and infestations | Faster Aspart (Meal) | 21 | 342 | 22 |
| other | Influenza | Infections and infestations | Faster Aspart (Post) | 14 | 341 | 14 |
| other | Influenza | Infections and infestations | NovoRapid (Meal) | 10 | 342 | 10 |
| other | Upper respiratory tract infection | Infections and infestations | Faster Aspart (Meal) | 30 | 342 | 38 |
| other | Upper respiratory tract infection | Infections and infestations | Faster Aspart (Post) | 26 | 341 | 34 |
| other | Upper respiratory tract infection | Infections and infestations | NovoRapid (Meal) | 27 | 342 | 34 |
| other | Viral upper respiratory tract infection | Infections and infestations | Faster Aspart (Meal) | 73 | 342 | 101 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Faster Aspart (Meal) | 0 | 342 |
| Total, all-cause mortality | Faster Aspart (Post) | 0 | 341 |
| Total, all-cause mortality | NovoRapid (Meal) | 0 | 342 |
| Total, other adverse events | Faster Aspart (Meal) | 154 | 342 |
| Total, other adverse events | Faster Aspart (Post) | 152 | 341 |
| Total, other adverse events | NovoRapid (Meal) | 161 | 342 |
| Total, serious adverse events | Faster Aspart (Meal) | 20 | 342 |
| Total, serious adverse events | Faster Aspart (Post) | 17 | 341 |
| Total, serious adverse events | NovoRapid (Meal) | 17 | 342 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02500706
GET https://conductscience.org/api/trials/v1/NCT02500706/registered?page=2