Trial · NCT01831765
Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes
NCT01831765, Phase 3, Completed, Novo Nordisk A/S; results first posted 2018-01-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes. Trials, record NCT01831765. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01831765
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes
- NCT number
- NCT01831765
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,290 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Interventions
- Faster-acting insulin aspart, insulin detemir, insulin aspart, Faster-acting insulin aspart
- First posted
- 2013-04-15
- Last updated
- 2019-06-12
- Other registries' IDs
- eudract:2010-024049-53
- Results first posted
- 2018-01-23
- Limitations and caveats
- Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in HbA1c (Glycosylated Haemoglobin) | Week 0, week 26 | Change from baseline in HbA1c after 26 weeks of randomised treatment. |
| Secondary | Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test) | Week 0, week 26 | Change from baseline in 2-hour PPG increments after 26 weeks of randomised treatment (meal test). |
| Secondary | Change From Baseline in HbA1c (Post Meal Arm) | Week 0, week 26 | Change from baseline in HbA1c (post meal arm) after 26 weeks of randomised treatment. |
| Secondary | Number of Treatment Emergent Confirmed Hypoglycaemic Episodes | From baseline until week 26 | Observed rate of treatment emergent severe or BG confirmed hypoglycaemic events per 100 patient years of exposure (PYE) from baseline until 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 randomised treatment and no later than 1 day after the last day of randomised treatment. Severe or BG confirmed is an episode that is severe according to the American Diabetes Association (ADA) classification (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \<3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia. |
| Secondary | Change From Baseline in Body Weight | Week 0, week 26 | Change from baseline in body weight after 26 weeks of randomised treatment. |
| Secondary | Frequency of Adverse Events | After 52 weeks of randomised treatment | All treatment emergent adverse events (TEAEs) from baseline until 52 weeks of randomised treatment. A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment. |
| Secondary | Change in HbA1c | Week 0, week 52 | Change from baseline in HbA1c (%) after 52 weeks of randomised treatment. |
| Secondary | Change in PPG (Postprandial Glucose) | Week 0, week 52 | Change from baseline in PPG and PPG increment (meal test) after 52 weeks of randomised treatment. |
Source ClinicalTrials.gov
Outcomes8
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 (Glycosylated Haemoglobin) | Week 0, week 26 | The FAS included all randomised subjects. For this endpoint, baseline and week 26 have been presented, where week 26 data is end of trial containing last available measurement. | Percentage of glycosylated haemoglobin | MEAN |
| SECONDARY | Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test) | Week 0, week 26 | The FAS included all randomised subjects. For this endpoint, baseline and week 26 have been presented, where week 26 data is end of trial containing last available measurement. At baseline (week 0) 379, 377, 375 and 381, 382, 380 subjects at week 26 were analysed for faster aspart (meal), faster aspart (post) and Novorapid (meal) arms respectively. | mmol/L | MEAN |
| SECONDARY | Change From Baseline in HbA1c (Post Meal Arm) | Week 0, week 26 | This endpoint was summarised using the FAS, which included all randomised subjects. For this endpoint, baseline and week 26 have been presented, where week 26 data is end of trial containing last available measurement. | Percentage of glycosylated haemoglobin | MEAN |
| SECONDARY | Number of Treatment Emergent Confirmed Hypoglycaemic Episodes | From baseline until week 26 | The safety analysis set included all subjects receiving at least one dose of trial product/its comparator and contributed to the evaluation as treated. Five (5) subjects randomised to the faster aspart (post) group have consistently taken their bolus insulin before meals throughout the trial and are handled as treated with faster aspart (meal). | event rate/100 patient yrs of exposure | NUMBER |
| SECONDARY | Change From Baseline in Body Weight | Week 0, week 26 | The FAS included all randomised subjects. For this endpoint baseline, and week 26 have been presented, where week 26 data is end of trial containing last available measurement. At baseline (week 0) 381, 382, 378 and 381, 382, 380 subjects at week 26 were analysed for faster aspart (meal), faster aspart (post) and Novorapid (meal) arms respectively. | Kg | MEAN |
| SECONDARY | Frequency of Adverse Events | After 52 weeks of randomised treatment | The safety analysis set included all subjects receiving at least one dose of trial product/its comparator and contributed to the evaluation as treated. Five (5) subjects randomised to the faster aspart (post) group have consistently taken their bolus insulin before meals throughout the trial and are handled as treated with faster aspart (meal). | event /100 patient yrs of exposure | NUMBER |
| SECONDARY | Change in HbA1c | Week 0, week 52 | The FAS included all randomised subjects. The statistical evaluation of the FAS was to follow the ITT principle and subjects contributed to the evaluation 'as randomised'. For this endpoint, baseline and week 52 have been presented, where week 52 data is the end of trial containing last available measurement. | Percentage of glycosylated haemoglobin | MEAN |
| SECONDARY | Change in PPG (Postprandial Glucose) | Week 0, week 52 | The FAS included all randomised subjects. The number of subjects with data available for PPG at 120 mins at baseline were 379, 379 and 380, 380 at week 52 and for PPG increment (120 mins) at baseline were 379, 375 and 381, 380 at week 26 for faster aspart (meal) and Novorapid (meal) respectively. | mmol/L | MEAN |
Source ClinicalTrials.gov
Results by group40
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 (Glycosylated Haemoglobin) | Faster Aspart (Meal) | Week 0 (Baseline) | 7.62 | Standard Deviation 0.71 | Percentage of glycosylated haemoglobin |
| Change From Baseline in HbA1c (Glycosylated Haemoglobin) | Faster Aspart (Post) | Week 0 (Baseline) | 7.63 | Standard Deviation 0.72 | Percentage of glycosylated haemoglobin |
| Change From Baseline in HbA1c (Glycosylated Haemoglobin) | NovoRapid (Meal) | Week 0 (Baseline) | 7.58 | Standard Deviation 0.68 | Percentage of glycosylated haemoglobin |
| Change From Baseline in HbA1c (Glycosylated Haemoglobin) | Faster Aspart (Meal) | Week 26 | 7.31 | Standard Deviation 0.77 | Percentage of glycosylated haemoglobin |
| Change From Baseline in HbA1c (Glycosylated Haemoglobin) | Faster Aspart (Post) | Week 26 | 7.51 | Standard Deviation 0.77 | Percentage of glycosylated haemoglobin |
| Change From Baseline in HbA1c (Glycosylated Haemoglobin) | NovoRapid (Meal) | Week 26 | 7.42 | Standard Deviation 0.78 | Percentage of glycosylated haemoglobin |
| Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test) | Faster Aspart (Meal) | Week 0: Baseline | 6.06 | Standard Deviation 5.16 | mmol/L |
| Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test) | Faster Aspart (Post) | Week 0: Baseline | 6.06 | Standard Deviation 4.9 | mmol/L |
| Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test) | NovoRapid (Meal) | Week 0: Baseline | 6.24 | Standard Deviation 4.81 | mmol/L |
| Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test) | Faster Aspart (Meal) | Week 26 | 5.88 | Standard Deviation 4.67 | mmol/L |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Faster Aspart (Meal) | 381 | |
| Overall Study | STARTED | Faster Aspart (Post) | 382 | |
| Overall Study | STARTED | NovoRapid (Meal) | 380 | |
| Overall Study | Completed 26 Weeks | Faster Aspart (Meal) | 351 | |
| Overall Study | Completed 26 Weeks | Faster Aspart (Post) | 355 | |
| Overall Study | Completed 26 Weeks | NovoRapid (Meal) | 356 | |
| Overall Study | Completed 52 Weeks | Faster Aspart (Meal) | 337 | |
| Overall Study | Completed 52 Weeks | Faster Aspart (Post) | 0 | |
| Overall Study | Completed 52 Weeks | NovoRapid (Meal) | 338 | |
| Overall Study | COMPLETED | Faster Aspart (Meal) | 337 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events234
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 | Back pain | Musculoskeletal and connective tissue disorders | Faster Aspart (Meal) | 28 | 386 | 36 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Faster Aspart (Post) | 15 | 377 | 17 |
| other | Back pain | Musculoskeletal and connective tissue disorders | NovoRapid (Meal) | 20 | 380 | 22 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Faster Aspart (Meal) | 17 | 386 | 21 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Faster Aspart (Post) | 12 | 377 | 13 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | NovoRapid (Meal) | 20 | 380 | 21 |
| other | Diarrhoea | Gastrointestinal disorders | Faster Aspart (Meal) | 27 | 386 | 34 |
| other | Diarrhoea | Gastrointestinal disorders | Faster Aspart (Post) | 11 | 377 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | NovoRapid (Meal) | 27 | 380 | 33 |
| other | Gastroenteritis | Infections and infestations | Faster Aspart (Meal) | 20 | 386 | 25 |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Faster Aspart (Meal) | ||
| Total, all-cause mortality | Faster Aspart (Post) | ||
| Total, all-cause mortality | NovoRapid (Meal) | ||
| Total, other adverse events | Faster Aspart (Meal) | 252 | 386 |
| Total, other adverse events | Faster Aspart (Post) | 189 | 377 |
| Total, other adverse events | NovoRapid (Meal) | 236 | 380 |
| Total, serious adverse events | Faster Aspart (Meal) | 35 | 386 |
| Total, serious adverse events | Faster Aspart (Post) | 28 | 377 |
| Total, serious adverse events | NovoRapid (Meal) | 33 | 380 |
Source ClinicalTrials.gov
Papers6
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.
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