Trial · NCT00982228
Comparison of NN1250 Plus Insulin Aspart With Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes
NCT00982228, Phase 3, Completed, Novo Nordisk A/S; results first posted 2015-12-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of NN1250 Plus Insulin Aspart With Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes. Trials, record NCT00982228. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00982228
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of NN1250 Plus Insulin Aspart With Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes
- NCT number
- NCT00982228
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 629 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Interventions
- insulin degludec, insulin glargine, insulin aspart
- First posted
- 2009-09-23
- Last updated
- 2017-04-06
- Other registries' IDs
- eudract:2008-005774-13, eudract:2009-015755-24
- Results first posted
- 2015-12-29
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment | Week 0, Week 52 | Change from baseline in HbA1c after 52 weeks of treatment |
| Primary | Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) | Week 0 to Week 104 + 7 days follow up | Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. |
| Primary | Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes | Week 0 to Week 104 + 7 days follow up | Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. |
| Primary | Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin | Week 0, Week 106 | The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing and after a 1-week wash-out period. |
| Secondary | Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes | Week 0 to Week 104 + 7 days follow up | Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m. |
| Secondary | Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment | Week 0, Week 104 | Change from baseline in HbA1c after 104 weeks of treatment |
| Secondary | Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 of Treatment | Treatment week 104 | Mean of 9-point self-measured plasma glucose profile (SMPG) after 104 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast. |
| Secondary | Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes | Week 0 to Week 52 + 7 days follow up | Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. |
| Secondary | Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes | Week 0 to Week 52 + 7 days follow up | Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m. |
| Secondary | Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52 | Week 52 | Mean of 9-point self-measured plasma glucose profile (SMPG) after 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment | Week 0, Week 52 | The full analysis set (FAS) included all randomised subjects and missing data was imputed using LOCF (last observation carried forward). | percentage of glycosylated haemoglobin | MEAN |
| PRIMARY | Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) | Week 0 to Week 104 + 7 days follow up | Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial. | Events/100 years of patient exposure | NUMBER |
| PRIMARY | Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes | Week 0 to Week 104 + 7 days follow up | The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial. | Episodes/100 years of patient exposure | NUMBER |
| SECONDARY | Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes | Week 0 to Week 104 + 7 days follow up | The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial. | Episodes/100 years of patient exposure | NUMBER |
| PRIMARY | Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin | Week 0, Week 106 | The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial. | %B/T | MEAN |
| SECONDARY | Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment | Week 0, Week 104 | The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. | percentage of glycosylated haemoglobin | MEAN |
| SECONDARY | Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 of Treatment | Treatment week 104 | The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 12 subjects all 9-point SMPG values were missing. | mmol/L | MEAN |
| SECONDARY | Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes | Week 0 to Week 52 + 7 days follow up | The SAS included all subjects who received at least one dose of the investigational product or its comparator. | Episodes/100 years of patient exposure | NUMBER |
| SECONDARY | Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes | Week 0 to Week 52 + 7 days follow up | The SAS included all subjects who received at least one dose of the investigational product or its comparator. | Episodes/100 years of patient exposure | NUMBER |
| SECONDARY | Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52 | Week 52 | The FAS included all randomised subjects and missing data was imputed using LOCF. For 7 subjects all 9-point SMPG values were missing. | mmol/L | MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment | IDeg OD | -0.40 | Standard Deviation 0.73 | percentage of glycosylated haemoglobin | |
| Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment | IGlar OD | -0.39 | Standard Deviation 0.84 | percentage of glycosylated haemoglobin | |
| Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) | IDeg OD | Adverse events (AE) | 383 | Events/100 years of patient exposure | |
| Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) | IGlar OD | Adverse events (AE) | 374 | Events/100 years of patient exposure | |
| Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) | IDeg OD | Serious AE | 14 | Events/100 years of patient exposure | |
| Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) | IGlar OD | Serious AE | 17 | Events/100 years of patient exposure | |
| Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) | IDeg OD | Severe AE | 22 | Events/100 years of patient exposure | |
| Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) | IGlar OD | Severe AE | 26 | Events/100 years of patient exposure | |
| Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) | IDeg OD | Moderate AE | 105 | Events/100 years of patient exposure | |
| Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) | IGlar OD | Moderate AE | 106 | Events/100 years of patient exposure |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main: Week 0 to 52 (NN1250-3583) | STARTED | IDeg OD | 472 | |
| Main: Week 0 to 52 (NN1250-3583) | STARTED | IGlar OD | 157 | |
| Main: Week 0 to 52 (NN1250-3583) | Full Analysis Set | IDeg OD | 472 | |
| Main: Week 0 to 52 (NN1250-3583) | Full Analysis Set | IGlar OD | 157 | |
| Main: Week 0 to 52 (NN1250-3583) | Exposed | IDeg OD | 472 | |
| Main: Week 0 to 52 (NN1250-3583) | Exposed | IGlar OD | 154 | |
| Main: Week 0 to 52 (NN1250-3583) | COMPLETED | IDeg OD | 404 | |
| Main: Week 0 to 52 (NN1250-3583) | COMPLETED | IGlar OD | 137 | |
| Main: Week 0 to 52 (NN1250-3583) | NOT COMPLETED | IDeg OD | 68 | |
| Main: Week 0 to 52 (NN1250-3583) | NOT COMPLETED | IGlar OD | 20 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events170
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 | Diarrhoea | Gastrointestinal disorders | IDeg OD | 39 | 472 | 44 |
| other | Diarrhoea | Gastrointestinal disorders | IGlar OD | 9 | 154 | 12 |
| other | Nausea | Gastrointestinal disorders | IDeg OD | 40 | 472 | 57 |
| other | Nausea | Gastrointestinal disorders | IGlar OD | 14 | 154 | 18 |
| other | Vomiting | Gastrointestinal disorders | IDeg OD | 25 | 472 | 26 |
| other | Vomiting | Gastrointestinal disorders | IGlar OD | 11 | 154 | 15 |
| other | Bronchitis | Infections and infestations | IDeg OD | 38 | 472 | 46 |
| other | Bronchitis | Infections and infestations | IGlar OD | 11 | 154 | 17 |
| other | Gastroenteritis | Infections and infestations | IDeg OD | 44 | 472 | 49 |
| other | Gastroenteritis | Infections and infestations | IGlar OD | 9 | 154 | 10 |
1 to 10 of 170Source ClinicalTrials.gov
See all 170 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IDeg OD | ||
| Total, all-cause mortality | IGlar OD | ||
| Total, other adverse events | IDeg OD | 353 | 472 |
| Total, other adverse events | IGlar OD | 118 | 154 |
| Total, serious adverse events | IDeg OD | 71 | 472 |
| Total, serious adverse events | IGlar OD | 29 | 154 |
Source ClinicalTrials.gov
Papers9
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| IDeg OD vs IGlar OD: serious adverse events |
Source Trial comparisons
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/NCT00982228
GET https://conductscience.org/api/trials/v1/NCT00982228/results?page=2