Trial · NCT02034513
A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes
NCT02034513, Phase 3, Completed, Novo Nordisk A/S; results first posted 2017-05-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes. Trials, record NCT02034513. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02034513
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes
- NCT number
- NCT02034513
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 501 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Interventions
- insulin degludec, insulin glargine, insulin aspart
- First posted
- 2014-01-13
- Last updated
- 2019-01-02
- Other registries' IDs
- eudract:2012-001930-32
- Results first posted
- 2017-05-15
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Treatment Emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period | A 16-week treatment period. | Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of \<3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Maintenance period: 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64). |
| Secondary | Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episodes During the Maintenance Period | After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64) | Severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of \<3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia and with time of onset between 00:01 and 05.59 a.m., both inclusive. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. |
| Secondary | Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period | After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64) | Percentage of subjects who experienced one or more severe hypoglycaemic episodes during the maintenance period. Severe hypoglycaemia (according to the American Diabetes Association 2013 definition): A hypoglycaemic episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose values 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. |
| Secondary | Incidence of Treatment Emergent Adverse Events | During 32 weeks of treatment for each treatment period | Treatment emergent adverse event was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. |
| Secondary | Change From Baseline in HbA1c (Glycosylated Haemoglobin) | Week 32, Week 64 | Change from baseline in HbA1c (glycosylated haemoglobin) at week 32 (treatment period 1) and at week 64 (treatment period 2). Week 32 HbA1c absolute value was considered as baseline for calculating change from baseline in HbA1c at week 64. |
| Secondary | FPG (Fasting Plasma Glucose) | Week 32 and Week 64 | Fasting plasma glucose values at week 32 and week 64. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Treatment Emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period | A 16-week treatment period. | The trial followed a cross over design. Descriptive analysis was based on the safety analysis set (SAS: subjects receiving at least 1 dose of the investigational product, IDeg or its comparator, IGlar). Number of subjects analysed=subjects in the SAS, who were exposed in at least one maintenance period. | Event | NUMBER |
| SECONDARY | Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episodes During the Maintenance Period | After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64) | The trial followed a cross over design. Descriptive analysis was based on the SAS. Number of subjects analysed=subjects in the SAS, who were exposed in at least one maintenance period. | Event | NUMBER |
| SECONDARY | Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period | After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64) | The trial followed a cross over design. Descriptive analysis was based on the SAS. Number of subjects analysed=subjects in the SAS, who were exposed in at least one maintenance period. | Percentage of subjects | NUMBER |
| SECONDARY | Incidence of Treatment Emergent Adverse Events | During 32 weeks of treatment for each treatment period | The trial followed a cross over design. Results are based on the SAS. | Event | NUMBER |
| SECONDARY | Change From Baseline in HbA1c (Glycosylated Haemoglobin) | Week 32, Week 64 | Both descriptive analysis and statistical analysis were based on the FAS. Here, 'n' specifies the number of subjects with available data at specified time-point. | Percentage of glycosylated haemoglobin | MEAN |
| SECONDARY | FPG (Fasting Plasma Glucose) | Week 32 and Week 64 | Results are based on the FAS. Here, 'n' specifies the number of subjects with available data at specified time-point. | mmol/L | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Treatment Emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period | Insulin Degludec (IDeg) | 2772 | Event | ||
| Number of Treatment Emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period | Insulin Glargine (IGlar) | 3126 | Event | ||
| Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episodes During the Maintenance Period | Insulin Degludec (IDeg) | 349 | Event | ||
| Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episodes During the Maintenance Period | Insulin Glargine (IGlar) | 544 | Event | ||
| Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period | Insulin Degludec (IDeg) | 10.3 | Percentage of subjects | ||
| Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period | Insulin Glargine (IGlar) | 17.1 | Percentage of subjects | ||
| Incidence of Treatment Emergent Adverse Events | Insulin Degludec (IDeg) | 925 | Event | ||
| Incidence of Treatment Emergent Adverse Events | Insulin Glargine (IGlar) | 937 | Event | ||
| Change From Baseline in HbA1c (Glycosylated Haemoglobin) | Insulin Degludec/Insulin Glargine (IDeg/IGlar) | week 32 (n=209, 205) | -0.73 | Standard Deviation 0.89 | Percentage of glycosylated haemoglobin |
| Change From Baseline in HbA1c (Glycosylated Haemoglobin) | Insulin Glargine/Insulin Degludec (IGlar/IDeg) | week 32 (n=209, 205) | -0.66 | Standard Deviation 0.76 | Percentage of glycosylated haemoglobin |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Insulin Degludec/Insulin Glargine (IDeg/IGlar) | 249 | |
| Overall Study | STARTED | Insulin Glargine/Insulin Degludec (IGlar/IDeg) | 252 | |
| Overall Study | Exposed | Insulin Degludec/Insulin Glargine (IDeg/IGlar) | 249 | |
| Overall Study | Exposed | Insulin Glargine/Insulin Degludec (IGlar/IDeg) | 251 | |
| Overall Study | COMPLETED | Insulin Degludec/Insulin Glargine (IDeg/IGlar) | 200 | |
| Overall Study | COMPLETED | Insulin Glargine/Insulin Degludec (IGlar/IDeg) | 195 | |
| Overall Study | NOT COMPLETED | Insulin Degludec/Insulin Glargine (IDeg/IGlar) | 49 | |
| Overall Study | NOT COMPLETED | Insulin Glargine/Insulin Degludec (IGlar/IDeg) | 57 |
Source ClinicalTrials.gov
Adverse events130
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 | Nasopharyngitis | Infections and infestations | Insulin Degludec (IDeg) | 68 | 454 | 92 |
| other | Nasopharyngitis | Infections and infestations | Insulin Glargine (IGlar) | 61 | 460 | 73 |
| other | Upper respiratory tract infection | Infections and infestations | Insulin Degludec (IDeg) | 29 | 454 | 34 |
| other | Upper respiratory tract infection | Infections and infestations | Insulin Glargine (IGlar) | 39 | 460 | 41 |
| serious | Abdominal pain | Gastrointestinal disorders | Insulin Degludec (IDeg) | 0 | 454 | 0 |
| serious | Abdominal pain | Gastrointestinal disorders | Insulin Glargine (IGlar) | 1 | 460 | 1 |
| serious | Accidental overdose | Injury, poisoning and procedural complications | Insulin Degludec (IDeg) | 2 | 454 | 2 |
| serious | Accidental overdose | Injury, poisoning and procedural complications | Insulin Glargine (IGlar) | 3 | 460 | 3 |
| serious | Acute coronary syndrome | Cardiac disorders | Insulin Degludec (IDeg) | 0 | 454 | 0 |
| serious | Acute coronary syndrome | Cardiac disorders | Insulin Glargine (IGlar) | 1 | 460 | 1 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Insulin Degludec (IDeg) | ||
| Total, all-cause mortality | Insulin Glargine (IGlar) | ||
| Total, other adverse events | Insulin Degludec (IDeg) | 97 | 454 |
| Total, other adverse events | Insulin Glargine (IGlar) | 97 | 460 |
| Total, serious adverse events | Insulin Degludec (IDeg) | 58 | 454 |
| Total, serious adverse events | Insulin Glargine (IGlar) | 70 | 460 |
Source ClinicalTrials.gov
Papers3
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 |
|---|
| Insulin Degludec (IDeg) vs Insulin Glargine (IGlar): 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/NCT02034513
GET https://conductscience.org/api/trials/v1/NCT02034513/events?page=2