Trial · NCT00659295
Observational Study to Evaluate the Safety of Levemir® in Diabetes
NCT00659295, Completed, Novo Nordisk A/S; results first posted 2011-08-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Observational Study to Evaluate the Safety of Levemir® in Diabetes. Trials, record NCT00659295. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00659295
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Observational Study to Evaluate the Safety of Levemir® in Diabetes
- NCT number
- NCT00659295
- Status
- Completed
- Enrollment
- 51,170 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Interventions
- insulin detemir
- First posted
- 2008-04-16
- Last updated
- 2017-03-10
- Results first posted
- 2011-08-16
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events | Months 0-12 | The incidence of serious adverse reactions (SARs), including major hypoglycaemic events, during 3 months of insulin detemir therapy for all countries participating in the study, and during 6 and 12 months of insulin detemir therapy for some of the participating countries. The three sub-groups were mutually exclusive. Physicians did not report all major hypoglycaemic events as SARs. The values in the SAE table are SARs including only those major hypoglycaemic events that were reported as SARs by physicians. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events | Months 0-12 | FAS (Full Analysis Set) consists of all patients with a baseline visit who were prescribed insulin detemir at least once | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events | Type 1 Diabetes | 3 months sub-group | 186 | participants | |
| Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events | Type 2 Diabetes | 3 months sub-group | 93 | participants | |
| Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events | Type 1 Diabetes | 6 months sub-group | 208 | participants | |
| Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events | Type 2 Diabetes | 6 months sub-group | 112 | participants | |
| Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events | Type 1 Diabetes | 12 months sub-group | 109 | participants | |
| Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events | Type 2 Diabetes | 12 months sub-group | 48 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Type 1 Diabetes | 13,529 | |
| Overall Study | STARTED | Type 2 Diabetes | 37,641 | |
| Overall Study | COMPLETED | Type 1 Diabetes | 10,821 | |
| Overall Study | COMPLETED | Type 2 Diabetes | 32,038 | |
| Overall Study | NOT COMPLETED | Type 1 Diabetes | 2,708 | |
| Overall Study | NOT COMPLETED | Type 2 Diabetes | 5,603 |
Source ClinicalTrials.gov
Adverse events152
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 |
|---|---|---|---|---|---|---|
| serious | Ventricular extrasystoles | Cardiac disorders | Type 1 Diabetes | 0 | 13,529 | 0 |
| serious | Ventricular extrasystoles | Cardiac disorders | Type 2 Diabetes | 1 | 37,641 | 1 |
| serious | Cardiac failure | Cardiac disorders | Type 1 Diabetes | 0 | 13,529 | 0 |
| serious | Cardiac failure | Cardiac disorders | Type 2 Diabetes | 1 | 37,641 | 1 |
| serious | Cardiac arrest | Cardiac disorders | Type 1 Diabetes | 0 | 13,529 | 0 |
| serious | Cardiac arrest | Cardiac disorders | Type 2 Diabetes | 1 | 37,641 | 1 |
| serious | Cardiac failure congestive | Cardiac disorders | Type 1 Diabetes | 0 | 13,529 | 0 |
| serious | Cardiac failure congestive | Cardiac disorders | Type 2 Diabetes | 1 | 37,641 | 1 |
| serious | Cardio-respiratory arrest | Cardiac disorders | Type 1 Diabetes | 0 | 13,529 | 0 |
| serious | Cardio-respiratory arrest | Cardiac disorders | Type 2 Diabetes | 1 | 37,641 | 1 |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Type 1 Diabetes | ||
| Total, all-cause mortality | Type 2 Diabetes | ||
| Total, other adverse events | Type 1 Diabetes | 0 | 13,529 |
| Total, other adverse events | Type 2 Diabetes | 0 | 37,641 |
| Total, serious adverse events | Type 1 Diabetes | 130 | 13,529 |
| Total, serious adverse events | Type 2 Diabetes | 80 | 37,641 |
Source ClinicalTrials.gov
Papers17
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 |
|---|
| Type 1 Diabetes vs Type 2 Diabetes: 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/NCT00659295
GET https://conductscience.org/api/trials/v1/NCT00659295/events?page=2