Trial · NCT00097786
Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Complications
NCT00097786, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2011-05-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Complications. Trials, record NCT00097786. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00097786
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Complications
- NCT number
- NCT00097786
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 9,306 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Valsartan 160 mg + nateglinide 60 mg, Valsartan 160 mg + nateglinide placebo, Nateglinide 60 mg + valsartan placebo, Valsartan placebo + nateglinide placebo
- First posted
- 2004-12-01
- Last updated
- 2023-11-08
- Results first posted
- 2011-05-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan | Mean patient duration of 4.2 years | Progression to diabetes was determined by (a) an algorithm based on central laboratory measurements of fasting plasma glucose and/or a 2 hour oral glucose tolerance test or (b) adjudication by the Diabetes Endpoint Adjudication Committee. |
| Primary | Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Valsartan Versus Non-valsartan | Mean patient duration of 5.6 years | The extended cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, revascularization procedure, hospitalization for congestive heart failure, and hospitalization for unstable angina. |
| Primary | Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Valsartan Versus Non-valsartan | Mean patient duration of 5.8 years | The core cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure. |
| Primary | Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Nateglinide Versus Non-nateglinide | Mean patient duration of 4.2 years | Progression to diabetes was determined by (a) an algorithm based on central laboratory measurements of fasting plasma glucose and/or a 2 hour oral glucose tolerance test or (b) adjudication by the Diabetes Endpoint Adjudication Committee. |
| Primary | Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide | Mean patient duration of 5.6 years | The extended cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, revascularization procedure, hospitalization for congestive heart failure, and hospitalization for unstable angina. |
| Primary | Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide | Mean patient duration of 5.8 years | The core cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure. |
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 | Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan | Mean patient duration of 4.2 years | Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies. | Percentage of patients | NUMBER |
| PRIMARY | Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Valsartan Versus Non-valsartan | Mean patient duration of 5.6 years | Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies. | Percentage of patients | NUMBER |
| PRIMARY | Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Valsartan Versus Non-valsartan | Mean patient duration of 5.8 years | Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies. | Percentage of patients | NUMBER |
| PRIMARY | Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Nateglinide Versus Non-nateglinide | Mean patient duration of 4.2 years | Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies. | Percentage of patients | NUMBER |
| PRIMARY | Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide | Mean patient duration of 5.6 years | Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies. | Percentage of patients | NUMBER |
| PRIMARY | Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide | Mean patient duration of 5.8 years | Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies. | Percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan | Valsartan | 33.1 | Percentage of patients | ||
| Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan | Non-valsartan | 36.8 | Percentage of patients | ||
| Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Valsartan Versus Non-valsartan | Valsartan | 14.5 | Percentage of patients | ||
| Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Valsartan Versus Non-valsartan | Non-valsartan | 14.8 | Percentage of patients | ||
| Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Valsartan Versus Non-valsartan | Valsartan | 8.1 | Percentage of patients | ||
| Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Valsartan Versus Non-valsartan | Non-valsartan | 8.1 | Percentage of patients | ||
| Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Nateglinide Versus Non-nateglinide | Nateglinide | 36.0 | Percentage of patients | ||
| Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Nateglinide Versus Non-nateglinide | Non-nateglinide | 33.9 | Percentage of patients | ||
| Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide | Nateglinide | 14.2 | Percentage of patients | ||
| Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide | Non-nateglinide | 15.2 | Percentage of patients |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Valsartan 160 mg od + Nateglinide 60 mg ac | 2,316 | |
| Overall Study | STARTED | Valsartan 160 mg od + Placebo Nateglinide | 2,315 | |
| Overall Study | STARTED | Nateglinide 60 mg ac + Placebo Valsartan | 2,329 | |
| Overall Study | STARTED | Placebo | 2,346 | |
| Overall Study | Complete FU for Progression to Diabetes | Valsartan 160 mg od + Nateglinide 60 mg ac | 1,709 | |
| Overall Study | Complete FU for Progression to Diabetes | Valsartan 160 mg od + Placebo Nateglinide | 1,712 | |
| Overall Study | Complete FU for Progression to Diabetes | Nateglinide 60 mg ac + Placebo Valsartan | 1,734 | |
| Overall Study | Complete FU for Progression to Diabetes | Placebo | 1,762 | |
| Overall Study | Complete Follow-up for Extended CV EPs | Valsartan 160 mg od + Nateglinide 60 mg ac | 1,969 | |
| Overall Study | Complete Follow-up for Extended CV EPs | Valsartan 160 mg od + Placebo Nateglinide | 1,985 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events6,816
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 | Angina pectoris | Cardiac disorders | Valsartan 160 mg od + Nateglinide 60 mg ac | 114 | 2,297 | |
| other | Angina pectoris | Cardiac disorders | Valsartan 160 mg od + Placebo Nateglinide | 110 | 2,283 | |
| other | Angina pectoris | Cardiac disorders | Nateglinide 60 mg ac + Placebo Valsartan | 125 | 2,305 | |
| other | Angina pectoris | Cardiac disorders | Placebo | 119 | 2,316 | |
| other | Vertigo | Ear and labyrinth disorders | Valsartan 160 mg od + Nateglinide 60 mg ac | 106 | 2,297 | |
| other | Vertigo | Ear and labyrinth disorders | Valsartan 160 mg od + Placebo Nateglinide | 117 | 2,283 | |
| other | Vertigo | Ear and labyrinth disorders | Nateglinide 60 mg ac + Placebo Valsartan | 108 | 2,305 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 100 | 2,316 | |
| other | Cataract | Eye disorders | Valsartan 160 mg od + Nateglinide 60 mg ac | 148 | 2,297 | |
| other | Cataract | Eye disorders | Valsartan 160 mg od + Placebo Nateglinide | 160 | 2,283 |
1 to 10 of 6,816Source ClinicalTrials.gov
See all 6,816 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Valsartan 160 mg od + Nateglinide 60 mg ac | ||
| Total, all-cause mortality | Valsartan 160 mg od + Placebo Nateglinide | ||
| Total, all-cause mortality | Nateglinide 60 mg ac + Placebo Valsartan | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Valsartan 160 mg od + Nateglinide 60 mg ac | 1,970 | 2,297 |
| Total, other adverse events | Valsartan 160 mg od + Placebo Nateglinide | 1,932 | 2,283 |
| Total, other adverse events | Nateglinide 60 mg ac + Placebo Valsartan | 1,951 | 2,305 |
| Total, other adverse events | Placebo | 1,934 | 2,316 |
| Total, serious adverse events | Valsartan 160 mg od + Nateglinide 60 mg ac | 1,031 | 2,297 |
| Total, serious adverse events | Valsartan 160 mg od + Placebo Nateglinide | 1,040 | 2,283 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers12
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/NCT00097786
GET https://conductscience.org/api/trials/v1/NCT00097786/flow?page=2