A Phase 3 interventional study of Valsartan 160 mg + nateglinide 60 mg and Valsartan 160 mg + nateglinide placebo in Diabetes Mellitus, Type 2, sponsored by Novartis Pharmaceuticals. Completed at 38 sites in 38 countries. Open to participants aged 50 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-11-08.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Prevention
This study is a test of the safety and effectiveness of two drugs, one for diabetes and one for hypertension, in keeping patients with high lab values of glucose from progressing to frank diabetes and developing cardiovascular complications. People in this study cannot have frank diabetes but are considered "borderline" based on blood tests. People in the study take none, one or both of the drugs and do not know which one(s) they are taking.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 9,306 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
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For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily, ante cibum \[ac\] before meals) and valsartan 80 mg (once daily \[od\] in the morning). After 2 weeks, patients were up-titrated to nateglinide 60 mg ac and valsartan 160 mg od.
Drug: Valsartan 160 mg + nateglinide 60 mg
For the first 2 weeks of treatment, patients took valsartan 80 mg capsules (once daily \[od\] in the morning). After 2 weeks, patients were up-titrated to 160 mg valsartan od. Patients also received nateglinide placebo tablets (3 times daily, ante cibum \[ac\] before meals).
Drug: Valsartan 160 mg + nateglinide placebo
For the first 2 weeks of treatment, patients took nateglinide 30 mg tablets (3 times daily, ante cibum \[ac\] before meals). After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received valsartan placebo capsules (once daily \[od\] in the morning).
Drug: Nateglinide 60 mg + valsartan placebo
Patients took 3 nateglinide placebo tablets (3 times daily, ante cibum \[ac\] before meals) and 1 valsartan placebo capsule (once daily \[od\] in the morning).
Drug: Valsartan placebo + nateglinide placebo
Drug page: Valsartan
The double-blinding of the randomized study medication was maintained by the use of identical placebo and active tablets and capsules for nateglinide and valsartan, respectively. Patients were instructed not to take the morning dose of either medication nor to eat breakfast on the day of a scheduled study visit, but to wait until after the visit was completed. Patients not tolerating the higher dose (Level 2) were down-titrated to receive Level 1. Patients not tolerating the lower dose (Level 1) had a treatment interruption. Starting at Week 2 and throughout the study, attempts were to be made to reach the highest dose level (Level 2), if medically acceptable. Following each change in dose level or re-initiation of treatment, tolerability was assessed after 2 weeks of exposure.
The double-blinding of the randomized study medication was maintained by the use of identical placebo and active tablets and capsules for nateglinide and valsartan, respectively. Patients were instructed not to take the morning dose of either medication nor to eat breakfast on the day of a scheduled study visit, but to wait until after the visit was completed. Patients not tolerating the higher dose (Level 2) were down-titrated to receive Level 1. Patients not tolerating the lower dose (Level 1) had a treatment interruption. Starting at Week 2 and throughout the study, attempts were to be made to reach the highest dose level (Level 2), if medically acceptable. Following each change in dose level or re-initiation of treatment, tolerability was assessed after 2 weeks of exposure.
The double-blinding of the randomized study medication was maintained by the use of identical placebo and active tablets and capsules for nateglinide and valsartan, respectively. Patients were instructed not to take the morning dose of either medication nor to eat breakfast on the day of a scheduled study visit, but to wait until after the visit was completed. Patients not tolerating the higher dose (Level 2) were down-titrated to receive Level 1. Patients not tolerating the lower dose (Level 1) had a treatment interruption. Starting at Week 2 and throughout the study, attempts were to be made to reach the highest dose level (Level 2), if medically acceptable. Following each change in dose level or re-initiation of treatment, tolerability was assessed after 2 weeks of exposure.
The double-blinding of the randomized study medication was maintained by the use of identical placebo and active tablets and capsules for nateglinide and valsartan, respectively. Patients were instructed not to take the morning dose of either medication nor to eat breakfast on the day of a scheduled study visit, but to wait until after the visit was completed. Patients not tolerating the higher dose (Level 2) were down-titrated to receive Level 1. Patients not tolerating the lower dose (Level 1) had a treatment interruption. Starting at Week 2 and throughout the study, attempts were to be made to reach the highest dose level (Level 2), if medically acceptable. Following each change in dose level or re-initiation of treatment, tolerability was assessed after 2 weeks of exposure.
Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan
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.
Time frame: Mean patient duration of 4.2 years
Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Valsartan Versus Non-valsartan
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.
Time frame: Mean patient duration of 5.6 years
Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Valsartan Versus Non-valsartan
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.
Time frame: Mean patient duration of 5.8 years
Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Nateglinide Versus Non-nateglinide
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.
Time frame: Mean patient duration of 4.2 years
Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide
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.
Time frame: Mean patient duration of 5.6 years
Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide
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.
Time frame: Mean patient duration of 5.8 years
Initially enrolled 9518, 212 excluded.
| Milestone | Valsartan 160 mg od + Nateglinide 60 mg ac | Valsartan 160 mg od + Placebo Nateglinide | Nateglinide 60 mg ac + Placebo Valsartan | Placebo |
|---|---|---|---|---|
| Started | 2316 | 2315 | 2329 | 2346 |
| Complete fu for progression to diabetes | 1709 | 1712 | 1734 | 1762 |
| Complete follow-up for extended cv eps | 1969 | 1985 | 1987 | 2015 |
| Complete follow-up for core cv eps | 1948 | 1963 | 1966 | 1988 |
| Completed | 2020 | 2023 | 2016 | 2036 |
| Not completed | 296 | 292 | 313 | 310 |
| Withdrew: Lost to follow-up for all-cause death | 296 | 292 | 313 | 310 |
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.
| Percentage of patients | Valsartan | Non-valsartan |
|---|---|---|
| Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan | 33.1 | 36.8 |
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.
| Percentage of patients | Valsartan | Non-valsartan |
|---|---|---|
| Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Valsartan Versus Non-valsartan | 14.5 | 14.8 |
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.
| Percentage of patients | Valsartan | Non-valsartan |
|---|---|---|
| Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Valsartan Versus Non-valsartan | 8.1 | 8.1 |
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.
| Percentage of patients | Nateglinide | Non-nateglinide |
|---|---|---|
| Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Nateglinide Versus Non-nateglinide | 36.0 | 33.9 |
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.
| Percentage of patients | Nateglinide | Non-nateglinide |
|---|---|---|
| Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide | 14.2 | 15.2 |
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.
| Percentage of patients | Nateglinide | Non-nateglinide |
|---|---|---|
| Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide | 7.9 | 8.3 |
Collected over The maximum follow-up time was 7.7 years with the mean follow-up time of approximately 6 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Valsartan 160 mg od + Nateglinide 60 mg ac | — | 1,031/2,297 (44.9%) | 1,970/2,297 (85.8%) |
| Valsartan 160 mg od + Placebo Nateglinide | — | 1,040/2,283 (45.6%) | 1,932/2,283 (84.6%) |
| Nateglinide 60 mg ac + Placebo Valsartan | — | 1,035/2,305 (44.9%) | 1,951/2,305 (84.6%) |
| Placebo | — | 1,049/2,316 (45.3%) | 1,934/2,316 (83.5%) |
| Event | Valsartan 160 mg od + Nateglinide 60 mg ac | Valsartan 160 mg od + Placebo Nateglinide | Nateglinide 60 mg ac + Placebo Valsartan | Placebo |
|---|---|---|---|---|
| Angina pectorisCardiac disorders | 92/2297 | 99/2283 | 71/2305 | 74/2316 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 77/2297 | 92/2283 | 92/2305 | 93/2316 |
| Angina unstableCardiac disorders | 46/2297 | 63/2283 | 61/2305 | 60/2316 |
| Atrial fibrillationCardiac disorders | 60/2297 | 46/2283 | 57/2305 | 63/2316 |
| FallInjury, poisoning and procedural complications | 46/2297 | 47/2283 | 59/2305 | 36/2316 |
| Coronary artery diseaseCardiac disorders | 43/2297 | 37/2283 | 50/2305 | 42/2316 |
| CholelithiasisHepatobiliary disorders | 26/2297 | 28/2283 | 48/2305 | 30/2316 |
| PneumoniaInfections and infestations | 47/2297 | 33/2283 | 41/2305 | 43/2316 |
| Myocardial infarctionCardiac disorders | 46/2297 | 41/2283 | 46/2305 | 46/2316 |
| Non-cardiac chest painGeneral disorders | 45/2297 | 33/2283 | 33/2305 | 46/2316 |
| Event | Valsartan 160 mg od + Nateglinide 60 mg ac | Valsartan 160 mg od + Placebo Nateglinide | Nateglinide 60 mg ac + Placebo Valsartan | Placebo |
|---|---|---|---|---|
| HypotensionVascular disorders | 732/2297 | 717/2283 | 582/2305 | 542/2316 |
| HypoglycaemiaMetabolism and nutrition disorders | 455/2297 | 271/2283 | 454/2305 | 251/2316 |
| HypertensionVascular disorders | 293/2297 | 302/2283 | 392/2305 | 444/2316 |
| DizzinessNervous system disorders | 440/2297 | 379/2283 | 397/2305 | 351/2316 |
| NasopharyngitisInfections and infestations | 396/2297 | 410/2283 | 408/2305 | 385/2316 |
| Back painMusculoskeletal and connective tissue disorders | 398/2297 | 358/2283 | 339/2305 | 326/2316 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 369/2297 | 377/2283 | 377/2305 | 367/2316 |
| InfluenzaInfections and infestations | 301/2297 | 309/2283 | 299/2305 | 315/2316 |
| HeadacheNervous system disorders | 242/2297 | 289/2283 | 306/2305 | 311/2316 |
| DiarrhoeaGastrointestinal disorders | 305/2297 | 299/2283 | 278/2305 | 277/2316 |
| Age, Continuous(years) | Valsartan 160 mg od + Nateglinide 60 mg ac | Valsartan 160 mg od + Placebo Nateglinide | Nateglinide 60 mg ac + Placebo Valsartan | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 63.7 ± 6.75 | 63.7 ± 6.91 | 63.8 ± 6.82 | 63.9 ± 6.88 | 63.8 ± 6.84 |
| Sex: Female, Male(Participants) | Valsartan 160 mg od + Nateglinide 60 mg ac | Valsartan 160 mg od + Placebo Nateglinide | Nateglinide 60 mg ac + Placebo Valsartan | Placebo | Total |
|---|---|---|---|---|---|
| Female | 1174 | 1140 | 1194 | 1203 | 4711 |
| Male | 1142 | 1175 | 1135 | 1143 | 4595 |
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Studies of the drug tested here: Valsartan