Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Complications (Navigator)

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Valsartan 160 mg + nateglinide 60 mg; Drug: Nateglinide 60 mg + valsartan placebo; Drug: Valsartan 160 mg + nateglinide placebo; Drug: Valsartan placebo + nateglinide placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00097786

CDJN608B2302

Details and patient eligibility

About

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.

Enrollment: 9,306 patients

Sex: All

Ages: 50 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults
• Impaired glucose tolerance
• Age dependent risk factors

Exclusion criteria

• Frank diabetes

For detailed information, call contact person.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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9,306 participants in 4 patient groups, including a placebo group

Valsartan 160 mg + nateglinide 60 mg

Experimental group

Description:

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.

Treatment:

Drug: Valsartan 160 mg + nateglinide 60 mg

Valsartan 160 mg + nateglinide placebo

Experimental group

Description:

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).

Treatment:

Drug: Valsartan 160 mg + nateglinide placebo

Nateglinide 60 mg + valsartan placebo

Experimental group

Description:

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).

Treatment:

Drug: Nateglinide 60 mg + valsartan placebo

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: Valsartan placebo + nateglinide placebo