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Long-term Study of Starlix+Diovan to Delay Type II Diabetes Mellitus - Article


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Spondyloepimetaphyseal dysplasia, Strudwick type

Dappled metaphysis syndrome; SED Strudwick; SEMD, Strudwick type; SMED, Strudwick type; SMED, type I; Spondylometaepiphyseal dysplasia congenita, Strudwick type; Spondylometaphyseal dysplasia (SMD); Spondylometaphyseal Dysplasia, Strudwick Type; Strudwick syndrome


Clinical Trial: Long-term Study of Starlix+Diovan to Delay Type II Diabetes Mellitus

This study is no longer recruiting patients.

Sponsored by: Novartis Pharmaceuticals
Information provided by: Novartis Pharmaceuticals

Purpose

This study is a test of the safety and effectiveness of two drugs, one for diabetes and one for hypertension, in keeping high normal patients from progressing to illness. People in this study cannot have diabetes but are considered "borderline" based on blood tests. People in the study take one or both of the drugs and do not know which one(s) they are taking.

Condition Treatment or Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Diovan (valsartan)
 Drug: Starlix (nateglinide)
Phase III

MedlinePlus related topics:  Diabetes

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title: Long-term Study of Starlix+Diovan to Delay Type II Diabetes Mellitus of this Disease in People who do not have it

Further Study Details: 
Primary Outcomes: The number of heart attacks and number of deaths due to heart disease and number developing diabetes.
Expected Total Enrollment:  9150

Study start: January 2002
Last follow-up: January 2008

Eligibility

Ages Eligible for Study:  50 Years   -   75 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Adults
  • Impaired glucose tolerance
  • Age dependent risk factors

Exclusion Criteria:

  • Frank diabetes

For detailed information, call contact person.


More Information

Study ID Numbers:  CDJN608B2302
Record last reviewed:  November 2004
Last Updated:  November 30, 2004
Record first received:  November 30, 2004
ClinicalTrials.gov Identifier:  NCT00097786
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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September 5, 2008



Page Updated: September 6, 2005
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