Safety and Efficacy of Nateglinide in Patients With Type 2 Diabetes Already Taking Insulin Glargine, Metformin and/or Pioglitazone or Rosiglitazone - Full Text View

Purpose

This study will assess the safety and efficacy of adding nateglinide to treatment with basal insulin glargine, metformin and/or thiazolidinedione (pioglitazone or rosiglitazone), for patients with type 2 diabetes who are not achieving glycemic control with glargine, metformin and/or thiazolidinedione only.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: Nateglinide	Phase IV

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Insulin Insulin glargine Pioglitazone Pioglitazone hydrochloride Metformin Metformin hydrochloride Rosiglitazone Rosiglitazone Maleate Dextrose A 4166

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A 16-Week, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Compare the Safety and Efficacy of Nateglinide vs. Placebo in Patients With Type 2 Diabetes Who Are Inadequately Controlled With Basal Insulin Glargine in Combination With Metformin and/or Thiazolidinedione (Pioglitazone or Rosiglitazone)

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in hemoglobin (Hb)_A1c

Secondary Outcome Measures:

Change from baseline in 2-hour postprandial glucose during standardized meal test
Proportion of patients achieving American Diabetes Association ADA goal of HbA1c <7.0%
Proportion of patients achieving reduction in HbA1c of 0.5%

Enrollment:	28
Study Start Date:	November 2006

Eligibility

Ages Eligible for Study:	18 Years to 78 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Male/female, age 18-78 inclusive
Type 2 diabetes, taking glargine, metformin and/or thiazolidinedione for 3 months prior to screening, stable doses for 2 months prior to screening
HbA1c 7.0-8.5% inclusive
Fasting plasma glucose <240 mg/dL at screening
Body Mass Index 22-41 kg/m2

Exclusion Criteria:

Pregnant or nursing
Other investigational drugs within 30 days of screening
Treatment with other anti-diabetic medications other than metformin, glargine and/or thiazolidinedione
History of type 1 diabetes
Abnormal kidney function
History of acute diabetic complications
Congestive heart failure requiring treatment
Myocardial infarction, coronary artery surgery, stroke within 6 months of screening
Liver disease, liver enzymes more than 3 times upper limit of normal
Fasting triglycerides >700 mg/dL within past 12 weeks
Acute infections or other conditions that may affect blood sugar or may interfere with interpretation of study data
Treatment with corticosteroids
Blood donation within past 12 weeks

Other protocol-defined inclusion/exclusion criterial may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402909

Locations


United States, New Jersey
	Novartis Pharmaceuticals
	East Hanover, New Jersey, United States, 07974

Sponsors and Collaborators

Novartis

Investigators


Study Director:	Novartis Pharmaceuticals	Novartis

More Information

Study ID Numbers:	CDJN608AUS13
First Received:	November 20, 2006
Last Updated:	September 14, 2007
ClinicalTrials.gov Identifier:	NCT00402909
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Type 2 diabetes,

fasting glucose,

postprandial glucose,

blood sugar,

HbA1c,

insulin,

glargine,

metformin,

thiazolidinedione

Study placed in the following topic categories:

Metabolic Diseases

Pioglitazone

Metformin

Diabetes Mellitus

Endocrine System Diseases

2,4-thiazolidinedione

Nateglinide

Insulin

Diabetes Mellitus, Type 2

Glargine

Endocrinopathy

Glucose Metabolism Disorders

Metabolic disorder

Rosiglitazone

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00402909