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

NCT00402909 | Completed Phase 4

• 1 other identifier: CDJN608AUS13
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes,; fasting glucose,; postprandial glucose,; blood sugar,; HbA1c,; insulin,; glargine,; metformin,; thiazolidinedione

Outcome Measures

Primary Outcomes (1)

• Change from baseline in hemoglobin (Hb)_A1c

Secondary Outcomes (3)

• 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%

Interventions

Nateglinide DRUG

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07974, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Nateglinide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2006
• First Posted: November 22, 2006
• Study Start: November 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: February 24, 2017

Record last verified: 2017-02

Locations

US (1)