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NCT Number: NCT00402909

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07974, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nateglinide

Drug

Primary outcomes

  1. Change from baseline in hemoglobin (Hb)_A1c

Secondary outcomes

  1. Change from baseline in 2-hour postprandial glucose during standardized meal test

  2. Proportion of patients achieving American Diabetes Association ADA goal of HbA1c <7.0%

  3. Proportion of patients achieving reduction in HbA1c of 0.5%

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 22, 2006
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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