GALLANT 9 Tesaglitazar vs. Placebo in Combination With Insulin

This study has been terminated.
(The development program has been terminated)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00242372
First received: October 19, 2005
Last updated: April 21, 2009
Last verified: April 2009
  Purpose

This is a 24-week randomized, double-blind, multi-center, placebo-controlled study of tesaglitazar in patients with type 2 diabetes who are not adequately controlled on insulin (along or in combination with one or more oral antidiabetic agents in addition to diet and lifestyle advice). The study comprises a 3-week enrollment period and a 24-week randomized, double blind, multi-center, placebo-controlled treatment period and a 3-week follow-up. Patients must receive at least 30 units of insulin per day and will continue their current oral antidiabetic treatment regimen throughout the study.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Tesaglitazar 0.5
Drug: Insulin at least 30 units/day
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 24-Week Randomised, Double-Blind, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Added to the Therapy of Patients With Type 2 Diabetes Poorly Controlled on Insulin

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)

Secondary Outcome Measures:
  • Changes in the following variables from baseline to the end of the randomized treatment period:
  • The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide from baseline to the end of the randomized treatment period
  • Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model from baseline to the end of the randomized treatment period
  • Lipid parameters (triglyceride [TG], total cholesterol, high-density lipoprotein cholesterol [HDL C], non-HDL C, low-density lipoprotein cholesterol [LDL C], apolipoproteins [Apo] A-I, Apo B, Apo CIII, free fatty acids, lipoprotein particle size and c
  • C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
  • FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
  • Tumor necrosis factor-alpha, intracellular adhesion molecule-1
  • Fibrinogen
  • Urinary albumin excretion
  • Waist/hip ratio
  • Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
  • Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
  • Pharmacokinetics of tesaglitazar
  • Safety and tolerability of tesaglitazar by assessment of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycemic events, body weight, cardiac evaluation, and physical examination
  • To validate the Work Productivity and Activity Impairment-Diabetes Questionnaire (WPAI-Diabetes) and the Diabetes Productivity Impairment Questionnaire (DPIQ) in patients with type 2 diabetes and to explore the effects of tesaglitazar (0.5 mg) on pati

Estimated Enrollment: 370
Study Start Date: August 2004
Study Completion Date: March 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of a written informed consent
  • Men or women who are >=18 years of age
  • Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
  • Diagnosed with type 2 diabetes for less than 20 years and receiving at least 30 U insulin per day

Exclusion Criteria:

  • Type 1 diabetes
  • New York Heart Association heart failure Class III or IV
  • Treatment with any thiazolidinedione class of antidiabetic agents
  • History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
  • History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
  • Creatinine levels above twice the normal range
  • Creatine kinase above 3 times the upper limit of normal
  • Received any investigational product in other clinical studies within 12 weeks
  • Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242372

  Show 71 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Galida Medical Sciences Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00242372     History of Changes
Other Study ID Numbers: D6160C00033
Study First Received: October 19, 2005
Last Updated: April 21, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Insulin dependent Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014