A Safety Study of ARRY-403 in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00952198
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : August 30, 2012
Information provided by (Responsible Party):
Array BioPharma

Brief Summary:
This is a Phase 1 study, involving a 10-day dosing period, designed to test the safety of investigational study drug ARRY-403 (as monotherapy or in addition to stable metformin therapy) in patients with Type 2 diabetes. Approximately 128 patients from the US will be enrolled in this study.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: ARRY-403, glucokinase activator; oral Drug: Placebo; oral Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : August 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ARRY-403 Drug: ARRY-403, glucokinase activator; oral
multiple dose, escalating

Placebo Comparator: Placebo Drug: Placebo; oral
matching placebo

Primary Outcome Measures :
  1. Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. [ Time Frame: Duration of study ]
  2. Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations. [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Assess the effect of study drug on glycemic control as determined by an oral glucose tolerance test (OGTT). [ Time Frame: 10 days ]
  2. Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers. [ Time Frame: 10 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • Male or female (females must be of non-childbearing potential), between the ages of 18 and 70 years, inclusive.
  • Diagnosis of Type 2 diabetes.
  • Fasted C-peptide value ≥ 0.8 ng/mL.
  • HbA1c ≥ 6.5% and ≤ 10.0% for monotherapy cohorts (study drug only) or HbA1c ≥ 7.5% and ≤ 10.0% for combination cohorts (study drug and on a stable regimen of metformin monotherapy that includes a morning dose for ≥ 8 weeks prior to first dose of study drug).
  • BMI ≥ 25.0 kg/m2 and ≤ 40.0 kg/m2
  • Additional criteria exist.

Key Exclusion Criteria:

  • Recent history (i.e. less than 6 months) or concomitant/ongoing clinically significant hematologic, renal, pulmonary, gastrointestinal, hepatic, psychiatric, neurologic, dermatologic or allergic disease (including drug allergies that are clinically significant and not remote, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), or other conditions at the discretion of the investigator.
  • Significant cardiac disease, myocardial infarction within 6 months of study start, unstable angina, congestive heart failure, known arrhythmias of ventricular etiology, unexplained syncope or syncope/seizures related to arrhythmia.
  • History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH, or absorption.
  • A positive test for drugs or alcohol.
  • Active infectious diseases including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). Past history and inactive hepatitis B and C, as confirmed by serological testing, are allowed.
  • Women who are pregnant or breastfeeding.
  • Donation or loss of ≥ 550 mL of blood (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to first dose of study drug.
  • Additional criteria exist.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00952198

United States, California
Profil Institute for Clinical Research
Chula Vista, California, United States, 91911
United States, Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Array BioPharma

Responsible Party: Array BioPharma Identifier: NCT00952198     History of Changes
Other Study ID Numbers: ARRAY-403-102
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: August 30, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases