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Safety, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Patients With Type 2 Diabetes Mellitus and Healthy Adults

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ClinicalTrials.gov Identifier: NCT01042106
Recruitment Status : Completed
First Posted : January 5, 2010
Last Update Posted : September 16, 2013
Sponsor:
Information provided by (Responsible Party):
Sunovion

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of DSP-8658 in patients with Type 2 diabetes mellitus and healthy adults.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: DSP-8658 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Oral Dose Study to Evaulate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Type 2 Diabetic and Healthy Subjects
Study Start Date : November 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: DSP-8658
DSP-8658 2.5, 10, 20, 40 mg once daily
 Drug: DSP-8658
Ascending doses of DSP-8658 - 2.5, 10, 20, 40 mg orally once daily
Placebo Comparator: Placebo
Placebo 2.5, 10, 20, and 40 mg doses once daily
 Drug: Placebo
Placebo 2.5, 10, 20, 40 mg orally once daily


Outcome Measures
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Primary Outcome Measures :
  1. Safety assessments include physical examination, laboratory variables and ECG. [ Time Frame: 20 days ]

Secondary Outcome Measures :
  1. Pharmacokinetics of DSP-8658 and its metabolites: levels of DSP-8658 and its metabolites will be measured and analyzed at various time points throughout the study. [ Time Frame: 20 days ]
  2. Pharmacodynamics of DSP-8658 (how DSP-8658 acts in the body to affect glucose and lipid control): glucose and lipid levels will be measured at various time points throughout the study. [ Time Frame: 18 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Diabetic subjects

  • Age ≥ 18 and ≤ 65 years
  • Body Mass Index ≤45
  • Drug naive type 2 diabetes or type 2 diabetes previously treated with an oral antidiabetic drug

Inclusion Criteria: Healthy subjects

  • Age ≥ 18 and ≤ 65 years
  • Body Mass Index ≥ 18 and ≤ 29
  • Good health as determined by medical history, ECG, clinical chemistry, hematology, urinalysis, virology, and a physical examination.

Exclusion Criteria: Diabetic subjects

  • Have a current or expected requirement for any antidiabetic or lipid-lowering drug

Exclusion Criteria: Healthy subjects

  • Have, or have had a history of clinically significant neurological, urological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders including cancer
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01042106


Locations
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United States, Texas
Cetero Research
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Sunovion
Investigators
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Study Director: Medical Director, MD Sunovion
More Information
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Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01042106    
Other Study ID Numbers: D6950153
First Posted: January 5, 2010    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: September 2013
Keywords provided by Sunovion:
diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases