Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 1 for:    dsp-8658
Previous Study | Return to List | Next Study

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01042106
First received: December 21, 2009
Last updated: September 12, 2013
Last verified: September 2013

December 21, 2009
September 12, 2013
November 2009
July 2010   (final data collection date for primary outcome measure)
Safety assessments include physical examination, laboratory variables and ECG. [ Time Frame: 20 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01042106 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Patients With Type 2 Diabetes Mellitus and Healthy Adults
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: DSP-8658
    Ascending doses of DSP-8658 - 2.5, 10, 20, 40 mg orally once daily
  • Drug: Placebo
    Placebo 2.5, 10, 20, 40 mg orally once daily
  • Experimental: DSP-8658
    DSP-8658 2.5, 10, 20, 40 mg once daily
    Intervention: Drug: DSP-8658
  • Placebo Comparator: Placebo
    Placebo 2.5, 10, 20, and 40 mg doses once daily
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01042106
D6950153
No
Sunovion
Sunovion
Not Provided
Study Director: Medical Director, MD Sunovion
Sunovion
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP