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

Sumitomo Pharma logo

Sumitomo Pharma

Status and phase

Completed
Phase 1

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Placebo
Drug: DSP-8658

Study type

Interventional

Funder types

Industry

Identifiers

NCT01042106
D6950153

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups, including a placebo group

DSP-8658
Experimental group
Description:
DSP-8658 2.5, 10, 20, 40 mg once daily
Treatment:
Drug: DSP-8658
Placebo
Placebo Comparator group
Description:
Placebo 2.5, 10, 20, and 40 mg doses once daily
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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