A Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus Receiving Sitagliptin

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Daiichi Sankyo

Status and phase

Completed
Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: placebo
Drug: DS-8500a 25 mg
Drug: DS-8500a 75 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02685345
DS8500-A-J204

Details and patient eligibility

About

The objectives of the study is to evaluate the efficacy and safety of DS-8500a compared with placebo in patients with type 2 diabetes mellitus (T2DM) receiving sitagliptin.

Full description

In patients with type 2 diabetes mellitus being treated with sitagliptin, efficacy and safety of DS-8500a are to be evaluated after 28-day multiple oral administration of DS-8500a at 25 or 75 mg, in a double-blind, placebo-controlled, parallel-group comparison study.

Enrollment

85 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Japanese patients with type 2 diabetes
  • Patients aged ≥ 20 years at the time of informed consent
  • Patients who have been treated with sitagliptin 50 mg monotherapy for the treatment of type 2 diabetes mellitus
  • Patients who have HbA1c ≥ 7.0% and < 9.0%

Exclusion criteria

  • Patients with type 1 diabetes mellitus or with a history of diabetic coma, precoma, or ketoacidosis
  • Patients receiving or requiring treatment with insulin
  • Patients with a body mass index (BMI) of < 18.5 kg/m2 or ≥ 35.0 kg/m2
  • Patients with clinically evident renal impairment (estimated glomerular filtration rate [eGFR] of < 45 mL/min per 1.73 m2) or clinically significant renal disease
  • Patients with fasting plasma glucose ≥ 240 mg/dL

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

85 participants in 3 patient groups, including a placebo group

DS-8500a 25 mg QD
Experimental group
Description:
DS-8500a 25 mg tablets, orally, once daily (QD) for up to 28 days
Treatment:
Drug: DS-8500a 25 mg
DS-8500a 75 mg QD
Experimental group
Description:
DS-8500a 75 mg tablets, orally, once daily (QD) for up to 28 days
Treatment:
Drug: DS-8500a 75 mg
placebo
Placebo Comparator group
Description:
placebo tablets, orally, once daily for up to 28 days
Treatment:
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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