An Exploratory Study of DS-8500a on Beta Cell Function Using Hyperglycemic Clamp

A Phase 2, Randomized, Placebo-controlled, Double-blind, Crossover Study of DS-8500a to Evaluate the Effects on Pancreatic Beta Cell Function in Japanese Patients With Type 2 Diabetes Mellitus.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02669732

Enrollment

Registered

2016-02-01

Start date

2016-01-31

Completion date

2016-10-31

Last updated

2019-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus, Adult, Developmental Phase II

Brief summary

The objective of the study is to evaluate change in insulin secretory capacity in patients with type 2 diabetes mellitus as determined by hyperglycemic clamp after a 28-day oral administration of DS-8500a at 75 mg in a placebo-controlled, 2 × 2 crossover study. In addition, safety of this regimen will be examined in this study.

Interventions

DRUGDS-8500a

tablets

DRUGplacebo

tablets

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients aged ≥ 20 years at the time of informed consent * Japanese patients with type 2 diabetes * 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

Design outcomes

Primary

Measure	Time frame	Description
First-phase and Second-phase secretion Insulin	Baseline to Day 28 (Period 1 and 2)	First-phase and Second-phase secretion Insulin Baseline to Day 28 (Period 1 and 2)
First-phase and Second-phase secretion C-peptide	Baseline to Day 28 (Period 1 and 2)	First-phase and Second-phase secretion (C-peptide)

Secondary

Measure	Time frame	Description
Disposition Index	Baseline to Day 28 (Period 1 and 2)	Disposition Index：Product of M value and First-phase secretion
M value	Baseline to Day 28 (Period 1 and 2)	M value：Mean of Glucose Infusion Rate from 90 to 120 min
plasma concentration of DS-8500a	Day 28 (Period 1 and 2)	—
Number and severity of Adverse Events	Day 28 (Period 1 and 2)	—
M/I value	Baseline to Day 28 (Period 1 and 2)	M/I value：M value / steady-state Insulin

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026