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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: DS-8500a; Drug: placebo

• Registration Number: NCT02669732
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-27
• Study First Submitted QC: 2016-01-29
• Study First Posted: 2016-02-01
• Primary Completion: 2016-08
• Study Completion: 2016-10
• Status Verified: 2016-12
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DS-8500a 75 mg once daily (QD)	DS-8500a	tablets, orally, once daily for up to 28 days
Placebo	placebo	tablets, orally, once daily for up to 28 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
plasma concentration of DS-8500a	Day 28 (Period 1 and 2)
M value	Baseline to Day 28 (Period 1 and 2)	M value：Mean of Glucose Infusion Rate from 90 to 120 min
Disposition Index	Baseline to Day 28 (Period 1 and 2)	Disposition Index：Product of M value and First-phase secretion

Trial Locations

Locations (1)

SOUSEIKAI Hakata Clinic; 🇯🇵 Hakata-ku, Fukuoka, Japan