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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02669732
• Other study ID #: DS8500-A-J205
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: October 2016

Study information

• Verified date: December 2016
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• DS-8500a
tablets
• placebo
tablets

Locations

Country	Name	City	State
Japan	SOUSEIKAI Hakata Clinic	Hakata-ku	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

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