A Phase 2 Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)

Type2 Diabetes Mellitus Clinical Trial

Official title:

A Phase 2, Randomized, Double-blind, Dose Finding Study of DS-8500a in Japanese Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02628392
• Other study ID #: DS8500-A-J203
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: September 2016

Study information

• Verified date: January 2017
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objectives of the study is to evaluate the efficacy, safety, and dose of DS-8500a compared with placebo in patients with type 2 diabetes mellitus.

Description:

The objectives of the study is to evaluate the efficacy, safety, and dose of DS-8500a compared with placebo in patients with type 2 diabetes mellitus after a 12-week oral administration of DS-8500a at 25, 50, or 75 mg in a double-blind, parallel-group comparison study. In addition, the clinical positioning of DS-8500a relative to an existing drug will be investigated using sitagliptin as a comparator.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: September 2016
• Est. primary completion date: September 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 < 10.0%

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
• Type2 Diabetes Mellitus

Intervention

Drug:
• DS-8500a
DS-8500a tablets 25mg, 50mg, 75mg
• Sitagliptin
capsules
• placebo
matching DS-8500a tablets and sitagliptin capsules

Locations

Country	Name	City	State
Japan	Heishinkai Medical Group Incorporated OCROM Clinic	Suita-shi	Osaka

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	change in HbA1c	HbA1c = glycated hemoglobin	baseline (Day -1) to Week 12
Secondary	change in HbA1c		baseline (Day -1) to Week 4
Secondary	change in HbA1c		baseline (Day -1) to Week 8
Secondary	proportion of subjects with HbA1c <7.0	proportion of subjects who achieve HbA1c <7.0	baseline (Day -1) to Week 12
Secondary	change in plasma glucose		baseline (Day -1) to Week 4
Secondary	change in plasma glucose		baseline (Day -1) to Week 12
Secondary	change in AUC derived from plasma glucose	change in pharmacodynamics profile consists of Area Under Curve (AUC), Concentration maximum (Cmax), Time of maximum concentration (Tmax)	baseline (Day -1) to Week 4
Secondary	change in AUC derived from plasma glucose	pharmacodynamics profile consists of AUC, Cmax, Tmax	baseline (Day -1) to Week 12
Secondary	change in serum insulin		baseline (Day -1) to Week 4
Secondary	change in AUC 0-3h serum insulin		baseline (Day -1) to Week 4
Secondary	change in serum insulin		baseline (Day -1) to Week 12
Secondary	change in AUC 0-3h serum insulin		baseline (Day -1) to Week 12
Secondary	change in proinsulin		baseline (Day -1) to Week 4
Secondary	change in AUC 0-3h proinsulin		baseline (Day -1) to Week 4
Secondary	change in proinsulin		baseline (Day -1) to Week 12
Secondary	change in AUC 0-3h proinsulin		baseline (Day -1) to Week 12
Secondary	change in C-peptide		baseline (Day -1) to Week 4
Secondary	change in AUC 0-3h C-peptide		baseline (Day -1) to Week 4
Secondary	change in C-peptide		baseline (Day -1) to Week 12
Secondary	change in AUC 0-3h C-peptide		baseline (Day -1) to Week 12
Secondary	change in PYY	PYY = peptide YY	baseline (Day -1) to Week 4
Secondary	change in AUC 0-3h PYY		baseline (Day -1) to Week 4
Secondary	change in PYY		baseline (Day -1) to Week 12
Secondary	change in AUC 0-3h PYY		baseline (Day -1) to Week 12
Secondary	change in total GLP-1	GLP-1 = Glucagon-Like Peptide-1	baseline (Day -1) to Week 4
Secondary	change in total AUC 0-3h GLP-1		baseline (Day -1) to Week 4
Secondary	change in total GLP-1		baseline (Day -1) to Week 12
Secondary	change in AUC 0-3h total GLP-1		baseline (Day -1) to Week 12
Secondary	change in active GLP-1		baseline (Day -1) to Week 4
Secondary	change in AUC 0-3h active GLP-1		baseline (Day -1) to Week 4
Secondary	change in active GLP-1		baseline (Day -1) to Week 12
Secondary	change in AUC 0-3h active GLP-1		baseline (Day -1) to Week 12
Secondary	change in total GIP	GIP = Gastric Inhibitory Polypeptide	baseline (Day -1) to Week 4
Secondary	change in AUC 0-3h total GIP		baseline (Day -1) to Week 4
Secondary	change in total GIP		baseline (Day -1) to Week 12
Secondary	change in AUC 0-3h total GIP		baseline (Day -1) to Week 12
Secondary	change in glucagon		baseline (Day -1) to Week 4
Secondary	change in AUC 0-3h glucagon		baseline (Day -1) to Week 4
Secondary	change in glucagon		baseline (Day -1) to Week 12
Secondary	change in AUC 0-3h glucagon		baseline (Day -1) to Week 12
Secondary	change in 1,5 AG	1,5 AG = 1,5 anhydrogucitol	baseline (Day -1) to Week 4
Secondary	change in AUC 0-3h 1,5 AG		baseline (Day -1) to Week 4
Secondary	change in 1,5 AG		baseline (Day -1) to Week 12
Secondary	change in AUC 0-3h 1,5 AG		baseline (Day -1) to Week 12
Secondary	change in total cholesterol		baseline (Day -1) to Week 2
Secondary	change in total cholesterol		baseline (Day -1) to Week 4
Secondary	change in total cholesterol		baseline (Day -1) to Week 8
Secondary	change in total cholesterol		baseline (Day -1) to Week 12
Secondary	change in HDL cholesterol	HDL = high density lipoprotein	baseline (Day -1) to Week 2
Secondary	change in HDL cholesterol		baseline (Day -1) to Week 4
Secondary	change in HDL cholesterol		baseline (Day -1) to Week 8
Secondary	change in HDL cholesterol		baseline (Day -1) to Week 12
Secondary	change in LDL cholesterol	LDL = low density lipoprotein	baseline (Day -1) to Week 2
Secondary	change in LDL cholesterol		baseline (Day -1) to Week 4
Secondary	change in LDL cholesterol		baseline (Day -1) to Week 8
Secondary	change in LDL cholesterol		baseline (Day -1) to Week 12
Secondary	change in triglyceride		baseline (Day -1) to Week 2
Secondary	change in triglyceride		baseline (Day -1) to Week 4
Secondary	change in triglyceride		baseline (Day -1) to Week 8
Secondary	change in triglyceride		baseline (Day -1) to Week 12