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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02628392
Other study ID # DS8500-A-J203
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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