Phase 2 Study of DS-8500a in Patients With Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase 2, Placebo-controlled, Double-blind Study of DS-8500a in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02222350
• Other study ID #: DS8500-A-J201
• Status: Completed
• Phase: Phase 2
• Start date: July 2014
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the efficacy and safety of DS-8500a compared with placebo in Japanese patients with Type 2 Diabetes Mellitus.

Description:

The objective of this study is to evaluate the efficacy and safety of DS-8500a 10 mg and 75 mg administered orally, once daily, for 28 days, compared with placebo, in Japanese patients with Type 2 Diabetes Mellitus in a double-blind, placebo-controlled parallel-group design. The primary endpoint is the change in 24-hour weighted mean glucose at day 28 from baseline. The safety, pharmacokinetics, and pharmacodynamics of DS-8500a will be evaluated as well.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 69 Years

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% if untreated with antidiabetic agent.

• Patients who have HbA1c = 6.5% and < 9.5% if treated with antidiabetic agent.

Exclusion Criteria:

• Patients aged = 70 years at the time of informed consent

• Patients with a history of type 1 diabetes or diabetic 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 an estimated glomerular filtration rate (eGFR), < 45 mL/min per 1.73 m2

• Patients with fasting plasma glucose = 240 mg/dL

Related Conditions & MeSH terms

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

Intervention

Drug:
• 10mg DS-8500a tablet

• 75mg DS-8500a tablet

• placebo

Locations

Country	Name	City	State
Japan	Heishinkai Medical Group Incorporated OCROM Clinic	Kasuga	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 24-hour weighted mean blood glucose		Day -1 (baseline) to Day 28
Secondary	change in 24 hour weighted mean blood glucose		Day -1 (baseline) to Day 14
Secondary	change in blood fasting plasma glucose level		Day -1 (baseline) to Days 7, 14, 21, 28
Secondary	change in blood plasma glucose level	Change in the parameter at Day 14 or 28 from Day -1	Day -1 (baseline) to Days 14 and 28
Secondary	change in blood insulin level	Change in the parameter at Day 14 or 28 from Day -1	Day -1 (baseline) to Days 14 and 28
Secondary	change in blood C-peptide level	Change in the parameter at Day 14 or 28 from Day -1	Day -1 (baseline) to Days 14 and 28
Secondary	change in blood active GLP-1 level	Change in the parameter at Day 14 or 28 from Day -1	Day -1 (baseline) to Days 14 and 28
Secondary	change in blood PYY level	Change in the parameter at Day 14 or 28 from Day -1	Day -1 (baseline) to Days 14 and 28
Secondary	change in blood HbA1c level	Change in the parameter at Day 14 or 28 from Day -1	Day -1 (baseline) to Days 14 and 28
Secondary	change in blood glycoalbumin level	Change in the parameter at Day 14 or 28 from Day -1	Day -1 (baseline) to Days 14 and 28
Secondary	Number of subjects experiencing adverse events as a measure of safety	Number of subjects experiencing adverse events	Day -1 (baseline) to Day 28
Secondary	pharmacokinetic profile of DS-8500a	Pharmacokinetic profile of DS-8500a in Japanese subjects with type 2 diabetes mellitus. i.e. Tmax, Cmax, AUC, t1/2	Day -1 (baseline) to Day 28
Secondary	change in postprandial plasma glucose level	Change in postprandial plasma glucose level (2 hours after a meal) at Day 14 or 28 from Day -1	Day -1 (baseline) to Days 14 and 28