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

NCT02222350 | Completed Phase 2

• 1 other identifier: DS8500-A-J201
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• change in 24-hour weighted mean blood glucose

  Day -1 (baseline) to Day 28

Secondary Outcomes (12)

• change in 24 hour weighted mean blood glucose

  Day -1 (baseline) to Day 14

• change in blood fasting plasma glucose level

  Day -1 (baseline) to Days 7, 14, 21, 28

• change in blood plasma glucose level

  Day -1 (baseline) to Days 14 and 28

• change in blood insulin level

  Day -1 (baseline) to Days 14 and 28

• change in blood C-peptide level

  Day -1 (baseline) to Days 14 and 28

Study Arms (3)

DS-8500a 10mg once daily

EXPERIMENTAL

10mg DS-8500a tablet given orally once daily

Drug: 10mg DS-8500a tablet

DS8500a 75 mg once daily

EXPERIMENTAL

75mg DS-8500a tablet given orally once daily

Drug: 75mg DS-8500a tablet

placebo to match DS-8500a tablet

PLACEBO COMPARATOR

placebo matching DS-8500a tablet

Drug: placebo

Interventions

10mg DS-8500a tablet DRUG

DS-8500a 10mg once daily

75mg DS-8500a tablet DRUG

DS8500a 75 mg once daily

placebo DRUG

placebo to match DS-8500a tablet

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (1)

Heishinkai Medical Group Incorporated OCROM Clinic

Kasuga, Osaka, 565-0853, Japan

Location

Related Publications (1)

• Inagaki N, Chou HS, Tsukiyama S, Washio T, Shiosakai K, Nakatsuka Y, Taguchi T. Glucose-lowering effects and safety of DS-8500a, a G protein-coupled receptor 119 agonist, in Japanese patients with type 2 diabetes: results of a randomized, double-blind, placebo-controlled, parallel-group, multicenter, phase II study. BMJ Open Diabetes Res Care. 2017 Sep 29;5(1):e000424. doi: 10.1136/bmjdrc-2017-000424. eCollection 2017.

  PMID: 29071087 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

firuglipel

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 21, 2014
• Study Start: July 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 12, 2019

Record last verified: 2015-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

JP (1)