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

NCT02628392 | Completed

• 1 other identifier: DS8500-A-J203
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; Adult; Developmental Phase II

Outcome Measures

Primary Outcomes (1)

• change in HbA1c

  HbA1c = glycated hemoglobin

  baseline (Day -1) to Week 12

Secondary Outcomes (59)

• change in HbA1c

  baseline (Day -1) to Week 4

• change in HbA1c

  baseline (Day -1) to Week 8

• proportion of subjects with HbA1c <7.0

  baseline (Day -1) to Week 12

• change in plasma glucose

  baseline (Day -1) to Week 4

• change in plasma glucose

  baseline (Day -1) to Week 12

Study Arms (5)

DS-8500a 25 mg QD

EXPERIMENTAL

DS-8500a 25 mg tablet once daily (QD), orally, for up to 12 weeks, and matching sitagliptin placebo capsule

Drug: DS-8500a; Drug: placebo

DS-8500a 50 mg QD

EXPERIMENTAL

DS-8500a 50 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule

Drug: DS-8500a; Drug: placebo

DS-8500a 75 mg QD

EXPERIMENTAL

DS-8500a 75 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule

Drug: DS-8500a; Drug: placebo

placebo

PLACEBO COMPARATOR

placebo tablet and placebo capsule, orally, once daily for up to 12 weeks to match DS-8500a and sitagliptin, respectively.

Drug: placebo

Sitagliptin

ACTIVE COMPARATOR

capsule, orally, once daily for up to 12 weeks and matching DS-8500 placebo tablet

Drug: Sitagliptin; Drug: placebo

Interventions

DS-8500a DRUG

DS-8500a tablets 25mg, 50mg, 75mg

DS-8500a 25 mg QD; DS-8500a 50 mg QD; DS-8500a 75 mg QD

Sitagliptin DRUG

capsules

Also known as: Januvia

Sitagliptin

placebo DRUG

matching DS-8500a tablets and sitagliptin capsules

DS-8500a 25 mg QD; DS-8500a 50 mg QD; DS-8500a 75 mg QD; Sitagliptin; placebo

Eligibility Criteria

• Age: 20 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (1)

Heishinkai Medical Group Incorporated OCROM Clinic

Suita-shi, Osaka, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

firuglipel; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: December 9, 2015
• First Posted: December 11, 2015
• Study Start: November 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 12, 2019

Record last verified: 2017-01

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)