A Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus Receiving Sitagliptin

NCT02685345 | Completed Phase 2

• 1 other identifier: DS8500-A-J204
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of the study is to evaluate the efficacy and safety of DS-8500a compared with placebo in patients with type 2 diabetes mellitus (T2DM) receiving sitagliptin.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; sitagliptin; adult; Phase 2

Outcome Measures

Primary Outcomes (1)

• change in 24 hour weighted mean glucose

  baseline (Day -1) to Day 28

Secondary Outcomes (24)

• change in fasting plasma glucose

  baseline (Day -1) to Day 28

• change in plasma glucose

  baseline (Day -1) and Day 28

• change in glycoalbumin

  baseline (Day -1) and Day 28

• change in serum insulin

  baseline (Day -1) and Day 28

• change in proinsulin

  baseline (Day -1) and Day 28

Study Arms (3)

DS-8500a 25 mg QD

EXPERIMENTAL

DS-8500a 25 mg tablets, orally, once daily (QD) for up to 28 days

Drug: DS-8500a 25 mg

DS-8500a 75 mg QD

EXPERIMENTAL

DS-8500a 75 mg tablets, orally, once daily (QD) for up to 28 days

Drug: DS-8500a 75 mg

placebo

PLACEBO COMPARATOR

placebo tablets, orally, once daily for up to 28 days

Drug: placebo

Interventions

DS-8500a 25 mg DRUG

DS-8500a 25 mg QD

DS-8500a 75 mg DRUG

DS-8500a 75 mg QD

placebo DRUG

placebo

Eligibility Criteria

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

You may qualify if:

• Japanese patients with type 2 diabetes
• Patients aged ≥ 20 years at the time of informed consent
• Patients who have been treated with sitagliptin 50 mg monotherapy for the treatment of type 2 diabetes mellitus
• Patients who have HbA1c ≥ 7.0% and \< 9.0%

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
• Mediscience Planning, Inc.: collaborator

Study Sites (1)

Unknown Facility

Yodogawaku, Osaka, 565-0853, Japan

Location

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 Officials

• Yasuo Terauchi, MD, PhD

  Yokohama City University

  PRINCIPAL INVESTIGATOR

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: February 3, 2016
• First Posted: February 18, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 12, 2019

Record last verified: 2016-11

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)