Overview

This trial is active, not recruiting.

Condition type2 diabetes mellitus
Treatments ds-8500a, sitagliptin, placebo
Sponsor Daiichi Sankyo Co., Ltd.
Start date November 2015
End date July 2016
Trial size 335 participants
Trial identifier NCT02628392, DS8500-A-J203

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
DS-8500a 25 mg tablet once daily (QD), orally, for up to 12 weeks, and matching sitagliptin placebo capsule
ds-8500a
DS-8500a tablets 25mg, 50mg, 75mg
placebo
matching DS-8500a tablets and sitagliptin capsules
(Experimental)
DS-8500a 50 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule
ds-8500a
DS-8500a tablets 25mg, 50mg, 75mg
placebo
matching DS-8500a tablets and sitagliptin capsules
(Experimental)
DS-8500a 75 mg QD tablet, orally, once daily for up to 12 weeks, and matching sitagliptin placebo capsule
ds-8500a
DS-8500a tablets 25mg, 50mg, 75mg
placebo
matching DS-8500a tablets and sitagliptin capsules
(Placebo Comparator)
placebo tablet and placebo capsule, orally, once daily for up to 12 weeks to match DS-8500a and sitagliptin, respectively.
placebo
matching DS-8500a tablets and sitagliptin capsules
(Active Comparator)
capsule, orally, once daily for up to 12 weeks and matching DS-8500 placebo tablet
sitagliptin Januvia
capsules
placebo
matching DS-8500a tablets and sitagliptin capsules

Primary Outcomes

Measure
change in HbA1c
time frame: baseline (Day -1) to Week 12

Secondary Outcomes

Measure
change in HbA1c
time frame: baseline (Day -1) to Week 4
change in HbA1c
time frame: baseline (Day -1) to Week 8
proportion of subjects with HbA1c <7.0
time frame: baseline (Day -1) to Week 12
change in plasma glucose
time frame: baseline (Day -1) to Week 4
change in plasma glucose
time frame: baseline (Day -1) to Week 12
change in AUC derived from plasma glucose
time frame: baseline (Day -1) to Week 4
change in AUC derived from plasma glucose
time frame: baseline (Day -1) to Week 12
change in serum insulin
time frame: baseline (Day -1) to Week 4
change in AUC 0-3h serum insulin
time frame: baseline (Day -1) to Week 4
change in serum insulin
time frame: baseline (Day -1) to Week 12
change in AUC 0-3h serum insulin
time frame: baseline (Day -1) to Week 12
change in proinsulin
time frame: baseline (Day -1) to Week 4
change in AUC 0-3h proinsulin
time frame: baseline (Day -1) to Week 4
change in proinsulin
time frame: baseline (Day -1) to Week 12
change in AUC 0-3h proinsulin
time frame: baseline (Day -1) to Week 12
change in C-peptide
time frame: baseline (Day -1) to Week 4
change in AUC 0-3h C-peptide
time frame: baseline (Day -1) to Week 4
change in C-peptide
time frame: baseline (Day -1) to Week 12
change in AUC 0-3h C-peptide
time frame: baseline (Day -1) to Week 12
change in PYY
time frame: baseline (Day -1) to Week 4
change in AUC 0-3h PYY
time frame: baseline (Day -1) to Week 4
change in PYY
time frame: baseline (Day -1) to Week 12
change in AUC 0-3h PYY
time frame: baseline (Day -1) to Week 12
change in total GLP-1
time frame: baseline (Day -1) to Week 4
change in total AUC 0-3h GLP-1
time frame: baseline (Day -1) to Week 4
change in total GLP-1
time frame: baseline (Day -1) to Week 12
change in AUC 0-3h total GLP-1
time frame: baseline (Day -1) to Week 12
change in active GLP-1
time frame: baseline (Day -1) to Week 4
change in AUC 0-3h active GLP-1
time frame: baseline (Day -1) to Week 4
change in active GLP-1
time frame: baseline (Day -1) to Week 12
change in AUC 0-3h active GLP-1
time frame: baseline (Day -1) to Week 12
change in total GIP
time frame: baseline (Day -1) to Week 4
change in AUC 0-3h total GIP
time frame: baseline (Day -1) to Week 4
change in total GIP
time frame: baseline (Day -1) to Week 12
change in AUC 0-3h total GIP
time frame: baseline (Day -1) to Week 12
change in glucagon
time frame: baseline (Day -1) to Week 4
change in AUC 0-3h glucagon
time frame: baseline (Day -1) to Week 4
change in glucagon
time frame: baseline (Day -1) to Week 12
change in AUC 0-3h glucagon
time frame: baseline (Day -1) to Week 12
change in 1,5 AG
time frame: baseline (Day -1) to Week 4
change in AUC 0-3h 1,5 AG
time frame: baseline (Day -1) to Week 4
change in 1,5 AG
time frame: baseline (Day -1) to Week 12
change in AUC 0-3h 1,5 AG
time frame: baseline (Day -1) to Week 12
change in total cholesterol
time frame: baseline (Day -1) to Week 2
change in total cholesterol
time frame: baseline (Day -1) to Week 4
change in total cholesterol
time frame: baseline (Day -1) to Week 8
change in total cholesterol
time frame: baseline (Day -1) to Week 12
change in HDL cholesterol
time frame: baseline (Day -1) to Week 2
change in HDL cholesterol
time frame: baseline (Day -1) to Week 4
change in HDL cholesterol
time frame: baseline (Day -1) to Week 8
change in HDL cholesterol
time frame: baseline (Day -1) to Week 12
change in LDL cholesterol
time frame: baseline (Day -1) to Week 2
change in LDL cholesterol
time frame: baseline (Day -1) to Week 4
change in LDL cholesterol
time frame: baseline (Day -1) to Week 8
change in LDL cholesterol
time frame: baseline (Day -1) to Week 12
change in triglyceride
time frame: baseline (Day -1) to Week 2
change in triglyceride
time frame: baseline (Day -1) to Week 4
change in triglyceride
time frame: baseline (Day -1) to Week 8
change in triglyceride
time frame: baseline (Day -1) to Week 12

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title A Phase 2, Randomized, Double-blind, Dose Finding Study of DS-8500a in Japanese 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Daiichi Sankyo Inc..