Overview

This trial has been completed.

Condition type 2 diabetes mellitus
Treatments ds-8500a, placebo
Phase phase 2
Sponsor Daiichi Sankyo Co., Ltd.
Start date January 2016
End date August 2016
Trial size 21 participants
Trial identifier NCT02669732, DS8500-A-J205

Summary

The objective of the study is to evaluate change in insulin secretory capacity in patients with type 2 diabetes mellitus as determined by hyperglycemic clamp after a 28-day oral administration of DS-8500a at 75 mg in a placebo-controlled, 2 × 2 crossover study. In addition, safety of this regimen will be examined in this study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
tablets, orally, once daily for up to 28 days
ds-8500a
tablets
(Placebo Comparator)
tablets, orally, once daily for up to 28 days
placebo
tablets

Primary Outcomes

Measure
First-phase and Second-phase secretion Insulin
time frame: Baseline to Day 28 (Period 1 and 2)
First-phase and Second-phase secretion C-peptide
time frame: Baseline to Day 28 (Period 1 and 2)

Secondary Outcomes

Measure
M value
time frame: Baseline to Day 28 (Period 1 and 2)
M/I value
time frame: Baseline to Day 28 (Period 1 and 2)
Disposition Index
time frame: Baseline to Day 28 (Period 1 and 2)
Number and severity of Adverse Events
time frame: Day 28 (Period 1 and 2)
plasma concentration of DS-8500a
time frame: Day 28 (Period 1 and 2)

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 < 9.0% 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, Placebo-controlled, Double-blind, Crossover Study of DS-8500a to Evaluate the Effects on Pancreatic Beta Cell Function in Japanese Patients With Type 2 Diabetes Mellitus.
Principal investigator Hirotaka Watada, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Daiichi Sankyo Inc..