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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase 2, Randomized, Double-blind, Placebo-controlled, add-on Study of DS-8500a in Japanese Patients With Type 2 Diabetes Mellitus Receiving Sitagliptin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02685345
• Other study ID #: DS8500-A-J204
• Status: Completed
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In patients with type 2 diabetes mellitus being treated with sitagliptin, efficacy and safety of DS-8500a are to be evaluated after 28-day multiple oral administration of DS-8500a at 25 or 75 mg, in a double-blind, placebo-controlled, parallel-group comparison study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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%

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• DS-8500a 25 mg

• DS-8500a 75 mg

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.	Mediscience Planning, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in 24 hour weighted mean glucose		baseline (Day -1) to Day 28
Secondary	change in fasting plasma glucose		baseline (Day -1) to Day 28
Secondary	change in plasma glucose	Day -1 and Day 28: Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast; 0.5, 1, 2, and 4 hours after starting lunch before evening meal; 0.5, 1, 2, and 4 hours after starting evening meal	baseline (Day -1) and Day 28
Secondary	change in glycoalbumin		baseline (Day -1) and Day 28
Secondary	change in serum insulin	Day -1 and Day 28: Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast; 0.5, 1, 2, and 4 hours after starting lunch before evening meal; 0.5, 1, 2, and 4 hours after starting evening meal	baseline (Day -1) and Day 28
Secondary	change in proinsulin		baseline (Day -1) and Day 28
Secondary	change in C-peptide	Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast	baseline (Day -1) and Day 28
Secondary	change in PYY (pancreatic peptide YY3-36)	Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast	baseline (Day -1) and Day 28
Secondary	change in total GLP-1 (Glucagon-like peptide-1)		baseline (Day -1) and Day 28
Secondary	change in active GLP-1 (Glucagon-like peptide-1)	Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast	baseline (Day -1) and Day 28
Secondary	change in total GIP (Gastric inhibitory polypeptide)	Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast	baseline (Day -1) and Day 28
Secondary	change in total glucagon	Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast	baseline (Day -1) and Day 28
Secondary	change in total total cholesterol		baseline (Day -1) to after dosing on Day 28
Secondary	change in total HDL (high density lipoprotein) cholesterol		baseline (Day -1) to after dosing on Day 28
Secondary	change in total LDL (low density lipoprotein) cholesterol		baseline (Day -1) to after dosing on Day 28
Secondary	change in total triglyceride		baseline (Day -1) to after dosing on Day 28
Secondary	number and severity of adverse events		baseline (Day -1) to after dosing on Day 28
Secondary	change in derived plasma glucose AUC	change in pharmacodynamic parameters derived from plasma glucose; AUC0-24h, AUC 0-4h, AUC4-8h, AUC9-13h	baseline (Day -1) to after dosing on Day 28
Secondary	change in derived serum insulin AUC	change in pharmacodynamic parameters derived from serum insulin; AUC0-24h, AUC 0-4h, AUC4-8h, AUC9-13h	baseline (Day -1) to after dosing on Day 28
Secondary	change in derived C-peptide AUC	change in pharmacodynamic parameters derived from C-peptide; AUC0-4h	baseline (Day -1) to after dosing on Day 28
Secondary	change in derived PYY AUC	change in pharmacodynamic parameters derived from PYY; AUC0-4h	baseline (Day -1) to after dosing on Day 28
Secondary	change in derived total GLP-1 AUC	change in pharmacodynamic parameters derived from total GLP-1; AUC0-4h	baseline (Day -1) to after dosing on Day 28
Secondary	change in derived active GLP-1 AUC	change in pharmacodynamic parameters derived from active GLP-1; AUC0-4h	baseline (Day -1) to after dosing on Day 28
Secondary	change in derived total GIP AUC	change in pharmacodynamic parameters derived from total GIP; AUC0-4h	baseline (Day -1) to after dosing on Day 28
Secondary	change in derived glucagon AUC	change in pharmacodynamic parameters derived from glucagon; AUC0-4h	baseline (Day -1) to after dosing on Day 28