Type2 Diabetes Mellitus Clinical Trial
Official title:
A Phase 2, Randomized, Double-blind, Dose Finding Study of DS-8500a in Japanese Patients With Type 2 Diabetes Mellitus
Verified date | January 2017 |
Source | Daiichi Sankyo, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 368 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Japan | Heishinkai Medical Group Incorporated OCROM Clinic | Suita-shi | Osaka |
Lead Sponsor | Collaborator |
---|---|
Daiichi Sankyo Co., Ltd. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in HbA1c | HbA1c = glycated hemoglobin | baseline (Day -1) to Week 12 | |
Secondary | change in HbA1c | baseline (Day -1) to Week 4 | ||
Secondary | change in HbA1c | baseline (Day -1) to Week 8 | ||
Secondary | proportion of subjects with HbA1c <7.0 | proportion of subjects who achieve HbA1c <7.0 | baseline (Day -1) to Week 12 | |
Secondary | change in plasma glucose | baseline (Day -1) to Week 4 | ||
Secondary | change in plasma glucose | baseline (Day -1) to Week 12 | ||
Secondary | change in AUC derived from plasma glucose | change in pharmacodynamics profile consists of Area Under Curve (AUC), Concentration maximum (Cmax), Time of maximum concentration (Tmax) | baseline (Day -1) to Week 4 | |
Secondary | change in AUC derived from plasma glucose | pharmacodynamics profile consists of AUC, Cmax, Tmax | baseline (Day -1) to Week 12 | |
Secondary | change in serum insulin | baseline (Day -1) to Week 4 | ||
Secondary | change in AUC 0-3h serum insulin | baseline (Day -1) to Week 4 | ||
Secondary | change in serum insulin | baseline (Day -1) to Week 12 | ||
Secondary | change in AUC 0-3h serum insulin | baseline (Day -1) to Week 12 | ||
Secondary | change in proinsulin | baseline (Day -1) to Week 4 | ||
Secondary | change in AUC 0-3h proinsulin | baseline (Day -1) to Week 4 | ||
Secondary | change in proinsulin | baseline (Day -1) to Week 12 | ||
Secondary | change in AUC 0-3h proinsulin | baseline (Day -1) to Week 12 | ||
Secondary | change in C-peptide | baseline (Day -1) to Week 4 | ||
Secondary | change in AUC 0-3h C-peptide | baseline (Day -1) to Week 4 | ||
Secondary | change in C-peptide | baseline (Day -1) to Week 12 | ||
Secondary | change in AUC 0-3h C-peptide | baseline (Day -1) to Week 12 | ||
Secondary | change in PYY | PYY = peptide YY | baseline (Day -1) to Week 4 | |
Secondary | change in AUC 0-3h PYY | baseline (Day -1) to Week 4 | ||
Secondary | change in PYY | baseline (Day -1) to Week 12 | ||
Secondary | change in AUC 0-3h PYY | baseline (Day -1) to Week 12 | ||
Secondary | change in total GLP-1 | GLP-1 = Glucagon-Like Peptide-1 | baseline (Day -1) to Week 4 | |
Secondary | change in total AUC 0-3h GLP-1 | baseline (Day -1) to Week 4 | ||
Secondary | change in total GLP-1 | baseline (Day -1) to Week 12 | ||
Secondary | change in AUC 0-3h total GLP-1 | baseline (Day -1) to Week 12 | ||
Secondary | change in active GLP-1 | baseline (Day -1) to Week 4 | ||
Secondary | change in AUC 0-3h active GLP-1 | baseline (Day -1) to Week 4 | ||
Secondary | change in active GLP-1 | baseline (Day -1) to Week 12 | ||
Secondary | change in AUC 0-3h active GLP-1 | baseline (Day -1) to Week 12 | ||
Secondary | change in total GIP | GIP = Gastric Inhibitory Polypeptide | baseline (Day -1) to Week 4 | |
Secondary | change in AUC 0-3h total GIP | baseline (Day -1) to Week 4 | ||
Secondary | change in total GIP | baseline (Day -1) to Week 12 | ||
Secondary | change in AUC 0-3h total GIP | baseline (Day -1) to Week 12 | ||
Secondary | change in glucagon | baseline (Day -1) to Week 4 | ||
Secondary | change in AUC 0-3h glucagon | baseline (Day -1) to Week 4 | ||
Secondary | change in glucagon | baseline (Day -1) to Week 12 | ||
Secondary | change in AUC 0-3h glucagon | baseline (Day -1) to Week 12 | ||
Secondary | change in 1,5 AG | 1,5 AG = 1,5 anhydrogucitol | baseline (Day -1) to Week 4 | |
Secondary | change in AUC 0-3h 1,5 AG | baseline (Day -1) to Week 4 | ||
Secondary | change in 1,5 AG | baseline (Day -1) to Week 12 | ||
Secondary | change in AUC 0-3h 1,5 AG | baseline (Day -1) to Week 12 | ||
Secondary | change in total cholesterol | baseline (Day -1) to Week 2 | ||
Secondary | change in total cholesterol | baseline (Day -1) to Week 4 | ||
Secondary | change in total cholesterol | baseline (Day -1) to Week 8 | ||
Secondary | change in total cholesterol | baseline (Day -1) to Week 12 | ||
Secondary | change in HDL cholesterol | HDL = high density lipoprotein | baseline (Day -1) to Week 2 | |
Secondary | change in HDL cholesterol | baseline (Day -1) to Week 4 | ||
Secondary | change in HDL cholesterol | baseline (Day -1) to Week 8 | ||
Secondary | change in HDL cholesterol | baseline (Day -1) to Week 12 | ||
Secondary | change in LDL cholesterol | LDL = low density lipoprotein | baseline (Day -1) to Week 2 | |
Secondary | change in LDL cholesterol | baseline (Day -1) to Week 4 | ||
Secondary | change in LDL cholesterol | baseline (Day -1) to Week 8 | ||
Secondary | change in LDL cholesterol | baseline (Day -1) to Week 12 | ||
Secondary | change in triglyceride | baseline (Day -1) to Week 2 | ||
Secondary | change in triglyceride | baseline (Day -1) to Week 4 | ||
Secondary | change in triglyceride | baseline (Day -1) to Week 8 | ||
Secondary | change in triglyceride | baseline (Day -1) to Week 12 |
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