Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus, sitagliptin, adult, Phase 2
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.
Detailed 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.
Interventions
DRUGDS-8500a 25 mg
DRUGDS-8500a 75 mg
DRUGplacebo
Sponsors
Mediscience Planning, Inc.
Daiichi Sankyo Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in 24 hour weighted mean glucose | baseline (Day -1) to Day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in fasting plasma glucose | baseline (Day -1) to Day 28 | — |
| change in plasma glucose | baseline (Day -1) and Day 28 | 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 |
| change in glycoalbumin | baseline (Day -1) and Day 28 | — |
| change in serum insulin | baseline (Day -1) and Day 28 | 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 |
| change in proinsulin | baseline (Day -1) and Day 28 | — |
| change in C-peptide | baseline (Day -1) and Day 28 | Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast |
| change in PYY (pancreatic peptide YY3-36) | baseline (Day -1) and Day 28 | Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast |
| change in active GLP-1 (Glucagon-like peptide-1) | baseline (Day -1) and Day 28 | Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast |
| change in total GIP (Gastric inhibitory polypeptide) | baseline (Day -1) and Day 28 | Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast |
| change in total glucagon | baseline (Day -1) and Day 28 | Before breakfast; 0.5, 1, 2, and 4 hours after starting breakfast |
| change in total total cholesterol | baseline (Day -1) to after dosing on Day 28 | — |
| change in total GLP-1 (Glucagon-like peptide-1) | baseline (Day -1) and Day 28 | — |
| change in total LDL (low density lipoprotein) cholesterol | baseline (Day -1) to after dosing on Day 28 | — |
| change in total triglyceride | baseline (Day -1) to after dosing on Day 28 | — |
| number and severity of adverse events | baseline (Day -1) to after dosing on Day 28 | — |
| change in derived plasma glucose AUC | baseline (Day -1) to after dosing on Day 28 | change in pharmacodynamic parameters derived from plasma glucose; AUC0-24h, AUC 0-4h, AUC4-8h, AUC9-13h |
| change in derived serum insulin AUC | baseline (Day -1) to after dosing on Day 28 | change in pharmacodynamic parameters derived from serum insulin; AUC0-24h, AUC 0-4h, AUC4-8h, AUC9-13h |
| change in derived C-peptide AUC | baseline (Day -1) to after dosing on Day 28 | change in pharmacodynamic parameters derived from C-peptide; AUC0-4h |
| change in derived PYY AUC | baseline (Day -1) to after dosing on Day 28 | change in pharmacodynamic parameters derived from PYY; AUC0-4h |
| change in derived total GLP-1 AUC | baseline (Day -1) to after dosing on Day 28 | change in pharmacodynamic parameters derived from total GLP-1; AUC0-4h |
| change in derived active GLP-1 AUC | baseline (Day -1) to after dosing on Day 28 | change in pharmacodynamic parameters derived from active GLP-1; AUC0-4h |
| change in derived total GIP AUC | baseline (Day -1) to after dosing on Day 28 | change in pharmacodynamic parameters derived from total GIP; AUC0-4h |
| change in derived glucagon AUC | baseline (Day -1) to after dosing on Day 28 | change in pharmacodynamic parameters derived from glucagon; AUC0-4h |
| change in total HDL (high density lipoprotein) cholesterol | baseline (Day -1) to after dosing on Day 28 | — |
Countries
Japan
Outcome results
None listed