NCT00857558CompletedPhase 2
A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Kyowa Kirin Co., Ltd.
- Enrollment
- 350
- Primary Endpoint
- changes in HbA1C from baseline
Study Overview
Brief Summary
A multicenter, randomized, double-blind, placebo-controlled, group-comparison study to investigate the safety and efficacy of OPC-262 in patients with type 2 diabetes
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 2 diabetes patients with HbA1c above 7.0% and below 10%
- •Patients who are capable of giving informed consent
- •Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner
Exclusion Criteria
- •Patients with type1 diabetes mellitus, patients with diabetes mellitus or impaired glucose tolerance (IGT) due to other specified mechanism or diseases, and patients with gestational diabetes mellitus
- •Patients with a medical history of diabetes coma
- •Patients with poorly-controlled hypertension
- •Patients with heart failure
- •Patients with a complication of active hepatitis or hepatic cirrhosis
- •Patients undergoing treatment of glomeruler diseases other than diabetic nephropathy
- •Patients with a history or complication of malignant tumor
Arms & Interventions
4
Placebo Comparator
Intervention: placebo (Drug)
3
Experimental
OPC-262 5mg
Intervention: saxagliptin (Drug)
1
Experimental
OPC-262 1mg
Intervention: saxagliptin (Drug)
2
Experimental
OPC-262 2.5mg
Intervention: saxagliptin (Drug)
Outcomes
Primary Outcomes
changes in HbA1C from baseline
Time Frame: 2w, 4w, 8w, 12w, 16w
Secondary Outcomes
- values and changes in fasting blood glucose (FSB) from baseline(2w, 4w, 8w, 12w, 16w)
- adverse event(at any time)
- values and changes in HbA1c form baseline(2w, 4w, 8w, 12w, 16w)
Investigators
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