NCT01333592CompletedPhase 3
A Multicenter, Open Label, Long-term Study of KAD-1229 in Type 2 Diabetes Patients Who Show Inadequate Glycemic Control With Diet, and Biguanide or DPP-4 Inhibitor Monotherapy
Kissei Pharmaceutical Co., Ltd.1 site in 1 country136 target enrollmentStarted: April 12, 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- Incidences of Adverse Events
Study Overview
Brief Summary
The purpose of this study is to evaluate the long-term safety and efficacy of KAD-1229 as combination therapy with biguanide or DPP-4 inhibitor in type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy
- •Age in the 20 years or over inclusive
- •HbA1c in the range of ≥ 6.5 to < 9%
Exclusion Criteria
- •Type 1 diabetes mellitus
- •Patients with serious diabetic complications and other serious complications
Arms & Interventions
KAD-1229
Experimental
Intervention: KAD-1229 (Drug)
Outcomes
Primary Outcomes
Incidences of Adverse Events
Time Frame: 52 weeks
Secondary Outcomes
- Change From Baseline in HbA1c at 52 Weeks(at week 0 and week 52)
Investigators
Study Sites (1)
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