Phase 3
Completed N=136
Long-term Study of KAD-1229 in Type 2 Diabetes Patients
Source: ClinicalTrials.gov NCT01333592 ↗Enrolled (actual)
136
Serious AEs
4.4%
Results posted
Nov 2014
Primary outcomePrimary: Incidences of Adverse Events — 48; 57 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidences of Adverse Events |
48; 57 | — |
| SECONDARY Change From Baseline in HbA1c at 52 Weeks |
-0.45; -0.28 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01333592). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.