Phase 4
Completed N=178
Post-marketing Clinical Trial of KAD-1229 in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02154347 ↗Enrolled (actual)
178
Serious AEs
6.8%
Results posted
Sep 2019
Primary outcomePrimary: Change From Baseline in HbA1c — 0.05; -0.61 % (value of HbA1c) — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to evaluate the safety and efficacy of KAD-1229 as combination therapy with insulin for 16 weeks and up to 52 weeks administration in patients with type 2 Diabetes Mellitus who show inadequate glycemic control with diet, and insulin monotherapy, or insulin and oral hypoglycemic agent.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c |
0.05; -0.61 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patients who has been receiving dietary therapy and a stable dose and regimen of insulin over 8 weeks before at the time of an observation term start
- Patients whose HbA1c at the time of an observation term start is 7.5% or more and less than 10.0%
Exclusion Criteria
- Type 1 Diabetes Mellitus
- Patients with serious diabetic complications and other serious complications
Data sourced from ClinicalTrials.gov (NCT02154347). 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.