Long-term Study of KAD-1229 in Type 2 Diabetes Patients

This study has been completed.
Sponsor:
Information provided by:
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01333592
First received: April 6, 2011
Last updated: October 31, 2013
Last verified: October 2013

April 6, 2011
October 31, 2013
Not Provided
August 2012   (final data collection date for primary outcome measure)
Incidences of Adverse Events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01333592 on ClinicalTrials.gov Archive Site
Change from Baseline in HbA1c at 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long-term Study of KAD-1229 in Type 2 Diabetes Patients
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
Drug: KAD-1229
Experimental: KAD-1229
Intervention: Drug: KAD-1229
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
November 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01333592
KAD4301
No
Not Provided
Kissei Pharmaceutical Co., Ltd.
Not Provided
Study Director: Katsumi Hontani Clinical Development Department, Kissei pharmaceutical Co., Ltd.
Kissei Pharmaceutical Co., Ltd.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP