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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01333592
First Posted: April 12, 2011
Last Update Posted: December 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kissei Pharmaceutical Co., Ltd.
April 6, 2011
April 12, 2011
November 17, 2014
November 24, 2014
December 15, 2014
Not Provided
August 2012   (Final data collection date for primary outcome measure)
Incidences of Adverse Events [ Time Frame: 52 weeks ]
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: at week 0 and week 52 ]
Change From Baseline in HbA1c at 52 Weeks [ Time Frame: 52 weeks ]
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
Intervention Model: Single Group Assignment
Masking: None (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
136
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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01333592
KAD4301
No
Not Provided
Not Provided
Not Provided
Kissei Pharmaceutical Co., Ltd.
Not Provided
Not Provided
Kissei Pharmaceutical Co., Ltd.
November 2014

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