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

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ClinicalTrials.gov Identifier: NCT01333592
Recruitment Status : Completed
First Posted : April 12, 2011
Results First Posted : November 24, 2014
Last Update Posted : December 15, 2014
Sponsor:
Information provided by:
Kissei Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: KAD-1229 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Primary Completion Date : August 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: KAD-1229 Drug: KAD-1229



Primary Outcome Measures :
  1. Incidences of Adverse Events [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Change From Baseline in HbA1c at 52 Weeks [ Time Frame: at week 0 and week 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333592


Locations
Japan
Japan
Kanto region, Chugoku region, Kyushu region, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier: NCT01333592     History of Changes
Other Study ID Numbers: KAD4301
First Posted: April 12, 2011    Key Record Dates
Results First Posted: November 24, 2014
Last Update Posted: December 15, 2014
Last Verified: November 2014

Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Type 2 diabetes
HbA1c
Long-term study

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mitiglinide
Hypoglycemic Agents
Physiological Effects of Drugs