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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.
  Purpose
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 Intervention Phase
Type 2 Diabetes Drug: KAD-1229 Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Kissei Pharmaceutical Co., Ltd.:

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

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

Enrollment: 136
Study Completion Date: November 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KAD-1229 Drug: KAD-1229

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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.
  More Information

ClinicalTrials.gov Identifier: NCT01333592     History of Changes
Other Study ID Numbers: KAD4301
First Submitted: April 6, 2011
First Posted: April 12, 2011
Results First Submitted: November 17, 2014
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


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