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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidences of Adverse Events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from Baseline in HbA1c at 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333592

Locations
Japan
Japan
Kanto region, Chugoku region, Kyushu region, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
Study Director: Katsumi Hontani Clinical Development Department, Kissei pharmaceutical Co., Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01333592     History of Changes
Other Study ID Numbers: KAD4301
Study First Received: April 6, 2011
Last Updated: October 31, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 10, 2014