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

This study has been completed.
Information provided by:
Kissei Pharmaceutical Co., Ltd. Identifier:
First received: April 6, 2011
Last updated: November 27, 2014
Last verified: November 2014
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: 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


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

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
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Please refer to this study by its identifier: NCT01333592

Kanto region, Chugoku region, Kyushu region, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
  More Information Identifier: NCT01333592     History of Changes
Other Study ID Numbers: KAD4301
Study First Received: April 6, 2011
Results First Received: November 17, 2014
Last Updated: November 27, 2014

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 25, 2017