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

NCT ID: NCT01333592

Last Updated: 2014-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Keywords

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Type 2 diabetes HbA1c Long-term study

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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KAD-1229

Group Type EXPERIMENTAL

KAD-1229

Intervention Type DRUG

Interventions

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KAD-1229

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kissei Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Locations

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Japan

Kanto Region, Chugoku Region, Kyushu Region, , Japan

Site Status

Countries

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Japan

Other Identifiers

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KAD4301

Identifier Type: -

Identifier Source: org_study_id