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Completed

NCT Number: NCT01333592

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Japan

Kanto Region, Chugoku Region, Kyushu Region, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KAD-1229

Drug

Primary outcomes

  1. Incidences of Adverse Events

    Time frame: 52 weeks

Secondary outcomes

  1. Change From Baseline in HbA1c at 52 Weeks

    Time frame: at week 0 and week 52

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Primary completion
2012
Study completion
2012
First posted
Apr 12, 2011
Registry last updated
Dec 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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