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OpenTrials
Completed

NCT Number: NCT02154347

Post-marketing Clinical Trial of KAD-1229 in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety and efficacy of KAD-1229 as combination therapy with insulin for 16 weeks and up to 52 weeks administration in patients with type 2 Diabetes Mellitus who show inadequate glycemic control with diet, and insulin monotherapy, or insulin and oral hypoglycemic agent.

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Key information

Conditions

Type 2 Diabetes Mellitus 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 4

Primary location

Multiple Locations, Japan

Who can participate

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

Inclusion criteria

  • Patients who has been receiving dietary therapy and a stable dose and regimen of insulin over 8 weeks before at the time of an observation term start
  • Patients whose HbA1c at the time of an observation term start is 7.5% or more and less than 10.0%

Exclusion criteria

  • Type 1 Diabetes Mellitus
  • Patients with serious diabetic complications and other serious complications

Treatment and study plan

KAD-1229

Drug

Placebo

Drug

Insulin

Drug

Primary outcomes

  1. Change From Baseline in HbA1c

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Primary completion
2016
First posted
Jun 3, 2014
Registry last updated
Sep 6, 2019

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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