NCT02154347

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

September 6, 2019

Completed
Last Updated

September 6, 2019

Status Verified

May 1, 2017

First QC Date

May 30, 2014

Results QC Date

July 12, 2019

Last Update Submit

September 4, 2019

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes MellitusHbA1c

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in HbA1c

    16 weeks

Study Arms (2)

KAD-1229/KAD-1229

EXPERIMENTAL

Patients are administered KAD-1229 for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with insulin throughout the study.

Drug: KAD-1229Drug: Insulin

Placebo/KAD-1229

OTHER

Patients are administered Placebo for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with Insulin throughout the study.

Drug: KAD-1229Drug: PlaceboDrug: Insulin

Interventions

KAD-1229DRUG
KAD-1229/KAD-1229Placebo/KAD-1229
PlaceboDRUG
Placebo/KAD-1229
InsulinDRUG
KAD-1229/KAD-1229Placebo/KAD-1229

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

mitiglinideInsulin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Clinical Development Division
Organization
Kissei Pharmaceutical Co., Ltd
rinsyousiken@pharm.kissei.co.jp
Email only

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2014

First Posted

June 3, 2014

Primary Completion

July 1, 2016

Last Updated

September 6, 2019

Results First Posted

September 6, 2019

Record last verified: 2017-05

Locations

JP(1)