NCT01333592

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P25-P50 for phase_3 type-2-diabetes

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 12, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

November 24, 2014

Completed
Last Updated

December 15, 2014

Status Verified

November 1, 2014

First QC Date

April 6, 2011

Results QC Date

November 17, 2014

Last Update Submit

November 27, 2014

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetesHbA1cLong-term study

Outcome Measures

Primary Outcomes (1)

  • Incidences of Adverse Events

    52 weeks

Secondary Outcomes (1)

  • Change From Baseline in HbA1c at 52 Weeks

    at week 0 and week 52

Study Arms (1)

KAD-1229

EXPERIMENTAL
Drug: KAD-1229

Interventions

KAD-1229DRUG
KAD-1229

Eligibility Criteria

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

You may qualify if:

  • 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%

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)

Japan

Kanto Region, Chugoku Region, Kyushu Region, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

mitiglinide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

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

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 6, 2011

First Posted

April 12, 2011

Primary Completion

August 1, 2012

Study Completion

November 1, 2012

Last Updated

December 15, 2014

Results First Posted

November 24, 2014

Record last verified: 2014-11

Locations

JP(1)