NCT00370942

Brief Summary

This study was designed to find dose response and as extension in treatment of GW823093C.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
159

participants targeted

Target at P50-P75 for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_2 diabetes-mellitus-type-2

Geographic Reach
1 country

4 active sites

Status
terminated

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

Study Start

First participant enrolled

April 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2006

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

August 30, 2006

Last Update Submit

August 30, 2018

Conditions

Diabetes Mellitus, Type 2

Keywords

GW823093Cdiabetestype 2 diabetes mellitusDPP-IV inhibitor

Outcome Measures

Primary Outcomes (1)

  • Efficacy variables Dose response (change from baseline in HbA1c) at stipulated date in each treatment group

    12 weeks

Secondary Outcomes (1)

  • Long term safety variables

    64 weeks

Study Arms (3)

GW823093C A

PLACEBO COMPARATOR

A=45 mg

Drug: GW823093C A

GW823093C B

PLACEBO COMPARATOR

B=30 mg

Drug: GW823093C B

GW823093C C

PLACEBO COMPARATOR

C=15 mg

Drug: GW823093C C

Interventions

GW823093C ADRUG

A=45 mg

GW823093C A
GW823093C BDRUG

B=30 mg

GW823093C B
GW823093C CDRUG

C=25 mg

GW823093C C

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus.
  • Managed by diet therapy or receiving treatment with oral anti-diabetic monotherapy (excluding TZD (Thiazolidinediones))

You may not qualify if:

  • Patients who have metabolic disease judged by investigator as a clinically significance
  • Serious cardiovascular disease or serious hepatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

GSK Investigational Site

Hokkaido, 051-0005, Japan

Location

GSK Investigational Site

Miyagi, 985-0852, Japan

Location

GSK Investigational Site

Tokyo, 130-0004, Japan

Location

GSK Investigational Site

Tokyo, 160-0017, Japan

Location

GSK Investigational Site

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2006

First Posted

September 1, 2006

Study Start

April 1, 2006

Primary Completion

November 1, 2006

Study Completion

November 25, 2006

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations

JP(4)