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A Study in Type 2 Diabetics of Single and Multiple Doses of Orally Administered GSK1292263 to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics | Clinical Trials | Clareo Health

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A Study in Type 2 Diabetics of Single and Multiple Doses of Orally Administered GSK1292263 to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics

A Study in Type II Diabetic Subjects of Single and Multiple Doses of Orally Administered GSK1292263 to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Compound Alone and When Co-administered With Sitagliptin or Metformin

NCT01119846•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The purpose of this study is to see if GSK1292263 is safe and well-tolerated when administered to type 2 diabetics, and to get preliminary information about whether it may be effective in the treatment of type 2 diabetes.

Detailed Description

Data from this study will be used to assess the potential of GSK1292263 as a treatment for T2DM, and will aid the design and dose selection of future studies of longer duration in T2DM subjects that will evaluate GSK1292263 alone or in combination with other anti-diabetic drugs.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female subjects, 18 - 60 years of age, inclusive, at the time of signing the informed consent.
•A female subject is eligible to participate if she is of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. FSH and estradiol levels will be checked at Screening for postmenopausal women. Simultaneous follicle stimulating hormone (FSH) \> 40 MlU/ml and estradiol \< 40pg/ml (\<140pmol/L) is confirmatory.

Exclusion Criteria

•BMI (body mass index) within the range 22-35 kg/m2, inclusive.
•Part A - T2DM diagnosed by American Diabetes Association criteria at least 3 months prior to Screening with:
•Currently controlled by diet and exercise.
•Fasting plasma glucose (FPG) level \<= 250mg/dL at the Screening visit
•FPG level \<= 250mg/dL on Day -1
•HbA1c between 6.5 and 11%, inclusive, at Screening visit
•For Parts B and C, T2DM diagnosed by American Diabetes Association criteria at least 3 months prior to Screening with:
•T2DM currently controlled by diet and exercise, or, if on medication, subjects must be treating their T2DM using one of the following regimens:
•Metformin as monotherapy
•Sulfonylurea as monotherapy
+56 more criteria

Locations (7)

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Chula Vista, California, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Durham, North Carolina, United States

GSK Investigational Site

Columbus, Ohio, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Tacoma, Washington, United States

Key Dates

Start Date

June 5, 2009

Primary Completion Date

March 19, 2010

Completion Date

March 19, 2010

Last Updated

January 17, 2018

Enrollment

100

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

GSK1292263

DRUG

GSK1292263 matching placebo

DRUG

Sitagliptin

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 17, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study in Type 2 Diabetics of Single and Multiple Doses of Orally Administered GSK1292263 to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

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