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In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus | Clinical Trials | Clareo Health

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In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus

A Single-blinded Randomized, Placebo-controlled, Staggered-parallel, Escalating-dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Injections of GSK 716155 in Subjects With Type 2 Diabetes Mellitus

NCT00354536•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream when it is given at the same dose 7 days apart, and the impact this medication has on various substances in the blood. Assessments include ECGs, vital signs, repeat blood sampling and monitoring of any side effects.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must have type 2 diabetes mellitus that has been diagnosed for at least three months.
•Must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea.
•Subjects must be willing to wash-out of these medications for 14 days prior to the start of the study.
•Subjects must have a BMII between 25 and 40 kg/m² and weigh at leas 50kg.
•Women must be of non-childbearing potential.

Exclusion Criteria

•Laboratory values that meet certain criteria (for example, total cholesterol \> 240 mg/dL).
•Clinically significant hepatic enzyme elevation.
•Fasting plasma glucose greater than 240mg/dL.
•Positive test result for Hepatitis B surface antigen, positive Hepatitis C or HIV.
•Any major illness other than diabetes.
•Previous use of insulin as treatment for diabetes.
•Significant renal disease as defined by screening lab tests.
•History of drug or other allergy, which in the opinion of the investigator contradicts subject participation.
•Smoking or use of nicotine-containing products within the previous 6 months.
•History of alcohol or drug abuse.
+5 more criteria

Locations (5)

GSK Investigational Site

Miramar, Florida, United States

GSK Investigational Site

Orlando, Florida, United States

GSK Investigational Site

Honolulu, Hawaii, United States

GSK Investigational Site

Portland, Oregon, United States

GSK Investigational Site

San Antonio, Texas, United States

Key Dates

Start Date

February 1, 2006

Primary Completion Date

September 1, 2006

Completion Date

September 1, 2006

Last Updated

October 26, 2016

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

GSK716155 subcutaneous injections

DRUG

placebo injection

BIOLOGICAL

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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: October 26, 2016Data 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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In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus

Inclusion Criteria

Exclusion Criteria

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