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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2; Non-Insulin-Dependent Diabetes Mellitus

Intervention: GSK716155 subcutaneous injections (Drug); placebo injection (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: blood plasma levels of GSK716155

Secondary outcome: blood plasma levels of GSK716155

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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.

- Unwilling to abstain from alcohol during the study.

- Unwilling to abstain from caffeine- or xanthine-containing products during the study.

- Use of St. John's Wort during the study.

- Has donated 500 nL or more blood within 56 days of dosing or plans to donate blood in

the month following study participation.

- Previously received any GLP-1 mimetic that has moe than 70% sequence homology to

GLP-1.

Locations and Contacts

GSK Investigational Site, Miramar, Florida 33025, United States

GSK Investigational Site, Orlando, Florida 32809, United States

GSK Investigational Site, Honolulu, Hawaii 96814-4224, United States

GSK Investigational Site, San Antonio, Texas 78229, United States

Additional Information

Starting date: February 2006
Last updated: May 31, 2012

Page last updated: August 23, 2015

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