Current partner codePEPTIDESDE
NCT00354536·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

60

Locations

5

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

GSK716155 subcutaneous injections

albiglutide subcutaneous injection

BIOLOGICAL

placebo injection

placebo injection

Timeline

From registration to results.

  1. First posted

    Jul 20, 2006

  2. Study start

    Feb 2006

  3. Primary completion

    Sep 2006

  4. Study completion

    Sep 2006

  5. Results posted

    Not reported

  6. Registry updated

    Oct 26, 2016

Outcomes

What the study measures.

Primary outcomes

blood plasma levels of GSK716155

Time frame · on days 2 & 9

Secondary outcomes

blood plasma levels of GSK716155

Time frame · on days 2 & 9

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

5 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

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

Related trials

More studies on Albiglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.