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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Glucagon-Like Peptide 1; rGLP-1 protein

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.