Injection Site Study In Patients With Type 2 Diabetes Mellitus (T2DM) And Healthy Volunteers

• Status: Completed
• Trial end date: 2007-03-20
• Target enrollment: 0
• Participant gender: All

Summary

This study is an open-label study in healthy volunteers and in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream after a single dose given at different injection sites, 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 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

Inclusion criteria:

• They can be healthy volunteers or subjects with type 2 diabetes mellitus that has been diagnosed for at least three months. T2DM subjects must be taking either (1) no medication for their diabetes or (2) taking metformin or (3) taking a TZD (thiazolidinedione).

• Subjects must have a BMI between 25 and 40 kg/m² and weigh at least 50kg.

• Women must be of non-childbearing potential.

Exclusion criteria:

• Bloodwork that meets certain criteria (for example, total cholesterol > 240 mg/dL)

• Clinically significant hepatic enzyme elevation

• HbA1c less than 6.5 or greater than 10

• 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 prior to and during the in-patient clinic stays

• Unwilling to abstain from caffeine- or xanthine-containing products prior to and during the in-patient clinic stays

• 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.