In-patient Study in Patients With Type 2 Diabetes Mellitus

GlaxoSmithKline30 enrolled

Overview

This study is a placebo-controlled study in both healthy normal subjects and patients with Type 2 Diabetes Mellitus to assess the levels of exenatide in the bloodstream when it is given for 7 days, and to assess the impact this medication has on various substances in the blood. Assessments include repeat blood sampling and monitoring of any side effects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2

Interventions

exenatideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 66 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 * must be willing to wash-out of these medications for 14 days prior to the start of the study * must have bloodwork that meets certain criteria (for example, total cholesterol \< 240 mg/dL) Exclusion Criteria: * must not have any other major illness other than diabetes

Outcomes

Primary Outcomes

Pharmacodynamic measurements during 7 days of dosing.

Secondary Outcomes

Pharmacokinetic measurements during 7 days of dosing.

Data from ClinicalTrials.gov

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