In-patient Study in Patients With Type 2 Diabetes Mellitus
Status and phase
Completed
Phase 1
Conditions
Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Treatments
Drug: exenatide
Details and patient eligibility
About
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.
Sex
All
Ages
18 to 66 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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