Study S003404

A Phase 1, Randomized, Placebo-Controlled, Sequential Parallel Group, Multiple Dose Escalation Trial To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of 4, Once-Weekly Subcutaneous Doses Of PF-04603629 To Subjects With Type 2 Diabetes Mellitus

ClinicalTrials.gov record

Registration

Registration: NCT00637338
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: TRIPLE
Status: TERMINATED
Enrollment: 42
Start: 2008-04
Primary completion: 2008-09
Lead sponsor: Pfizer
Conditions: Diabetes Mellitus, Type 2
Interventions: BIOLOGICAL:PF-04603629; BIOLOGICAL:Placebo
Results posted: FALSE

Registered primary outcomes

To characterize the pharmacokinetics of PF-04603629 in serum after administration of escalating, multiple, subcutaneously injected doses of PF-04603629 to subjects with T2DM. [4 weeks per dose group]
To evaluate the effects of multiple, escalating, subcutaneously injected doses of PF-04603629, on the pharmacodynamic responses of glucose, insulin, C-peptide and glucagon during a mixed meal tolerance test (MMTT). [4 weeks per dose group]
To describe the safety and tolerability of escalating, multiple, subcutaneously injected doses of PF-04603629 administered to subjects with T2DM. [4 weeks per dose group]

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