A Study of DPP-IV (3) in Patients With Type 2 Diabetes.



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:6/3/2016
Start Date:July 2007
End Date:July 2008

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A Randomized, Double-blind Dose-ranging Study of the Effect of DPP-IV (3) on HbA1c, Other Efficacy Parameters, Pharmacokinetics and Safety in Patients With Type 2 Diabetes (BC20779)

This 5 arm study will assess the efficacy, pharmacokinetics, safety and tolerability of a
DPP-IV inhibitor compared to placebo in patients with type 2 diabetes. Patients will be
randomized to receive DPP-IV(3) at one of 4 doses (of 12.5mg and above), or placebo p.o.
Patients receiving metformin before the study will continue on the same dose of metformin.
The anticipated time on study treatment is 3-12 months, and the target sample size is
100-500 individuals.


Inclusion Criteria:

- adult patients, 18-75 years of age;

- type 2 diabetes diagnosed >= 1 month before screening;

- drug-naive, or pretreated with MTD of metformin;

- BMI 25-45kg/m2.

Exclusion Criteria:

- type 1 diabetes;

- any anti-hyperglycemic medication other than metformin, or weight-lowering drug,
during last 3 months.
We found this trial at
13
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Charlotte, North Carolina 28207
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