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 |
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.
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
sites
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