A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 10/14/2017 |
| Start Date: | September 2006 |
| End Date: | December 2009 |
Mechanism of Action and Efficacy of Saxagliptin (BMS-477118) in the Treatment of Type 2 Diabetic Patients
The purpose of this clinical research study is to learn whether Saxagliptin can improve the
body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes
body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes
All subjects will participate in a lead-in period, and qualifying subjects will continue into
a short-term randomized treatment period. Subjects who complete the short-term period will be
eligible to enter the long term extension period. Also, subjects who have an elevated blood
sugar that requires additional medication for blood sugar control will be eligible to receive
open-label metformin added onto their blinded study medication
a short-term randomized treatment period. Subjects who complete the short-term period will be
eligible to enter the long term extension period. Also, subjects who have an elevated blood
sugar that requires additional medication for blood sugar control will be eligible to receive
open-label metformin added onto their blinded study medication
Inclusion Criteria:
- Type 2 diabetes mellitus
- Drug naive
- Hemoglobin A1c (HbA1c) ≥6.0% and ≤8.0%
- Fasting C-peptide ≥1.0 ng/mL
- Body mass index ≤40 kg/m²
Exclusion Criteria:
- Recent cardiac or cerebrovascular event
- Elevated serum creatinine
We found this trial at
3
sites
VA San Diego Healthcare System The VA San Diego Healthcare System (VASDHS) provides high quality...
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Pennington Biomedical Research Center Unlike other medical research facilities where science occurs in separate labs...
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