| Trial ID: | L6261 |
| Source ID: | NCT00374907
|
| Associated Drug: |
Saxagliptin
|
| Title: |
A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00374907/results
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| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Saxagliptin|DRUG: Placebo|DRUG: Metformin (blinded)|DRUG: Metformin (open-label)
|
| Outcome Measures: |
Primary: Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12, Adjusted percent change in the insulin secretion rate AUC during a hyperglycemic clamp with an enteral glucose load \[intravenous-oral hyperglycemic clamp (180-480 minutes)\] at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution., Baseline, Week 12 | Secondary: Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12, Adjusted percent change in the insulin secretion rate AUC during an intravenous hyperglycemic clamp (120-180 minutes) at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution., Baseline, Week 12 | Other: Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period, AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing., 116 weeks|Marked Laboratory Abnormalities - During ST + LT Treatment Period, A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; BUN=blood urea nitrogen; unspec.=unspecified; sodium serum low: \<0.9 x Pre-Rx \& \<=130mEq/L / high: \>1.1 x Pre-Rx \& \>=150mEq/L; potassium, serum low: \<=0.8 x Pre-Rx \& \>=6.0mEq/L / high: 1.2 x Pre-Rx \& \>=6.0mEq/L; LLN=lower limit of normal., 116 weeks
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca
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| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
156
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-09
|
| Completion Date: |
2009-12
|
| Results First Posted: |
2011-01-21
|
| Last Update Posted: |
2015-05-07
|
| Locations: |
Va San Diego Healthcare System, San Diego, California, 92161, United States|Pennington Biomedical Research Center, Baton Rouge, Louisiana, 70808, United States|Diabetes & Glandular Disease Research Assoc,, Inc., San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00374907
|
