| Trial ID: | L6991 |
| Source ID: | NCT00420511
|
| Associated Drug: |
Sitagliptin
|
| Title: |
Beta-Cell Function and Sitagliptin Trial (BEST)
|
| Acronym: |
BEST
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00420511/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Sitagliptin|DRUG: Placebo|DRUG: metformin
|
| Outcome Measures: |
Primary: Preservation of Beta-cell Function Measured by Area-under-the-curve (C-peptide/Glucose)/HOMA-IR, Area-under-the-C-peptide-curve (AUCCpep) and area-under-the-glucose-curve (AUCgluc) from 0 to 240 minutes during meal tests were calculated using the trapezoidal rule. Insulin resistance was assessed using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR). Beta-cell function was assessed using the ratio of total AUCCpep to AUCgluc divided by HOMA-IR (AUCCpep/gluc/HOMA-IR), a measure of insulin secretion in the context of ambient insulin sensitivity, analogous to the disposition index and adaptation index. Higher AUCCpep/gluc/HOMA-IR is indicative of better beta-cell function., 48 weeks | Secondary: Insulinogenic Index Divided by HOMA-IR at 48 Weeks, Insulinogenic index was calculated as the incremental change in insulin from 0 to 30 minutes divided by the incremental change in glucose over the same period of time. Insulinogenic index divided by HOMA-IR provides an additional measure of beta-cell function. A higher value indicates better beta-cell function, 48 weeks|Fasting Blood Glucose at 48 Weeks, 48 weeks|Area-under-the-glucose-curve (AUCglucose) on Meal Test at 1 Year, 1 year|Time to Loss of Glycemic Control, 1 year|Proportion of Patients Achieving Sustained Normoglycemia Off Medication at 1-week Post-insulin Therapy, 1 year
|
| Sponsor/Collaborators: |
Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital | Collaborators: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
21
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-01
|
| Completion Date: |
2009-09
|
| Results First Posted: |
2011-12-29
|
| Last Update Posted: |
2012-01-02
|
| Locations: |
Leadership Sinai Centre for Diabetes, Toronto, Ontario, M5T 3L9, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT00420511
|
