This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
93
Tablets, Oral, 5mg, once daily, 4 weeks
Tablets, Oral, 0 mg, once daily, 4 weeks
Dedicated Phase I, Inc.
Phoenix, Arizona, United States
Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4
Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value.
Time frame: Baseline, Week 4
Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4
Adjusted mean change from baseline in 4-hour mean weighted postprandial (after mealtime) plasma glucose after the evening meal during 24-hour domicile visits evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.
Time frame: Baseline, Week 4
Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4
Adjusted mean change from baseline in 2-hour postprandial plasma glucose after the evening meal during 24-hour domicile visits, evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.
Time frame: Baseline, Week 4
Change From Baseline in Mean Daily Glucose at Week 4
Adjusted mean change from baseline in daily glucose at Week 4. Mean daily glucose was calculated based on finger stick glucose measurements collected by the subjects at home in a 3-day period, prior to collection of the 24-hour blood samples at baseline and Week 4. Mean change from baseline was adjusted for baseline value.
Time frame: Baseline, Week 4
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Amcr Institute, Inc
Escondido, California, United States
Irvine Center For Clinical Research, Inc.
Irvine, California, United States
Pacific Sleep Medicine Services (Avastra Clinical Trials)
Redlands, California, United States
Advantage Clinical Research
Santa Ana, California, United States
Orange County Research Center
Tustin, California, United States
River Birch Research Alliance, Llc
Blue Ridge, Georgia, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
Jasper Clinic, Inc.
Kalamazoo, Michigan, United States
Clinilabs, Inc.
New York, New York, United States
...and 17 more locations
Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4
Adjusted mean change from baseline in 2-day average of FPG at baseline and Week 4. Baseline value=the average of the values at Day -2 and Day 1. Week 4 measurement=average of Day 26 and Day 28 value during the double blind period. At pre-randomization and Day 28 the FPG value was the plasma glucose value collected 30 minutes prior to the morning meal during domicile visits. Mean change from baseline was adjusted for baseline value.
Time frame: Baseline, Week 4