The intent of this study is to assess the safety of LY2409021 in participants with Type 2 diabetes mellitus taking metformin and sulfonylurea as prescribed by their personal physician. The study treatment is expected to last 12 months (52 weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
174
Change From Baseline to 6 Months in Hepatic Fat Fraction
The hepatic fat fraction (HFF) was calculated by a core imaging laboratory from noncontrast magnetic resonance imaging (MRI) of the liver. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (\<=8.0%, \>8.0%), visit, baseline score, and treatment-by-visit.
Time frame: Baseline, 6 months
Change From Baseline to 6 Months in Alanine Aminotransferase Levels
Alanine aminotransferase (ALT) assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (\<=8.0%, \>8.0%), visit, baseline score, and treatment-by-visit.
Time frame: Baseline, 6 months
Number of Participants With Hepatobiliary Adverse Events of Special Interest (AESI)
Number of participants with ALT or AST greater than 3 times the upper limit of normal at a post-baseline visit. A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time frame: Baseline, 6 months
Change From Baseline to 6 Months in Fasting Lipids Levels
Lipid values (cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides) assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (\<=8.0%, \>8.0%), visit, baseline score, and treatment-by-visit.
Time frame: Baseline, 6 months
Change From Baseline to 6 Months in Fasting Blood Glucagon
Glucagon values assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (\<=8.0%, \>8.0%), visit, baseline score, and treatment-by-visit.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Administered orally
Administered orally
John Muir Health Network - The Osteoporosis Center
Concord, California, United States
Valley Endocrine, Fresno
Fresno, California, United States
National Research Institute
Los Angeles, California, United States
Suncoast Research Group, LLC
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
University of Hawaii
Honolulu, Hawaii, United States
East West Medical Institute
Honolulu, Hawaii, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States
Cedar-Crosse Research Center
Chicago, Illinois, United States
...and 23 more locations
Time frame: Baseline, 6 months
Change From Baseline to 6 Months in Body Weight
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (\<=8.0%, \>8.0%), visit, baseline score, and treatment-by-visit.
Time frame: Baseline, 6 months
Change From Baseline to 6 Months in Hemoglobin A1c (HbA1c)
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, visit, baseline score, and treatment-by-visit.
Time frame: Baseline, 6 months
Change From Baseline to 6 Months in Fasting Plasma Glucose
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (\<=8.0%, \>8.0%), visit, baseline score, and treatment-by-visit.
Time frame: Baseline, 6 months
Change From Baseline to 6 Months in Blood Pressure
Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured in triplicate throughout the study. At each visit, all available blood pressure measurements for a subject were averaged to provide the blood pressure for that visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (\<=8.0%, \>8.0%), visit, baseline score, and treatment-by-visit.
Time frame: Baseline, 6 months
Change From Baseline to 6 Months in Pulse Rate
Seated pulse rate was measured in triplicate throughout the study. At each visit, all available pulse measurements for a subject were averaged to provide the pulse for that visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (\<=8.0%, \>8.0%), visit, baseline score, and treatment-by-visit.
Time frame: Baseline, 6 months
Change From Baseline to 6 Months in 7-Point Self-Monitoring of Blood Glucose (SMBG)
7-point profile consists of pre-meal and 2-hour postprandial SMBG measurements for the morning, midday, and evening meals in 1 day and at 3 AM (nocturnal blood glucose measurement). Pre-meal measurements were taken before the subject began eating the meal. Participants recorded their glucose measurements in their study diaries.
Time frame: Baseline, 6 months
Population Pharmacokinetics: Apparent Clearance of LY2409021
Reported as a Population Estimate with % Standard Errors of Estimation (SEE), 5th-95th confidence interval.
Time frame: Day 1 Month 1, 3, 6, 9, predose, 1 hour postdose,
Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021
Time frame: Day 1 Month 1, 3, 6, 9, predose, 1 hour postdose,
Rate of Hypoglycemic Events Adjusted Per 30 Days
Documented symptomatic hypoglycemia, an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration \<=70 mg/dL (\<=39 mmol/L),is presented. Rate: (30 days) is calculated as: (number of episodes during the time period divided by the number of days during the time period) multiplied by 30.
Time frame: Baseline through 6 months
Number of Participants With Hypoglycemic Events
Documented symptomatic hypoglycemia, an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration \<=70 mg/dL (\<=39 mmol/L), is presented. The number of subjects with an event are subjects who had at least one episode of documented symptomatic hypoglycemia during the time period.
Time frame: Baseline through 6 months