Clinical Trial Search

Primary: Percent Change in Plasma Triglycerides — -2.0; 16.0; -5.0; -5.0 percent change

Primary: Change in Weight From Baseline at 12 Months or More — -8.37 Kg — p=<0.05

Primary: Change From Baseline for Mean Hemoglobin A1c (HbA1C) — 6.9; -0.5 Percent of glycosylated hemoglobin

Primary: Hemoglobin A1C — -0.39; -0.26 percent — p=0.079

Primary: Frequency of Eating in Response to Cravings (Primary Mechanistic Outcome) — -20.39; -25.27 % of EMAs with craving related eating

Primary: Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days — 0.41; 0.23; 1135.7; 309.0 index

Primary: Beta-cell Function - C-peptide AUC (Area Under the Curve) — 2096; 1725 ng*min/mL

Primary: Disposition Index — 0.023; 0.149 index

Primary: Glycemic Index — 76.79; 86.92 percentage of AUC from GI100 — p=0.005

Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 — 0.46; 0.18; -0.07; 0.01 Percentage of HbA1c — p=0.061

Primary: Sleep Efficiency — 79.5; 83.1 Percentage of time asleep — p=0.04

Primary: Fasting Plasma Glucose at Baseline — 170.2; 168.2 mg/dL

Primary: The Percentage Change in HbA1c Level From Baseline to 12 Weeks — -11.1; 0.0 percentage change

Primary: Change From Baseline in Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) at 4 Years — 50.2; 48.3 Percentage of Beta Cell Function — p=0.24

Primary: The Change From Baseline of DQ8 Antigen Presentation by Peripheral Blood Mononuclear Cells After 6 Weeks of Methyldopa Treatment. — 642; 430; 27.4; 17.9 pg/mL

Primary: Blood Glucose Levels — 5.6; 5.7; 6.7; 7.7 mmol/L — p=<0.001

Primary: Fasting Serum Glucose — 6.6; 7.3; 8.2 mmol/L — p=0.031

Primary: Change in E to A Ratio — 1.04; 1.25 Ratio — p=<0.01

Primary: Median Percent Change From Baseline to Week 6 in LDL-c in FDC and RSG Monotherapy — -39.9; 5.4 Percent change in LDL-c — p=<0.0001

Primary: Number of Participants Had Protocol-Defined Total Hypoglycemic Adverse Event (HAE) - Part A — 2; 2; 1; 1 participants

Primary: Change in Glycemic Measures- HbA1c (12w) — -0.22; -0.25 percentage of glycated hemoglobin

Primary: Change in Absolute Gluconeogenesis From Baseline to 12 Weeks — 0.018; -0.050 mg/kg LBM/min

Primary: Treatment Failure (Loss of Glycemic Control) — 120; 90; 109; 112 participants

Primary: Normalization of Glucose Levels — 9; 2; 4 Participants — p=.035

Primary: Change in the Frequency of Hyper- and Hypo-glycemic Events From Baseline to Week 8-12. — -18; -7.5 Events

Primary: Normoglycemia on Therapy — 14; 1; 19; 1 Participants

Primary: Psychomotor Speed — 48.7; 56.6 score on a scale

Primary: Glycosylated Hemoglobin Change — 6.82; 7.17; 6.80; 6.33 percentage of glycosylated hemoglobin — p=0.830

Primary: Change From Baseline in A1C at Week 18 — -0.48; -0.36; 0.12 percent — p=<0.001

Primary: Number of Participants With Composite Neonatal Morbidity — 149; 163; 62; 55 Participants — p=0.14