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: Disposition Index — 0.023; 0.149 index

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

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

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

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

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

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

Primary: Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population — -2.01; -1.75 percent — p=<0.0001

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

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

Primary: Change From Baseline in A1C at Week 18 — -1.00; 0.02 Percent — p=<0.001

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: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), or Serious Adverse Events (SAEs), or Hypoglycemic Adverse Events (HAE) or Withdrawals Due to…

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

Primary: Change in Postprandial Glucose — -2803; 629 mmol/6hr — p=<0.05

Primary: Area Under the Curve (AUC(0-16)) of Endogenous Glucose Production — 3436.8; 3139.3 mg*hr/dL — p=0.1628

Primary: Program Enrollment Rate (%) — 14 Percentage of participants

Primary: HbA1c Level — 6.9; 6.4 percentage of glycated hemoglobin

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

Primary: Changes in LDL Cholesterol — -0.83; -1.47; -0.93; -0.32 mmol/L

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: Change in Insulin Sensitivity — 3.18; 3.85; 3.57; 5.22 mg/kg.min per µU/ml

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

Primary: Δ Mean AUC (Area Under the Curve) Plasma [Glucose] — -17.7; 54.9 mmol.min.L-1

Primary: Total Physical Activity Log Means and Geometric Means With Standard Deviation in Intervention and Control Groups After Intervention. — 216.07; 201.47 log calories/day…

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