Clinical Trial Search

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

Primary: % Participants Downloading Huma App — 95; 0 Participants

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

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

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

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

Primary: Glycemic Variability: Mean Amplitude of Glucose Excursion (MAGE) — 75.2; 68.5 mg/dl — p=0.630

Primary: Disposition Index — 0.023; 0.149 index

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

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

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

Primary: Between Group Difference in HbA1c When Comparing CSII to MDI — -1.1; -0.4 Change in % HbA1c

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

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

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

Primary: Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose — 0.92; 0.98 h*nmol/L — p=0.02

Primary: Change in Glucose Levels Between Pre-treatment and End of Treatment as Measured by 24-hour Continuous Glucose Monitoring (CGM) — -4.94; -10.00; -1.21; -11.42 mg/dL…

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: Neuropathic Pain — 482; 461; 560 Participants

Primary: Change in Hyperglycemia (Percent Change in HbA1c) — -2.2; -1.0 HbA1c percent 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: Normalization of Glucose Levels — 9; 2; 4 Participants — p=.035

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: Fasting Plasma Glucose <126 mg/dL and HbA1c < 6.5% at Three Years of Follow-up. — 13; 5; 42; 0 % of patients — p=0.60

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

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

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

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

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