APD, CAPD, Diabetes, ESRD
Conditions
Keywords
ESRD, Diabetes, CAPD, APD
Brief summary
Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal only) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) and Automated Peritoneal Dialysis (APD)patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels. Secondary Objectives: To demonstrate that use of glucose-sparing PD solutions (PEN vs Dianeal only) in diabetic (Type 1 and Type 2) CAPD and APD patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and Quality of Life. In a subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs Dianeal only) on abdominal fat and left ventricular (LV) structure and function will be assessed.
Detailed description
The data represented in this module is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067). Given that the glucose content of the PD solutions is similar, the pooling of the results were considered a valid method to answer the underlying research questions.
Interventions
DRUGPhysioneal
Physioneal 40 or Physioneal 35
DRUGDianeal
Dianeal 1.5% Dextrose (1.30% glucose), 2.5% Dextrose (2.27% glucose), 4.5% Dextrose (3.86% glucose)
DRUGExtraneal
7.5% Icodextrin
DRUGNutrineal
Amino Acids 1.1%
Sponsors
Baxter Healthcare Corporation
Vantive Health LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. M/F patients 18 years of age or older 2. Diagnosis of ESRD (GFR ≤ 15 mL/min) 3. CAPD or APD using only Dianealand/or Physioneal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no prescribed dry time 4. DM (Type 1 and 2) on glycemic-control medication, for 90 days 5. HbA1c \> 6.0% but ≤ 12.0% 6. Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL
Exclusion criteria
1. Cardiovascular event within the last 90 days 2. Ongoing clinically significant congestive heart failure (NYHA class III or IV) 3. Allergy to starch-based polymers 4. Glycogen storage disease 5. Maltose, or isomaltose intolerance 6. Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30 days 7. Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP \< 77) at Screening. 8. Serum urea \> 30 mmol/L 9. Exposure to Extraneal or Nutrineal within the last 60 days prior to Screening visit, Day 1. 10. Receiving rosiglitazone maleate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From the Baseline Value in HbA1c at Month 3 and 6 | Baseline, Month 3, Month 6 (End of Study) | HbA1c is a specific glycohemoglobin, and adduct of glucose attached to the beta-chain terminal valine residue. Measured using a Tina-quant immunological assay suitable for samples from end stage renal disease (ESRD) patients and with icodextrin metabolites or equivalent. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Severe Hypoglycemic Event Requiring Medical Intervention | Baseline through Month 6 (End of Study) | Severe hypoglycemia is defined by DCCT (Diabetes Control and Complications Trial) as any episode requiring external assistance to aid recovery or resulted in seizures or coma and included, as part of the definition, that the subject's blood glucose concentration had to have been documented as \< 50mg/dL (\<2.8mmol/L) for hypoglycemia, and/or the clinical manifestations had to have been reversed with oral carbohydrate, intramuscular glucagon, or intravenous glucose. Descriptive statistics were done, no inferential statistical analyses were performed. |
| Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 | Baseline, Month 3, Month 6 (End of Study) | Values for Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDLC), High Density Lipoprotein Cholesterol (HDLC), Very Low Density Lipoprotein (VLDL), and Triglycerides are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. |
| Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6 | Baseline, Month 3, Month 6 (End of Study) | Values for Lipoprotein A (Lp(a)), Apolipoprotein A1 (Apo A1), and Apolipoprotein B (Apo B) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. |
| Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6 | Baseline, Month 3, Month 6 (End of Study) | Values for Insulin and C-peptide are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. |
| Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6 | Baseline, Month 3, Month 6 (End of Study) | Values for Pro-Insulin are provided. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. |
| Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6 | Baseline and Month 6 (End of Study) | Nutritional Status by SGA include the following: (a) Weight change over 6 months, (b) dietary history of food intake over the previous 24-hour period with a determination by the subject as to whether this was a typical or atypical diet for the subject, (c) significant and sustained gastrointestinal distress, (d) functional status, (e) metabolic stress including frequent infections, fever, peritonitis, uncontrolled diabetes and active inflammatory bowel disease. The SGA used a 7-point scale, where a decrease score in the change from baseline shows signs of increased malnourishment, and an increased score (e.g., +2) is improved nourishment. Scale: 6 - 7 = very mild risk to well-nourished; 3 - 5 = no clear sign of normal status or severe malnutrition; 1 - 2 = severely malnourished |
| Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6 | Baseline, Month 3, Month 6 (End of Study) | Values for Albumin and Total Protein are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. |
| Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6 | Baseline, Month 3, Month 6 (End of Study) | Values for Protein Nitrogen Appearance (PNA) and normalized protein nitrogen appearance (nPRNA) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. |
| Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6 | Baseline, Month 3, Month 6 (End of Study) | Values for Pre-albumin are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. |
| Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6 | Baseline, Month 3, Month 6 (End of Study) | Values for Drained Body Weight are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. |
| Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6 | Baseline, Month 3, Month 6 (End of Study) | This data used diabetic prescription drug information from insulin and oral glycemic control concomitant medications reported. Glycemic control medications classes allowed were limited to insulin, sulfonylureas, and thiazolidinediones. Subjects were provided with a paper diary on which they recorded doses of all glycemic control medications taken for 1 day prior to the Screening visit and for 8 days prior to the study visits at Month 3 and Month 6. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. |
| Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6 | Baseline, Month 6 (End of Study) | Values for Waist Circumference are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. |
| Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6 | Baseline, Month 3, Month 6 (End of Study) | Values for Protein and Calories are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. |
| Change From Baseline in QOL Based on the EQ 5D Questionnaire Index at Month 3 and 6 | Baseline, Month 3, Month 6 (End of Study) | European Quality of Life, 5 Dimensions (EQ-5D) generates a single index score based on a descriptive system that defines health in terms of 5 dimensions, consisting of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension is 1 to 3, where 1=no problems, 2=moderate problems, 3=extreme problems. Higher score implies more problems (worsening). According to this classification, 243 potential health states are defined. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. |
| Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6 | Baseline, Month 3, Month 6 (End of Study) | Visual analogue scale to generate a self-perceived rating of health status. Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to the worst health you can imagine, and the highest rate (100) corresponds to the best health you can imagine. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. |
| Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Baseline, Month 3, Month 6 (End of Study) | The Diabetes Symptoms Checklist was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5=extremely to 1=not at all. For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychological fatigue, psychological cognitive, neurology pain, neurology sensory, cardiology, ophthalmology, hypoglycemia, hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. |
| Change From Baseline of MRI Body Composition at Month 6 | Baseline, Month 6 (End of Study) | Values for Abdominal Subcutaneous Fat Volume and Abdominal Visceral Fat Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. |
| Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6 | Baseline, Month 6 (End of Study) | Values for Left Ventricular (LV) End Diastolic and Systolic Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. |
| Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6 | Baseline, Month 6 (End of Study) | Values for Left Ventricular (LV) Mass Without and With Pap Muscles are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. |
| Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6 | Baseline, Month 6 (End of Study) | Values for Left Ventricular (LV) Ejection Fraction are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. |
| Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6 | Baseline, Month 3, Month 6 (End of Study) | Values for BMI are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. |
Countries
Hong Kong, Russia, Singapore, South Korea, Taiwan
Participant flow
Recruitment details
The data represented in this module is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067). Given that the glucose content of the PD solutions is similar, the pooling of the results were considered a valid method to answer the underlying research questions.
Participants by arm
| Arm | Count |
|---|---|
| Non-Glucose Sparing Prescriptions Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only | 127 |
| Glucose Sparing Prescriptions Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study. | 124 |
| Total | 251 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 14 |
| Overall Study | Other | 1 | 0 |
| Overall Study | Physician Decision | 0 | 4 |
| Overall Study | Renal Transplantation | 0 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Glucose Sparing Prescriptions | Total | Non-Glucose Sparing Prescriptions |
|---|---|---|---|
| Age, Continuous | 57.3 years STANDARD_DEVIATION 12 | 57.65 years STANDARD_DEVIATION 12.4 | 58 years STANDARD_DEVIATION 12.8 |
| Race/Ethnicity, Customized Baseline Asian | 42 Participants | 83 Participants | 41 Participants |
| Race/Ethnicity, Customized Baseline Black | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Baseline Caucasian | 41 Participants | 82 Participants | 41 Participants |
| Race/Ethnicity, Customized Baseline Hispanic | 31 Participants | 63 Participants | 32 Participants |
| Race/Ethnicity, Customized Baseline Other | 10 Participants | 22 Participants | 12 Participants |
| Sex: Female, Male Female | 64 Participants | 123 Participants | 59 Participants |
| Sex: Female, Male Male | 60 Participants | 128 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 101 / 127 | 98 / 124 |
| serious Total, serious adverse events | 41 / 127 | 58 / 124 |
Outcome results
Primary
Change From the Baseline Value in HbA1c at Month 3 and 6
HbA1c is a specific glycohemoglobin, and adduct of glucose attached to the beta-chain terminal valine residue. Measured using a Tina-quant immunological assay suitable for samples from end stage renal disease (ESRD) patients and with icodextrin metabolites or equivalent. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time frame: Baseline, Month 3, Month 6 (End of Study)
Population: Primary Efficacy Intent-to-Treat (ITT) population included all subjects randomized with a minimum of a baseline HbA1c value determined and one PD exchange using study solution performed. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489, NCT00567398, NCT01219959.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Glucose Sparing Prescriptions | Change From the Baseline Value in HbA1c at Month 3 and 6 | Month 3 | 0.2 Percent Change | Standard Deviation 1.1 |
| Non-Glucose Sparing Prescriptions | Change From the Baseline Value in HbA1c at Month 3 and 6 | Month 6 | 0 Percent Change | Standard Deviation 1.2 |
| Glucose Sparing Prescriptions | Change From the Baseline Value in HbA1c at Month 3 and 6 | Month 3 | -0.6 Percent Change | Standard Deviation 1.3 |
| Glucose Sparing Prescriptions | Change From the Baseline Value in HbA1c at Month 3 and 6 | Month 6 | -0.6 Percent Change | Standard Deviation 1.5 |
Comparison: Month 3p-value: <0.00195% CI: [0.2, 0.9]ANOVA
Comparison: Month 6p-value: 0.00695% CI: [0.1, 0.8]ANOVA
Secondary
Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6
This data used diabetic prescription drug information from insulin and oral glycemic control concomitant medications reported. Glycemic control medications classes allowed were limited to insulin, sulfonylureas, and thiazolidinediones. Subjects were provided with a paper diary on which they recorded doses of all glycemic control medications taken for 1 day prior to the Screening visit and for 8 days prior to the study visits at Month 3 and Month 6. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time frame: Baseline, Month 3, Month 6 (End of Study)
Population: Analysis used data from prescription information of concomitant medications reported. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Glucose Sparing Prescriptions | Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6 | Insulin: Month 3 | 3.5 Percent Change | Standard Deviation 21.2 |
| Non-Glucose Sparing Prescriptions | Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6 | Insulin: Month 6 | 2.9 Percent Change | Standard Deviation 25.4 |
| Non-Glucose Sparing Prescriptions | Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6 | Oral hypoglycemic: Month 3 | 1.3 Percent Change | Standard Deviation 12.6 |
| Non-Glucose Sparing Prescriptions | Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6 | Oral hypoglycemic: Month 6 | -0.5 Percent Change | Standard Deviation 12.7 |
| Glucose Sparing Prescriptions | Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6 | Oral hypoglycemic: Month 6 | 6.4 Percent Change | Standard Deviation 52.3 |
| Glucose Sparing Prescriptions | Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6 | Insulin: Month 3 | -3.3 Percent Change | Standard Deviation 16.4 |
| Glucose Sparing Prescriptions | Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6 | Oral hypoglycemic: Month 3 | 5 Percent Change | Standard Deviation 51.3 |
| Glucose Sparing Prescriptions | Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6 | Insulin: Month 6 | -3.8 Percent Change | Standard Deviation 23.9 |
Comparison: Insulin-Month 3p-value: 0.31295% CI: [-4.7, 14.7]ANOVA
Comparison: Insulin-Month 6p-value: 0.34295% CI: [-5, 14.4]ANOVA
Secondary
Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6
The Diabetes Symptoms Checklist was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5=extremely to 1=not at all. For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychological fatigue, psychological cognitive, neurology pain, neurology sensory, cardiology, ophthalmology, hypoglycemia, hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time frame: Baseline, Month 3, Month 6 (End of Study)
Population: ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Psychology, fatigue: Month 3 | 2.34 Scores on a scale | Standard Deviation 20.73 |
| Non-Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Psychology, fatigue: Month 6 | 2.48 Scores on a scale | Standard Deviation 22.95 |
| Non-Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Psychology, cognitive: Month 3 | 0.16 Scores on a scale | Standard Deviation 18.54 |
| Non-Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Psychology, cognitive: Month 6 | 2.23 Scores on a scale | Standard Deviation 18.87 |
| Non-Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Neurology, pain: Month 3 | -3.46 Scores on a scale | Standard Deviation 17.87 |
| Non-Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Neurology, pain: Month 6 | -1.57 Scores on a scale | Standard Deviation 21.09 |
| Non-Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Neurology, sensory: Month 3 | -2.25 Scores on a scale | Standard Deviation 16.96 |
| Non-Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Neurology, sensory: Month 6 | -0.19 Scores on a scale | Standard Deviation 17.15 |
| Non-Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Cardiology: Month 3 | 1.18 Scores on a scale | Standard Deviation 17.32 |
| Non-Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Cardiology: Month 6 | 3.60 Scores on a scale | Standard Deviation 17.74 |
| Non-Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Ophthalmology: Month 3 | 1.53 Scores on a scale | Standard Deviation 21.98 |
| Non-Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Ophthalmology: Month 6 | -0.26 Scores on a scale | Standard Deviation 24.53 |
| Non-Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Hypoglycemia: Month 3 | 0.49 Scores on a scale | Standard Deviation 20.72 |
| Non-Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Hypoglycemia: Month 6 | 0.50 Scores on a scale | Standard Deviation 22.25 |
| Non-Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Hyperglycemia: Month 3 | -2.07 Scores on a scale | Standard Deviation 17.38 |
| Non-Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Hyperglycemia: Month 6 | -0.79 Scores on a scale | Standard Deviation 19.5 |
| Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Hyperglycemia: Month 6 | -2.82 Scores on a scale | Standard Deviation 18.25 |
| Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Psychology, fatigue: Month 3 | 2.39 Scores on a scale | Standard Deviation 20.33 |
| Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Cardiology: Month 3 | 0.87 Scores on a scale | Standard Deviation 15.84 |
| Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Psychology, fatigue: Month 6 | -0.49 Scores on a scale | Standard Deviation 24.64 |
| Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Hypoglycemia: Month 3 | 0.12 Scores on a scale | Standard Deviation 21.02 |
| Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Psychology, cognitive: Month 3 | 2.66 Scores on a scale | Standard Deviation 18.38 |
| Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Cardiology: Month 6 | 0.29 Scores on a scale | Standard Deviation 18.11 |
| Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Psychology, cognitive: Month 6 | 1.70 Scores on a scale | Standard Deviation 17.23 |
| Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Hyperglycemia: Month 3 | -1.79 Scores on a scale | Standard Deviation 18.83 |
| Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Neurology, pain: Month 3 | 0.32 Scores on a scale | Standard Deviation 19.18 |
| Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Ophthalmology: Month 3 | 2.24 Scores on a scale | Standard Deviation 19.71 |
| Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Neurology, pain: Month 6 | -1.75 Scores on a scale | Standard Deviation 22.34 |
| Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Hypoglycemia: Month 6 | -1.62 Scores on a scale | Standard Deviation 21.72 |
| Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Neurology, sensory: Month 3 | 0.55 Scores on a scale | Standard Deviation 16.09 |
| Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Ophthalmology: Month 6 | 0.23 Scores on a scale | Standard Deviation 19.43 |
| Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 | Neurology, sensory: Month 6 | -3.59 Scores on a scale | Standard Deviation 15.76 |
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 3p-value: 0.52695% CI: [-7.64, 3.91]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 6p-value: 0.77995% CI: [-5.01, 6.68]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 3p-value: 0.24695% CI: [-7.95, 2.04]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 6p-value: 0.7895% CI: [-5.78, 4.34]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 3p-value: 0.88595% CI: [-5.22, 6.04]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 6p-value: 0.12895% CI: [-1.28, 10.1]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 3p-value: 0.70195% CI: [-4.4, 6.54]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 6p-value: 0.0195% CI: [1.7, 12.73]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 3p-value: 0.93495% CI: [-4.63, 5.03]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 6p-value: 0.20995% CI: [-1.75, 8.01]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 3p-value: 0.58595% CI: [-4.9, 8.68]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 6p-value: 0.64195% CI: [-5.22, 8.47]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 3p-value: 0.58695% CI: [-6.89, 3.9]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 6p-value: 0.90695% CI: [-5.79, 5.14]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 3p-value: 0.9795% CI: [-4.93, 4.75]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 6p-value: 0.3495% CI: [-2.52, 7.28]ANOVA
Secondary
Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6
Visual analogue scale to generate a self-perceived rating of health status. Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to the worst health you can imagine, and the highest rate (100) corresponds to the best health you can imagine. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time frame: Baseline, Month 3, Month 6 (End of Study)
Population: ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6 | Month 6 | -1.60 Score on a Scale | Standard Deviation 24.02 |
| Non-Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6 | Month 3 | -2.33 Score on a Scale | Standard Deviation 23.37 |
| Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6 | Month 3 | -2.58 Score on a Scale | Standard Deviation 27.14 |
| Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6 | Month 6 | 0.92 Score on a Scale | Standard Deviation 30.22 |
Comparison: Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 3p-value: 0.52595% CI: [-4.56, 8.93]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 6p-value: 0.99595% CI: [-6.79, 6.83]ANOVA
Secondary
Change From Baseline in QOL Based on the EQ 5D Questionnaire Index at Month 3 and 6
European Quality of Life, 5 Dimensions (EQ-5D) generates a single index score based on a descriptive system that defines health in terms of 5 dimensions, consisting of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension is 1 to 3, where 1=no problems, 2=moderate problems, 3=extreme problems. Higher score implies more problems (worsening). According to this classification, 243 potential health states are defined. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time frame: Baseline, Month 3, Month 6 (End of Study)
Population: ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the EQ 5D Questionnaire Index at Month 3 and 6 | Month 3 | -0.01 Percent Change | Standard Deviation 0.18 |
| Non-Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the EQ 5D Questionnaire Index at Month 3 and 6 | Month 6 | -0.04 Percent Change | Standard Deviation 0.19 |
| Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the EQ 5D Questionnaire Index at Month 3 and 6 | Month 3 | -0.04 Percent Change | Standard Deviation 0.19 |
| Glucose Sparing Prescriptions | Change From Baseline in QOL Based on the EQ 5D Questionnaire Index at Month 3 and 6 | Month 6 | -0.03 Percent Change | Standard Deviation 0.17 |
Comparison: Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 3p-value: 0.41295% CI: [-0.03, 0.07]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 6p-value: 0.48595% CI: [-0.07, 0.03]ANOVA
Secondary
Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6
Values for Left Ventricular (LV) Ejection Fraction are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time frame: Baseline, Month 6 (End of Study)
Population: ITT of MRI sub-study (n=88 consented to participate), however, only a subset of MRI sub-study that had evaluable data were used.. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Glucose Sparing Prescriptions | Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6 | -0.3 Percent | Standard Deviation 8.2 |
| Glucose Sparing Prescriptions | Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6 | 0.9 Percent | Standard Deviation 10.4 |
Comparison: Estimate of Least Square Means Comparing Treatment Groups for LV Ejection Fraction-Month 6p-value: 0.95595% CI: [-6.9, 6.5]ANOVA
Secondary
Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6
Values for Left Ventricular (LV) End Diastolic and Systolic Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time frame: Baseline, Month 6 (End of Study)
Population: ITT of MRI sub-study (n=88 consented to participate),however, only a subset of MRI sub-study that had evaluable data were used.. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Glucose Sparing Prescriptions | Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6 | LV End Diastolic Volume | 2.1 mL | Standard Deviation 35.5 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6 | LV End Systolic Volume | 3.3 mL | Standard Deviation 28.1 |
| Glucose Sparing Prescriptions | Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6 | LV End Diastolic Volume | 0.7 mL | Standard Deviation 28.4 |
| Glucose Sparing Prescriptions | Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6 | LV End Systolic Volume | -0.2 mL | Standard Deviation 28.4 |
Comparison: Estimate of Least Square Means Comparing Treatment Groups for LV End Diastolic Volume-Month 6p-value: 0.62695% CI: [-19.3, 31.9]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for LV End Systolic Volume-Month 6p-value: 0.48695% CI: [-14.5, 30.1]ANOVA
Secondary
Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6
Values for Left Ventricular (LV) Mass Without and With Pap Muscles are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time frame: Baseline, Month 6 (End of Study)
Population: ITT of MRI sub-study (n=88 consented to participate), however, only a subset of MRI sub-study that had evaluable data were used.. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Glucose Sparing Prescriptions | Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6 | LV Mass Without Pap Muscles | 0.6 grams | Standard Deviation 38.4 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6 | LV Mass With Pap Muscles | 1.1 grams | Standard Deviation 39.2 |
| Glucose Sparing Prescriptions | Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6 | LV Mass Without Pap Muscles | 3.3 grams | Standard Deviation 26.5 |
| Glucose Sparing Prescriptions | Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6 | LV Mass With Pap Muscles | 3.5 grams | Standard Deviation 26.6 |
Comparison: Estimate of Least Square Means Comparing Treatment Groups for LV Mass with Pap Muscles-Month 6p-value: 0.83295% CI: [-18.9, 23.4]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for LV Mass without Pap Muscles-Month 6p-value: 0.8295% CI: [-18.3, 23.1]ANOVA
Secondary
Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6
Values for Insulin and C-peptide are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time frame: Baseline, Month 3, Month 6 (End of Study)
Population: Evaluable subset of ITT population that had blood draw at baseline for these lab parameters were used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6 | Insulin: Month 3 | 70.3 pg/mL | Standard Deviation 514.2 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6 | Insulin: Month 6 | 146.3 pg/mL | Standard Deviation 616 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6 | C-peptide: Month 3 | 340.8 pg/mL | Standard Deviation 2393.7 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6 | C-peptide: Month 6 | 388.3 pg/mL | Standard Deviation 2660.5 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6 | C-peptide: Month 6 | 504.1 pg/mL | Standard Deviation 2462.5 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6 | Insulin: Month 3 | 69.4 pg/mL | Standard Deviation 809.4 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6 | C-peptide: Month 3 | 70.5 pg/mL | Standard Deviation 2687.2 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6 | Insulin: Month 6 | 96.6 pg/mL | Standard Deviation 1301.9 |
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 3p-value: 0.65595% CI: [-304.6, 191.7]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 6p-value: 0.81195% CI: [-268.9, 210.5]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 3p-value: 0.41995% CI: [-630.4, 1513.1]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 6p-value: 0.8295% CI: [-927.9, 1171.5]ANOVA
Secondary
Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6
Values for Pro-Insulin are provided. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time frame: Baseline, Month 3, Month 6 (End of Study)
Population: Evaluable subset of ITT population that had blood draw at baseline for these lab parameters were used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6 | Pro-Insulin: Month 3 | -1.8 pmol/L | Standard Deviation 19.6 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6 | Pro-Insulin: Month 6 | 3 pmol/L | Standard Deviation 41.9 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6 | Pro-Insulin: Month 3 | 13 pmol/L | Standard Deviation 71.3 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6 | Pro-Insulin: Month 6 | 0.4 pmol/L | Standard Deviation 33.5 |
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 3p-value: 0.72195% CI: [-27.5, 19]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 6p-value: 0.24795% CI: [-9.4, 36.4]ANOVA
Secondary
Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6
Values for Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDLC), High Density Lipoprotein Cholesterol (HDLC), Very Low Density Lipoprotein (VLDL), and Triglycerides are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time frame: Baseline, Month 3, Month 6 (End of Study)
Population: ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 | Cholesterol: Month 3 | 0.1 mmol/L | Standard Deviation 1.1 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 | Cholesterol: Month 6 | 0 mmol/L | Standard Deviation 1.2 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 | LDLC: Month 3 | 0.1 mmol/L | Standard Deviation 1 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 | LDLC: Month 6 | 0.1 mmol/L | Standard Deviation 1.1 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 | HDLC: Month 3 | 0 mmol/L | Standard Deviation 0.2 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 | HDLC: Month 6 | 0 mmol/L | Standard Deviation 0.3 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 | VLDL: Month 3 | -0.1 mmol/L | Standard Deviation 0.9 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 | VLDL: Month 6 | -0.1 mmol/L | Standard Deviation 0.8 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 | Triglycerides: Month 3 | -0.1 mmol/L | Standard Deviation 1.9 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 | Triglycerides: Month 6 | -0.3 mmol/L | Standard Deviation 1.9 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 | VLDL: Month 6 | -0.3 mmol/L | Standard Deviation 0.9 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 | Cholesterol: Month 3 | -0.5 mmol/L | Standard Deviation 1.2 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 | HDLC: Month 6 | 0 mmol/L | Standard Deviation 0.3 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 | Cholesterol: Month 6 | -0.4 mmol/L | Standard Deviation 1.2 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 | Triglycerides: Month 6 | -0.6 mmol/L | Standard Deviation 1.9 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 | LDLC: Month 3 | -0.2 mmol/L | Standard Deviation 1.1 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 | VLDL: Month 3 | -0.3 mmol/L | Standard Deviation 0.8 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 | LDLC: Month 6 | -0.1 mmol/L | Standard Deviation 1.2 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 | Triglycerides: Month 3 | -0.7 mmol/L | Standard Deviation 1.8 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 | HDLC: Month 3 | 0 mmol/L | Standard Deviation 0.3 |
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 3p-value: 0.0195% CI: [0.1, 0.9]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 6p-value: 0.07395% CI: [0, 0.7]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 3p-value: 0.18195% CI: [-0.1, 0.5]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 6p-value: 0.59395% CI: [-0.2, 0.4]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 3p-value: 0.19895% CI: [-0.2, 0]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 6p-value: 0.29895% CI: [-0.1, 0]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 3p-value: <0.00195% CI: [0.2, 0.6]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 6p-value: 0.00395% CI: [0.1, 0.5]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 3p-value: <0.00195% CI: [0.4, 1.3]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 6p-value: 0.00295% CI: [0.3, 1.1]ANOVA
Secondary
Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6
Values for Lipoprotein A (Lp(a)), Apolipoprotein A1 (Apo A1), and Apolipoprotein B (Apo B) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time frame: Baseline, Month 3, Month 6 (End of Study)
Population: Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6 | Lp(a): Month 3 | 2.3 mg/dL | Standard Deviation 8.9 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6 | Lp(a): Month 6 | 6.7 mg/dL | Standard Deviation 15.4 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6 | Apo A1: Month 3 | -2.1 mg/dL | Standard Deviation 16.4 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6 | Apo A1: Month 6 | -3.8 mg/dL | Standard Deviation 17.7 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6 | Apo B: Month 3 | 5.3 mg/dL | Standard Deviation 24.2 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6 | Apo B: Month 6 | 5.2 mg/dL | Standard Deviation 25.4 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6 | Apo B: Month 3 | -8.5 mg/dL | Standard Deviation 18.4 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6 | Lp(a): Month 3 | 3.3 mg/dL | Standard Deviation 9.8 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6 | Apo A1: Month 6 | -10.5 mg/dL | Standard Deviation 18.4 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6 | Lp(a): Month 6 | 6.8 mg/dL | Standard Deviation 18 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6 | Apo B: Month 6 | -3.6 mg/dL | Standard Deviation 23.9 |
| Glucose Sparing Prescriptions | Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6 | Apo A1: Month 3 | -9.3 mg/dL | Standard Deviation 17.5 |
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 3p-value: 0.48595% CI: [-8.6, 4.1]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 6p-value: 0.55695% CI: [-8.2, 4.4]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 3p-value: 0.10195% CI: [-1.1, 12.2]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 6p-value: 0.13495% CI: [-1.5, 11.5]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 3p-value: 0.00495% CI: [3.6, 19.2]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 6p-value: 0.0395% CI: [0.8, 15.9]ANOVA
Secondary
Change From Baseline of MRI Body Composition at Month 6
Values for Abdominal Subcutaneous Fat Volume and Abdominal Visceral Fat Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time frame: Baseline, Month 6 (End of Study)
Population: ITT of MRI sub-study (n=88 consented to participate), however, only a subset of MRI sub-study that had evaluable data were used in this analysis. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Glucose Sparing Prescriptions | Change From Baseline of MRI Body Composition at Month 6 | Abdominal Visceral Fat Volume: Month 6 | -49 mL | Standard Deviation 81.7 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of MRI Body Composition at Month 6 | Abdominal Subcutaneous Fat Volume: Month 6 | -12 mL | Standard Deviation 58.9 |
| Glucose Sparing Prescriptions | Change From Baseline of MRI Body Composition at Month 6 | Abdominal Visceral Fat Volume: Month 6 | -64.8 mL | Standard Deviation 73.2 |
| Glucose Sparing Prescriptions | Change From Baseline of MRI Body Composition at Month 6 | Abdominal Subcutaneous Fat Volume: Month 6 | -3.3 mL | Standard Deviation 70.2 |
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Abdominal Subcutaneous Fat Volume-Month 6p-value: 0.49595% CI: [-46.9, 96]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Abdominal Visceral Fat Volume-Month 6p-value: 0.08195% CI: [-7, 117.8]ANOVA
Secondary
Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6
Values for Albumin and Total Protein are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time frame: Baseline, Month 3, Month 6 (End of Study)
Population: ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6 | Albumin: Month 3 | -0.1 g/L | Standard Deviation 3.1 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6 | Albumin: Month 6 | 0.5 g/L | Standard Deviation 3 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6 | Total Protein: Month 3 | 0.1 g/L | Standard Deviation 4.3 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6 | Total Protein: Month 6 | 0.7 g/L | Standard Deviation 4.9 |
| Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6 | Total Protein: Month 6 | -0.9 g/L | Standard Deviation 6.1 |
| Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6 | Albumin: Month 3 | -0.6 g/L | Standard Deviation 3.6 |
| Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6 | Total Protein: Month 3 | 0.2 g/L | Standard Deviation 5.1 |
| Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6 | Albumin: Month 6 | -0.8 g/L | Standard Deviation 3.9 |
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 3p-value: 0.33895% CI: [-0.6, 1.8]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 6p-value: 0.02995% CI: [0.1, 2.5]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 3p-value: 0.81795% CI: [-1.9, 1.5]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 6p-value: 0.09195% CI: [-0.2, 2.9]ANOVA
Secondary
Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6
Values for BMI are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time frame: Baseline, Month 3, Month 6 (End of Study)
Population: ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6 | Month 3 | -0.1 kg/m2 | Standard Deviation 1.5 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6 | Month 6 | 0.1 kg/m2 | Standard Deviation 1.9 |
| Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6 | Month 3 | -0.1 kg/m2 | Standard Deviation 1.3 |
| Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6 | Month 6 | -0.3 kg/m2 | Standard Deviation 1.2 |
Comparison: Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 3p-value: 0.96195% CI: [-1.2, 1.1]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 6p-value: 0.58195% CI: [-0.8, 1.5]ANOVA
Secondary
Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6
Values for Drained Body Weight are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time frame: Baseline, Month 3, Month 6 (End of Study)
Population: ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6 | Month 3 | -0.2 kg | Standard Deviation 4.5 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6 | Month 6 | 0.2 kg | Standard Deviation 5.2 |
| Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6 | Month 3 | -0.2 kg | Standard Deviation 3.5 |
| Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6 | Month 6 | -0.7 kg | Standard Deviation 3.3 |
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 3p-value: 0.88495% CI: [-3.9, 3.4]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 6p-value: 0.71695% CI: [-3, 4.3]ANOVA
Secondary
Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6
Values for Protein Nitrogen Appearance (PNA) and normalized protein nitrogen appearance (nPRNA) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time frame: Baseline, Month 3, Month 6 (End of Study)
Population: Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6 | PNA: Month 3 | -0.8 g/kg/day | Standard Deviation 14.1 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6 | PNA: Month 6 | 1 g/kg/day | Standard Deviation 18.6 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6 | nPNA: Month 3 | 0 g/kg/day | Standard Deviation 0.2 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6 | nPNA: Month 6 | 0 g/kg/day | Standard Deviation 0.3 |
| Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6 | nPNA: Month 6 | 0.2 g/kg/day | Standard Deviation 0.3 |
| Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6 | PNA: Month 3 | 12.8 g/kg/day | Standard Deviation 14.4 |
| Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6 | nPNA: Month 3 | 0.2 g/kg/day | Standard Deviation 0.2 |
| Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6 | PNA: Month 6 | 12.9 g/kg/day | Standard Deviation 17.5 |
Comparison: Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 3p-value: 0.12795% CI: [-23.3, 2.9]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 6p-value: <0.00195% CI: [-16.4, -4.3]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 3p-value: 0.01295% CI: [-0.4, -0.1]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 6p-value: <0.00195% CI: [-0.3, -0.1]ANOVA
Secondary
Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6
Values for Pre-albumin are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time frame: Baseline, Month 3, Month 6 (End of Study)
Population: Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6 | Month 3 | 0.4 mg/dL | Standard Deviation 7.2 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6 | Month 6 | -1.0 mg/dL | Standard Deviation 8.3 |
| Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6 | Month 3 | -1.9 mg/dL | Standard Deviation 5.5 |
| Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6 | Month 6 | -2.9 mg/dL | Standard Deviation 5.9 |
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 3p-value: 0.01995% CI: [0.5, 5.8]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 6p-value: 0.01995% CI: [0.5, 5.6]ANOVA
Secondary
Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6
Values for Protein and Calories are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time frame: Baseline, Month 3, Month 6 (End of Study)
Population: Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6 | Protein: Month 3 | -5.6 grams | Standard Deviation 14.1 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6 | Protein: Month 6 | -0.1 grams | Standard Deviation 24.8 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6 | Calories: Month 3 | -76.8 grams | Standard Deviation 316.9 |
| Non-Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6 | Calories: Month 6 | 30.9 grams | Standard Deviation 589.5 |
| Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6 | Calories: Month 6 | 108 grams | Standard Deviation 654 |
| Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6 | Protein: Month 3 | -4.9 grams | Standard Deviation 45.3 |
| Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6 | Calories: Month 3 | -199.1 grams | Standard Deviation 525.1 |
| Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6 | Protein: Month 6 | 4.5 grams | Standard Deviation 32.9 |
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 3p-value: 0.60895% CI: [-14.7, 25]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 6p-value: 0.73195% CI: [-11.5, 8.1]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 3p-value: 0.37795% CI: [-227.5, 598.1]ANOVA
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 6p-value: 0.85495% CI: [-214.4, 177.8]ANOVA
Secondary
Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6
Values for Waist Circumference are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time frame: Baseline, Month 6 (End of Study)
Population: Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6 | 0 cm | Standard Deviation 6.4 |
| Glucose Sparing Prescriptions | Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6 | 0.4 cm | Standard Deviation 5.9 |
Comparison: Estimate of Least Square Means Comparing Treatment Groups for Waist Circumference-Month 6p-value: 0.87195% CI: [-3.7, 3.1]ANOVA
Secondary
Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6
Nutritional Status by SGA include the following: (a) Weight change over 6 months, (b) dietary history of food intake over the previous 24-hour period with a determination by the subject as to whether this was a typical or atypical diet for the subject, (c) significant and sustained gastrointestinal distress, (d) functional status, (e) metabolic stress including frequent infections, fever, peritonitis, uncontrolled diabetes and active inflammatory bowel disease. The SGA used a 7-point scale, where a decrease score in the change from baseline shows signs of increased malnourishment, and an increased score (e.g., +2) is improved nourishment. Scale: 6 - 7 = very mild risk to well-nourished; 3 - 5 = no clear sign of normal status or severe malnutrition; 1 - 2 = severely malnourished
Time frame: Baseline and Month 6 (End of Study)
Population: Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Glucose Sparing Prescriptions | Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6 | +2 Score | 1 participants |
| Non-Glucose Sparing Prescriptions | Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6 | +1 Score | 19 participants |
| Non-Glucose Sparing Prescriptions | Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6 | 0 Score | 76 participants |
| Non-Glucose Sparing Prescriptions | Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6 | -1 Score | 20 participants |
| Non-Glucose Sparing Prescriptions | Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6 | -2 Score | 3 participants |
| Non-Glucose Sparing Prescriptions | Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6 | -3 Score | 1 participants |
| Glucose Sparing Prescriptions | Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6 | -2 Score | 4 participants |
| Glucose Sparing Prescriptions | Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6 | +2 Score | 2 participants |
| Glucose Sparing Prescriptions | Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6 | -1 Score | 17 participants |
| Glucose Sparing Prescriptions | Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6 | +1 Score | 24 participants |
| Glucose Sparing Prescriptions | Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6 | -3 Score | 0 participants |
| Glucose Sparing Prescriptions | Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6 | 0 Score | 57 participants |
Comparison: Estimates of Ratio-Month 6p-value: 0.62495% CI: [0.55, 1.43]ANOVA
Secondary
Number of Severe Hypoglycemic Event Requiring Medical Intervention
Severe hypoglycemia is defined by DCCT (Diabetes Control and Complications Trial) as any episode requiring external assistance to aid recovery or resulted in seizures or coma and included, as part of the definition, that the subject's blood glucose concentration had to have been documented as \< 50mg/dL (\<2.8mmol/L) for hypoglycemia, and/or the clinical manifestations had to have been reversed with oral carbohydrate, intramuscular glucagon, or intravenous glucose. Descriptive statistics were done, no inferential statistical analyses were performed.
Time frame: Baseline through Month 6 (End of Study)
Population: Intent-to-Treat (ITT) population included all subjects randomized with a minimum of a baseline HbA1c value determined and one PD exchange using study solution performed. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Glucose Sparing Prescriptions | Number of Severe Hypoglycemic Event Requiring Medical Intervention | 1 events |
| Glucose Sparing Prescriptions | Number of Severe Hypoglycemic Event Requiring Medical Intervention | 3 events |