| Outcome Measures: |
Primary: Treatment Failure (Loss of Glycemic Control), Defined as A1c persistently \>=8% over a 6-month period or persistent metabolic decompensation (inability to wean insulin within 3 months of initiation or the occurrence of a second episode within three months of discontinuing insulin), Study duration - 2 years to 6.5 years of follow up from randomization | Secondary: Insulin Sensitivity, All participants were followed to 24 months. Insulin sensitivity is measured from OGTT as inverse of fasting insulin (mL/uU). The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time., 24 months|Number of Serious Adverse Events, Number of serious adverse events reported during the trial. Participant could have multiple episodes reported., Reported as occurred during study follow-up - 2 years to 6.5 years from randomization.|Insulin Secretion, Insulinogenic index determined from OGTT as difference in insulin at 30 minutes minus 0 minutes divided by difference in glucose at 30 minutes minus 0 minutes. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time., 24 months|Body Composition -- BMI, Body mass index (BMI) measured in kg per meters squared. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time., 24 months|Body Composition -- Waist Circumference, Waist circumference (cm) measured at the iliac crest at its outermost point with the measuring tape placed around the participant in a horizontal plane parallel to the floor at the mark and the measurement teken at the end of normal expiration without the tape compressing the skin. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time., 24 months|Body Composition -- Bone Density, Measured by DXA, both whole body scan and AP-spine scan. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time. In addition, in about 1/3 of participants DXA scans could not be obtained on participants weighing more than 300 pounds (136 kg), the upper limit in size set by the machine manufacturers. Scans were considered invalid if a body part (e.g., arm, leg) was completely off or partially off the scanner, there was hand-hip overlap, or there was motion or movement during the scan., 24 months|Body Composition -- Fat Mass, Determined by DXA whole body scan. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time. In addition, in about 1/3 of participants DXA scans could not be obtained on participants weighing more than 300 pounds (136 kg), the upper limit in size set by the machine manufacturers. Scans were considered invalid if a body part (e.g., arm, leg) was completely off or partially off the scanner, there was hand-hip overlap, or there was motion or movement during the scan., 24 months|Comorbidity -- Hypertension, A diagnosis was made by an out-of-range value \>=95th percentile or systolic \>=130 or diastolic \>=80 sustained over 6 months or on an anti-hypertensive medication., Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.|Comorbidity -- LDL Dyslipidemia, A diagnosis was made from out-of-range value \>= 130 mg/dL sustained over 6 months or put on lipid lowering medication., Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.|Comorbidity -- Triglycerides Dyslipidemia, A diagnosis was made by an out-of-range value \>=150 mg/dL sustained over 6 months or on appropriate lipid lowering medication., Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.
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| Locations: |
Children's Hospital Los Angeles, Los Angeles, California, 90027, United States|University of Colorado Health Sciences Center, The Children's Hospital, Denver, Colorado, 80262, United States|Yale University, New Haven, Connecticut, 06520, United States|George Washington University Biostatistics Center, Rockville, Maryland, 20852, United States|Massachusetts General Hospital Diabetes Center, Boston, Massachusetts, 02114, United States|Joslin Diabetes Center, Boston, Massachusetts, 02215, United States|Saint Louis University Health Sciences Center, Saint Louis, Missouri, 63104, United States|Washington University Department of Pediatrics, Saint Louis, Missouri, 63110, United States|Columbia University Medical Center, New York, New York, 10032, United States|State University of New York Upstate Medical University, Syracuse, New York, 13210, United States|Case Western Reserve, Cleveland, Ohio, 44106, United States|University of Oklahoma, Oklahoma City, Oklahoma, 93104, United States|Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States|Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States|Baylor College of Medicine, Houston, Texas, 77030, United States|University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States
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