After the screening visit, the patients were seen at weeks 2, 4, 12, 24, 38 and 52. C-peptide and glucose levels were measured during the 120-minute MMTT at weeks 12, 24 and 52. The average insulin use per day was determined from patient diaries that recorded insulin use for 3 days prior to a study visit. Insulin use was expressed as the total units or units/kg/d. Hypoglycaemia was graded according to the Common Terminology Criteria for Adverse Events (version 4). Hypoglycaemia was captured from patient diaries, with glucose measurements up to six times daily for 3 days prior to study visits or with symptoms. Severe hypoglycaemia was designated if assistance from others was required for recovery, or if it resulted in hospitalization or seizure.
Two-hour MMTTs were performed at each study visit. HbA1c and C-peptide (Tosoh assay) levels were measured at the Northwest Lipid Research Laboratory. In a subgroup of patients, glucagon levels were measured with the Millipore assay (n = 29) and glucagon-like peptide (GLP) and gastric inhibitory peptide (GIP) by ELISA (n = 35) in the Yale Diabetes Center Core Laboratory.
Two-hour MMTTs were performed at each study visit. HbA1c and C-peptide (Tosoh assay) levels were measured at the Northwest Lipid Research Laboratory. In a subgroup of patients, glucagon levels were measured with the Millipore assay (n = 29) and glucagon-like peptide (GLP) and gastric inhibitory peptide (GIP) by ELISA (n = 35) in the Yale Diabetes Center Core Laboratory.