Response Rate in Plasma Glucose Level
Time frame · at Month 6 (M6), Month 12 (M12)
Response rate is defined as percentage of patients with no glucose values \< 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of 6 months (end of LAR/Core phase) and at the end of 12 months (extension phase)
Response Rate in Pulse Rate
Time frame · at baseline, M3, M6, M12
Pulse rate was defined as percentage of patients with change in pulse rate \>=10 bpm from pre-OGTT to 30 minutes post OGTT.
Response Rate in Hematocrit Levels
Time frame · M3, M6, M12
Percentage of patients with change in hematocrit \>= 3% from pre-OGTT to 30 minutes post OGTT.
Insulin Levels During OGTT
Time frame · M3, M6, M12
Absolute insulin levels at the end of M3, M6, M12
Glucagon Levels During OGTT
Time frame · M3, M6, M12
Absolute glucagon levels at the end of Months 3, 6 \& 12
Glucagon-like Peptide 1 (GLP-1) Levels During OGTT
Time frame · M3, M6, M12
Absolute Glucagon-like peptide 1 (GLP-1) levels at the end of at the end of Months 3, 6 and 12 at different time points.
Gastric Inhibitory Polypeptide (GIP) Levels at During OGTT
Time frame · M3, M6, M12
Absolute Gastric Inhibitory Polypeptide (GIP) levels at the end of Months 3, 6 and 12 at different time points.
Health-related Quality of Live (HRQoL) Short Form- 36 (SF-36) Score(s)
Time frame · M3, M6, M12
Absolute HRQoL SF-36 Scores at end of the Months 3, 6 and 12 from s.c. baseline. SF-36, a 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. Items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Dumping Severity Score (DSS) at the End of Months 3, 6 and 8
Time frame · M3, M6, M8
Absolute Dumping Severity Score (DSS) scores at end of M3, M6 \& M8. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients were expected to use DSQ. No results available for M12 as last patient that answered the DSS was at M8. DSS = disease-specific patient (Pt.) reported outcome (PRO) questionnaire uses a 4-point Likert scale (0, absent; 1, mild; 2, relevant; 3, severe; 4) to ask Pt. to evaluate intensity of early dumping symptoms (within 30 minutes (\<30 minutes) after food ingestion). The questionnaire also evaluates 65 late dumping symptoms (more than 1.5 hours (\>90 minutes) after food ingestion). Early \& late dumping score calculated by adding the scores of the respective questions. Cumulative dumping score is obtained by adding early \& late scores. DSS Range (min (absent) - max (severe)): Early dumping: 0-24; Late Dumping: 0-18; Cumulative: 0-42. Lower scores represent a better outcome.
Dumping Score Questionnaire (DSQ) at the End of Months 3, 6 and 12
Time frame · M3, M6, M12
Absolute Dumping Score Questionnaire (DSQ) scores at end of Months 3, 6 \& 12 from s.c. baseline. DSQ = disease-specific PRO scale. The questionnaire uses a 5-point Likert scale (0, none; 1, mild; 2, moderate; 3, severe; 4, very severe) to ask Pt. to evaluate intensity of 10 early dumping symptoms (within 30 minutes (\<30 minutes) after food ingestion). The questionnaire also evaluates 5 late dumping symptoms (more than 1.5 hours (\>90 minutes) after food ingestion). Early \& late dumping score calculated by adding the scores of respective questions. A cumulative dumping score is obtained by adding early \& late scores. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients used DSQ. DSQ Range: (min (None) - max (Very severe)): Early dumping: 0-40; Late Dumping: 0-20; Cumulative: 0-60. Lower scores represent a better outcome.