Effects of 4 weeks' administration of pramlintide, a human amylin analogue, on glycaemia control in patients with IDDM : effects on plasma glucose profiles and serum fructosamine concentrations

• Published in: Diabetologia 1997-11, Vol.40 (11), p.1278-1285
• Main Authors: THOMPSON, R. G, PEARSON, L, KOLTERMAN, O. G
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Amylin; Amyloid - administration & dosage; Amyloid - adverse effects; Biological and medical sciences; Blood glucose; Blood Glucose - analysis; Diabetes mellitus (insulin dependent); Diabetes Mellitus, Type 1 - drug therapy; Double-Blind Method; Female; Fructosamine - blood; Glucose; Hormones. Endocrine system; Humans; Hypoglycemia; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - adverse effects; Insulin; Islet Amyloid Polypeptide; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Placebos; Statistical analysis; Treatment Outcome
• ISSN: 0012-186X; 1432-0428
• DOI: 10.1007/s001250050821

The effects of 4 weeks' administration of pramlintide, an analogue of the human hormone amylin, on blood glucose control in 215 patients with insulin-dependent diabetes mellitus were examined in a 4-week, randomized, double-blind, placebo-controlled, parallel-group trial. Pramlintide was administered subcutaneously prior to meals in four dosing regimens: 30 microg four times per day (breakfast, lunch, dinner, and evening snack), 30 microg three times per day (breakfast, lunch and dinner [BLD]), 30 microg three times per day (breakfast, dinner and evening snack [BDS]), and 60 microg twice per day (breakfast and dinner). After 4 weeks of pramlintide 30 microg four times per day administration, there was a statistically significant reduction in the mean 24 h plasma glucose concentration when compared to placebo (-1.4 +/- 0.5 vs 0.3 +/- 0.5 micromol/l, p = 0.009). Serum fructosamine concentrations were reduced 62 +/- 10 micromol/l in the pramlintide 30 mg four times per day group, 43 +/- 7 micromol/l in the pramlintide 30 microg three times per day (BLD) group, 47 +/- 6 micromol/l in the pramlintide 30 microg three times per day (BDS) group, 46 +/- 7 micromol/l in the pramlintide 60 microg twice per day group, and 29 +/- 8 micromol/l by placebo. The incidence of hypoglycaemia was not different in any pramlintide group compared to the placebo group. Nausea, the most frequent adverse event, subsided after the first week of treatment in the majority of patients. In conclusion, pramlintide improved blood glucose control over a 4-week period without increased hypoglycaemia and was well tolerated. Future studies using a longer period of pramlintide administration with assessment of HbA1c as the measurement of glycaemic control are warranted.