Amylin replacement with pramlintide as an adjunct to insulin therapy improves long-term glycaemic and weight control in Type 1 diabetes mellitus: a 1-year, randomized controlled trial
Version of Record online: 20 OCT 2004
Volume 21, Issue 11, pages 1204–1212, November 2004
How to Cite
Ratner, R. E., Dickey, R., Fineman, M., Maggs, D. G., Shen, L., Strobel, S. A., Weyer, C. and Kolterman, O. G. (2004), Amylin replacement with pramlintide as an adjunct to insulin therapy improves long-term glycaemic and weight control in Type 1 diabetes mellitus: a 1-year, randomized controlled trial. Diabetic Medicine, 21: 1204–1212. doi: 10.1111/j.1464-5491.2004.01319.x
- Issue online: 20 OCT 2004
- Version of Record online: 20 OCT 2004
- Accepted 26 November 2003
- β-cell hormone;
- gastric emptying;
- Type 1 diabetes
Aims The autoimmune-mediated destruction of pancreatic β-cells in Type 1 diabetes mellitus renders patients deficient in two glucoregulatory peptide hormones, insulin and amylin. With insulin replacement alone, most patients do not achieve glycaemic goals. We aimed to determine the long-term efficacy and safety of adjunctive therapy with pramlintide, a synthetic human amylin analogue, in patients with Type 1 diabetes.
Methods In a double-blind, placebo-controlled, parallel-group, multicentre study, 651 patients with Type 1 diabetes (age 41 ± 13 years, HbA1c 8.9 ± 1.0%, mean ± sd) were randomized to mealtime injections of placebo or varying doses of pramlintide, in addition to their insulin therapy, for 52 weeks.
Results Addition of pramlintide [60 µg three times daily (TID) or four times daily (QID)] to insulin led to significant reductions in HbA1c from baseline to Week 52 of 0.29% (P < 0.011) and 0.34% (P < 0.001), respectively, compared with a 0.04% reduction in placebo group. Three times the proportion of pramlintide- than placebo-treated patients achieved an HbA1c of < 7%. The greater reduction in HbA1c with pramlintide was achieved without an increase in concomitant insulin use and was accompanied by a significant reduction in body weight from baseline to Week 52 of 0.4 kg in the 60 µg TID (P < 0.027) or QID (P < 0.040) pramlintide treatment groups, compared with a 0.8-kg gain in body weight in the placebo group. The most common adverse event in pramlintide-treated patients was transient, mild-to-moderate nausea.
Conclusions These results show that mealtime amylin replacement with pramlintide, as an adjunct to insulin therapy, improves long-term glycaemic and weight control in patients with Type 1 diabetes.