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Review of pramlintide as adjunctive therapy in treatment of type 1 and type 2 diabetes.

ABSTRACT: Pramlintide (Symlin), a synthetic analog of a neurohormone amylin, was approved by the US Food and Drug Administration for use along with premeal insulin in patients with type 1. In patients with type 2 diabetes, pramlintide is approved for addition to pre-meal insulin in those patients who are either only on pre-meal insulin or those receiving the combination of insulin and metformin and/or a sulfonylurea. This article reviews the pharmacology, pharmacokinetics, dosing, clinical trials, safety, contraindications, and drug interactions of pramlintide therapy. A search for published clinical trials and therapeutic reviews in the English language was done in the following databases: Iowa Drug Information Service (1966 to July 2008), MEDLINE (1966 to July 2008), and International Pharmaceutical Abstracts (1970 to July 2008). Pramlintide and amylin were used as keywords and title words. References of key articles were also reviewed to identify additional publications. Amylin is a 37 amino acid peptide neurohormone co-secreted from the beta cells of the pancreas, along with insulin, in response to meals. Amylin lowers serum glucose by decreasing glucagon release, slowing gastric emptying and decreasing food intake. Pramlintide, a synthetic analog of amylin, reduces 2-hour postprandial blood glucose between 3.4 and 5 mmol/L, reduces A1C by 0.2% to 0.7% and has no effect on fasting glucose levels. The use of pramlintide was associated with up to a 1.6 kg weight loss. Nausea was the most commonly reported adverse event. Pramlintide is an amylin analog that was FDA approved for the treatment of type 1 and type 2 diabetes. Its use results in modest reduction of A1C and the most frequent side effects are hypoglycemia and nausea.

SUBMITTER: Ryan G

PROVIDER: S-EPMC2761191 | biostudies-other | 2009 Feb

REPOSITORIES: biostudies-other

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Review of pramlintide as adjunctive therapy in treatment of type 1 and type 2 diabetes.

Ryan Gina G Briscoe Tim A TA Jobe Lynette L

Drug design, development and therapy 20090206

Pramlintide (Symlin), a synthetic analog of a neurohormone amylin, was approved by the US Food and Drug Administration for use along with premeal insulin in patients with type 1. In patients with type 2 diabetes, pramlintide is approved for addition to pre-meal insulin in those patients who are either only on pre-meal insulin or those receiving the combination of insulin and metformin and/or a sulfonylurea. This article reviews the pharmacology, pharmacokinetics, dosing, clinical trials, safety, ...[more]

PMID: 19920907

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Project description:Insulin resistance has been proposed as one of the causes of poor glycemic control in overweight/obese youth with type 1 diabetes (T1D). However, the role of adjunctive metformin, an insulin sensitizer, on glycemic control in these patients is unclear.To compare the effect of metformin vs. placebo on hemoglobin A1c (HbA1c), total daily dose (TDD) of insulin, and other parameters in overweight/obese youth with T1D.Adjunctive metformin therapy will improve glycemic control in overweight/obese youth with T1D.A 9-mo randomized, double-blind, placebo controlled trial of metformin and placebo in 28 subjects (13m/15f) of ages 10-20years (y), with HbA1c >8% (64 mmol/mol), BMI >85%, and T1D > 12 months was conducted at a university outpatient facility. The metformin group consisted of 15 subjects (8 m/ 7f), of age 15.0 ± 2.5 y; while the control group was made up of 13 subjects (5m/ 8f), of age 14.5 ± 3.1y. All participants employed a self-directed treat-to-target insulin regimen based on a titration algorithm of (-2)-0-(+2) units to adjust their long-acting insulin dose every 3rd day from -3 mo through +9 mo to maintain fasting plasma glucose (FPG) between 90-120 mg/dL (5.0-6.7 mmol/L). Pubertal maturation was determined by Tanner stage.Over the course of the 9 months of observation, the between-treatment differences in HbA1c of 0.4% (9.85% [8.82 to 10.88] for placebo versus 9.46% [8.47 to 10.46] for metformin) was not significant (p = 0.903). There were non-significant reduction in fasting plasma glucose (189.4 mg/dL [133.2 to 245.6] for placebo versus 170.5 mg/dL [114.3 to 226.7] for metformin), (p = 0.927); total daily dose (TDD) of short-acting insulin per kg body weight/day(p = 0.936); and the TDD of long-acting insulin per kg body weight per day (1.15 units/kg/day [0.89 to 1.41] for placebo versus 0.90 units/kg/day [0.64 to 1.16] for metformin) (p = 0.221). There was no difference in the occurrence of hypoglycemia between the groups.This 9-month RCT of adjunctive metformin therapy in overweight and obese youth with T1D resulted in a 0.4% lower HbA1c value in the metformin group compared to the placebo group.ClinicalTrial.gov NCT01334125.

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Review of pramlintide as adjunctive therapy in treatment of type 1 and type 2 diabetes.

Publications

Review of pramlintide as adjunctive therapy in treatment of type 1 and type 2 diabetes.

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