Effects of Pramlintide, an Analog of Human Amylin, on Plasma Glucose Profiles in Patients With IDDM: Results of a Multicenter Trial

Rg, Thompson; Peterson, Julia; Gottlieb, Alan; Mullane, John F.

doi:10.2337/diab.46.4.632

Cited by 37 publications

(14 citation statements)

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“…In combination with insulin, pramlintide reduces postprandial glucose in patients with type 1 or type 2 diabetes without increasing insulin levels (Kong et al 1997; Thompson et al 1997a, c; Weyer et al 2003; Maggs et al 2004). In patients with type 1 diabetes, it reduces one-hour postprandial glucose by 5–7 mmol/L and 2-hour postprandial glucose by 3.6 to 5 mmol/L.…”

Section: Chemistry and Preclinical Pharmacologymentioning

confidence: 99%

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

Ryan¹,

Briscoe²,

Jobe³

2008

DDDT

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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 premeal insulin in those patients who are either only on premeal 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 cosecreted 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.

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Section: Chemistry and Preclinical Pharmacologymentioning

confidence: 99%

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

Ryan¹,

Briscoe²,

Jobe³

2008

DDDT

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“…82 Subcutaneous injection or intravenous infusion of pramlintide reduces postprandial glucose excursions in patients with type 1 or type 2 diabetes. 111,112 However, the necessity for injection and its relatively weak efficacy (approximately 0.5% HbA 1c lowering) will probably limit use of this agent.…”

Section: Nonpharmacologic Interventionsmentioning

confidence: 99%

Clinical Significance, Pathogenesis, and Management of Postprandial Hyperglycemia

2003

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It is well established that strict glycemic control (hemoglobin A1c <7.0%) can prevent the microvascular complications of diabetes mellitus. Recent studies indicate that elevated plasma glucose concentrations are an independent and clinically significant risk factor for cardiovascular disease in nondiabetic and diabetic individuals. Thus, isolated postprandial hyperglycemia (2-hour postprandial glucose level >140 mg/dL [>7.8 mmol/L]) in the face of normal fasting plasma glucose (<110 mg/dL [<6.1 mmol/L]) and normal hemoglobin A1c (<6.1%) values is associated with a 2-fold increased risk of death from cardiovascular disease. These observations imply that more strict glycemic control is required to prevent macrovascular disease than microvascular disease. This review summarizes epidemiologic and experimental studies linking postprandial hyperglycemia to cardiovascular disease and therapeutic approaches available and in development to treat this disorder.

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“…Pramlintide is being evaluated as a drug candidate for treating people with type 1 and insulin-using type 2 diabetes. [5][6][7] Figure 1 shows the pramlintide amino acid sequence with the disulfide bridge between cysteines 2 and 7 and highlights the amino acid differences between pramlintide and amylin.…”

Section: Introductionmentioning

confidence: 99%

Kinetics of pramlintide degradation in aqueous solution as a function of temperature and pH

et al. 2000

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The stability of the 37− amino acid peptide pramlintide, in aqueous solution, was studied as a function of pH and temperature. Samples of pramlintide formulated as a parenteral product were exposed to elevated temperatures and to realistic storage conditions for as long as 30 months. Pramlintide degradation was monitored by three high-performance liquid chromatography (HPLC) methods: a reversedphase (RP-HPLC) and a strong-cation exchange (SCX-HPLC) method for percentage purity determination by area normalization, plus a second RP-HPLC method for potency determination versus external standards. The pH-rate profile for pramlintide shows increasing degradation rate constants with increasing pH over the range pH = 3.5 to 5.0. The Arrhenius expression for pramlintide degradation at pH = 4.0 over the temperature range 5°C to 50° C is ln(k 0)= 37.39-21.900/RT, where k 0 is the zero-order rate constant (in %/mo) for pramlintide degradation. The pramlintide parenteral product formulated at pH = 4.0 is extremely stable, with percentage purity and percentage potency loss of only approximately 2% over 30 months at 5°C. The formulated pramlintide drug product has acceptable shelf life for long-term storage at 5°C and up to a 30-day patient use when stored at ambient temperature.

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Effects of Pramlintide, an Analog of Human Amylin, on Plasma Glucose Profiles in Patients With IDDM: Results of a Multicenter Trial

Cited by 37 publications

References 0 publications

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

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

Clinical Significance, Pathogenesis, and Management of Postprandial Hyperglycemia

Kinetics of pramlintide degradation in aqueous solution as a function of temperature and pH

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