Randomized comparison of pramlintide or mealtime insulin added to basal insulin treatment for patients with type 2 diabetes.

Abstract

OBJECTIVE:

To compare the efficacy and safety of adding mealtime pramlintide or rapid-acting insulin analogs (RAIAs) to basal insulin for patients with inadequately controlled type 2 diabetes.

RESEARCH DESIGN AND METHODS:

In a 24-week open-label, multicenter study, 113 patients were randomly assigned 1:1 to addition of mealtime pramlintide (120 microg) or a titrated RAIA to basal insulin and prior oral antihyperglycemic drugs (OADs). At screening, patients were insulin naive or had been receiving <50 units/day basal insulin for <6 months. The basal insulin dosage was titrated from day 1, seeking fasting plasma glucose (FPG) > or =70-<100 mg/dl. Pramlintide and an RAIA were initiated on day 1 and week 4, respectively. The proportion of patients achieving A1C < or =7.0% without weight gain or severe hypoglycemia at week 24 was the primary end point.

RESULTS:

More pramlintide- than RAIA-treated patients achieved the primary end point (30 vs. 11%, P = 0.018) with a similar dose of basal insulin. Pramlintide and an RAIA yielded similar mean +/- SEM values for FPG and A1C at 24 weeks (122 +/- 7 vs. 123 +/- 5 mg/dl and 7.2 +/- 0.2 vs. 7.0 +/- 0.1%, respectively) and similar least squares mean reductions from baseline to end point (-31 +/- 6 vs. -34 +/- 6 mg/dl and -1.1 +/- 0.2 vs. -1.3 +/- 0.2%, respectively). RAIAs but not pramlintide caused weight gain (+4.7 +/- 0.7 vs. +0.0 +/- 0.7 kg, P < 0.0001). Fewer patients reported mild to moderate hypoglycemia with pramlintide than with the RAIA (55 vs. 82%), but more patients reported nausea (21 vs. 0%). No severe hypoglycemia occurred in either group.

CONCLUSIONS:

In patients taking basal insulin and OADs, premeal fixed-dose pramlintide improved glycemic control as effectively as titrated RAIAs. The pramlintide regimen sometimes caused nausea but no weight gain and less hypoglycemia.

• Authors: Matthew Riddle, Richard Pencek, Supoat Charenkavanich, Karen Lutz, Ken Wilhelm, Lisa Porter
• Journal: Diabetes care (Diabetes Care) Vol. 32 Issue 9 Pg. 1577-82 (Sep 2009) ISSN: 1935-5548 [Electronic] United States
• PMID: 19502544 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Amyloid
• Blood Glucose
• Hypoglycemic Agents
• Insulin
• Insulin, Long-Acting
• Islet Amyloid Polypeptide
• pramlintide

Topics

• Adolescent
• Adult
• Aged
• Amyloid (administration & dosage, adverse effects, pharmacology, therapeutic use)
• Blood Glucose (drug effects)
• Diabetes Mellitus, Type 2 (blood, drug therapy)
• Female
• Humans
• Hypoglycemic Agents (administration & dosage, adverse effects, pharmacology, therapeutic use)
• Insulin (administration & dosage, adverse effects, analogs & derivatives, pharmacology, therapeutic use)
• Insulin, Long-Acting
• Islet Amyloid Polypeptide
• Male
• Middle Aged
• Postprandial Period
• Treatment Outcome
• Young Adult