Continuous subcutaneous delivery of exenatide via ITCA 650 leads to sustained glycemic control and weight loss for 48 weeks in metformin-treated subjects with type 2 diabetes.

Abstract

AIMS:

Evaluate the efficacy and tolerability of ITCA 650 in subjects with type 2 diabetes treated for up to 48 weeks.

METHODS:

This was a 24-week extension to a randomized, 24-week, open-label, phase 2 study in subjects with type 2 diabetes inadequately controlled with metformin. Subjects received ITCA 650 mg (20, 40, 60 or 80 μg/day). Mean changes for HbA1c, weight, and fasting plasma glucose (FPG) were evaluated.

RESULTS:

Mean changes in HbA1c from baseline to week 48 ranged from -0.85% to -1.51%. At week 48, ≥64% of subjects with an HbA1c ≤7% at week 24 maintained an HbA1c ≤7%. The incidence of adverse events (AEs) was dose-related and ranged from 13.3% with 20 μg/day to 37.5% with 80 μg/day. Most AEs were mild and transient; the incidence of nausea declined from 12.9% to 9.5% over the 24-week extension. One subject on ITCA 650 80 μg/day experienced mild intermittent vomiting. Three (3.5%) subjects experienced severe AEs, but none were considered related to study drug.

CONCLUSION:

Significant changes in HbA1c, body weight, and FPG attained with ITCA 650 were maintained to 48 weeks. The incidence of AEs was lower in the 24-week extension than in the initial 24-week treatment phase.

• Authors: Robert R Henry, Julio Rosenstock, Douglas Logan, Thomas Alessi, Kenneth Luskey, Michelle A Baron
• Journal: Journal of diabetes and its complications (J Diabetes Complications) 2014 May-Jun Vol. 28 Issue 3 Pg. 393-8 ISSN: 1873-460X [Electronic] United States
• PMID: 24631129 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Published by Elsevier Inc.

Chemical References

• Blood Glucose
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Peptides
• Venoms
• Metformin
• Exenatide

Topics

• Adult
• Aged
• Blood Glucose (drug effects, metabolism)
• Body Weight (drug effects, physiology)
• Diabetes Mellitus, Type 2 (blood, drug therapy, physiopathology)
• Dose-Response Relationship, Drug
• Drug Therapy, Combination
• Exenatide
• Female
• Glycated Hemoglobin (drug effects, metabolism)
• Humans
• Hypoglycemic Agents (administration & dosage, adverse effects, pharmacology)
• Infusions, Subcutaneous
• Longitudinal Studies
• Male
• Metformin (therapeutic use)
• Middle Aged
• Peptides (administration & dosage, adverse effects, pharmacology)
• Treatment Outcome
• Venoms (administration & dosage, adverse effects, pharmacology)
• Weight Loss (drug effects, physiology)