| Early clinical studies with liraglutide. | |
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MedLine Citation:
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PMID: 20887300 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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AIMS: To describe Phase 1 and 2 clinical trials of liraglutide with a focus on clinical pharmacology. KEY FINDINGS: In early clinical trials of liraglutide, 0.05-1.9 mg daily improved multiple aspects of glycaemic control and beta-cell function. Early trials demonstrated typical reductions in glycated haemoglobin (HbA(1c) ) and fasting plasma glucose (FPG) of up to 1.5% and 3.3-3.9 mmol/l, respectively, at daily doses of 1.25-1.9 mg, with 45-50% of patients reaching HbA(1c) < 7%. The effects of liraglutide in restoring beta-cell response to fasting and postprandial hyperglycaemia and in reinstating near-normal insulin secretion under hyperglycaemic conditions suggest a beta-cell-protective effect. By delaying gastric emptying and promoting satiety, liraglutide is weight sparing at low doses and causes clinically meaningful weight loss at higher doses and in combination with other anti-diabetes therapies with weight-modifying benefits, such as metformin. Significant improvements in other cardiovascular risk factors, including blood pressure, lipids and cardiovascular risk biomarkers, were also evident. Adverse effects of liraglutide were primarily gastrointestinal; dose-dependent nausea was the most commonly reported effect, but was typically mild-to-moderate in severity and transient in nature. CONCLUSIONS: Early clinical trials of liraglutide indicate the ability to improve glycaemic control in a glucose-dependent manner, with low risk of hypoglycaemia. Promotion of weight loss, along with improvements in multiple cardiovascular risk factors, suggests that liraglutide may offer a novel and clinically valuable approach to disease management for patients with type 2 diabetes. |
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Authors:
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W E Schmidt |
Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't; Review |
Journal Detail:
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Title: International journal of clinical practice. Supplement Volume: - ISSN: 1368-504X ISO Abbreviation: Int J Clin Pract Suppl Publication Date: 2010 Oct |
Date Detail:
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Created Date: 2010-10-04 Completed Date: 2011-04-27 Revised Date: 2011-11-15 |
Medline Journal Info:
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Nlm Unique ID: 9712380 Medline TA: Int J Clin Pract Suppl Country: England |
Other Details:
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Languages: eng Pagination: 12-20 Citation Subset: IM |
Copyright Information:
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© 2010 Blackwell Publishing Ltd. |
Affiliation:
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Dept of Medicine I, St. Josef Hospital, Ruhr-University of Bochum Medical School, Bochum, Germany. Wolfgang.e.schmidt@ruhr-unibochum.de |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Blood Glucose
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drug effects,
metabolism Body Weight / drug effects Cardiotonic Agents Cardiovascular Diseases / complications Clinical Trials, Phase I as Topic Clinical Trials, Phase II as Topic Diabetes Mellitus, Type 2* / complications, drug therapy, metabolism, physiopathology Disease Management Drug Therapy, Combination Gastric Emptying / drug effects Glucagon-Like Peptide 1 / administration & dosage, adverse effects, analogs & derivatives*, pharmacokinetics Hemoglobin A, Glycosylated / metabolism Humans Hypoglycemic Agents / administration & dosage, adverse effects, pharmacokinetics Insulin / metabolism, therapeutic use Insulin-Secreting Cells / drug effects Metformin / administration & dosage, adverse effects, pharmacokinetics |
| Chemical | |
Reg. No./Substance:
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0/Blood Glucose; 0/Cardiotonic Agents; 0/Hemoglobin A, Glycosylated; 0/Hypoglycemic Agents; 0/liraglutide; 11061-68-0/Insulin; 657-24-9/Metformin; 89750-14-1/Glucagon-Like Peptide 1 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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