| Effect of pramlintide on weight in overweight and obese insulin-treated type 2 diabetes patients. | |
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MedLine Citation:
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PMID: 15090634 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: Several randomized, placebo-controlled, double-blind trials in insulin-treated patients with type 2 diabetes have shown that adjunctive therapy with pramlintide reduces hemoglobin (Hb)A1c with concomitant weight loss. This analysis further characterizes the weight-lowering effect of pramlintide in this patient population. RESEARCH METHODS AND PROCEDURES: This pooled post hoc analysis of two long-term trials included all patients who were overweight/obese at baseline (BMI > 25 kg/m2), and who were treated with either 120 microg pramlintide BID (n = 254; HbA1c 9.2%; weight, 96.1 kg) or placebo (n = 244; HbA1c 9.4%; weight, 95.0 kg). Statistical endpoints included changes from baseline to week 26 in HbA1c, body weight, and insulin use. RESULTS: Pramlintide treatment resulted in significant reductions from baseline to week 26, compared with placebo, in HbA1c and body weight (both, p < 0.0001), for placebo-corrected reductions of -0.41% and -1.8 kg, respectively. Approximately three times the number of patients using pramlintide experienced a > or = 5% reduction of body weight than with placebo (9% vs. 3%, p = 0.0005). Patients using pramlintide also experienced a proportionate decrease in total daily insulin use (r = 0.39, p < 0.0001). The greatest placebo-corrected reductions in weight at week 26 were observed in pramlintide-treated patients with a BMI >40 kg/m2 and in those concomitantly treated with metformin (both, p < 0.001), for placebo-corrected reductions of -3.2 kg and -2.5 kg, respectively. DISCUSSION: These findings support further evaluation of the weight-lowering potential of pramlintide in obese patients with type 2 diabetes. |
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Authors:
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Priscilla Hollander; David G Maggs; James A Ruggles; Mark Fineman; Larry Shen; Orville G Kolterman; Christian Weyer |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Obesity research Volume: 12 ISSN: 1071-7323 ISO Abbreviation: Obes. Res. Publication Date: 2004 Apr |
Date Detail:
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Created Date: 2004-04-19 Completed Date: 2004-07-16 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 9305691 Medline TA: Obes Res Country: United States |
Other Details:
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Languages: eng Pagination: 661-8 Citation Subset: IM |
Affiliation:
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Baylor College of Medicine, Dallas, Texas, USA. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Aged Amyloid / adverse effects, therapeutic use* Body Mass Index Body Weight / drug effects* Diabetes Mellitus / drug therapy* Diabetes Mellitus, Type 2 / drug therapy* Double-Blind Method Drug Therapy, Combination Female Hemoglobin A, Glycosylated / analysis Humans Hypoglycemic Agents / therapeutic use* Insulin / administration & dosage, therapeutic use* Male Metformin / administration & dosage Middle Aged Nausea / chemically induced Obesity* Placebos Weight Loss |
| Chemical | |
Reg. No./Substance:
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0/Amyloid; 0/Hemoglobin A, Glycosylated; 0/Hypoglycemic Agents; 0/Placebos; 11061-68-0/Insulin; 151126-32-8/pramlintide; 657-24-9/Metformin |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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