MARC details
| 000 -LEADER |
|---|
| fixed length control field |
03877nam a22006017a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
191010s20192019 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
|---|
| International Standard Serial Number |
0149-5992 |
| 024 ## - OTHER STANDARD IDENTIFIER |
|---|
| Standard number or code |
10.2337/dc19-0898 [doi] |
| 024 ## - OTHER STANDARD IDENTIFIER |
|---|
| Standard number or code |
dc19-0898 [pii] |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
|---|
| PMID |
31530667 |
| 245 ## - TITLE STATEMENT |
|---|
| Title |
Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial. |
| 251 ## - Source |
|---|
| Source |
Diabetes Care. 42(12):2262-2271, 2019 12. |
| 252 ## - Abbreviated Source |
|---|
| Abbreviated source |
Diabetes Care. 42(12):2262-2271, 2019 12. |
| 252 ## - Abbreviated Source |
|---|
| Former abbreviated source |
Diabetes Care. 2019 Sep 17 |
| 253 ## - Journal Name |
|---|
| Journal name |
Diabetes care |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Year |
2019 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Manufacturer |
FY2020 |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
|---|
| Publication status |
aheadofprint |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
|---|
| Publication status |
ppublish |
| 266 ## - Date added to catalog |
|---|
| Date added to catalog |
2019-10-10 |
| 268 ## - Previous citation |
|---|
| -- |
Diabetes Care. 2019 Sep 17 |
| 501 ## - WITH NOTE |
|---|
| Local holdings |
Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006 |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
CONCLUSIONS: Oral semaglutide was superior to placebo in reducing HbA1c and body weight when added to insulin +/- metformin in patients with type 2 diabetes. The safety profile was consistent with other glucagon-like peptide-1 receptor agonists. Copyright (c) 2019 by the American Diabetes Association. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
OBJECTIVE: To investigate the efficacy, safety and tolerability of oral semaglutide added to insulin +/- metformin. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
RESEARCH DESIGN AND METHODS: Patients with type 2 diabetes uncontrolled on insulin, +/- metformin, were randomized to oral semaglutide 3 mg (N=184), 7 mg (N=182), or 14 mg (N=181), or placebo (N=184) in a 52-week, double-blind trial (NCT03021187). Endpoints were change from baseline to week 26 in HbA1c (primary) and body weight (confirmatory secondary). Two estimands were defined: treatment policy (effect regardless of trial product discontinuation or rescue medication) and trial product (effect assuming trial product continuation without rescue medication) in randomized patients. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
RESULTS: Oral semaglutide was superior to placebo in reducing HbA1c (estimated treatment differences [ETD] [95% CI]: -0.5% [-0.7, -0.3], -0.9% [-1.1, -0.7], -1.2% [-1.4, -1.0] for 3, 7, and 14 mg, respectively; P<0.001) and body weight (ETD [95% CI]: -0.9 kg [-1.8, -0.0], -2.0 kg [-3.0, -1.0], -3.3 kg [-4.2, -2.3]; P=0.0392 for 3 mg, P<=0.0001 for 7 and 14 mg) at week 26 (treatment policy estimand). Significantly greater, dose-dependent HbA1c, and body weight reductions versus placebo were achieved with oral semaglutide at weeks 26 and 52 (both estimands). The most frequent adverse event with oral semaglutide was nausea (11.4-23.2% of patients vs 7.1% with placebo; mostly mild-to-moderate). |
| 546 ## - LANGUAGE NOTE |
|---|
| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
*Diabetes Mellitus, Type 2/dt [Drug Therapy] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
*Glucagon-Like Peptides/ad [Administration & Dosage] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
*Hypoglycemic Agents/ad [Administration & Dosage] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
*Insulin/ad [Administration & Dosage] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
*Metformin/ad [Administration & Dosage] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Adult |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Body Weight/de [Drug Effects] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Diabetes Mellitus, Type 2/bl [Blood] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Double-Blind Method |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Drug Therapy, Combination |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Female |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Glycated Hemoglobin A/de [Drug Effects] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Humans |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Male |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Middle Aged |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Nausea/ci [Chemically Induced] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Treatment Outcome |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Weight Loss/de [Drug Effects] |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
|---|
| Institution |
MedStar Health Research Institute |
| 657 ## - INDEX TERM--FUNCTION |
|---|
| Medline publication type |
Journal Article |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
|---|
| Local Authors |
Aroda, Vanita R |
| 790 ## - Authors |
|---|
| All authors |
Araki E, Aroda VR, Buse JB, Cariou B, Harris SB, Hoff ST, Pedersen KB, PIONEER 8 investigators, Tarp-Johansen MJ, Zinman B |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
|---|
| DOI |
<a href="https://dx.doi.org/10.2337/dc19-0898">https://dx.doi.org/10.2337/dc19-0898</a> |
| Public note |
https://dx.doi.org/10.2337/dc19-0898 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Journal Article |
| Item type description |
Article |
