Single‐dose euglycaemic clamp studies demonstrating pharmacokinetic and pharmacodynamic similarity between MK ‐1293 insulin glargine and originator insulin glargine ( L antus) in subjects with type 1 diabetes and healthy subjects-Reference-Cited by-同舟云学术

Single‐dose euglycaemic clamp studies demonstrating pharmacokinetic and pharmacodynamic similarity between MK ‐1293 insulin glargine and originator insulin glargine ( L antus) in subjects with type 1 diabetes and healthy subjects

Published:2017-09-26 Issue:2 Volume:20 Page:400-408
ISSN:1462-8902
Container-title:Diabetes, Obesity and Metabolism
language:en
Short-container-title:Diabetes Obes Metab

Author:

Crutchlow Michael F.¹^ORCID,Palcza John S.¹,Mostoller Kate M.¹,Mahon Chantal D.¹,Barbour April M.¹,Marcos Michael C.¹,Xu Yang¹,Watkins Elaine²,Morrow Linda²,Hompesch Marcus²

Affiliation:

1. Merck & Co., Inc Kenilworth New Jersey

2. ProSciento, Inc Chula Vista California

Funder

Merck

Publisher

Wiley

Subject

Endocrinology,Endocrinology, Diabetes and Metabolism,Internal Medicine

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/dom.13084

Reference25 articles.

1. U.S. Prescribing Information: LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection.2015.http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021081s063lbl.pdf. Last accessed September 6 2017.

2. Lantus 100 units/mL solution for injection in a vial: Summary of product characteristics.http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_‐_Product_Information/human/000284/WC500036082.pdf. Last accessed September 6 2017.

3. European Medicines Agency. Guideline on non‐clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues.2015.http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/03/WC500184161.pdf. Last accessed September 6 2017.

4. FDA. Guidance for Industry. Applications Covered by Section 505(b)(2). Draft Guidance.1999.https://www.fda.gov/downloads/Drugs/Guidances/ucm079345.pdf. Last accessed September 6 2017.

5. Efficacy and safety of MK‐1293 insulin glargine compared with originator insulin glargine (Lantus) in type 1 diabetes (T1D);Home P;Diabetes,2016

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