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Wednesday, 13 September 2017

Soliqua® 100/33 provided earlier blood sugar control than insulin glargine 100 units/mL

Zealand Pharma    

Published: 12:17 CEST 13-09-2017 /GlobeNewswire /Source: Zealand Pharma / : ZEAL /ISIN: DK0060257814

Soliqua® 100/33 provided earlier blood sugar control than insulin glargine 100 units/mL

Press release - No. 7/2017

Soliqua® 100/33 provided earlier blood sugar control than insulin glargine 100 units/mL

  • More adults reached HbA1c target at 8 and 12 weeks versus those receiving insulin glargine 100 units/ml
  • Data presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Lisbon, Portugal


Copenhagen, Denmark, September 13, 2017 - Sanofi has announced that in certain adults with type 2 diabetes, Soliqua® 100/33 (insulin glargine and lixisenatide injection, 100 units/mL and 33 mcg/mL) provided blood sugar control earlier and in more adults than those treated with insulin glargine 100 units/mL alone, according to a new post-hoc analysis of key late-stage clinical trials.


This post-hoc analysis reviewed data from the Phase 3 trials, LixiLan-O and LixiLan-L1,2, which compared the effectiveness of Soliqua® 100/33 vs. insulin glargine 100 units/mL on top of metformin (if previously taken) in more than 1,900 adults with type 2 diabetes (LixiLan-O n=1,170 and LixiLan-L n=736). Primary results and safety information for both studies were previously reported.1,2  Blood glucose levels were evaluated at 8 and 12 weeks, and the Kaplan-Meier method was used to estimate time to control, defined as time (days) to first achieve an HbA1c of less than 7% or fasting plasma glucose of less than or equal to 7.2 mmol/L (130 mg/dL).


The analysis was presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Lisbon, Portugal. The abstract is titled "Shorter time to glycaemic control with fixed-ratio combination of insulin glargine and lixisenatide compared with insulin glargine treatment alone" (Frias J.P. et al. Poster presentation #803).


For further information, please contact:

Britt Meelby Jensen, President and CEO
Tel.: +45 51 67 61 28, e-mail: bmj@zealandpharma.com

Mats Blom, Executive Vice President and Chief Financial Officer

Tel.: +45 31 53 79 73, e-mail: mabl@zealandpharma.com


About Zealand Pharma A/S

Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) ("Zealand") is a biotechnology company focused on the discovery, design and development of innovative peptide-based medicines. Zealand has a portfolio of medicines and product candidates under license collaborations with Sanofi and Boehringer Ingelheim as well as a pipeline of internal product candidates focusing on specialty gastrointestinal and metabolic diseases.

Zealand's first invented medicine, lixisenatide, a once-daily prandial GLP-1 receptor agonist for the treatment of type 2 diabetes, is licensed to Sanofi. Lixisenatide is marketed as Adlyxin® in the U.S. and as Lyxumia® in the rest of the world. Lixisenatide has been developed in a combination with basal insulin glargine (Lantus®) and is marketed as Soliqua® 100/33 in the U.S. and has been approved as Suliqua® in Europe and launched in the Netherlands.

Zealand's clinical pipeline includes: dasiglucagon (ZP4207, single-dose rescue treatment) for acute, severe hypoglycemia (Phase 3); glepaglutide (ZP1848) for short bowel syndrome (Phase 2 completed); dasiglucagon (ZP4207, multiple-dose version) intended for use in a dual-hormone artificial pancreas system to reduce the risk of hypoglycemia and provide better diabetes management (Phase 2) as well as for the treatment of congenital hyperinsulinism; and other earlier-stage clinical and preclinical peptide therapeutics.

Zealand is based in Copenhagen (Glostrup), Denmark. For further information about the Company's business and activities, please visit www.zealandpharma.com or follow us on Twitter @ZealandPharma or LinkedIn.

1. Aroda VR, et al. Diabetes Care. 2016, DOI: 10.2337/dc16-1495.

2. Rosenstock J. et al. Diabetes Care Aug 2016, dc160917; DOI: 10.2337/dc16-0917.

* Dasiglucagon and glepaglutide are proposed International Nonproprietary Names (pINN).

07-17_0913 Soliqua data on EASD

This announcement is distributed by Nasdaq Corporate Solutions (One Liberty Plaza, 165 Broadway, New York, NY 10006. Tel: +1 212 401 8700. www.nasdaqomx.com) on behalf of NASDAQ OMX Corporate Solutions clients. Source: Zealand Pharma, Smedeland 36, Glostrup 2600, Danmark
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