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-- Real World Outcome Study of Patients with Type 2 Diabetes Presented at American Diabetes Association 74th Scientific Sessions --
BRIDGEWATER, N.J., June 14, 2014 /PRNewswire/ -- Sanofi US announced today results from a real world outcome study of type 2 diabetes (T2D) patients that show switching from Lantus® (insulin glargine [rDNA origin] injection) to insulin detemir demonstrated higher average blood sugar levels (A1C) and lower A1C reduction over a span of 12 months compared to maintaining patients on Lantus. Alternatively, switching patients from insulin detemir to Lantus resulted in a significantly lower A1C compared to maintaining patients on insulin detemir. The study findings were presented at the 74th Scientific Sessions of the American Diabetes Association in San Francisco, Calif.
"The results of this real world study demonstrate variable patient outcomes when switching between basal insulin analogs," said Philip Levin, MD, Co-Director, Model Clinical Research, Greater Baltimore Medical Center, Baltimore, MD, and lead author of the study. "It is important to understand that every patient is different and healthcare professionals need to determine the best treatment approach based on individual needs."
This was a retrospective study (using an electronic medical records database) of two cohorts of adult T2D patients who had hemoglobin A1C (A1C) and weight measures at baseline that were examined between 2006 and 2012. Overall, 13,942 patients were included (female 54%, mean baseline age 58 year, average A1C 8.7%). Cohort 1 was switched to insulin detemir (DET-S) from insulin glargine or continued on insulin glargine (GLA-C) and Cohort 2 was switched to insulin glargine (GLA-S) from insulin detemir or continued on insulin detemir (DET-S).
At one year follow up, in Cohort 1, compared with GLA-C patients, DET-S patients were significantly less persistent with treatment (52.5% vs 61.4%; P < 0.0001), had a significantly higher A1C (8.5% vs. 8.2%, P < 0.0001), experienced significantly less A1C reduction (-0.24% vs. -0.46%, P<0.0001) and a significantly lower proportion of patients achieved A1C <7% (21.0% vs. 26.1%, P<0.0001) and A1C <8% (45.7% vs. 53.2%, P<0.0001) despite a significantly higher proportion of DET-S patients using rapid acting insulin (57.7% vs. 52.5%, P<0.0001); there were no significant differences in hypoglycemia rate (DET-S: 2.1% vs. GLA-C: 2.1%, P=0.8894) or weight gain (DET-S: -0.35 lbs. vs. GLA-C: 0.21 lbs., P=0.3480) between the groups.
In contrast, at one year follow up, in Cohort 2, compared with DET-C patients, GLA-S patients had a significantly lower A1C (GLA-S: 8.1% vs. DET-C: 8.3%, P=0.0213) and a similar A1C reduction (GLA-S: -0.6% vs. DET-C: -0.5%, P=0.0703); the proportions of patients achieving A1C <7% (GLA-S: 25.1% vs. DET-C: 23.6%, P=0.3929), A1C <8% (GLA-S: 54.8% vs. DET-C: 51.3%, P=0.0794), and hypoglycemia rates (GLA-S: 2.3% vs. DET-C: 1.7%, P=0.2314) were similar between groups; GLA-S patients had significantly greater weight gain than DET-C (GLA-S: 3.2 lbs. vs. DET-C: 0.07 lbs., P<0.001).
"Sanofi is committed to helping the 26 million people in the U.S. who are living with diabetes through our portfolio of innovative, integrated and personalized offerings," said Andrew Purcell, Vice President, Head of U.S. Diabetes Patient Centered Unit, Sanofi US. "This study reinforces the importance of evaluating potential patient outcomes when there might be a change in therapy."
Clinical data also needs to be considered when making treatment decisions as there are some limitations to real world outcomes data.
Abstract: Therapeutically Exchangeable? A Real-World Outcome Study of Switching Between Basal Insulin Analogs Among T2DM Patients (Levin et al.) [Abstract No. 915-P, Poster Presentation on Saturday, June 14, 11:30 a.m. to 1:30 p.m. PDT].
About Lantus (insulin glargine [rDNA origin] injection)
Prescription Lantus is a long-acting insulin used to treat adults with type 2 diabetes and adults and patients (6 years and older) with type 1 diabetes for the control of high blood sugar. It should be taken once a day at the same time each day to lower blood glucose.
Do not use Lantus to treat diabetic ketoacidosis.
Important Safety Information for Lantus (insulin glargine [rDNA origin] injection)
Do not take Lantus if you are allergic to insulin or any of the inactive ingredients in Lantus.
You must test your blood sugar levels while using insulin, such as Lantus. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made cautiously and only under medical supervision.
Do NOT dilute or mix Lantus with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. Lantus must only be used if the solution is clear and colorless with no particles visible. Do not share needles, insulin pens or syringes with others.
Tell your doctor about other medicines, especially ones called TZDs (thiazolidinediones), and supplements you are taking because they can change the way insulin works. Before starting Lantus, tell your doctor about all your medical conditions including if you have heart failure or other heart problems, liver or kidney problems, are pregnant or planning to become pregnant, or are breast-feeding or planning to breast-feed. If you have heart failure, it may get worse while you take TZDs with Lantus.
The most common side effect of insulin, including Lantus, is low blood sugar (hypoglycemia), which may be serious. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and blurred vision. Severe hypoglycemia may be serious and life threatening. It may cause harm to your heart or brain. Other possible side effects may include swelling, weight gain, injection site reactions, including changes in fat tissue at the injection site, and allergic reactions, including itching and rash. In rare cases, some allergic reactions may be life threatening.
Please see the accompanying full prescribing information or visit http://products.sanofi.us/lantus/lantus.html.
About Sanofi Diabetes
Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insights that come from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services, and devices including blood glucose monitoring systems. Sanofi markets both injectable and oral medications for people with type 1 or type 2 diabetes.
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi is the holding company of a consolidated group of subsidiaries and operates in the United States as Sanofi US, also referred to as sanofi-aventis U.S. LLC. For more information on Sanofi US, please visit http://www.sanofi.us or call 1-800-981-2491.
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
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