PARIS, April 2, 2017 /PRNewswire/ -- Sanofi announced today the presentation of a new observational study1 in real-world clinical practice demonstrating significantly lower risk of hypoglycemia without compromising blood sugar control in patients with type 2 diabetes (T2D) using basal insulin who switched to Toujeo® (insulin glargine 300 Units/mL) when compared to other basal insulins. The results of the study were presented at the Endocrine Society 2017 Annual Meeting (ENDO 2017) in Orlando, FL, U.S.
A previous real-world observational study2 (DELIVER 1) assessed the change in HbA1c (average blood sugar levels) and occurrence of hypoglycemia in 881 patients, based on electronic medical records up to six months after switching to Toujeo from another basal insulin. This new observational study (DELIVER 2) analyzed electronic medical records for 1,894 patients in two matched cohorts. The comparative study assessed the HbA1c change, occurrence of hypoglycemia (identified by ICD-9-CM/ICD-10-CM and/or plasma glucose level ≤ 70 mg/dL) and hypoglycemic events related to inpatient or emergency department (ED) visits with Toujeo versus other basal insulins (insulin glargine 100 Units/mL, insulin detemir and insulin degludec).
In the DELIVER 2 study, after six months, patients who switched to Toujeo experienced 33 percent fewer hypoglycemic events (event rate per 100 patients-months: 7.98 vs 5.32, respectively; p<0.01) versus those who switched to other basal insulins, without compromising blood sugar control. In addition, patients who switched to Toujeo showed a 48 percent reduction in hypoglycemic events related to inpatient or ED encounters (event rate: 3.82 of patients vs 1.97, respectively; p<0.01) versus other basal insulins.
"These results increase the body of evidence on the use of Toujeo in people with type 2 diabetes from observational studies. While randomized clinical trials provide the highest level of evidence, comparative data from real-world observational studies can be relevant for payors and other organizations evaluating how findings from clinical trials can translate into routine clinical practice," said Riccardo Perfetti, Head of Global Diabetes Medical Team, Sanofi. "Sanofi is committed to going beyond traditional models to conduct further studies to assess Toujeo, combining the broad populations, and type of interaction between healthcare professionals and patients seen in routine care with the rigorous methodology of clinical trials. The randomized Real Life Study program will provide further evidence that directly reflects Toujeo's performance in standard clinical practice."
Complementing these observational studies in routine clinical practice and the EDITION program of Phase 3 clinical trials, Sanofi is conducting a program, unique in diabetes, of three randomized, prospective real-life clinical studies with Toujeo. These studies, called ACHIEVE CONTROL, REACH CONTROL and REGAIN CONTROL, involve more than 4,500 people with type 2 diabetes across the U.S. and Europe who are starting basal insulin treatment or switching from another basal insulin. In addition to clinical measures, the studies will also collect patient feedback on treatment satisfaction and their experience of hypoglycemia, along with impact on healthcare resource utilization. Initial results are anticipated later in 2017.
DELIVER 2 Real-World Setting Study Methodology & Population
The DELIVER 2 retrospective observational study used data from the Predictive Health Intelligence Environment (PHIE) database of U.S. real-world electronic medical records (representing 26 integrated health delivery networks). Included patients were adults with type 2 diabetes using basal insulin, with data for 12 months prior to (baseline) and 6 months after (follow-up) switching to either Toujeo or other basal insulins. The study used a matched cohort model, based on baseline demographics and clinical characteristics, and analyzed outcomes for 947 patients who switched to Toujeo alongside 947 who switched to other basal insulins (insulin glargine 100 Units/mL, insulin detemir or insulin degludec). Outcome assessments included reduction in HbA1c from baseline, HbA1c goal attainment (<7.0% and <8.0%) and incidence and event rate of hypoglycemia (identified by ICD-9-CM/ICD-10-CM and/or plasma glucose level ≤ 70 mg/dL).
These findings represent actual prescribing patterns and clinical outcomes outside the confines of a clinical trial, which might include drug use outside U.S. Food and Drug Administration (FDA)-approved prescribing information. As a result, reporting of hypoglycemia at baseline and in both treatment arms were not based on self-monitored blood glucose, which could result in less severe events not being reported by patients.
DELIVER 2 Real-World Setting Study Results
- Mean baseline HbA1c was 8.89% in the Toujeo cohort and 8.91% in the other basal insulin cohort, and levels decreased significantly to 8.42% and 8.50%, respectively, during the 6-month follow-up period (p<0.01 for both).
- After six months, patients who switched to Toujeo experienced 33 percent fewer hypoglycemic events (event rate per 100 patient-months: 7.98 vs 5.32, respectively; p<0.01) versus those who switched to other basal insulins (difference: −2.67 events/100 patient-months; P < 0.01).
- A similar trend was observed for hypoglycemia related to inpatient or emergency department (ED) encounters (event rate: 3.82 of patients vs 1.97, respectively; p<0.01).
- Significantly lower hypoglycemia risk was also seen at 3 months of follow-up among patients who switched to Gla-300.
What is Toujeo® (insulin glargine injection) 300 Units/mL?
Prescription Toujeo® is a long-acting insulin used to control blood sugar in adults with diabetes mellitus.
- Toujeo® contains 3 times as much insulin in 1 mL as standard insulin (100 Units/mL).
- Toujeo® is not for use to treat diabetic ketoacidosis.
- Toujeo® should not be used in children.
Important Safety Information for Toujeo® (insulin glargine injection) 300 Units/mL
Do not take Toujeo® if you have low blood sugar or if you are allergic to insulin or any of the ingredients in Toujeo®.
Do NOT reuse needles or share insulin pens even if the needle has been changed.
Before starting Toujeo® tell your doctor about all your medical conditions, including if you have liver or kidney problems, if you are pregnant or planning to become pregnant or if you are breastfeeding or planning to breastfeed.
Heart failure can occur if you are taking insulin together with certain medicines called TZDs (thiazolidinediones), even if you have never had heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Toujeo®. Your treatment with TZDs and Toujeo® may need to be changed or stopped by your doctor if you have new or worsening heart failure. Tell your doctor if you have any new or worsening symptoms of heart failure, including:
- Shortness of breath
- Sudden weight gain
- Swelling of your ankles or feet
Tell your doctor about all the medications you take, including OTC medicines, vitamins, and supplements, including herbal supplements.
Toujeo should be taken at the same time once a day. Test your blood sugar levels daily while using any insulin, including Toujeo®. Do not make changes to your dose or type of insulin without talking to your doctor. Verify you have the correct insulin before each injection. Your dose for Toujeo® may be different from other insulins you have taken. Any change of insulin should be made cautiously and only under medical supervision.
Do NOT dilute or mix Toujeo® with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. Use Toujeo® only if the solution is clear and colorless with no particles visible.
While using Toujeo®, do not drive or operate heavy machinery until you know how Toujeo® affects you. Don't drink alcohol or use other medicines that contain alcohol.
The most common side effects of any insulin, including Toujeo®, is low blood sugar (hypoglycemia), which may be serious and can be life-threatening. Severe hypoglycemia may cause harm to your heart or brain. Symptoms of serious low blood sugar may include shaking, sweating, fast heartbeat, and blurred vision.
Toujeo® may cause serious side effects that can lead to death, such as severe allergic reactions. Get medical help right away if you have:
- A rash over your whole body
- Extreme drowsiness, dizziness, or confusion
- Shortness of breath
- Trouble breathing
- Swelling of your face, tongue, or throat
- Fast heartbeat
Toujeo® may have additional side effects including swelling, weight gain, low potassium, and injection site reactions which may include change in fat tissue, skin thickening, redness, swelling, and itching.
Please see full Prescribing Information for Toujeo® on Toujeo.com or click here http://products.sanofi.us/Toujeo/Toujeo.pdf.
About Sanofi Diabetes & Cardiovascular
Diabetes and cardiovascular disease affect millions of people worldwide, with many managing the complex challenges of both. Building on our portfolio evolution, heritage and expertise, Sanofi has a focused business unit dedicated to delivering innovative, value-based medicines and integrated solutions in these therapeutic areas. We are committed to a collaborative approach that involves strategic alliances with professional and patient associations, research institutions and leaders in healthcare and other industries, with the goal of advancing scientific knowledge, driving the convergence of science and technology, helping to improve outcomes and inspiring an evolution in care.
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
- Zhou FL et al, Lower Risk of Hypoglycemia after Switch to Insulin Glargine 300 U/Ml (Gla-300) Vs Other Basal Insulins in Patients with Type 2 Diabetes (T2D) on Basal Insulin in Real-World Clinical Settings (DELIVER 2 study), Poster presentation LB SUN 81, Endocrine Society 2017 Annual Meeting [ENDO 2017], Orlando, FL, U.S.
- Ye, F et al, Real-World Assessment of Patient Characteristics and Clinical Outcomes of Early Users of the New Insulin Glargine 300U/mL, Poster presentation 943-P, American Diabetes Association 76th Scientific Sessions, New Orleans, LA, U.S. Saturday, June 11, 2016.