Sanofi, a global healthcare leader, announced results from the EDITION JP 1 and EDITION JP 2 extension studies where Japanese participants with type 1 and type 2 diabetes, respectively received Toujeo, insulin glargine, (rDNA origin) injection, 300 U/mL) or Lantus, insulin glargine, (rDNA origin) injection, 100 U/mL treatment for a total of 12 months.

Over this entire study period, Toujeo maintained similar blood sugar control, with fewer people experiencing night-time low blood sugar events (blood sugar levels <= 54 mg/dL in the study with people with type 1 diabetes, and <= 70 mg/dL in the study with people with type 2 people), compared with Lantus. These new results from EDITION JP 1 and 2 were presented at the 75th scientific sessions of the American Diabetes Association.

"The results of the EDITION JP 1 and 2 extension studies reaffirm the clinical benefit that Toujeo can bring to people who are living with uncontrolled diabetes", said Pierre Chancel, senior vice president, head of global diabetes, Sanofi.

"As a new addition to our portfolio, Toujeo gives patients a further option to help them reach their glycemic goals, and demonstrates our commitment to providing innovative therapies to enhance diabetes care."

In Japanese people with uncontrolled type 1 diabetes (EDITION JP 1), confirmed night-time low blood sugar (<=70 mg/dL) event rates and percentage of participants experiencing >=1 event over the 12-month study period were comparable in both groups. However, hypoglycemic event rate at the lower threshold (<54 mg/dL) was 38 per cent lower with Toujeo. Risk reduction of night-time low blood sugar events at this threshold showed that 21 per cent fewer patients experienced night-time low blood sugar events with Toujeo vs. Lantus.

In Japanese people with type 2 diabetes uncontrolled on basal insulin and oral anti-diabetics (EDITION JP 2), incidence of low blood sugar events at night-time (blood sugar levels <= 70 mg/dL) was also reduced (27 per cent fewer patients experiencing >=1 event over 12-month study period). Event rates (per patient-year) of low blood sugar at night-time and any time of the day (over 24 hours) were consistently lower with Toujeo compared with Lantus. Over the 12-month period, people with type 2 diabetes treated with Toujeo and oral medications also saw a slight reduction in body weight, in comparison to those treated with Lantus who saw a slight increase.

"The additional data from the EDITION JP 2 study demonstrate Toujeo's ability to achieve sustainable glycemic control in the Japanese type 2 population," commented Yasuo Terauchi, principal investigator of the EDITION JP 2 study and professor at Yokohama City University School of Medicine, Kanagawa.

"The reduction in episodes of hypoglycemia observed and the additional weight findings demonstrated in EDITION JP 2 mean that Toujeo has the potential to help the people with type 2 diabetes in Japan to start and remain on insulin therapy in order to reach their long-term targets."

The abstracts are titled: Sustained Glycemic Control and Less Nocturnal Hypoglycemia with New Insulin Glargine 300 U/mL compared with Glargine 100 U/mL over 12 month in Japanese people with T1DM l (EDITION JP 1).

New Insulin Glargine 300 U/mL provides Sustained Glycemic Control and Reduced Hypoglycemia over 12 months Compared with Glargine 100 U/mL in Japanese People with T2DM Managed with Basal Insulin plus OAD(s) (EDITION JP 2).

In EDITION JP 1 (n=228), Japanese people with type 1 diabetes that continued to receive treatment for an additional 6 months showed comparable blood sugar level control (reduction in HbA1C and FPG) from baseline between Toujeo and Lantus at 12 months (mean [SD] change -0.20 [0.80] per cent and -14.0 [86.5] mg/dL and (mean [SD] change -0.25 [0.72] per cent and -7.0 [93.2] mg/dL respectively).

The percentages of participants with >=1 severe or confirmed (defined as plasma glucose <=70 mg/dL) night-time low blood sugar event over the 12-month study period were comparable between groups. At the lower <54 mg/dL threshold, a reduction in event rate was observed with Toujeo compared with Lantus during the night (rate ratio 0.62; 95 per cent CI: 0.39 to 0.97). The percentage of participants experiencing >=1 nocturnal event at this threshold was also reduced with Toujeo compared with Lantus (relative risk 0.79; 95 per cent CI: 0.64 to 0.98). Severe hypoglycemia occurred in 12 and 11 participants receiving Toujeo and Lantus respectively. There were similar findings between groups for adverse events.

In EDITION JP 2 (n=222), Japanese people with type 2 diabetes who failed to control their blood sugar levels on previous basal insulin and oral medication, and continued to receive treatment for an additional 6 months, showed similar blood sugar level control (reduction in HbA1C and FPG) from baseline between Toujeo and Lantus at 12 months (mean [SD] change -0.28 [0.84] per cent and -12.1 [56.6] mg/dL, and mean [SD] change -0.33 [0.79] per cent and -18.6 [43.3] mg/dL respectively).

The percentage of participants with >=1 severe or confirmed (defined as plasma glucose <=70 mg/dL) low blood sugar event at night-time over the 12-month treatment period was lower with Toujeo vs. Lantus (relative risk 0.73; 95 per cent CI: 0.55 to 0.97). There were also consistently fewer nocturnal and at any-time (24 hours) confirmed (<=70 mg/dL) or severe hypoglycemic events per patient-year seen with Toujeo compared with Lantus (rate ratio 0.41; 95 per cent CI: 0.18 to 0.92; rate ratio 0.64; 95 per cent CI: 0.44 to 0.94, respectively). Severe hypoglycemia was rare with only 3 and 2 events reported for Toujeo and Lantus respectively.

In addition, the patients treated with Toujeo lost some weight, compared with a slight increase in the Lantus group (-0.7 kg vs. 0.5 kg respectively; NS). There were similar findings between groups for adverse events.

Despite basal insulin being a cornerstone treatment for diabetes for decades, significant unmet medical needs remain a reality, with approximately half of patients on treatment not reaching their blood sugar level targets.3-8 In addition, optimal insulin dose is often not reached during initiation or maintenance phase. Toujeo is a next-generation, once-daily basal insulin based on a broadly-used molecule (insulin glargine) with a well-established benefit-risk profile.

Its compact subcutaneous depot leads to more stable and more prolonged pharmacokinetic/pharmacodynamic (PK/PD) profiles. Toujeo has been approved by the US Food and Drug Administration (FDA), the European Commission and Health Canada, and is under review by other regulatory authorities around the world.