- Center on Health Equity & Access
- Clinical
- Health Care Cost
- Health Care Delivery
- Insurance
- Policy
- Technology
- Value-Based Care
Late-Stage Study of Diabetes Combo Meets Primary Endpoint, Sanofi Says
The combination involves long-acting insulin and a GLP-1 receptor agonist.
Sanofi announced today it has met the primary endpoint in a phase 3 clinical trial that evaluated a combination its insulin glargine Lantus, its long-acting product that recently came off patent, and Lyxumia (lixisenatide), a prandial GLP-1 receptor agonist that will be resubmitted to FDA this quarter.
The trial, called LixiLan-O, involved 1170 patients whose type 2 diabetes mellitus (T2DM) was not adequately controlled on metformin alone or on metformin with a second oral anti-diabetic agent.
Study participants received metformin and a fixed-ratio combination of 100 units/mL of insulin glargine (Lantus) plus lixisenatide, versus metformin and lixisenatide, or metformin and 100 units/mL of insulin glargine. T2DM patients took therapy for 30 weeks in a once-daily injection.
Patients taking metformin plus the combination therapy “demonstrated statistically superior reduction” in glycated hemoglobin over the previous 3 months, and the fixed-ratio combination “had a safety profile reflecting those of lixisenatide and insulin glargine 100 units/mL,” according to a statement from Sanofi.
“Meeting the primary objective of this important phase 3 study highlights the potential clinical value of this investigational therapeutic option,” said Elias Zerhouni, MD, president of Global Research and Development at Sanofi. “We look forward to advancing the LixiLan program and bringing this combination of insulin glargine and lixisenatide to patients.”
According to the company’s statement, full results will be presented at a future scientific meeting.
Intensive Blood Pressure Regimen Lowers CVD Risk for People With Diabetes
November 19th 2024Reducing systolic blood pressure to less than 120 mmHg lowered the risk of major cardiovascular events for most people with type 2 diabetes in the Blood Pressure Control Target in Diabetes trial.
Read More
Exploring Pharmaceutical Innovations, Trust, and Access With CVS Health's CMO
July 11th 2024On this episode of Managed Care Cast, we're talking with the chief medical officer of CVS Health about recent pharmaceutical innovations, patient-provider relationships, and strategies to reduce drug costs.
Listen
Contributor: The Diabetes Vendor Resource Guide—A Useful Directory for Employers
November 13th 2024Employees living with diabetes often face unique challenges, such as managing blood sugar levels, balancing medication, and preventing complications, all while maintaining their professional responsibilities. This condition can lead to increased absenteeism, reduced productivity, and rising health care costs.
Read More
How Can Employers Leverage the DPP to Improve Diabetes Rates?
February 15th 2022On this episode of Managed Care Cast, Jill Hutt, vice president of member services at the Greater Philadelphia Business Coalition on Health, explains the Coalition’s efforts to reduce diabetes rates through the Diabetes Prevention Program (DPP).
Listen
