NCT02320721

Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications

A Randomized, Open-label, 2-arm Parallel-group, Multicenter, 26-week Study Assessing the Safety and Efficacy of H0E901-U300 Versus Lantus in Older Patients With Type 2 Diabetes Inadequately Controlled on Antidiabetic Regimens Either Including no Insulin, or With Basal Insulin as Their Only Insulin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,014 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c). Secondary Objectives: To demonstrate the superiority of H0E901-U300 in comparison with Lantus in: * Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event from 22:00 to 08:59 next morning * Percentage of participants with at least one nocturnal (from 00:00-05:59) severe and/or confirmed (≤70mg/dL \[3.9mmol/L\]) hypoglycemia event * Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event occurring at any time of day * HbA1c change

Detailed description

The study consisted of a 4-week screening period, a 26-week treatment period comparing HOE901-U300 to Lantus, and a 2-day safety follow-up period.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Insulin Glargine (HOE901 - U300)	Self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 90 to 130 mg/dL (5.0 to 7.2 mmol/L).
DRUG	Insulin Glargine (HOE901 - U100)	Self-administered by SC injection in the evening using a pre-filled pen. Dose titration to achieve fasting SMPG from 90 to 130 mg/dL (5.0 to 7.2 mmol/L).
DRUG	Background therapy	Non-insulin anti-diabetic drugs with the exception of thiazolidinediones.

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2014-12-19
• Last updated: 2020-04-21
• Results posted: 2017-07-11

Locations

162 sites across 18 countries: United States, Argentina, Australia, Canada, Colombia, France, Germany, Hungary, Italy, Japan, Mexico, Peru, Poland, Romania, South Korea, Spain, Sweden, United Kingdom