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

NCT02320721 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1014

Last updated 2020-04-21

Study results available
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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

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Colombia
  • France
  • Germany
  • Hungary
  • Italy
  • Japan
  • Mexico
  • Peru
  • Poland
  • Romania
  • South Korea
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02320721 on ClinicalTrials.gov