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6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both Plus Mealtime Insulin in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period
Primary Objective: * To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with type 2 diabetes mellitus Secondary Objectives: * To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal Hypoglycemia
The maximum study duration was up to approximately 58 weeks per participant, consisting of: * up to 2 week screening period * 6-month comparative efficacy and safety treatment period * 6-month comparative safety extension period * 4-week safety follow-up period in a subset of participants * a 3-month administration substudy period starting after completion of the 6-month study period for participants willing to in a subset of participants randomized to HOE901-U300
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Investigational Site Number 840156
Chandler, Arizona, United States
Investigational Site Number 840102
Glendale, Arizona, United States
Investigational Site Number 840071
Phoenix, Arizona, United States
Investigational Site Number 840121
Sun City, Arizona, United States
Investigational Site Number 840070
Tempe, Arizona, United States
Investigational Site Number 840016
Hot Springs, Arkansas, United States
Investigational Site Number 840015
Little Rock, Arkansas, United States
Investigational Site Number 840124
Little Rock, Arkansas, United States
Investigational Site Number 840032
Searcy, Arkansas, United States
Investigational Site Number 840076
Anaheim, California, United States
Start Date
December 1, 2011
Primary Completion Date
January 1, 2013
Completion Date
September 1, 2013
Last Updated
March 25, 2022
807
ACTUAL participants
HOE901-U300 (new formulation of insulin glargine)
DRUG
Lantus (insulin glargine)
DRUG
Lead Sponsor
Sanofi
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04943861