At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 59 enrolled
Drug / intervention
HOE901-U300 (new formulation of insulin glargine) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 16-week, Randomized, Open-label, Controlled Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine Versus Lantus in Patients With Type 1 Diabetes Mellitus
In Brief
A Phase 2 clinical trial evaluating HOE901-U300 (new formulation of insulin glargine) and Lantus (insulin glargine) for Type 1 Diabetes Mellitus. Completed, enrolled 59 participants across 3 sites.
Detailed Summary
Primary Objective: * To compare the glucose control during treatment with a new formulation of insulin glargine and Lantus in adult participants with type 1 diabetes mellitus Secondary Objectives: * To compare a new formulation of insulin glargine and Lantus given in the morning or in the evening * To compare the incidence and frequency of hypoglycemic episodes * To assess the safety and tolerability of the new formulation of insulin glargine
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2012
First PostedAug 2012
Primary CompletionMay 2013
TodayJul 2026
First PostedAug 7, 2012
Enrollment StartAug 1, 2012
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 13.9 years ago
Interventions
HOE901-U300 (new formulation of insulin glargine)drug
Lantus (insulin glargine)drug