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

Sanofi193 sites in 1 country807 target enrollmentDecember 2011

ConditionsType 2 Diabetes Mellitus

InterventionsHOE901-U300 (new formulation of insulin glargine)Lantus (insulin glargine)

DrugsHOE901-U300 (new formulation of insulin glargine)Lantus (insulin glargine)

Overview

Phase: Phase 3
Intervention: HOE901-U300 (new formulation of insulin glargine)
Conditions: Type 2 Diabetes Mellitus
Sponsor: Sanofi
Enrollment: 807
Locations: 193
Primary Endpoint: Change in HbA1c From Baseline to Month 6 Endpoint
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

September 2013

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

HOE901-U300

Intervention: HOE901-U300 (new formulation of insulin glargine)

Lantus

Intervention: Lantus (insulin glargine)

Outcomes

Primary Outcomes

Change in HbA1c From Baseline to Month 6 Endpoint

Time Frame: Baseline, Month 6

Secondary Outcomes

Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint(Week 9 Up to Month 6)
Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint(Baseline, Month 6)
Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint(Baseline, Month 6)
Percentage of Participants With HbA1c <7% at Month 6 Endpoint(Month 6)
Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint(Baseline, Month 6)
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint(Baseline, Month 6)
Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint(Month 6)
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint(Baseline, Month 6)
Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint(Baseline, Month 6)
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12(Up to Month 12)