NCT01499095|CompletedPhase 3Results

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy

EDITION II

6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period

Sanofi ClinicalTrials.gov

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3 other identifiers

EFC116292010-023770-39U1111-1118-6943

Study Type

interventional

Target

811

Locations

13 countries

Sites

213

Timeline

RegisteredDec 2011

StartedDec 2011

CompletionNov 2013

Brief Summary

Primary Objective:

To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus Secondary Objective:
To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal hypoglycemia

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

811

participants targeted

Target at P75+ for phase_3 type-2-diabetes-mellitus

Timeline

Completed

Started Dec 2011

Typical duration for phase_3 type-2-diabetes-mellitus

Geographic Reach

13 countries

213 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.9 years study duration

Study Start

First participant enrolled

December 1, 2011

Completed

15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2011

Completed

10 days until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed

1.5 years until next milestone

Results Posted

Study results publicly available

April 23, 2015

Completed

Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

1.3 years

First QC Date

December 16, 2011

Results QC Date

March 24, 2015

Last Update Submit

March 15, 2022

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

Change in HbA1c From Baseline to Month 6 Endpoint
Only measurements performed before initiation of rescue therapy were considered in the analysis.
Baseline, Month 6

Secondary Outcomes (10)

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 Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint
Baseline, Month 6
+5 more secondary outcomes

Other Outcomes (1)

Change in HbA1c From Month 6 to Month 9
Month 6 up to Month 9

Study Arms (2)

HOE901-U300

EXPERIMENTAL

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

Lantus

ACTIVE COMPARATOR

Drug: Lantus (Insulin glargine)

Interventions

Lantus (Insulin glargine)DRUG

Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).

Also known as: Lantus

Lantus

HOE901-U300 (new formulation of insulin glargine)DRUG

HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s). Dose titration seeking fasting plasma glucose 4.4 - 5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter \[mg/dL\]). After 6 months participants were proposed to participate to the administration substudy and to receive either HOE901-U300 once daily at intervals of 24 +/- 3 hours (adaptable dosing intervals) or to continue once daily injections of HOE901-U300 every 24 hours (fixed dosing intervals) up to Month 9.

HOE901-U300

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participants with type 2 diabetes mellitus
Completion of the 6-month study period in main study (Visit 10)
Randomized and treated with insulin glargine new formulation during the 6- month treatment period (Baseline - Month 6)

You may not qualify if:

Age less than (\<) 18 years
HbA1c \<7.0% or greater than (\>) 10% at screening
Diabetes other than type 2 diabetes mellitus
Less than 6 months on basal insulin treatment together with oral antihyperglycemic drug(s) and self-monitoring of blood glucose
Participants using sulfonylurea in the last 2 months before screening visit
Any contraindication to use of insulin glargine as defined in the national product label
Use of insulin pump in the last 6 months before screening
Initiation of new glucose-lowering medications in the last 3 months before screening visit
History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period
Pregnant or breast-feeding women or women who intend to become pregnant during the study period
Participant not willing to use the adaptable injection intervals on at least two days per week
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Sanofilead

Study Sites (213)

Investigational Site Number 840517

Birmingham, Alabama, 35213, United States

Location

Investigational Site Number 840149

Chandler, Arizona, 85224, United States

Location

Investigational Site Number 840093

Glendale, Arizona, 85306, United States

Location

Investigational Site Number 840069

Phoenix, Arizona, 85028, United States

Location

Investigational Site Number 840110

Sun City, Arizona, 85351, United States

Location

Investigational Site Number 840068

Tempe, Arizona, 85282, United States

Location

Investigational Site Number 840015

Hot Springs, Arkansas, 71913, United States

Location

Investigational Site Number 840014

Little Rock, Arkansas, 72205, United States

Location

Investigational Site Number 840114

Little Rock, Arkansas, 72205, United States

Location

Investigational Site Number 840018

Mountain Home, Arkansas, 72653, United States

Location

Investigational Site Number 840027

Searcy, Arkansas, 72143, United States

Location

Investigational Site Number 840074

Anaheim, California, 92801, United States

Location

Investigational Site Number 840509

Bell Gardens, California, 90201, United States

Location

Investigational Site Number 840060

Greenbrae, California, 94904, United States

Location

Investigational Site Number 840057

La Jolla, California, 92037, United States

Location

Investigational Site Number 840003

La Mesa, California, 91942, United States

Location

Investigational Site Number 840026

Los Angeles, California, 90073, United States

Location

Investigational Site Number 840090

Mission Hills, California, 91345, United States

Location

Investigational Site Number 840099

Palm Springs, California, 92262, United States

Location

Investigational Site Number 840004

San Diego, California, 92161, United States

Location

Investigational Site Number 840124

Santa Barbara, California, 93110, United States

Location

Investigational Site Number 840012

Tustin, California, 92780, United States

Location

Investigational Site Number 840104

Colorado Springs, Colorado, 80906, United States

Location

Investigational Site Number 840128

Colorado Springs, Colorado, 80909, United States

Location

Investigational Site Number 840098

Denver, Colorado, 80206, United States

Location

Investigational Site Number 840518

Brandon, Florida, 33511, United States

Location

Investigational Site Number 840049

Daytona Beach, Florida, 32117, United States

Location

Investigational Site Number 840008

Jacksonville, Florida, 32258, United States

Location

Investigational Site Number 840520

Miami, Florida, 33015, United States

Location

Investigational Site Number 840025

New Port Richey, Florida, 34652, United States

Location

Investigational Site Number 840011

Ocoee, Florida, 34761, United States

Location

Investigational Site Number 840141

Palm Harbor, Florida, 34684, United States

Location

Investigational Site Number 840513

Pembroke Pines, Florida, 33029, United States

Location

Investigational Site Number 840528

Columbus, Georgia, 31901, United States

Location

Investigational Site Number 840050

Idaho Falls, Idaho, 83404, United States

Location

Investigational Site Number 840107

Nampa, Idaho, 83686, United States

Location

Investigational Site Number 840199

Chicago, Illinois, 60612, United States

Location

Investigational Site Number 840021

McHenry, Illinois, 60050, United States

Location

Investigational Site Number 840020

Springfield, Illinois, 62704, United States

Location

Investigational Site Number 840045