Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus

NCT ID: NCT01683266

Last Updated: 2015-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 549 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-03-31

Brief Summary

Primary Objective:

• To compare the efficacy of a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus

Secondary Objective:

• To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms of:
• Change of HbA1c from baseline to endpoint (scheduled Month 6)
• Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with Type 1 Diabetes Mellitus (T1DM)
• Reaching target HbA1c values and controlled plasma glucose (all and reaching target without hypoglycemia)
• Frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative)
• Safety and tolerability of HOE901-U300 including development of anti-insulin antibody (AIAs) during the 12-month study period

Detailed Description

The maximum study duration was up to approximately 54 weeks per participants:

• Up to 2-week screening period
• 6-month open-label comparative efficacy and safety treatment period
• 6-month open-label comparative safety extension period
• 48-hour post-treatment safety follow-up period

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HOE901-U300

HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter \[mg/dL\]).

Group Type: EXPERIMENTAL

HOE901-U300 (Insulin glargine new formulation)

Intervention Type: DRUG

Lantus

Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).

Group Type: ACTIVE_COMPARATOR

Lantus (Insulin glargine)

Intervention Type: DRUG

Interventions

HOE901-U300 (Insulin glargine new formulation)

Intervention Type: DRUG

Lantus (Insulin glargine)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult participants with type 1 diabetes mellitus

Exclusion Criteria

• HbA1c less than (<) 7.0% (53 mmol/mol) or greater than (>) 10% (86 mmol/mol) at screening
• Less than 1 year on any basal plus mealtime insulin and self-monitoring of blood glucose before screening visit
• Participants not on stable insulin dose (+/-20 percent total basal insulin dose) in the last 30 days prior to screening visit
• Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit
• Use of an insulin pump in the last 6 months before screening visit and no plan to switch to insulin pump in the next 12 months
• Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening;
• Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit
• Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (example laser, surgical treatment or injectable drugs) during the study period

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 840156

Chandler, Arizona, United States

Investigational Site Number 840177

Little Rock, Arkansas, United States

Investigational Site Number 840430

Bell Gardens, California, United States

Investigational Site Number 840131

Escondido, California, United States

Investigational Site Number 840140

Fresno, California, United States

Investigational Site Number 840107

Greenbrae, California, United States

Investigational Site Number 840149

Huntington Beach, California, United States

Investigational Site Number 840120

La Jolla, California, United States

Investigational Site Number 840123

La Mesa, California, United States

Investigational Site Number 840159

La Mesa, California, United States

Investigational Site Number 840114

Long Beach, California, United States

Investigational Site Number 840189

Mission Hills, California, United States

Investigational Site Number 840105

Temecula, California, United States

Investigational Site Number 840155

Tustin, California, United States

Investigational Site Number 840115

Walnut Creek, California, United States

Investigational Site Number 840160

Denver, Colorado, United States

Investigational Site Number 840188

Denver, Colorado, United States

Investigational Site Number 840196

New Haven, Connecticut, United States

Investigational Site Number 840113

Bradenton, Florida, United States

Investigational Site Number 840102

Hialeah, Florida, United States

Investigational Site Number 840134

Hollywood, Florida, United States

Investigational Site Number 840185

Jacksonville, Florida, United States

Investigational Site Number 840116

Jacksonville, Florida, United States

Investigational Site Number 840126

Miami, Florida, United States

Investigational Site Number 840179

Miami, Florida, United States

Investigational Site Number 840117

New Port Richey, Florida, United States

Investigational Site Number 840174

Orlando, Florida, United States

Investigational Site Number 840110

Oviedo, Florida, United States

Investigational Site Number 840178

Palm Harbor, Florida, United States

Investigational Site Number 840181

Tampa, Florida, United States

Investigational Site Number 840420

West Palm Beach, Florida, United States

Investigational Site Number 840195

Atlanta, Georgia, United States

Investigational Site Number 840124

Honolulu, Hawaii, United States

Investigational Site Number 840167

Idaho Falls, Idaho, United States

Investigational Site Number 840163

Nampa, Idaho, United States

Investigational Site Number 840162

Springfield, Illinois, United States

Investigational Site Number 840172

Avon, Indiana, United States

Investigational Site Number 840197

Indianapolis, Indiana, United States

Investigational Site Number 840108

Des Moines, Iowa, United States

Investigational Site Number 840407

Iowa City, Iowa, United States

Investigational Site Number 840170

Topeka, Kansas, United States

Investigational Site Number 840421

Lexington, Kentucky, United States

Investigational Site Number 840426

Metairie, Louisiana, United States

Investigational Site Number 840104

Baltimore, Maryland, United States

Investigational Site Number 840180

Rockville, Maryland, United States

Investigational Site Number 840137

Haverhill, Massachusetts, United States

Investigational Site Number 840408

Detroit, Michigan, United States

Investigational Site Number 840153

Madison Heights, Michigan, United States

Investigational Site Number 840171

Saint Louis Park, Minnesota, United States

Investigational Site Number 840184

St Louis, Missouri, United States

Investigational Site Number 840106

Omaha, Nebraska, United States

Investigational Site Number 840145

Omaha, Nebraska, United States

Investigational Site Number 840139

Las Vegas, Nevada, United States

Investigational Site Number 840151

Albuquerque, New Mexico, United States

Investigational Site Number 840191

New Hyde Park, New York, United States

Investigational Site Number 840173

Syracuse, New York, United States

Investigational Site Number 840133

Asheville, North Carolina, United States

Investigational Site Number 840175

Chapel Hill, North Carolina, United States

Investigational Site Number 840161

Morganton, North Carolina, United States

Investigational Site Number 840169

Mentor, Ohio, United States

Investigational Site Number 840119

Norman, Oklahoma, United States

Investigational Site Number 840112

Bend, Oregon, United States

Investigational Site Number 840136

Greer, South Carolina, United States

Investigational Site Number 840122

Dakota Dunes, South Dakota, United States

Investigational Site Number 840144

Chattanooga, Tennessee, United States

Investigational Site Number 840187

Nashville, Tennessee, United States

Investigational Site Number 840109

Austin, Texas, United States

Investigational Site Number 840157

Austin, Texas, United States

Investigational Site Number 840150

Dallas, Texas, United States

Investigational Site Number 840412

Dallas, Texas, United States

Investigational Site Number 840130

Houston, Texas, United States

Investigational Site Number 840141

Houston, Texas, United States

Investigational Site Number 840166

San Antonio, Texas, United States

Investigational Site Number 840101

Murray, Utah, United States

Investigational Site Number 840125

Burke, Virginia, United States

Investigational Site Number 840427

Chesapeake, Virginia, United States

Investigational Site Number 840103

Manassas, Virginia, United States

Investigational Site Number 840132

Renton, Washington, United States

Investigational Site Number 840403

Seattle, Washington, United States

Investigational Site Number 840402

Spokane, Washington, United States

Investigational Site Number 840127

Tacoma, Washington, United States

Investigational Site Number 840411

Milwaukee, Wisconsin, United States

Investigational Site Number 124110

Coquitlam, , Canada

Investigational Site Number 124104

Laval, , Canada

Investigational Site Number 124108

Mirabel, , Canada

Investigational Site Number 124109

Montreal, , Canada

Investigational Site Number 124105

Thornhill, , Canada

Investigational Site Number 124101

Toronto, , Canada

Investigational Site Number 203102

Brno, , Czechia

Investigational Site Number 203104

Prague, , Czechia

Investigational Site Number 203103

Prague, , Czechia

Investigational Site Number 208102

Aalborg, , Denmark

Investigational Site Number 208103

Esbjerg, , Denmark

Investigational Site Number 208105

Gentofte Municipality, , Denmark

Investigational Site Number 208104

København NV, , Denmark

Investigational Site Number 208107

Køge, , Denmark

Investigational Site Number 233104

Pärnu, , Estonia

Investigational Site Number 233105

Tallinn, , Estonia

Investigational Site Number 233106

Tartu, , Estonia

Investigational Site Number 233101

Tartu, , Estonia

Investigational Site Number 233103

Viljandimaa, , Estonia

Investigational Site Number 246102

Kokkola, , Finland

Investigational Site Number 246101

Kuopio, , Finland

Investigational Site Number 246106

Loimaa, , Finland

Investigational Site Number 246105

Oulu, , Finland

Investigational Site Number 246103

Tampere, , Finland

Investigational Site Number 348103

Budapest, , Hungary

Investigational Site Number 348108

Budapest, , Hungary

Investigational Site Number 348107

Budapest, , Hungary

Investigational Site Number 348106

Debrecen, , Hungary

Investigational Site Number 348102

Gyula, , Hungary

Investigational Site Number 348101

Úrhida, , Hungary

Investigational Site Number 392110

Aisai, , Japan

Investigational Site Number 392105

Ise-Shi, , Japan

Investigational Site Number 392104

Karatsu-Shi, , Japan

Investigational Site Number 392111

Kitakyushu-Shi, , Japan

Investigational Site Number 392108

Matsumoto, , Japan

Investigational Site Number 392112

Matsumoto-Shi, , Japan

Investigational Site Number 392103

Midori, , Japan

Investigational Site Number 392107

Mito, , Japan

Investigational Site Number 392101

Sakaishi, , Japan

Investigational Site Number 392102

Tomishiro, , Japan

Investigational Site Number 392106

Yamagata, , Japan

Investigational Site Number 428106

Limbaži, , Latvia

Investigational Site Number 428103

Riga, , Latvia

Investigational Site Number 428105

Riga, , Latvia

Investigational Site Number 428102

Sigulda, , Latvia

Investigational Site Number 428101

Ventspils, , Latvia

Investigational Site Number 528101

Almere Stad, , Netherlands

Investigational Site Number 528103

Beek, , Netherlands

Investigational Site Number 528105

Nijmegen, , Netherlands

Investigational Site Number 528104

Venlo, , Netherlands

Investigational Site Number 528102

Zwijndrecht, , Netherlands

Investigational Site Number 840602

Ponce, , Puerto Rico

Investigational Site Number 642107

Bacau, , Romania

Investigational Site Number 642103

Brasov, , Romania

Investigational Site Number 642109

Oradea, , Romania

Investigational Site Number 642106

Reşiţa, , Romania

Investigational Site Number 642104

Sibiu, , Romania

Investigational Site Number 642101

Târgu Mureş, , Romania

Investigational Site Number 642102

Târgu Mureş, , Romania

Investigational Site Number 642105

Timișoara, , Romania

Investigational Site Number 642108

Timișoara, , Romania

Investigational Site Number 752103

Gothenburg, , Sweden

Investigational Site Number 752105

Kristianstad, , Sweden

Investigational Site Number 752101

Stockholm, , Sweden

Investigational Site Number 752104

Vällingby, , Sweden

Countries

United States; Canada; Czechia; Denmark; Estonia; Finland; Hungary; Japan; Latvia; Netherlands; Puerto Rico; Romania; Sweden

References

Home PD, Bergenstal RM, Bolli GB, Ziemen M, Rojeski M, Espinasse M, Riddle MC. Glycaemic control and hypoglycaemia during 12 months of randomized treatment with insulin glargine 300 U/mL versus glargine 100 U/mL in people with type 1 diabetes (EDITION 4). Diabetes Obes Metab. 2018 Jan;20(1):121-128. doi: 10.1111/dom.13048. Epub 2017 Aug 8.

Reference Type: DERIVED

PMID: 28661585 (View on PubMed)

Other Identifiers

2012-001524-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1128-5517

Identifier Type: OTHER

Identifier Source: secondary_id

EFC12456

Identifier Type: -

Identifier Source: org_study_id