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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 1 Diabetes Mellitus

Intervention: HOE901-U300 (Insulin glargine new formulation) (Drug); Lantus (Insulin glargine) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi

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

Clinical Details

Official title: A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected in the Morning or Evening in Patients With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change In HbA1c From Baseline to Month 6 Endpoint

Secondary outcome:

Percentage of Participants With HbA1c <7% at Month 6 Endpoint

Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint

Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint

Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint

Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint

Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6

Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint

Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint

Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint

Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint

Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Investigational Site Number 124110, Coquitlam V3K 3P4, Canada

Investigational Site Number 124104, Laval H7T 2P5, Canada

Investigational Site Number 124108, Mirabel J7J 2K8, Canada

Investigational Site Number 124109, Montreal H1Y 3L1, Canada

Investigational Site Number 124105, Thornhill L4J 8L7, Canada

Investigational Site Number 124101, Toronto M4R 2G4, Canada

Investigational Site Number 203102, Brno 62500, Czech Republic

Investigational Site Number 203104, Praha 10 10034, Czech Republic

Investigational Site Number 203103, Praha 8 18100, Czech Republic

Investigational Site Number 208103, Esbjerg 6700, Denmark

Investigational Site Number 208105, Gentofte 2900, Denmark

Investigational Site Number 208104, København Nv 2400, Denmark

Investigational Site Number 208107, Køge 4600, Denmark

Investigational Site Number 208102, Ă…lborg 9100, Denmark

Investigational Site Number 233104, Pärnu 80018, Estonia

Investigational Site Number 233105, Tallinn 13419, Estonia

Investigational Site Number 233101, Tartu 50410, Estonia

Investigational Site Number 233106, Tartu 50406, Estonia

Investigational Site Number 233103, Viljandimaa 71024, Estonia

Investigational Site Number 246102, Kokkola 67100, Finland

Investigational Site Number 246101, Kuopio 70210, Finland

Investigational Site Number 246106, Loimaa 32200, Finland

Investigational Site Number 246105, Oulu 90100, Finland

Investigational Site Number 246103, Tampere 33100, Finland

Investigational Site Number 348103, Budapest 1036, Hungary

Investigational Site Number 348107, Budapest 1088, Hungary

Investigational Site Number 348108, Budapest 1083, Hungary

Investigational Site Number 348106, Debrecen 4031, Hungary

Investigational Site Number 348102, Gyula 5700, Hungary

Investigational Site Number 348101, Urhida 8142, Hungary

Investigational Site Number 392110, Aisai-Shi, 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 392112, Matsumoto-Shi, Japan

Investigational Site Number 392108, Matumoto, Japan

Investigational Site Number 392103, Midori-Shi, Japan

Investigational Site Number 392107, Mito-Shi, Japan

Investigational Site Number 392101, Sakai-Shi, Japan

Investigational Site Number 392102, Tomishiro, Japan

Investigational Site Number 392106, Yamagata-Shi, Japan

Investigational Site Number 428106, Limbazi LV-4001, Latvia

Investigational Site Number 428103, Riga LV-1002, Latvia

Investigational Site Number 428105, Riga LV-1050, Latvia

Investigational Site Number 428102, Sigulda LV-2150, Latvia

Investigational Site Number 428101, Ventspils LV-3601, Latvia

Investigational Site Number 528101, Almere 1311 RL, Netherlands

Investigational Site Number 528103, Beek 6191 JW, Netherlands

Investigational Site Number 528105, Nijmegen 6525 GA, Netherlands

Investigational Site Number 528104, Venlo 5912 BL, Netherlands

Investigational Site Number 528102, Zwijndrecht 3331 LZ, Netherlands

Investigational Site Number 840602, Ponce 00717, Puerto Rico

Investigational Site Number 642107, Bacau 600164, Romania

Investigational Site Number 642103, Brasov 500365, Romania

Investigational Site Number 642109, Oradea 410169, Romania

Investigational Site Number 642106, Resita 320076, Romania

Investigational Site Number 642104, Sibiu 550371, Romania

Investigational Site Number 642101, Targu Mures 540142, Romania

Investigational Site Number 642102, Targu Mures 540142, Romania

Investigational Site Number 642105, Timisoara 300133, Romania

Investigational Site Number 642108, Timisoara 300456, Romania

Investigational Site Number 752103, Goteborg 41345, Sweden

Investigational Site Number 752105, Kristianstad 29185, Sweden

Investigational Site Number 752101, Stockholm 11526, Sweden

Investigational Site Number 752104, Vällingby 16268, Sweden

Investigational Site Number 840156, Chandler, Arizona 85224, United States

Investigational Site Number 840177, Little Rock, Arkansas 72205, United States

Investigational Site Number 840430, Bell Gardens, California 90201, United States

Investigational Site Number 840131, Escondido, California 92025, United States

Investigational Site Number 840140, Fresno, California 93720, United States

Investigational Site Number 840107, Greenbrae, California 94904, United States

Investigational Site Number 840149, Huntington Beach, California 92648, United States

Investigational Site Number 840120, La Jolla, California 92037, United States

Investigational Site Number 840123, La Mesa, California 91942, United States

Investigational Site Number 840159, La Mesa, California 91942, United States

Investigational Site Number 840114, Long Beach, California 90806, United States

Investigational Site Number 840189, Mission Hills, California 91345, United States

Investigational Site Number 840105, Temecula, California 92591, United States

Investigational Site Number 840155, Tustin, California 92780, United States

Investigational Site Number 840115, Walnut Creek, California 94598, United States

Investigational Site Number 840160, Denver, Colorado 80239, United States

Investigational Site Number 840188, Denver, Colorado 80262, United States

Investigational Site Number 840196, New Haven, Connecticut 06520, United States

Investigational Site Number 840113, Bradenton, Florida 34208, United States

Investigational Site Number 840102, Hialeah, Florida 33012, United States

Investigational Site Number 840134, Hollywood, Florida 33021, United States

Investigational Site Number 840116, Jacksonville, Florida 32258, United States

Investigational Site Number 840185, Jacksonville, Florida 32216, United States

Investigational Site Number 840126, Miami, Florida 33144, United States

Investigational Site Number 840179, Miami, Florida 33176, United States

Investigational Site Number 840117, New Port Richey, Florida 34652, United States

Investigational Site Number 840174, Orlando, Florida 32806, United States

Investigational Site Number 840110, Oviedo, Florida 32765, United States

Investigational Site Number 840178, Palm Harbor, Florida 34684, United States

Investigational Site Number 840181, Tampa, Florida 33613, United States

Investigational Site Number 840420, West Palm Beach, Florida 33401, United States

Investigational Site Number 840195, Atlanta, Georgia 30318, United States

Investigational Site Number 840124, Honolulu, Hawaii 96814, United States

Investigational Site Number 840167, Idaho Falls, Idaho 83404, United States

Investigational Site Number 840163, Nampa, Idaho 83686, United States

Investigational Site Number 840162, Springfield, Illinois 62704, United States

Investigational Site Number 840172, Avon, Indiana 46123, United States

Investigational Site Number 840197, Indianapolis, Indiana 46202, United States

Investigational Site Number 840108, Des Moines, Iowa 50314, United States

Investigational Site Number 840407, Iowa City, Iowa, United States

Investigational Site Number 840170, Topeka, Kansas 66606, United States

Investigational Site Number 840421, Lexington, Kentucky 40503, United States

Investigational Site Number 840426, Metairie, Louisiana 70006, United States

Investigational Site Number 840104, Baltimore, Maryland 21237, United States

Investigational Site Number 840180, Rockville, Maryland 20852, United States

Investigational Site Number 840137, Haverhill, Massachusetts 1830, United States

Investigational Site Number 840408, Detroit, Michigan 48202, United States

Investigational Site Number 840153, Madison Heights, Michigan 48071, United States

Investigational Site Number 840171, St Louis Park, Minnesota 55416, United States

Investigational Site Number 840184, St Louis, Missouri 63110, United States

Investigational Site Number 840106, Omaha, Nebraska 68131, United States

Investigational Site Number 840145, Omaha, Nebraska 68131, United States

Investigational Site Number 840139, Las Vegas, Nevada 89148, United States

Investigational Site Number 840151, Albuquerque, New Mexico 87106, United States

Investigational Site Number 840191, New Hyde Park, New York 11042, United States

Investigational Site Number 840173, Syracuse, New York 13210, United States

Investigational Site Number 840133, Asheville, North Carolina 28803, United States

Investigational Site Number 840175, Chapel Hill, North Carolina 27599-7295, United States

Investigational Site Number 840161, Morganton, North Carolina 28655, United States

Investigational Site Number 840169, Mentor, Ohio 44060, United States

Investigational Site Number 840119, Norman, Oklahoma 73069, United States

Investigational Site Number 840112, Bend, Oregon 97701, United States

Investigational Site Number 840136, Greer, South Carolina 29651, United States

Investigational Site Number 840122, Dakota Dunes, South Dakota 57049, United States

Investigational Site Number 840144, Chattanooga, Tennessee 37404, United States

Investigational Site Number 840187, Nashville, Tennessee 37232, United States

Investigational Site Number 840109, Austin, Texas 78731, United States

Investigational Site Number 840157, Austin, Texas 78731, United States

Investigational Site Number 840150, Dallas, Texas 75230, United States

Investigational Site Number 840412, Dallas, Texas 75231, United States

Investigational Site Number 840130, Houston, Texas 77030, United States

Investigational Site Number 840141, Houston, Texas 77095, United States

Investigational Site Number 840166, San Antonio, Texas 78229, United States

Investigational Site Number 840101, Murray, Utah 84123, United States

Investigational Site Number 840125, Burke, Virginia 22015, United States

Investigational Site Number 840427, Chesapeake, Virginia 23321, United States

Investigational Site Number 840103, Manassas, Virginia 20110, United States

Investigational Site Number 840132, Renton, Washington 98055, United States

Investigational Site Number 840403, Seattle, Washington 98195, United States

Investigational Site Number 840402, Spokane, Washington 99220, United States

Investigational Site Number 840127, Tacoma, Washington 98415-0299, United States

Investigational Site Number 840411, Milwaukee, Wisconsin 53209-0996, United States

Additional Information

Starting date: September 2012
Last updated: May 28, 2015

Page last updated: August 23, 2015

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