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Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure

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

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Insulin glargine (Drug); Liraglutide (Drug); Metformin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

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

Summary

Primary objective: To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of patients reaching a Glycosylated Haemoglobin (HbA1c) < 7% at the end of the comparative period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents Secondary objectives of the comparative period (24 weeks): >To assess the effect of insulin glargine in comparison with liraglutide on:

- HbA1c level

- Percentage of patients whose HbA1c has decreased but remains >= 7% at the end of the

comparative period

- Percentage of patients whose HbA1c has increased at the end of the comparative period

- Fasting Plasma Glucose (FPG)

- 7-point Plasma Glucose (PG) profiles

- Hypoglycemia occurrence

- Body weight

- Adverse events

Objectives of the extension period (24 weeks): >To assess the effect of insulin glargine in patients not adequately controlled with liraglutide on:

- HbA1c level

- FPG

- 7-point PG profiles

- Hypoglycemia occurrence

- Body weight

- Adverse events

Clinical Details

Official title: A 24-week, Multicenter, International, Randomized (1:1), Parallel-group, Open-label, Comparative Study of Insulin Glargine Versus Liraglutide in Insulin-nave Patients With Type 2 Diabetes Treated With Oral Agents and Not Adequately Controlled, Followed by a 24-week Extension Period With Insulin Glargine for Patients Not Adequately Controlled With Liraglutide

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

Primary outcome: Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Comparative Period

Secondary outcome:

Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Decreased But Remains ≥7% at the End of the Comparative Period

Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Increased at the End of the Comparative Period

Glycosylated Haemoglobin (HbA1c): Change From Baseline to the End of Comparative Period

Glycosylated Haemoglobin (HbA1c): Change From Beginning to the End of the Extension Period

Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Extension Period

Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Baseline to the End of the Comparative Period

Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Beginning to the End of the Extension Period

Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Baseline to the End of the Comparative Period

Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Beginning to the End of the Extension Period

Body Weight: Change From Baseline to the End of the Comparative Period

Body Weight: Change From Beginning to End of the Extension Period

Daily Dose of Insulin Glargine

Daily Dose of Liraglutide

Daily Dose of Insulin Glargine Administered During the Extension Period

Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Comparative Period

Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Extension Period

Detailed description: Maximum estimated study duration per patient: either 27 weeks (patients randomized to insulin glargine arm) or 51 weeks (patients randomized to liraglutide arm) broken down as follow:

- A 2-week of screening period,

- A 24-week comparative period,

- A 24-week extension period (only for patients treated with liraglutide, not adequately

controlled at the end of the comparative period),

- A 1-week follow-up period

Eligibility

Minimum age: 35 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion criteria (comparative period):

- Patients With Type 2 Diabetes diagnosed for at least 1 year,

- Treated with lifestyle interventions and metformin at the maximum tolerated dosage

(with a minimum daily dosage of 1g), either alone or in combination with an oral insulin secretagogue (sulfonylurea, glinide or DiPeptidyl Peptidase IV inhibitor), for more than 3 months,

- 7. 5% < HbA1c <= 12%,

- Body Mass Index (BMI) between 25 and 40 kg/m2 inclusively,

- Ability and willingness to perform PG (Plasma Glucose) self monitoring using the

sponsor-provided glucose meter and to complete the patient diary,

- Willingness and ability to comply with the study protocol,

- Signed informed consent obtained prior to any study procedure.

Inclusion criteria (extension period):

- Patients treated with liraglutide (at the maximal tolerated dosage), having a mean

FPG ≥ 250 mg/dL at visit 10 (Week 12) or visit 11 (Week 18), or a HbA1c≥ 7% at visit 12 (Week 24)

- Dosage of metformin compliant with the inclusion criteria of visit 1 (i. e. maximum

tolerated dosage, with a minimum daily dosage of 1g), and maintained stable during the comparative period. Exclusion criteria:

- Previous treatment with Glucagon Like Peptide-1 analogues or insulin in the past year

(except in case of temporary treatment for gestational diabetes, surgery, hospitalization...),

- Treatment with thiazolidinediones or α-Glucosidases inhibitors within 3 months prior

to study entry,

- Diabetes other than Type 2 diabetes (e. g. secondary to pancreatic disorders, drug or

chemical agents intake),

- Pregnant women (women of childbearing potential must have a negative pregnancy test

at study entry and a medically approved contraceptive method),

- Lactating women,

- Hospitalized patients (except hospitalization for routine diabetes check-up),

- Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy

occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by a retina examination within 2 years prior to study entry,

- Impaired renal function (creatinine clearance < 60 mL/mn),

- Impaired hepatic function (Alanine Aminotransferase, Aspartate Aminotransferase 2. 5

times the upper limit of normal range),

- Personal or family history of medullary thyroid carcinoma,

- Multiple endocrine neoplasia syndrome type 2,

- Severe gastro-intestinal disease (including inflammatory bowel disease or diabetic

gastroparesis),

- Congestive heart failure,

- History of acute pancreatitis,

- Treatment with corticosteroids with potential systemic action for more than 10 days

within 3 months prior to study entry,

- Alcohol or drug abuse in the past 5 years,

- History of sensitivity to the study drugs or to drugs with a similar chemical

structure.

- Night shift worker,

- Presence of any condition (medical, psychological, social or geographical), current

or anticipated that would compromise the patients safety or limit the patient successful participation in the study,

- Participation in a clinical trial (drug or device) within 3 months prior to study

entry,

- Refusal or inability to give informed consent to participate in the study,

- Patient is the Investigator or any sub-Investigator, research assistant, pharmacist,

study coordinator, other staff or relative thereof directly involved in the conduct of the protocol. Additional exclusion criteria for the extension period:

- Treatment with oral antidiabetic drugs other than metformin and patient's usual

sulfonylurea if any, or with insulin during the comparative period (except in case of an emergency, for a period of time less than 7 days),

- Treatment with corticosteroids with potential systemic action within the last 3

months of the comparative period.

- History of sensitivity to insulin glargine.

Locations and Contacts

Investigational Site Number 040-006, Salzburg 5010, Austria

Investigational Site Number 040-007, Salzburg 5020, Austria

Investigational Site Number 040-003, Stockerau A-2000, Austria

Investigational Site Number 040-001, Vienna A-1130, Austria

Investigational Site Number 040-002, Vienna A-1090, Austria

Investigational Site Number 040-004, Vienna A-1220, Austria

Investigational Site Number 040-005, Vienna A-1010, Austria

Investigational Site Number 076-004, Belém 66073-000, Brazil

Investigational Site Number 076-001, Fortaleza 60115-282, Brazil

Investigational Site Number 076-006, Fortaleza 60430-370, Brazil

Investigational Site Number 076-007, Fortaleza 60015-052, Brazil

Investigational Site Number 076-005, Marília 17519-101, Brazil

Investigational Site Number 076-002, São Paulo 01244-030, Brazil

Investigational Site Number 124-003, Mississauga L5M2V8, Canada

Investigational Site Number 124-001, Montreal H2W1T8, Canada

Investigational Site Number 124-006, Montreal H3A1A1, Canada

Investigational Site Number 124-004, Toronto M5C 2T2, Canada

Investigational Site Number 124-008, Vancouver V5Z1M9, Canada

Investigational Site Number 124-007, Victoria V8R1J8, Canada

Investigational Site Number 203001, Hradec Kralove 50005, Czech Republic

Investigational Site Number 203003, Krnov 79401, Czech Republic

Investigational Site Number 203005, Kromeriz 76701, Czech Republic

Investigational Site Number 203002, Olomouc 77900, Czech Republic

Investigational Site Number 203006, Praha 5 15000, Czech Republic

Investigational Site Number 246003, Harjavalta 29200, Finland

Investigational Site Number 246001, Kuopio 70210, Finland

Investigational Site Number 246002, Oulu 90100, Finland

Investigational Site Number 246004, Turku 20100, Finland

Investigational Site Number 250-007, Annecy 74000, France

Investigational Site Number 250-017, Bois Guillaume Cedex 76233, France

Investigational Site Number 250-003, Boulogne Billancourt 92100, France

Investigational Site Number 250-011, Brest 29000, France

Investigational Site Number 250-008, Cahors Cedex 9 46005, France

Investigational Site Number 250-012, Corbeil Essonnes 91100, France

Investigational Site Number 250-009, La Rochelle Cedex 1 17019, France

Investigational Site Number 250-004, Le Creusot 71200, France

Investigational Site Number 250-006, Mantes La Jolie 78200, France

Investigational Site Number 250-021, Nanterre 92014, France

Investigational Site Number 250-020, Strasbourg 67091, France

Investigational Site Number 250022, Strasbourg 67000, France

Investigational Site Number 250-002, Toulouse 31300, France

Investigational Site Number 250-016, Venissieux 69200, France

Investigational Site Number 300003, Athens, Greece

Investigational Site Number 300004, Athens, Greece

Investigational Site Number 300001, Haidari, Athens 12462, Greece

Investigational Site Number 372001, Dublin 4, Ireland

Investigational Site Number 376004, Hadera, Israel

Investigational Site Number 376002, Petah Tiqwa 49361, Israel

Investigational Site Number 376003, Tel-Aviv, Israel

Investigational Site Number 484004, Guadalajara 44630, Mexico

Investigational Site Number 484001, Mexico 07760, Mexico

Investigational Site Number 484002, Mexico 14000, Mexico

Investigational Site Number 484003, Zapopan 45200, Mexico

Investigational Site Number 528001, Beek 6191JW, Netherlands

Investigational Site Number 528006, Enschede 7523JJ, Netherlands

Investigational Site Number 528002, Hoogeveen 7909AA, Netherlands

Investigational Site Number 528007, Nijverdal 7442LS, Netherlands

Investigational Site Number 528003, Rotterdam, Netherlands

Investigational Site Number 528004, s-Hertogenbosch, Netherlands

Investigational Site Number 528005, Woerden, Netherlands

Investigational Site Number 643-009, Kazan, Russian Federation

Investigational Site Number 643008, Kirov 610014K, Russian Federation

Investigational Site Number 643001, Moscow 117036, Russian Federation

Investigational Site Number 643006, Samara, Russian Federation

Investigational Site Number 643007, Samara, Russian Federation

Investigational Site Number 643005, Saratov, Russian Federation

Investigational Site Number 643004, St-Petersburg 195257, Russian Federation

Investigational Site Number 643003, St-Ptetersburg 194354, Russian Federation

Investigational Site Number 703002, Bratislava 81102, Slovakia

Investigational Site Number 703004, Kosice 04013, Slovakia

Investigational Site Number 703001, Nitra 94911, Slovakia

Investigational Site Number 703005, Nove Mesto nad Vahom 091501, Slovakia

Investigational Site Number 703003, Zilina 01001, Slovakia

Investigational Site Number 724007, Bilbao 48013, Spain

Investigational Site Number 724006, Cádiz 11009, Spain

Investigational Site Number 724001, Las Palmas de Gran Canaria 35020, Spain

Investigational Site Number 724005, LLeida, Spain

Investigational Site Number 724008, Madrid 28040, Spain

Investigational Site Number 724003, Málaga 29010, Spain

Investigational Site Number 724009, Sabadell 08208, Spain

Investigational Site Number 721002, Valencia 46014, Spain

Investigational Site Number 724004, Valencia 46015, Spain

Investigational Site Number 724010, Vigo 36211, Spain

Investigational Site Number 752-002, Göteborg 41665, Sweden

Investigational Site Number 752-005, Karlskoga 69181, Sweden

Investigational Site Number 752-006, Motala 59185, Sweden

Investigational Site Number 752-001, Stockholm 17176, Sweden

Investigational Site Number 752-03, Ängelholm 26281, Sweden

Investigational Site Number 752-007, Örebro 70235, Sweden

Investigational Site Number 792-001, Antalya 07070, Turkey

Investigational Site Number 792-002, Istanbul 34890, Turkey

Investigational Site Number 840023, Birmingham, Alabama 35294, United States

Investigational Site Number 840002, Goodyear, Arizona 85395, United States

Investigational Site Number 840047, Phoenix, Arizona 85020, United States

Investigational Site Number 840017, La Jolla, California 92037, United States

Investigational Site Number 840036, La Mesa, California 91942, United States

Investigational Site Number 840037, Loma Linda, California 92357, United States

Investigational Site Number 840045, Long Beach, California 90822, United States

Investigational Site Number 840048, Mission Hills, California 91345, United States

Investigational Site Number 840033, Mission Viejo, California 92691, United States

Investigational Site Number 840019, Palm Springs, California 92262, United States

Investigational Site Number 840039, San Diego, California 92101, United States

Investigational Site Number 840042, San Diego, California 92161, United States

Investigational Site Number 840043, Tustin, California 92780, United States

Investigational Site Number 840028, Denver, Colorado 80220, United States

Investigational Site Number 840034, Grand Junction, Colorado 81501, United States

Investigational Site Number 840026, Longmont, Colorado 80501, United States

Investigational Site Number 840022, Lawrenceville, Georgia, United States

Investigational Site Number 840029, Roswell, Georgia 30076, United States

Investigational Site Number 840009, Arlington Heights, Illinois 60004, United States

Investigational Site Number 840051, Springfield, Illinois 62704, United States

Investigational Site Number 840050, Indianapolis, Indiana 46222, United States

Investigational Site Number 840031, Kansas City, Kansas 66160, United States

Investigational Site Number 840004, Paducah, Kentucky 42003, United States

Investigational Site Number 840010, Rockville, Maryland 20850, United States

Investigational Site Number 840038, Eagan, Minnesota 55122, United States

Investigational Site Number 840030, Minneapolis, Minnesota 55414, United States

Investigational Site Number 840012, St Louis, Missouri 63128, United States

Investigational Site Number 840044, St. Louis, Missouri 63141, United States

Investigational Site Number 840015, Atco, New Jersey 08004, United States

Investigational Site Number 840008, Blackwood, New Jersey 08012, United States

Investigational Site Number 840027, Mineola, New York 11501, United States

Investigational Site Number 840011, Staten Island, New York 10301-3914, United States

Investigational Site Number 840005, Hickory, North Carolina 28601, United States

Investigational Site Number 840052, Winston-Salem, North Carolina 27103, United States

Investigational Site Number 840049, Fargo, North Dakota 58103, United States

Investigational Site Number 840006, Bryan, Ohio 43506, United States

Investigational Site Number 840035, Cincinnati, Ohio 45220, United States

Investigational Site Number 840016, Carnegie, Pennsylvania 15106, United States

Investigational Site Number 840020, Uniontown, Pennsylvania 15401, United States

Investigational Site Number 840024, Rapid City, South Dakota 57701, United States

Investigational Site Number 840001, Dallas, Texas 75230, United States

Investigational Site Number 840007, Dallas, Texas 75246, United States

Investigational Site Number 840013, Houston, Texas 77030, United States

Investigational Site Number 840014, Renton, Washington 98057, United States

Investigational Site Number 840046, Spokane, Washington 99220-3649, United States

Additional Information

Starting date: July 2010
Last updated: March 5, 2014

Page last updated: August 23, 2015

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