24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine

NCT00975286 | Completed Phase 3 Results DMC

• 2 other identifiers: EFC10781EudraCT : 2008-007335-40
• Study Type: interventional
• Target: 446
• Locations: 26 countries
• Sites: 140

Brief Summary

The purpose of the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment. The primary objective is to assess the effects of lixisenatide in comparison to placebo, when added to insulin glargine and metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on the percentage of patients reaching HbA1c less than (\<) 7 percent (%) and less than or equal to (\<=) 6.5%, plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability (including anti-lixisenatide antibody assessment), and to assess the impact on treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the participating countries where it is validated.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

  Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

  Baseline, Week 24

Secondary Outcomes (10)

• Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24

  Baseline, Week 24

• Change From Baseline in Glucose Excursion at Week 24

  Baseline, Week 24

• Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile at Week 24

  Baseline, Week 24

• Change From Baseline in Body Weight at Week 24

  Baseline, Week 24

• Change From Baseline in Average Insulin Glargine Daily Dose at Week 24

  Baseline, Week 24

Other Outcomes (2)

• Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24

  Baseline, Week 24

• Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia

  First dose of study drug up to 3 days after the last dose administration

Study Arms (2)

Lixisenatide

EXPERIMENTAL

2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.

Drug: Lixisenatide (AVE0010); Drug: Insulin glargine; Device: Pen auto-injector; Drug: Metformin; Drug: Thiazolidinedione (TZD)

Placebo

PLACEBO COMPARATOR

2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.

Drug: Placebo; Drug: Insulin glargine; Device: Pen auto-injector; Drug: Metformin; Drug: Thiazolidinedione (TZD)

Interventions

Lixisenatide (AVE0010) DRUG

Self administered by subcutaneous injections once daily within the hour preceding breakfast.

Lixisenatide

Placebo DRUG

Self administered by subcutaneous injections once daily within the hour preceding breakfast.

Placebo

Insulin glargine DRUG

Dose to be adjusted to maintain a fasting SMPG between 100 and 80 mg/dL (5.6 and 4.4 mmol/L), inclusive.

Also known as: Lantus®

Lixisenatide; Placebo

Pen auto-injector DEVICE

Lantus® SoloStar® OptiClik®

Lixisenatide; Placebo

Metformin DRUG

Metformin to be continued at stable dose (at least 1.5 gram per day) up to Week 24.

Lixisenatide; Placebo

Thiazolidinedione (TZD) DRUG

TZD (either rosiglitazone or pioglitazone) if given, to be continued at stable dose up to Week 24.

Lixisenatide; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit, insufficiently controlled with insulin glargine and metformin

You may not qualify if:

• HbA1c \<7% or greater than (\>)10% at screening
• At the time of screening age \< legal age of majority
• Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method
• Type 1 diabetes mellitus
• Metformin not at a stable dose of at least 1.5 gram per day for at least 3 months prior to the screening visit
• Use of oral or injectable antidiabetic or hypoglycemic agents other than metformin, sulfonylurea (SU) and TZDs (for example, alpha glucosidase inhibitor, other glucagon like peptide-1 \[GLP-1\] receptor agonists, dipeptidyl peptidase-IV \[DPP-IV\] inhibitors, insulin etc.) within 3 months prior to the time of screening, use of weight loss drugs if not at a stable dose for at least 3 months prior to the screening visit
• History of hypoglycemia unawareness
• Body Mass Index (BMI) less than or equal to (\<=) 20 kilogram per square meter (kg/m\^2)
• History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease, personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (for example, multiple endocrine neoplasia syndromes)
• History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
• Hemoglobinopathy or hemolytic anemia, blood or plasma products transfusion within 3 months prior to the time of screening
• Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization
• Known history of drug or alcohol abuse within 6 months prior to the time of screening
• Any clinically significant abnormality identified on physical examination, laboratory tests, electrocardiogram or vital signs at the time of screening that in the judgment of the Investigator or any sub investigator precludes safe completion of the study or constrains efficacy assessment such as active malignant tumor or other major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema likely to require laser treatment within the study period
• Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic or diastolic blood pressure \>180 millimeter of mercury (mmHg) or \>110 mmHg, respectively

Sponsors & Collaborators

• Sanofi: lead

Study Sites (140)

Sanofi-Aventis Investigational Site Number 840223

Mesa, Arizona, 85206, United States

Location

Sanofi-Aventis Investigational Site Number 840206

Hot Springs, Arkansas, 71913, United States

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Sanofi-Aventis Investigational Site Number 840201

Little Rock, Arkansas, 72205, United States

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Sanofi-Aventis Investigational Site Number 840212

Mountain Home, Arkansas, 72653, United States

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Sanofi-Aventis Investigational Site Number 840215

Concord, California, 94520, United States

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Sanofi-Aventis Investigational Site Number 840214

Greenbrae, California, 94904, United States

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Sanofi-Aventis Investigational Site Number 840221

Orlando, Florida, 32835, United States

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Sanofi-Aventis Investigational Site Number 840211

Baton Rouge, Louisiana, 70808, United States

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Sanofi-Aventis Investigational Site Number 840230

Hyattsville, Maryland, 20781, United States

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Sanofi-Aventis Investigational Site Number 840209

Rockville, Maryland, 20852, United States

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Sanofi-Aventis Investigational Site Number 840219

Brighton, Michigan, 48114, United States

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Sanofi-Aventis Investigational Site Number 840231

Sea Girt, New Jersey, 08750, United States

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Sanofi-Aventis Investigational Site Number 840208

Fargo, North Dakota, 58103, United States

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Sanofi-Aventis Investigational Site Number 840225

Mentor, Ohio, 44060, United States

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Sanofi-Aventis Investigational Site Number 840222

Portland, Oregon, 97201-3098, United States

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Sanofi-Aventis Investigational Site Number 840202

Philadelphia, Pennsylvania, 19146, United States

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Sanofi-Aventis Investigational Site Number 840229

Bristol, Tennessee, 37620, United States

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Sanofi-Aventis Investigational Site Number 840205

Germantown, Tennessee, 38138, United States

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Sanofi-Aventis Investigational Site Number 840210

Dallas, Texas, 75230, United States

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Sanofi-Aventis Investigational Site Number 840217

Houston, Texas, 77081, United States

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Sanofi-Aventis Investigational Site Number 840228

Houston, Texas, 77081, United States

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Sanofi-Aventis Investigational Site Number 840213

Plano, Texas, 75093, United States

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Sanofi-Aventis Investigational Site Number 840227

Norfolk, Virginia, 23502, United States

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Sanofi-Aventis Investigational Site Number 032204

Buenos Aires, Argentina

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Sanofi-Aventis Investigational Site Number 032205

Capital Federal, 1012, Argentina

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Sanofi-Aventis Investigational Site Number 032201

Capital Federal, 1425, Argentina

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Sanofi-Aventis Investigational Site Number 032209

Capital Federal, C1056ABJ, Argentina

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Sanofi-Aventis Investigational Site Number 032211

Corrientes, Argentina

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Sanofi-Aventis Investigational Site Number 032202

Paraná, (E3100BBJ), Argentina

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Sanofi-Aventis Investigational Site Number 032203

Rosario, 2000, Argentina

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Sanofi-Aventis Investigational Site Number 076207

Belém, 66073-000, Brazil

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Sanofi-Aventis Investigational Site Number 076202

Brasília, 71625-009, Brazil

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Sanofi-Aventis Investigational Site Number 076205

Porto Alegre, 90035001, Brazil

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Sanofi-Aventis Investigational Site Number 076204

São Paulo, 04024-002, Brazil

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Sanofi-Aventis Investigational Site Number 124219

Brampton, L6R 3J5, Canada

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Sanofi-Aventis Investigational Site Number 124213

Chatham, N7L 1C1, Canada

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Sanofi-Aventis Investigational Site Number 124208

Chilliwack, V2P 4M9, Canada

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Sanofi-Aventis Investigational Site Number 124215

Etobicoke, M9R 4E1, Canada

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Sanofi-Aventis Investigational Site Number 124205

Québec, G1V 4G5, Canada

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Sanofi-Aventis Investigational Site Number 124202

Red Deer, T4N 6V7, Canada

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Sanofi-Aventis Investigational Site Number 124218

Thornhill, L4J 8L7, Canada

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Sanofi-Aventis Investigational Site Number 124201

Toronto, M4R 2G4, Canada

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Sanofi-Aventis Investigational Site Number 124207

Toronto, M9V 4B4, Canada

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Sanofi-Aventis Investigational Site Number 124209

Victoria, V8V 4A1, Canada

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Sanofi-Aventis Investigational Site Number 124217

Winnipeg, R3E 3P4, Canada

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Sanofi-Aventis Investigational Site Number 152202

Santiago, 7500010, Chile

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Sanofi-Aventis Investigational Site Number 152203

Santiago, 7980378, Chile

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Sanofi-Aventis Investigational Site Number 152206

Santiago, 8053095, Chile

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Sanofi-Aventis Investigational Site Number 152204

Santiago, 8360156, Chile

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Sanofi-Aventis Investigational Site Number 152205

Santiago, 8930211, Chile

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Sanofi-Aventis Investigational Site Number 152201

Santiago, Chile

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Sanofi-Aventis Investigational Site Number 170204

Barranquilla, Colombia

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Sanofi-Aventis Investigational Site Number 170201

Bogotá, Colombia

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Sanofi-Aventis Investigational Site Number 170202

Bogotá, Colombia

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Sanofi-Aventis Investigational Site Number 203202

Hradec Králové, 50005, Czechia

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Sanofi-Aventis Investigational Site Number 203204

Prague, 15006, Czechia

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Sanofi-Aventis Investigational Site Number 208202

Frederiksberg, 2000, Denmark

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Sanofi-Aventis Investigational Site Number 208201

København NV, 2400, Denmark

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Sanofi-Aventis Investigational Site Number 208205

Slagelse, 4200, Denmark

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Sanofi-Aventis Investigational Site Number 233201

Pärnu, 80018, Estonia

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Sanofi-Aventis Investigational Site Number 233203

Tallinn, 13415, Estonia

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Sanofi-Aventis Investigational Site Number 233204

Tartu, 50410, Estonia

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Sanofi-Aventis Investigational Site Number 233202

Viljandimaa, 71024, Estonia

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Sanofi-Aventis Investigational Site Number 250204

Amiens, 80054, France

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Sanofi-Aventis Investigational Site Number 250206

La Rochelle, 17019, France

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Sanofi-Aventis Investigational Site Number 250203

Le Creusot, 71200, France

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Sanofi-Aventis Investigational Site Number 250201

Nantes, 44093, France

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Sanofi-Aventis Investigational Site Number 250202

Pierre-Bénite, 69310, France

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Sanofi-Aventis Investigational Site Number 276201

Dresden, 01307, Germany

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Sanofi-Aventis Investigational Site Number 276202

Mainz, 55116, Germany

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Sanofi-Aventis Investigational Site Number 276204

Saint Ingbert-Oberwürzbach, 66386, Germany

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Sanofi-Aventis Investigational Site Number 348205

Balatonfüred, 8230, Hungary

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Sanofi-Aventis Investigational Site Number 348202

Budapest, 1036, Hungary

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Sanofi-Aventis Investigational Site Number 348207

Budapest, Hungary

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Sanofi-Aventis Investigational Site Number 348204

Debrecen, 4031, Hungary

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Sanofi-Aventis Investigational Site Number 348206

Gyula, 5700, Hungary

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Sanofi-Aventis Investigational Site Number 348203

Szeged, 6722, Hungary

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Sanofi-Aventis Investigational Site Number 348201

Zalaegerszeg, 8900, Hungary

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Sanofi-Aventis Investigational Site Number 356210

Ahmedabad, 380015, India

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Sanofi-Aventis Investigational Site Number 356206

Bangalore, 560043, India

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Sanofi-Aventis Investigational Site Number 356204

Bangalore, 560052, India

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Sanofi-Aventis Investigational Site Number 356202

Bangalore, India

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Sanofi-Aventis Investigational Site Number 356201

Belagavi, 590001, India

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Sanofi-Aventis Investigational Site Number 356205

Chennai, 600086, India

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Sanofi-Aventis Investigational Site Number 356208

Indore, 452010, India

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Sanofi-Aventis Investigational Site Number 356203

Karnāl, 132001, India

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Sanofi-Aventis Investigational Site Number 356207

Kochi, India

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Sanofi-Aventis Investigational Site Number 356209

Nagpur, 440012, India

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Sanofi-Aventis Investigational Site Number 376202

Haifa, 31096, Israel

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Sanofi-Aventis Investigational Site Number 376201

Holon, 58100, Israel

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Sanofi-Aventis Investigational Site Number 376204

Kfar Saba, 44281, Israel

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Sanofi-Aventis Investigational Site Number 376203

Tel Litwinsky, 52621, Israel

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Sanofi-Aventis Investigational Site Number 380201

Milan, 20132, Italy

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Sanofi-Aventis Investigational Site Number 380202

Perugia, 61260, Italy

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Sanofi-Aventis Investigational Site Number 458203

Kelantan, 16150, Malaysia

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Sanofi-Aventis Investigational Site Number 458202

Kuala Lumpur, 56000, Malaysia

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Sanofi-Aventis Investigational Site Number 484201

Cuernavaca, 62250, Mexico

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Sanofi-Aventis Investigational Site Number 484204

Durango, 34270, Mexico

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Sanofi-Aventis Investigational Site Number 484203

Guadalajara, 44600, Mexico

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Sanofi-Aventis Investigational Site Number 484206

México, 14050, Mexico

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Sanofi-Aventis Investigational Site Number 484205

Tlalnepantla, 53160, Mexico

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Sanofi-Aventis Investigational Site Number 528203

Amsterdam, 1066 EC, Netherlands

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Sanofi-Aventis Investigational Site Number 528202

Groningen, 9728 NT, Netherlands

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Sanofi-Aventis Investigational Site Number 528204

Zwijndrecht, 3331 LZ, Netherlands

Location

Sanofi-Aventis Investigational Site Number 616202

Krakow, 31-548, Poland

Location

Sanofi-Aventis Investigational Site Number 616208

Lubin, 59-300, Poland

Location

Sanofi-Aventis Investigational Site Number 616207

Puławy, 24-100, Poland

Location

Sanofi-Aventis Investigational Site Number 616206

Płock, 09-400, Poland

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Sanofi-Aventis Investigational Site Number 616205

Sopot, 81-756, Poland

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Sanofi-Aventis Investigational Site Number 616201

Szczecin, 70-506, Poland

Location

Sanofi-Aventis Investigational Site Number 616203

Zabrze, 41-8--, Poland

Location

Sanofi-Aventis Investigational Site Number 840226

Ponce, 00717, Puerto Rico

Location

Sanofi-Aventis Investigational Site Number 840216

San Juan, 00917, Puerto Rico

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Sanofi-Aventis Investigational Site Number 642204

Brasov, 500326, Romania

Location

Sanofi-Aventis Investigational Site Number 642208

Bucharest, 020725, Romania

Location

Sanofi-Aventis Investigational Site Number 642205

Deva, 330084, Romania

Location

Sanofi-Aventis Investigational Site Number 642203

Iași, 700515, Romania

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Sanofi-Aventis Investigational Site Number 642202

Oradea, 410598, Romania

Location

Sanofi-Aventis Investigational Site Number 642206

Târgu Mureş, 540061, Romania

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Sanofi-Aventis Investigational Site Number 642207

Timișoara, 300456, Romania

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Sanofi-Aventis Investigational Site Number 642201

Timișoara, 300593, Romania

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Sanofi-Aventis Investigational Site Number 643202

Saint Petersburg, 194358, Russia

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Sanofi-Aventis Investigational Site Number 643203

Saratov, 410030, Russia

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Sanofi-Aventis Investigational Site Number 710202

Cape Town, 7708, South Africa

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Sanofi-Aventis Investigational Site Number 710201

Durban, 4092, South Africa

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Sanofi-Aventis Investigational Site Number 710203

Pretoria, South Africa

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Sanofi-Aventis Investigational Site Number 752204

Gothenburg, 413 45, Sweden

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Sanofi-Aventis Investigational Site Number 752203

Härnösand, 871 82, Sweden

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Sanofi-Aventis Investigational Site Number 752205

Luleå, 972 33, Sweden

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Sanofi-Aventis Investigational Site Number 752202

Malmo, 211 52, Sweden

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Sanofi-Aventis Investigational Site Number 752201

Stockholm, 111 57, Sweden

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Sanofi-Aventis Investigational Site Number 158204

Changhua, 500, Taiwan

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Sanofi-Aventis Investigational Site Number 158203

Taichung, 433, Taiwan

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Sanofi-Aventis Investigational Site Number 158201

Taichung R.o.c., 407, Taiwan

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Sanofi-Aventis Investigational Site Number 158202

Tainan Hsien, 710, Taiwan

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Sanofi-Aventis Investigational Site Number 804203

Chernivtsi, 58022, Ukraine

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Sanofi-Aventis Investigational Site Number 804201

Kiev, 2091, Ukraine

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Sanofi-Aventis Investigational Site Number 804205

Kyiv, 31156, Ukraine

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Sanofi-Aventis Investigational Site Number 804202

Kyiv, Ukraine

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Sanofi-Aventis Investigational Site Number 804204

Vinnytsia, 21010, Ukraine

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Related Publications (6)

• Riddle MC, Forst T, Aronson R, Sauque-Reyna L, Souhami E, Silvestre L, Ping L, Rosenstock J. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled with newly initiated and continuously titrated basal insulin glargine: a 24-week, randomized, placebo-controlled study (GetGoal-Duo 1). Diabetes Care. 2013 Sep;36(9):2497-503. doi: 10.2337/dc12-2462. Epub 2013 Apr 5.

  PMID: 23564915 RESULT

• Yao J, Zhang M, Zhang X, Zhang J. Impact of Type 2 Diabetes Duration on the Efficacy and Safety of Add-on Lixisenatide in Asian Individuals Receiving Basal Insulin: A Pooled Analysis. Diabetes Ther. 2023 Apr;14(4):653-669. doi: 10.1007/s13300-023-01369-6. Epub 2023 Feb 21.

  PMID: 36809495 DERIVED

• Davidson JA, Stager W, Paranjape S, Berria R, Leiter LA. Achieving postprandial glucose control with lixisenatide improves glycemic control in patients with type 2 diabetes on basal insulin: a post-hoc analysis of pooled data. Clin Diabetes Endocrinol. 2020 Jan 14;6:2. doi: 10.1186/s40842-019-0088-5. eCollection 2020.

  PMID: 31956422 DERIVED

• Rosenstock J, Handelsman Y, Vidal J, Ampudia Blasco FJ, Giorgino F, Liu M, Perfetti R, Meier JJ. Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes. Diabetes Obes Metab. 2018 Dec;20(12):2821-2829. doi: 10.1111/dom.13462. Epub 2018 Aug 13.

  PMID: 29974618 DERIVED

• Charbonnel B, Bertolini M, Tinahones FJ, Domingo MP, Davies M. Lixisenatide plus basal insulin in patients with type 2 diabetes mellitus: a meta-analysis. J Diabetes Complications. 2014 Nov-Dec;28(6):880-6. doi: 10.1016/j.jdiacomp.2014.07.007. Epub 2014 Jul 18.

  PMID: 25130920 DERIVED

• Riddle MC, Aronson R, Home P, Marre M, Niemoeller E, Miossec P, Ping L, Ye J, Rosenstock J. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L). Diabetes Care. 2013 Sep;36(9):2489-96. doi: 10.2337/dc12-2454. Epub 2013 Apr 29.

  PMID: 23628617 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lixisenatide; Insulin Glargine; Metformin; 2,4-thiazolidinedione

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-us@sanofi.com

Study Officials

• Clinical Study Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 11, 2009
• Study Start: October 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 11, 2016
• Results First Posted: October 11, 2016

Record last verified: 2016-08

Locations

ZA (3); IT (2); TW (4); RO (8); SE (5); CO (3); IL (4); AR (7); CA (11); HU (7); DK (3); BR (4); ES (4); FR (5); US (23); MY (2); ME (5); PR (2); RU (2); UA (5); CZ (2); DE (3); CL (6); PL (7); NL (3); IN (10)