Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients (GetGoal Duo-2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01768559
First received: January 11, 2013
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

Primary Objective:

- To compare lixisenatide versus insulin glulisine in terms of HbA1c reduction and body weight change at week 26 in type 2 diabetic patients not adequately controlled on insulin glargine ± metformin.

Secondary Objectives:

- To compare the treatments/regimens on:

  • The percentage of patients reaching the target of HbA1c <7% or ≤6.5%
  • Body weight
  • Self-Monitored Glucose profiles
  • Fasting Plasma Glucose (FPG)
  • Post-prandial plasma glucose /glucose excursions during a standardized meal test (subset of patients)
  • Daily doses of insulins
  • Safety and tolerability

Condition Intervention Phase
Type 2 Diabetes
Drug: lixisenatide (AVE0010)
Drug: insulin glulisine (HMR1964)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine With or Without Metformin

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline in HbA1c [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients reaching HbA1c <7% [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Percentage of patients reaching HbA1c ≤6.5% [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Change in body weight from baseline [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Percentage of patients with no weight gain [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Change in 7-point SMPG profiles from baseline [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in FPG [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in post-prandial glucose /glucose excursions during a standardized meal test (subset of patients) [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in insulin glargine dose [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Daily dose of insulin glulisine [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Total daily dose of insulin [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Documented (PG <60 mg/dl) symptomatic hypoglycemia (percentage of subjects with at least one episode, number of events per patient-year) [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • Severe hypoglycemia [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 855
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lixisenatide
lixisenatide once a day (injected before breakfast or dinner) on top of insulin glargine with or without metformin. Starting dose will be 10µg, then increased to the 20µg maintenance dose after 2 weeks
Drug: lixisenatide (AVE0010)

Pharmaceutical form:solution for injection (disposable self injector)

Route of administration: subcutaneous injection

Active Comparator: insulin glulisine once a day
Insulin glulisine once a day (injected before breakfast or dinner) on top of insulin glargine with or without metformin. Treatment will be initiated and then individually titrated
Drug: insulin glulisine (HMR1964)

Pharmaceutical form:solution for injection (disposable self injector)

Route of administration: subcutaneous injection

Other Name: Apidra©
Active Comparator: insulin glulisine three times a day
Insulin glulisine three times a day (injected before breakfast, lunch and dinner) on top of insulin glargine with or without metformin. Treatment will be initiated and then individually titrated
Drug: insulin glulisine (HMR1964)

Pharmaceutical form:solution for injection (disposable self injector)

Route of administration: subcutaneous injection

Other Name: Apidra©

Detailed Description:

Approximately 41 weeks including a 26 week treatment period

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Patients with type 2 diabetes mellitus diagnosed at least 1 year before screening visit (V1) .
  • Patients treated with basal insulin for at least 6 months.
  • Patients treated for at least 3 months prior to visit 1 with a stable basal insulin regimen (ie type of insulin and time/frequency of the injection). The insulin dose should be stable (± 20 %) and ≥20 U/day for at least 2 months prior to visit 1.
  • Patients treated with basal insulin alone or in combination with 1 to 3 oral anti-diabetic drugs (OADs) that can be: metformin (≥1.5g/day or maximal tolerated dose), a sulfonylurea (SU), a dipeptidyl-peptidase-4 (DPP-4) inhibitor, a glinide. The dose of OADs should be stable for at least 3 months prior to visit 1.

Exclusion criteria:

  • At screening: age < legal age of majority
  • At screening, HbA1c: < 7.5% and > 10.0% for patients treated with basal insulin alone or in combination with metformin only; < 7.0% and > 10.0% for patients treated with basal insulin and a combination of oral anti-diabetic drugs which includes a SU and/or a DPP-4 inhibitor and/or a glinide.
  • Women of childbearing potential with no effective contraceptive method, pregnancy or lactation
  • Type 1 diabetes mellitus
  • Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 3 months prior to screening.
  • Previous treatment with short or rapid acting insulin other than in relation to hospitalization or an acute illness.
  • Any previous treatment with lixisenatide, or any discontinuation from another GLP-1 receptor agonist due to safety/tolerability issue or lack of efficacy.
  • At screening, Body Mass Index (BMI) ≤20 or >40 kg/m².
  • Weight change of more than 5 kg during the 3 months prior to the screening visit; use of weight loss drugs within 3 months prior to screening.
  • Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures.
  • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.
  • At screening resting systolic blood pressure > 180 mmHg or diastolic blood pressure > 95 mmHg
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes)
  • Contraindication related to metformin (for patient receiving this treatment), insulin glargine, insulin glulisine or lixisenatide.
  • Patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease.
  • At screening, amylase and/or lipase > 3 times the upper limit of the normal laboratory range (ULN)
  • At screening ALT or AST>3ULN
  • At screening calcitonin ≥20 pg/ml (5.9 pmol/L)

Exclusion Criteria for randomization at the end of the screening period before randomization:

  • HbA1c <7.0% or >9.0%.
  • 7-day mean fasting SMPG >140 mg/dl (7.8 mmol/L).
  • Amylase and/or lipase > 3 times ULN.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768559

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Locations
United States, Arizona
Investigational Site Number 840043
Sun City, Arizona, United States, 85351
Investigational Site Number 840042
Tempe, Arizona, United States, 85282
United States, Arkansas
Investigational Site Number 840003
Little Rock, Arkansas, United States, 72205
United States, California
Investigational Site Number 840031
La Mesa, California, United States, 91942
Investigational Site Number 840005
Mission Viejo, California, United States, 92691
Investigational Site Number 840057
Northridge, California, United States, 91325
Investigational Site Number 840035
Santa Ana, California, United States, 92704
Investigational Site Number 840002
Temecula, California, United States, 92591
Investigational Site Number 840037
Walnut Creek, California, United States, 94598
Investigational Site Number 840023
West Hills, California, United States, 91345
United States, Colorado
Investigational Site Number 840041
Denver, Colorado, United States, 80246
United States, Florida
Investigational Site Number 840012
Miami, Florida, United States, 33136
Investigational Site Number 840061
Miami, Florida, United States, 33142
United States, Georgia
Investigational Site Number 840045
Lawrenceville, Georgia, United States, 30045
United States, Idaho
Investigational Site Number 840036
Nampa, Idaho, United States, 83686
United States, Illinois
Investigational Site Number 840024
Chicago, Illinois, United States, 60611
Investigational Site Number 840009
Evanston, Illinois, United States, 60201
United States, Indiana
Investigational Site Number 840004
Avon, Indiana, United States, 46123
Investigational Site Number 840055
Avon, Indiana, United States, 46123
United States, Iowa
Investigational Site Number 840027
Des Moines, Iowa, United States, 50314
United States, Kansas
Investigational Site Number 840006
Wichita, Kansas, United States, 67203
United States, Kentucky
Investigational Site Number 840047
Lexington, Kentucky, United States, 40504
Investigational Site Number 840056
Paducah, Kentucky, United States, 42003
United States, Louisiana
Investigational Site Number 840022
Marrero, Louisiana, United States, 70072
United States, Maryland
Investigational Site Number 840016
Baltimore, Maryland, United States, 21237
Investigational Site Number 840017
Rockville, Maryland, United States, 20852
United States, Michigan
Investigational Site Number 840025
Buckley, Michigan, United States, 49620
Investigational Site Number 840048
Dearborn, Michigan, United States, 48124
Investigational Site Number 840026
Kalamazoo, Michigan, United States, 49048
United States, Nevada
Investigational Site Number 840049
Las Vegas, Nevada, United States, 89148
United States, New York
Investigational Site Number 840029
New Hyde Park, New York, United States, 11042
Investigational Site Number 840060
Smithtown, New York, United States, 11787
Investigational Site Number 840030
Staten Island, New York, United States, 10301-3914
United States, North Carolina
Investigational Site Number 840011
Salisbury, North Carolina, United States, 28144
United States, North Dakota
Investigational Site Number 840028
Fargo, North Dakota, United States, 58103
United States, Oklahoma
Investigational Site Number 840007
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Investigational Site Number 840021
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Investigational Site Number 840052
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Investigational Site Number 840032
Chattanooga, Tennessee, United States, 37404
Investigational Site Number 840033
Nashville, Tennessee, United States, 37232
United States, Texas
Investigational Site Number 840034
Corpus Christi, Texas, United States, 78404
Investigational Site Number 840001
Dallas, Texas, United States, 75230
Investigational Site Number 840020
Houston, Texas, United States, 77081
United States, Virginia
Investigational Site Number 840018
Norfolk, Virginia, United States, 23502
Investigational Site Number 840015
Salem, Virginia, United States, 24153
United States, Wisconsin
Investigational Site Number 840010
Milwaukee, Wisconsin, United States, 53217
Canada
Investigational Site Number 124008
Brampton, Canada, L6R 3J5
Investigational Site Number 124015
Burlington, Canada, L7M 4Y1
Investigational Site Number 124018
Chatham, Canada, N7L 1C1
Investigational Site Number 124004
Coquitlam, Canada, V3K 3P4
Investigational Site Number 124016
Etobicoke, Canada, M9R 4E1
Investigational Site Number 124014
Hamilton, Canada, L8L 5G8
Investigational Site Number 124011
Montreal, Canada, H3A 1A1
Investigational Site Number 124020
Montreal, Canada, H1Y 3L1
Investigational Site Number 124017
Newmarket, Canada, L3Y 5G8
Investigational Site Number 124021
Quebec, Canada, G1N 4V3
Investigational Site Number 124003
Red Deer, Canada, T4N 6V7
Investigational Site Number 124002
Sherbrooke, Canada, J1H 5N4
Investigational Site Number 124012
St-Romuald, Canada, G6W 5M6
Investigational Site Number 124001
Toronto, Canada, M4G 3E8
Investigational Site Number 124010
Toronto, Canada, M5C 2T2
Investigational Site Number 124005
Vancouver, Canada, V5Z 1M9
Investigational Site Number 124006
Victoria, Canada, V8V 4A1
Investigational Site Number 124007
Winnipeg, Canada, R3E 3P4
Chile
Investigational Site Number 152102
Santiago, Chile, 7980378
Investigational Site Number 152101
Santiago, Chile, 7500710
Investigational Site Number 152105
Santiago, Chile, 7591047
Investigational Site Number 152103
Santiago, Chile, 7500010
Investigational Site Number 152107
Santiago, Chile, 7500347
Investigational Site Number 152109
Santiago, Chile
Investigational Site Number 152108
Santiago, Chile, 8053095
Investigational Site Number 152106
Santiago, Chile, 8053095
Czech Republic
Investigational Site Number 203107
Beroun, Czech Republic, 26601
Investigational Site Number 203103
Jilove U Prahy, Czech Republic, 254 01
Investigational Site Number 203101
Ostrava 2, Czech Republic, 702 00
Investigational Site Number 203110
Police Nad Metuji, Czech Republic, 549 54
Investigational Site Number 203105
Praha 4, Czech Republic, 14021
Investigational Site Number 203102
Praha 4, Czech Republic, 148 00
Investigational Site Number 203108
Praha 4, Czech Republic, 14900
Investigational Site Number 203104
Trutnov, Czech Republic, 54101
Estonia
Investigational Site Number 233102
Pärnu, Estonia, 80018
Investigational Site Number 233103
Tallinn, Estonia, 13415
Investigational Site Number 233104
Tallinn, Estonia, 13419
Investigational Site Number 233101
Viljandimaa, Estonia, 71024
France
Investigational Site Number 250108
Bois Guillaume, France, 76230
Investigational Site Number 250107
Brest, France, 29100
Investigational Site Number 250105
Corbeil Essonnes, France, 91108
Investigational Site Number 250104
La Rochelle Cedex, France, 17019
Investigational Site Number 250106
Lyon, France, 69495
Investigational Site Number 250109
Mantes La Jolie, France, 78200
Investigational Site Number 250102
Paris Cedex 15, France, 75908
Investigational Site Number 250101
Vandoeuvre Les Nancy, France, 54511
Investigational Site Number 250103
Venissieux, France, 69200
Germany
Investigational Site Number 276112
Bad Mergentheim, Germany, 97980
Investigational Site Number 276108
Berlin, Germany, 13125
Investigational Site Number 276102
Dortmund, Germany, 44137
Investigational Site Number 276106
Dresden, Germany, 01307
Investigational Site Number 276120
Dresden, Germany, 01067
Investigational Site Number 276117
Frankfurt A.M., Germany, 60596
Investigational Site Number 276116
Görlitz, Germany, 02826
Investigational Site Number 276113
Heidelberg, Germany, 69115
Investigational Site Number 276118
Leipzig, Germany, 04103
Investigational Site Number 276119
Magdeburg, Germany, 39104
Investigational Site Number 276103
Neumünster, Germany, 24534
Investigational Site Number 276115
Speyer, Germany, 67346
Investigational Site Number 276109
St. Ingbert-Oberwürzbach, Germany, 66386
Hungary
Investigational Site Number 348108
Budapest, Hungary, 1138
Investigational Site Number 348107
Budapest, Hungary, 1134
Investigational Site Number 348102
Budapest, Hungary, 1139
Investigational Site Number 348101
Eger, Hungary, 3300
Investigational Site Number 348103
Pápa, Hungary, 8500
Investigational Site Number 348104
Szeged, Hungary, 6720
Investigational Site Number 348106
Sátoraljaújhely, Hungary, 3980
Investigational Site Number 348105
Zalaegerszeg, Hungary, 8900
Italy
Investigational Site Number 380103
Bologna, Italy, 40138
Investigational Site Number 380102
Catania, Italy, 93124
Investigational Site Number 380101
Milano, Italy, 20132
Investigational Site Number 380105
Napoli, Italy, 80131
Investigational Site Number 380104
Torino, Italy, 10126
Latvia
Investigational Site Number 428103
Jelgava, Latvia, LV-3001
Investigational Site Number 428104
Ogre, Latvia, LV-5001
Investigational Site Number 428102
Riga, Latvia, LV-1002
Investigational Site Number 428105
Riga, Latvia, LV-1006
Investigational Site Number 428101
Sigulda, Latvia, LV-2150
Lithuania
Investigational Site Number 440104
Jonava, Lithuania, LT-55201
Investigational Site Number 440103
Kaunas, Lithuania, LT-48259
Investigational Site Number 440101
Kaunas, Lithuania, LT-51270
Investigational Site Number 440102
Kaunas, Lithuania, LT-49456
Investigational Site Number 440105
Klaipeda, Lithuania, LT-92288
Mexico
Investigational Site Number 484108
Chihuahua, Mexico, 31200
Investigational Site Number 484101
Cuernavaca, Mexico, 62250
Investigational Site Number 484111
Durango, Mexico, 34080
Investigational Site Number 484107
Guadalajara, Mexico, 44600
Investigational Site Number 484104
Guadalajara, Mexico, 44150
Investigational Site Number 484105
Guadalajara, Mexico, 44650
Investigational Site Number 484110
Guadalajara, Mexico, 44656
Investigational Site Number 484109
Guadalajara, Mexico, 44210
Investigational Site Number 484103
Mexico Df, Mexico, 11850
Investigational Site Number 484106
Monterrey, Mexico, 64000
Investigational Site Number 484102
México, Mexico, 06700
Poland
Investigational Site Number 616101
Bialystok, Poland, 15-435
Investigational Site Number 616103
Bydgoszcz, Poland, 85-822
Investigational Site Number 616102
Bytom, Poland, 41-902
Investigational Site Number 616106
Krakow, Poland, 31-455
Investigational Site Number 616104
Krakow, Poland, 31-548
Investigational Site Number 616105
Pulawy, Poland, 24-100
Investigational Site Number 616107
Warszawa, Poland, 02-507
Romania
Investigational Site Number 642105
Bacau, Romania, 600114
Investigational Site Number 642108
Cluj Napoca, Romania, 400006
Investigational Site Number 642106
Deva, Romania, 330084
Investigational Site Number 642113
Galati, Romania, 800098
Investigational Site Number 642107
Hunedoara, Romania, 331057
Investigational Site Number 642117
Iasi, Romania, 700547
Investigational Site Number 642104
Oradea, Romania, 410169
Investigational Site Number 642103
Oradea, Romania, 410169
Investigational Site Number 642112
Pitesti, Romania, 110084
Investigational Site Number 642114
Ploiesti, Romania, 100342
Investigational Site Number 642102
Resita, Romania, 320076
Investigational Site Number 642111
Sibiu, Romania, 550371
Investigational Site Number 642110
Targu Mures, Romania, 540142
Investigational Site Number 642109
Targu Mures, Romania, 540142
Investigational Site Number 642101
Timisoara, Romania, 300456
Investigational Site Number 642116
Timisoara, Romania, 300133
Investigational Site Number 642115
Timisoara, Romania, 300723
Russian Federation
Investigational Site Number 643107
Moscow, Russian Federation, 119991
Investigational Site Number 643105
Moscow, Russian Federation, 129110
Investigational Site Number 643111
Moscow, Russian Federation, 117036
Investigational Site Number 643110
Penza, Russian Federation, 440026
Investigational Site Number 643102
Saratov, Russian Federation, 410026
Investigational Site Number 643109
St-Petersburg, Russian Federation, 194354
Investigational Site Number 643104
St-Petersburg, Russian Federation, 194354
Investigational Site Number 643103
St-Petersburg, Russian Federation, 195257
Investigational Site Number 643101
St-Petersburg, Russian Federation, 194044
Investigational Site Number 643108
St-Petersburg, Russian Federation, 195112
Investigational Site Number 643106
St. Petersburg, Russian Federation, 194358
Spain
Investigational Site Number 724102
El Ferrol, Spain, 15403
Investigational Site Number 724105
La Coruña, Spain, 15006
Investigational Site Number 724103
Malaga, Spain, 29010
Investigational Site Number 724104
Sevilla, Spain, 41010
Ukraine
Investigational Site Number 804104
Chernivtsi, Ukraine, 58022
Investigational Site Number 804103
Donetsk, Ukraine, 83059
Investigational Site Number 804107
Donetsk, Ukraine
Investigational Site Number 804108
Mykolaiv, Ukraine, 54003
Investigational Site Number 804110
Odessa, Ukraine, 65059
Investigational Site Number 804105
Vinnytsya, Ukraine, 21001
Investigational Site Number 804102
Vinnytsya, Ukraine, 21010
Investigational Site Number 804111
Zaporozhie, Ukraine, 69600
United Kingdom
Investigational Site Number 826006
Ashton-Under-Lyne, United Kingdom, OL6 9RW
Investigational Site Number 826002
Birmingham, United Kingdom, B9 5SS
Investigational Site Number 826007
Carmarthen, United Kingdom, SA31 2AF
Investigational Site Number 826005
Chester, United Kingdom, CH2 1UL
Investigational Site Number 826008
Coventry, United Kingdom, CV1 4FH
Investigational Site Number 826009
Dundee, United Kingdom, DD1 9SI
Investigational Site Number 826001
Durham, United Kingdom, DH1 5TW
Investigational Site Number 826011
Haddington, United Kingdom, EH41 3PF
Investigational Site Number 826012
Leicester, United Kingdom, LE5 4PW
Investigational Site Number 826010
Plymouth, United Kingdom, PL6 8BX
Investigational Site Number 826004
Sheffield, United Kingdom, S5 7AU
Investigational Site Number 826003
St Helens, United Kingdom, WA93DA
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01768559     History of Changes
Other Study ID Numbers: EFC12626, 2012-004096-38, U1111-1131-4936
Study First Received: January 11, 2013
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Glargine
Insulin glulisine
Insulin
Metformin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014