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24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine (GetGoal-Duo1)

18. august 2016 opdateret af: Sanofi

A Randomized, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Double-blind Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine and Metformin

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The study comprises 3 periods:

  • An up to 14-week screening period, which includes an up to 2-week screening phase and a 12-week run-in phase with introduction and titration of insulin glargine on top of metformin +/-TZDs.
  • At the end of the run-in phase, patients whose HbA1c (centralized assay) is greater than or equal to (>=) 7% and less than or equal to (<=) 9% and whose mean fasting self-monitored plasma glucose (SMPG) calculated from the self measurements for the 7 days prior to Visit 12 (Week -1) is <=140 milligram per deciliter (mg/dL) (7.8 millimole per liter [mmol/L]), would enter a 24-week double-blind randomized treatment period comparing lixisenatide to placebo (on top of insulin glargine + metformin +/- TZDs).
  • A 3-day safety follow up period.

Maximum duration is of 39 weeks +/- 7 days.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

446

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina
        • Sanofi-Aventis Investigational Site Number 032204
      • Capital Federal, Argentina, 1012
        • Sanofi-Aventis Investigational Site Number 032205
      • Capital Federal, Argentina, 1425
        • Sanofi-Aventis Investigational Site Number 032201
      • Capital Federal, Argentina, C1056ABJ
        • Sanofi-Aventis Investigational Site Number 032209
      • Corrientes, Argentina
        • Sanofi-Aventis Investigational Site Number 032211
      • Parana, Argentina, (E3100BBJ)
        • Sanofi-Aventis Investigational Site Number 032202
      • Rosario, Argentina, 2000
        • Sanofi-Aventis Investigational Site Number 032203
  • Brasilien
      • Belem, Brasilien, 66073-000
        • Sanofi-Aventis Investigational Site Number 076207
      • Brasilia, Brasilien, 71625-009
        • Sanofi-Aventis Investigational Site Number 076202
      • Porto Alegre, Brasilien, 90035001
        • Sanofi-Aventis Investigational Site Number 076205
      • Sao Paulo, Brasilien, 04024-002
        • Sanofi-Aventis Investigational Site Number 076204
  • Canada
      • Brampton, Canada, L6R 3J5
        • Sanofi-Aventis Investigational Site Number 124219
      • Chatham, Canada, N7L 1C1
        • Sanofi-Aventis Investigational Site Number 124213
      • Chilliwack, Canada, V2P 4M9
        • Sanofi-Aventis Investigational Site Number 124208
      • Etobicoke, Canada, M9R 4E1
        • Sanofi-Aventis Investigational Site Number 124215
      • Quebec, Canada, G1V 4G5
        • Sanofi-Aventis Investigational Site Number 124205
      • Red Deer, Canada, T4N 6V7
        • Sanofi-Aventis Investigational Site Number 124202
      • Thornhill, Canada, L4J 8L7
        • Sanofi-Aventis Investigational Site Number 124218
      • Toronto, Canada, M4R 2G4
        • Sanofi-Aventis Investigational Site Number 124201
      • Toronto, Canada, M9V 4B4
        • Sanofi-Aventis Investigational Site Number 124207
      • Victoria, Canada, V8V 4A1
        • Sanofi-Aventis Investigational Site Number 124209
      • Winnipeg, Canada, R3E 3P4
        • Sanofi-Aventis Investigational Site Number 124217
  • Chile
      • Santiago, Chile, 7500010
        • Sanofi-Aventis Investigational Site Number 152202
      • Santiago, Chile, 7980378
        • Sanofi-Aventis Investigational Site Number 152203
      • Santiago, Chile, 8053095
        • Sanofi-Aventis Investigational Site Number 152206
      • Santiago, Chile, 8360156
        • Sanofi-Aventis Investigational Site Number 152204
      • Santiago, Chile, 8930211
        • Sanofi-Aventis Investigational Site Number 152205
      • Santiago, Chile
        • Sanofi-Aventis Investigational Site Number 152201
  • Colombia
      • Barranquilla, Colombia
        • Sanofi-Aventis Investigational Site Number 170204
      • Bogota, Colombia
        • Sanofi-Aventis Investigational Site Number 170201
      • Bogota, Colombia
        • Sanofi-Aventis Investigational Site Number 170202
  • Danmark
      • Frederiksberg, Danmark, 2000
        • Sanofi-Aventis Investigational Site Number 208202
      • København Nv, Danmark, 2400
        • Sanofi-Aventis Investigational Site Number 208201
      • Slagelse, Danmark, 4200
        • Sanofi-Aventis Investigational Site Number 208205
  • Den Russiske Føderation
      • Saratov, Den Russiske Føderation, 410030
        • Sanofi-Aventis Investigational Site Number 643203
      • St. Petersburg, Den Russiske Føderation, 194358
        • Sanofi-Aventis Investigational Site Number 643202
  • Estland
      • Pärnu, Estland, 80018
        • Sanofi-Aventis Investigational Site Number 233201
      • Tallinn, Estland, 13415
        • Sanofi-Aventis Investigational Site Number 233203
      • Tartu, Estland, 50410
        • Sanofi-Aventis Investigational Site Number 233204
      • Viljandimaa, Estland, 71024
        • Sanofi-Aventis Investigational Site Number 233202
  • Forenede Stater
    • Arizona
      • Mesa, Arizona, Forenede Stater, 85206
        • Sanofi-Aventis Investigational Site Number 840223
    • Arkansas
      • Hot Springs, Arkansas, Forenede Stater, 71913
        • Sanofi-Aventis Investigational Site Number 840206
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Sanofi-Aventis Investigational Site Number 840201
      • Mountain Home, Arkansas, Forenede Stater, 72653
        • Sanofi-Aventis Investigational Site Number 840212
    • California
      • Concord, California, Forenede Stater, 94520
        • Sanofi-Aventis Investigational Site Number 840215
      • Greenbrae, California, Forenede Stater, 94904
        • Sanofi-Aventis Investigational Site Number 840214
    • Florida
      • Orlando, Florida, Forenede Stater, 32835
        • Sanofi-Aventis Investigational Site Number 840221
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70808
        • Sanofi-Aventis Investigational Site Number 840211
    • Maryland
      • Hyattsville, Maryland, Forenede Stater, 20781
        • Sanofi-Aventis Investigational Site Number 840230
      • Rockville, Maryland, Forenede Stater, 20852
        • Sanofi-Aventis Investigational Site Number 840209
    • Michigan
      • Brighton, Michigan, Forenede Stater, 48114
        • Sanofi-Aventis Investigational Site Number 840219
    • New Jersey
      • Sea Girt, New Jersey, Forenede Stater, 08750
        • Sanofi-Aventis Investigational Site Number 840231
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58103
        • Sanofi-Aventis Investigational Site Number 840208
    • Ohio
      • Mentor, Ohio, Forenede Stater, 44060
        • Sanofi-Aventis Investigational Site Number 840225
    • Oregon
      • Portland, Oregon, Forenede Stater, 97201-3098
        • Sanofi-Aventis Investigational Site Number 840222
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19146
        • Sanofi-Aventis Investigational Site Number 840202
    • Tennessee
      • Bristol, Tennessee, Forenede Stater, 37620
        • Sanofi-Aventis Investigational Site Number 840229
      • Germantown, Tennessee, Forenede Stater, 38138
        • Sanofi-Aventis Investigational Site Number 840205
    • Texas
      • Dallas, Texas, Forenede Stater, 75230
        • Sanofi-Aventis Investigational Site Number 840210
      • Houston, Texas, Forenede Stater, 77081
        • Sanofi-Aventis Investigational Site Number 840217
      • Houston, Texas, Forenede Stater, 77081
        • Sanofi-Aventis Investigational Site Number 840228
      • Plano, Texas, Forenede Stater, 75093
        • Sanofi-Aventis Investigational Site Number 840213
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23502
        • Sanofi-Aventis Investigational Site Number 840227
  • Frankrig
      • Amiens Cedex 1, Frankrig, 80054
        • Sanofi-Aventis Investigational Site Number 250204
      • La Rochelle Cedex, Frankrig, 17019
        • Sanofi-Aventis Investigational Site Number 250206
      • Le Creusot, Frankrig, 71200
        • Sanofi-Aventis Investigational Site Number 250203
      • Nantes, Frankrig, 44093
        • Sanofi-Aventis Investigational Site Number 250201
      • Pierre Benite, Frankrig, 69310
        • Sanofi-Aventis Investigational Site Number 250202
  • Holland
      • Amsterdam, Holland, 1066 EC
        • Sanofi-Aventis Investigational Site Number 528203
      • Groningen, Holland, 9728 NT
        • Sanofi-Aventis Investigational Site Number 528202
      • Zwijndrecht, Holland, 3331 LZ
        • Sanofi-Aventis Investigational Site Number 528204
  • Indien
      • Ahmedabad, Indien, 380015
        • Sanofi-Aventis Investigational Site Number 356210
      • Bangalore, Indien, 560043
        • Sanofi-Aventis Investigational Site Number 356206
      • Bangalore, Indien, 560052
        • Sanofi-Aventis Investigational Site Number 356204
      • Bangalore, Indien
        • Sanofi-Aventis Investigational Site Number 356202
      • Belgaum, Indien, 590001
        • Sanofi-Aventis Investigational Site Number 356201
      • Chennai, Indien, 600086
        • Sanofi-Aventis Investigational Site Number 356205
      • Indore, Indien, 452010
        • Sanofi-Aventis Investigational Site Number 356208
      • Karnal, Indien, 132001
        • Sanofi-Aventis Investigational Site Number 356203
      • Kochi, Indien
        • Sanofi-Aventis Investigational Site Number 356207
      • Nagpur, Indien, 440012
        • Sanofi-Aventis Investigational Site Number 356209
  • Israel
      • Haifa, Israel, 31096
        • Sanofi-Aventis Investigational Site Number 376202
      • Holon, Israel, 58100
        • Sanofi-Aventis Investigational Site Number 376201
      • Kfar Saba, Israel, 44281
        • Sanofi-Aventis Investigational Site Number 376204
      • Tel Hashomer, Israel, 52621
        • Sanofi-Aventis Investigational Site Number 376203
  • Italien
      • Milano, Italien, 20132
        • Sanofi-Aventis Investigational Site Number 380201
      • Perugia, Italien, 61260
        • Sanofi-Aventis Investigational Site Number 380202
  • Malaysia
      • Kelantan, Malaysia, 16150
        • Sanofi-Aventis Investigational Site Number 458203
      • Kuala Lumpur, Malaysia, 56000
        • Sanofi-Aventis Investigational Site Number 458202
  • Mexico
      • Cuernavaca, Mexico, 62250
        • Sanofi-Aventis Investigational Site Number 484201
      • Durango, Mexico, 34270
        • Sanofi-Aventis Investigational Site Number 484204
      • Guadalajara, Mexico, 44600
        • Sanofi-Aventis Investigational Site Number 484203
      • México City, Mexico, 14050
        • Sanofi-Aventis Investigational Site Number 484206
      • Tlalnepantla, Mexico, 53160
        • Sanofi-Aventis Investigational Site Number 484205
  • Polen
      • Krakow, Polen, 31-548
        • Sanofi-Aventis Investigational Site Number 616202
      • Lubin, Polen, 59-300
        • Sanofi-Aventis Investigational Site Number 616208
      • Plock, Polen, 09-400
        • Sanofi-Aventis Investigational Site Number 616206
      • Pulawy, Polen, 24-100
        • Sanofi-Aventis Investigational Site Number 616207
      • Sopot, Polen, 81-756
        • Sanofi-Aventis Investigational Site Number 616205
      • Szczecin, Polen, 70-506
        • Sanofi-Aventis Investigational Site Number 616201
      • Zabrze, Polen, 41-8--
        • Sanofi-Aventis Investigational Site Number 616203
  • Puerto Rico
      • Ponce, Puerto Rico, 00717
        • Sanofi-Aventis Investigational Site Number 840226
      • San Juan, Puerto Rico, 00917
        • Sanofi-Aventis Investigational Site Number 840216
  • Rumænien
      • Brasov, Rumænien, 500326
        • Sanofi-Aventis Investigational Site Number 642204
      • Bucharest, Rumænien, 020725
        • Sanofi-Aventis Investigational Site Number 642208
      • Deva, Rumænien, 330084
        • Sanofi-Aventis Investigational Site Number 642205
      • Iasi, Rumænien, 700515
        • Sanofi-Aventis Investigational Site Number 642203
      • Oradea, Rumænien, 410598
        • Sanofi-Aventis Investigational Site Number 642202
      • Targu Mures, Rumænien, 540061
        • Sanofi-Aventis Investigational Site Number 642206
      • Timisoara, Rumænien, 300456
        • Sanofi-Aventis Investigational Site Number 642207
      • Timisoara, Rumænien, 300593
        • Sanofi-Aventis Investigational Site Number 642201
  • Sverige
      • Göteborg, Sverige, 413 45
        • Sanofi-Aventis Investigational Site Number 752204
      • Härnösand, Sverige, 871 82
        • Sanofi-Aventis Investigational Site Number 752203
      • Luleå, Sverige, 972 33
        • Sanofi-Aventis Investigational Site Number 752205
      • Malmö, Sverige, 211 52
        • Sanofi-Aventis Investigational Site Number 752202
      • Stockholm, Sverige, 111 57
        • Sanofi-Aventis Investigational Site Number 752201
  • Sydafrika
      • Cape Town, Sydafrika, 7708
        • Sanofi-Aventis Investigational Site Number 710202
      • Durban, Sydafrika, 4092
        • Sanofi-Aventis Investigational Site Number 710201
      • Pretoria, Sydafrika
        • Sanofi-Aventis Investigational Site Number 710203
  • Taiwan
      • Changhua, Taiwan, 500
        • Sanofi-Aventis Investigational Site Number 158204
      • Taichung, Taiwan, 433
        • Sanofi-Aventis Investigational Site Number 158203
      • Taichung R.O.C., Taiwan, 407
        • Sanofi-Aventis Investigational Site Number 158201
      • Tainan Hsien, Taiwan, 710
        • Sanofi-Aventis Investigational Site Number 158202
  • Tjekkiet
      • Hradec Kralove, Tjekkiet, 50005
        • Sanofi-Aventis Investigational Site Number 203202
      • Praha 5, Tjekkiet, 15006
        • Sanofi-Aventis Investigational Site Number 203204
  • Tyskland
      • Dresden, Tyskland, 01307
        • Sanofi-Aventis Investigational Site Number 276201
      • Mainz, Tyskland, 55116
        • Sanofi-Aventis Investigational Site Number 276202
      • St. Ingbert-Oberwürzbach, Tyskland, 66386
        • Sanofi-Aventis Investigational Site Number 276204
  • Ukraine
      • Chernivtsi, Ukraine, 58022
        • Sanofi-Aventis Investigational Site Number 804203
      • Kiev, Ukraine, 2091
        • Sanofi-Aventis Investigational Site Number 804201
      • Kyiv, Ukraine, 31156
        • Sanofi-Aventis Investigational Site Number 804205
      • Kyiv, Ukraine
        • Sanofi-Aventis Investigational Site Number 804202
      • Vinnytsya, Ukraine, 21010
        • Sanofi-Aventis Investigational Site Number 804204
  • Ungarn
      • Balatonfüred, Ungarn, 8230
        • Sanofi-Aventis Investigational Site Number 348205
      • Budapest, Ungarn, 1036
        • Sanofi-Aventis Investigational Site Number 348202
      • Budapest, Ungarn
        • Sanofi-Aventis Investigational Site Number 348207
      • Debrecen, Ungarn, 4031
        • Sanofi-Aventis Investigational Site Number 348204
      • Gyula, Ungarn, 5700
        • Sanofi-Aventis Investigational Site Number 348206
      • Szeged, Ungarn, 6722
        • Sanofi-Aventis Investigational Site Number 348203
      • Zalaegerszeg, Ungarn, 8900
        • Sanofi-Aventis Investigational Site Number 348201

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

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

Exclusion criteria:

  • 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
  • Laboratory findings at the time of screening: amylase and/or lipase, alanine aminotransferase >3 times upper limit of the normal (ULN) laboratory range; total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome); hemoglobin <11 gram/deciliter and/or neutrophils <1500 per cubic millimeter (mm^3) and/or platelets <100 000/mm^3; positive test for Hepatitis B surface antigen and/or Hepatitis C antibody, positive serum pregnancy test in females of childbearing potential; and calcitonin >=20 picogram per milliliter (pg/mL) (5.9 picomole per milliliter [pmol/L])
  • Patients who are considered by the Investigator or any sub investigator as inappropriate for this study for any reason (for example, impossibility to meet specific protocol requirements, such as scheduled visits, being able to do self-injections, likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol, patient being investigator or any sub investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol etc.)
  • Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening
  • Use of any investigational drug within 3 months prior to screening
  • Renal impairment defined with serum creatinine > 1.4 mg/dL in women and > 1.5 mg/dL in men
  • History of hypersensitivity to insulin glargine or to any of the excipients
  • Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (that is, worsening) and not controlled (that is, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening
  • Any previous treatment with lixisenatide (for example, participation in a previous study with lixisenatide)
  • Allergic reaction to any GLP-1 receptor agonist in the past (for example, exenatide, liraglutide) or to metacresol
  • Additional exclusion criteria during or at the end of the run-in phase before randomization: informed consent withdrawal (patient who was not willing to continue or failed to return), mean fasting SMPG calculated from the self-measurements for the 7 days prior to Visit 12 (Week -1) was >140 mg/dL (7.8 mmol/L) and HbA1c measured at Visit 12 (Week -1) is <7% or >9%, amylase and/or lipase > 3 times the ULN at Visit 12 (Week -1), patients with fasting plasma glucose (FPG) above the threshold value described for rescue (that is, FPG >240 mg/dL [13.3 mmol/L]), patients with any adverse event, which, by the judgment of the Investigator precludes the inclusion in the double-blind randomized treatment phase, and lack of compliance to protocol or to insulin glargine treatment during the run-in phase

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Lixisenatid
2-trins initieringsregime for lixisenatid: 10 mikrogram (mcg) én gang dagligt (QD) i 1 uge, efterfulgt af 15 mcg QD i 1 uge, derefter 20 mcg QD op til uge 24.
Medicin: Lixisenatid (AVE0010)
Selvindgivet ved subkutane injektioner én gang dagligt inden for timen før morgenmaden.
Medicin: Metformin
Metformin skal fortsættes med stabil dosis (mindst 1,5 gram pr. dag) op til uge 24.
Medicin: Insulin glargine
Dose to be adjusted to maintain a fasting SMPG between 100 and 80 mg/dL (5.6 and 4.4 mmol/L), inclusive.
Andre navne:
  • Lantus®
Enhed: Pen auto-injector
Lantus® SoloStar® OptiClik®
Medicin: Thiazolidinedione (TZD)
TZD (either rosiglitazone or pioglitazone) if given, to be continued at stable dose up to Week 24.
Placebo komparator: Placebo
2-trins initieringsregime for volumen matchende placebo: 10 mcg QD i 1 uge, efterfulgt af 15 mcg QD i 1 uge, derefter 20 mcg QD op til uge 24.
Medicin: Placebo
Selvindgivet ved subkutane injektioner én gang dagligt inden for timen før morgenmaden.
Medicin: Metformin
Metformin skal fortsættes med stabil dosis (mindst 1,5 gram pr. dag) op til uge 24.
Medicin: Insulin glargine
Dose to be adjusted to maintain a fasting SMPG between 100 and 80 mg/dL (5.6 and 4.4 mmol/L), inclusive.
Andre navne:
  • Lantus®
Enhed: Pen auto-injector
Lantus® SoloStar® OptiClik®
Medicin: Thiazolidinedione (TZD)
TZD (either rosiglitazone or pioglitazone) if given, to be continued at stable dose up to Week 24.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Tidsramme: Baseline, 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring fra baseline i kropsvægt i uge 24
Tidsramme: Baseline, uge ​​24
Ændring blev beregnet ved at trække basislinjeværdien fra uge 24-værdien. Behandlingsperioden for denne effektvariabel er tiden fra den første dosis af undersøgelseslægemidlet op til 3 dage efter den sidste dosis af undersøgelseslægemidlet eller op til introduktionen af ​​redningsterapi, alt efter hvad der er den tidligste. For at en patient skulle inkluderes i mITT-populationen var både baseline og mindst 1 post-baseline-vurdering påkrævet for mindst 1 effektvariabel.
Baseline, uge ​​24
Ændring fra baseline i gennemsnitlig 7-punkts selvovervåget plasmaglukoseprofil (SMPG) i uge 24
Tidsramme: Baseline, uge ​​24
Patienterne registrerede en 7-punkts plasmaglukoseprofil målt før og 2 timer efter hvert måltid og ved sengetid én gang om ugen, og den gennemsnitlige værdi for de 7-tidspunkter blev beregnet. Behandlingsperioden for denne effektvariabel er tiden fra den første dosis af undersøgelseslægemidlet op til den sidste doseringsdag af undersøgelseslægemidlet eller op til introduktionen af ​​redningsterapi, alt efter hvad der er den tidligste. For at en patient skulle inkluderes i mITT-populationen var både baseline og mindst 1 post-baseline-vurdering påkrævet for mindst 1 effektvariabel.
Baseline, uge ​​24
Ændring fra baseline i fastende plasmaglukose (FPG) i uge 24
Tidsramme: Baseline, uge ​​24
Ændring blev beregnet ved at trække basislinjeværdien fra uge 24-værdien. Behandlingsperioden for denne effektvariabel er tiden fra den første dosis af undersøgelseslægemidlet op til 1 dag efter den sidste dosis af undersøgelseslægemidlet eller op til introduktionen af ​​redningsterapi, alt efter hvad der er den tidligste. For at en patient skulle inkluderes i mITT-populationen var både baseline og mindst 1 post-baseline-vurdering påkrævet for mindst 1 effektvariabel.
Baseline, uge ​​24
Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24
Tidsramme: Baseline, Week 24
The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day 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
Change From Baseline in Glucose Excursion at Week 24
Tidsramme: Baseline, Week 24
Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day 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
Change From Baseline in Average Insulin Glargine Daily Dose at Week 24
Tidsramme: Baseline, Week 24
Change was calculated by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day 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
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24
Tidsramme: Week 24
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.
Week 24
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24
Tidsramme: Week 24
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.
Week 24
Percentage of Patients Requiring Rescue Therapy During the Double-blind Period
Tidsramme: Baseline up to Week 24
Routine fasting SMPG, central laboratory FPG and HbA1c values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG and HbA1c were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >200 milligram/deciliter (mg/dL) (11.1 mmol/L) or HbA1c >9%, from Week 8 to Week 24: fasting SMPG/FPG >180 mg/dL (10.0 mmol/L) or HbA1c >8.5%. 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 up to Week 24
Change From Baseline in Treatment Satisfaction Score (Sum of Items 1, 4, 5, 6, 7 and 8 of DTSQ) at Week 24
Tidsramme: Baseline, Week 24
Change was calculated by subtracting baseline value from Week 24 value. DTSQ: 8-item questionnaire to assess treatment satisfaction and patient perception of hyper and hypoglycemia. Each question (Q) scored on a Likert scale from 0 to 6. Six items (Q1 and 4-8; higher score = more satisfaction) measured treatment satisfaction and were summed to calculate treatment satisfaction score which ranged from 0 (very dissatisfied) to 36 (very satisfied). Two items (Q2 and 3), which were not included, measured perceived hyperglycemia and hypoglycemia, respectively and lower scores represented good perceived blood glucose control. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Antal patienter med symptomatisk hypoglykæmi og svær symptomatisk hypoglykæmi
Tidsramme: Første dosis af undersøgelseslægemidlet op til 3 dage efter den sidste dosisindgivelse
Symptomatisk hypoglykæmi var en hændelse med kliniske symptomer, der blev anset for at være et resultat af en hypoglykæmisk episode med en ledsagende plasmaglucose på mindre end 60 mg/dL (3,3 mmol/L) eller forbundet med hurtig bedring efter oral kulhydrat, intravenøs glukose eller glucagon administration, hvis ingen plasmaglukosemåling var tilgængelig. Alvorlig symptomatisk hypoglykæmi var symptomatisk hypoglykæmi, hvor patienten krævede hjælp fra en anden person og var forbundet med enten et plasmaglukoseniveau under 36 mg/dL (2,0 mmol/L) eller hurtig bedring efter oral kulhydrat-, intravenøs glukose- eller glukagonadministration , hvis ingen plasmaglukosemåling var tilgængelig.
Første dosis af undersøgelseslægemidlet op til 3 dage efter den sidste dosisindgivelse
Procentdel af patienter med mindst 5 % vægttab fra baseline i uge 24
Tidsramme: Baseline, uge ​​24
Behandlingsperioden for denne effektvariabel er tiden fra den første dosis af undersøgelseslægemidlet op til 3 dage efter den sidste dosis af undersøgelseslægemidlet eller op til introduktionen af ​​redningsterapi, alt efter hvad der er den tidligste. For at en patient skulle inkluderes i mITT-populationen var både baseline og mindst 1 post-baseline-vurdering påkrævet for mindst 1 effektvariabel.
Baseline, uge ​​24

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sanofi

Efterforskere

  • Studieleder: Clinical Study Operations, Sanofi

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2009

Primær færdiggørelse (Faktiske)

1. august 2011

Studieafslutning (Faktiske)

1. august 2011

Datoer for studieregistrering

Først indsendt

10. september 2009

Først indsendt, der opfyldte QC-kriterier

10. september 2009

Først opslået (Skøn)

11. september 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. august 2016

Sidst verificeret

1. august 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EFC10781
  • EudraCT : 2008-007335-40

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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