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

18 augusti 2016 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

446

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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
  • 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
  • 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
  • Frankrike
      • Amiens Cedex 1, Frankrike, 80054
        • Sanofi-Aventis Investigational Site Number 250204
      • La Rochelle Cedex, Frankrike, 17019
        • Sanofi-Aventis Investigational Site Number 250206
      • Le Creusot, Frankrike, 71200
        • Sanofi-Aventis Investigational Site Number 250203
      • Nantes, Frankrike, 44093
        • Sanofi-Aventis Investigational Site Number 250201
      • Pierre Benite, Frankrike, 69310
        • Sanofi-Aventis Investigational Site Number 250202
  • Förenta staterna
    • Arizona
      • Mesa, Arizona, Förenta staterna, 85206
        • Sanofi-Aventis Investigational Site Number 840223
    • Arkansas
      • Hot Springs, Arkansas, Förenta staterna, 71913
        • Sanofi-Aventis Investigational Site Number 840206
      • Little Rock, Arkansas, Förenta staterna, 72205
        • Sanofi-Aventis Investigational Site Number 840201
      • Mountain Home, Arkansas, Förenta staterna, 72653
        • Sanofi-Aventis Investigational Site Number 840212
    • California
      • Concord, California, Förenta staterna, 94520
        • Sanofi-Aventis Investigational Site Number 840215
      • Greenbrae, California, Förenta staterna, 94904
        • Sanofi-Aventis Investigational Site Number 840214
    • Florida
      • Orlando, Florida, Förenta staterna, 32835
        • Sanofi-Aventis Investigational Site Number 840221
    • Louisiana
      • Baton Rouge, Louisiana, Förenta staterna, 70808
        • Sanofi-Aventis Investigational Site Number 840211
    • Maryland
      • Hyattsville, Maryland, Förenta staterna, 20781
        • Sanofi-Aventis Investigational Site Number 840230
      • Rockville, Maryland, Förenta staterna, 20852
        • Sanofi-Aventis Investigational Site Number 840209
    • Michigan
      • Brighton, Michigan, Förenta staterna, 48114
        • Sanofi-Aventis Investigational Site Number 840219
    • New Jersey
      • Sea Girt, New Jersey, Förenta staterna, 08750
        • Sanofi-Aventis Investigational Site Number 840231
    • North Dakota
      • Fargo, North Dakota, Förenta staterna, 58103
        • Sanofi-Aventis Investigational Site Number 840208
    • Ohio
      • Mentor, Ohio, Förenta staterna, 44060
        • Sanofi-Aventis Investigational Site Number 840225
    • Oregon
      • Portland, Oregon, Förenta staterna, 97201-3098
        • Sanofi-Aventis Investigational Site Number 840222
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19146
        • Sanofi-Aventis Investigational Site Number 840202
    • Tennessee
      • Bristol, Tennessee, Förenta staterna, 37620
        • Sanofi-Aventis Investigational Site Number 840229
      • Germantown, Tennessee, Förenta staterna, 38138
        • Sanofi-Aventis Investigational Site Number 840205
    • Texas
      • Dallas, Texas, Förenta staterna, 75230
        • Sanofi-Aventis Investigational Site Number 840210
      • Houston, Texas, Förenta staterna, 77081
        • Sanofi-Aventis Investigational Site Number 840217
      • Houston, Texas, Förenta staterna, 77081
        • Sanofi-Aventis Investigational Site Number 840228
      • Plano, Texas, Förenta staterna, 75093
        • Sanofi-Aventis Investigational Site Number 840213
    • Virginia
      • Norfolk, Virginia, Förenta staterna, 23502
        • Sanofi-Aventis Investigational Site Number 840227
  • 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
  • Kanada
      • Brampton, Kanada, L6R 3J5
        • Sanofi-Aventis Investigational Site Number 124219
      • Chatham, Kanada, N7L 1C1
        • Sanofi-Aventis Investigational Site Number 124213
      • Chilliwack, Kanada, V2P 4M9
        • Sanofi-Aventis Investigational Site Number 124208
      • Etobicoke, Kanada, M9R 4E1
        • Sanofi-Aventis Investigational Site Number 124215
      • Quebec, Kanada, G1V 4G5
        • Sanofi-Aventis Investigational Site Number 124205
      • Red Deer, Kanada, T4N 6V7
        • Sanofi-Aventis Investigational Site Number 124202
      • Thornhill, Kanada, L4J 8L7
        • Sanofi-Aventis Investigational Site Number 124218
      • Toronto, Kanada, M4R 2G4
        • Sanofi-Aventis Investigational Site Number 124201
      • Toronto, Kanada, M9V 4B4
        • Sanofi-Aventis Investigational Site Number 124207
      • Victoria, Kanada, V8V 4A1
        • Sanofi-Aventis Investigational Site Number 124209
      • Winnipeg, Kanada, R3E 3P4
        • Sanofi-Aventis Investigational Site Number 124217
  • Malaysia
      • Kelantan, Malaysia, 16150
        • Sanofi-Aventis Investigational Site Number 458203
      • Kuala Lumpur, Malaysia, 56000
        • Sanofi-Aventis Investigational Site Number 458202
  • Mexiko
      • Cuernavaca, Mexiko, 62250
        • Sanofi-Aventis Investigational Site Number 484201
      • Durango, Mexiko, 34270
        • Sanofi-Aventis Investigational Site Number 484204
      • Guadalajara, Mexiko, 44600
        • Sanofi-Aventis Investigational Site Number 484203
      • México City, Mexiko, 14050
        • Sanofi-Aventis Investigational Site Number 484206
      • Tlalnepantla, Mexiko, 53160
        • Sanofi-Aventis Investigational Site Number 484205
  • Nederländerna
      • Amsterdam, Nederländerna, 1066 EC
        • Sanofi-Aventis Investigational Site Number 528203
      • Groningen, Nederländerna, 9728 NT
        • Sanofi-Aventis Investigational Site Number 528202
      • Zwijndrecht, Nederländerna, 3331 LZ
        • Sanofi-Aventis Investigational Site Number 528204
  • 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
  • Rumänien
      • Brasov, Rumänien, 500326
        • Sanofi-Aventis Investigational Site Number 642204
      • Bucharest, Rumänien, 020725
        • Sanofi-Aventis Investigational Site Number 642208
      • Deva, Rumänien, 330084
        • Sanofi-Aventis Investigational Site Number 642205
      • Iasi, Rumänien, 700515
        • Sanofi-Aventis Investigational Site Number 642203
      • Oradea, Rumänien, 410598
        • Sanofi-Aventis Investigational Site Number 642202
      • Targu Mures, Rumänien, 540061
        • Sanofi-Aventis Investigational Site Number 642206
      • Timisoara, Rumänien, 300456
        • Sanofi-Aventis Investigational Site Number 642207
      • Timisoara, Rumänien, 300593
        • Sanofi-Aventis Investigational Site Number 642201
  • Ryska Federationen
      • Saratov, Ryska Federationen, 410030
        • Sanofi-Aventis Investigational Site Number 643203
      • St. Petersburg, Ryska Federationen, 194358
        • Sanofi-Aventis Investigational Site Number 643202
  • 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
  • Tjeckien
      • Hradec Kralove, Tjeckien, 50005
        • Sanofi-Aventis Investigational Site Number 203202
      • Praha 5, Tjeckien, 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
  • Ukraina
      • Chernivtsi, Ukraina, 58022
        • Sanofi-Aventis Investigational Site Number 804203
      • Kiev, Ukraina, 2091
        • Sanofi-Aventis Investigational Site Number 804201
      • Kyiv, Ukraina, 31156
        • Sanofi-Aventis Investigational Site Number 804205
      • Kyiv, Ukraina
        • Sanofi-Aventis Investigational Site Number 804202
      • Vinnytsya, Ukraina, 21010
        • Sanofi-Aventis Investigational Site Number 804204
  • Ungern
      • Balatonfüred, Ungern, 8230
        • Sanofi-Aventis Investigational Site Number 348205
      • Budapest, Ungern, 1036
        • Sanofi-Aventis Investigational Site Number 348202
      • Budapest, Ungern
        • Sanofi-Aventis Investigational Site Number 348207
      • Debrecen, Ungern, 4031
        • Sanofi-Aventis Investigational Site Number 348204
      • Gyula, Ungern, 5700
        • Sanofi-Aventis Investigational Site Number 348206
      • Szeged, Ungern, 6722
        • Sanofi-Aventis Investigational Site Number 348203
      • Zalaegerszeg, Ungern, 8900
        • Sanofi-Aventis Investigational Site Number 348201

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Lixisenatid
2-stegs initieringsregim av lixisenatid: 10 mikrogram (mcg) en gång dagligen (QD) i 1 vecka, följt av 15 mcg QD i 1 vecka, sedan 20 mcg QD upp till vecka 24.
Läkemedel: Lixisenatid (AVE0010)
Självadministrerad genom subkutana injektioner en gång dagligen inom timmen före frukost.
Läkemedel: Metformin
Metformin ska fortsätta med stabil dos (minst 1,5 gram per dag) fram till vecka 24.
Läkemedel: 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.
Andra namn:
  • Lantus®
Enhet: Pen auto-injector
Lantus® SoloStar® OptiClik®
Läkemedel: Thiazolidinedione (TZD)
TZD (either rosiglitazone or pioglitazone) if given, to be continued at stable dose up to Week 24.
Placebo-jämförare: Placebo
2-stegs initieringsregim med volymmatchande placebo: 10 mcg QD i 1 vecka, följt av 15 mcg QD i 1 vecka, sedan 20 mcg QD upp till vecka 24.
Läkemedel: Placebo
Självadministrerad genom subkutana injektioner en gång dagligen inom timmen före frukost.
Läkemedel: Metformin
Metformin ska fortsätta med stabil dos (minst 1,5 gram per dag) fram till vecka 24.
Läkemedel: 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.
Andra namn:
  • Lantus®
Enhet: Pen auto-injector
Lantus® SoloStar® OptiClik®
Läkemedel: Thiazolidinedione (TZD)
TZD (either rosiglitazone or pioglitazone) if given, to be continued at stable dose up to Week 24.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Förändring från baslinjen i kroppsvikt vecka 24
Tidsram: Baslinje, vecka 24
Förändringen beräknades genom att subtrahera baslinjevärdet från värdet för vecka 24. Behandlingsperioden för denna effektvariabel är tiden från den första dosen av studieläkemedlet upp till 3 dagar efter den sista dosen av studieläkemedlet eller fram till införandet av räddningsterapi, beroende på vilket som är tidigast. För att en patient skulle inkluderas i mITT-populationen krävdes både baslinje och minst en bedömning efter baslinjen för minst en effektvariabel.
Baslinje, vecka 24
Förändring från baslinjen i genomsnittlig 7-punkts självövervakad plasmaglukosprofil (SMPG) vid vecka 24
Tidsram: Baslinje, vecka 24
Patienterna registrerade en 7-punkts plasmaglukosprofil mätt före och 2 timmar efter varje måltid och vid sänggåendet en gång i veckan och medelvärdet för 7-tidpunkterna beräknades. Behandlingsperioden för denna effektvariabel är tiden från den första dosen av studieläkemedlet fram till den sista doseringsdagen av studieläkemedlet eller fram till införandet av räddningsterapi, beroende på vilket som är tidigast. För att en patient skulle inkluderas i mITT-populationen krävdes både baslinje och minst en bedömning efter baslinjen för minst en effektvariabel.
Baslinje, vecka 24
Ändring från baslinjen i fastande plasmaglukos (FPG) vid vecka 24
Tidsram: Baslinje, vecka 24
Förändringen beräknades genom att subtrahera baslinjevärdet från värdet för vecka 24. Behandlingsperioden för denna effektvariabel är tiden från den första dosen av studieläkemedlet upp till 1 dag efter den sista dosen av studieläkemedlet eller fram till införandet av räddningsterapi, beroende på vilket som är tidigast. För att en patient skulle inkluderas i mITT-populationen krävdes både baslinje och minst en bedömning efter baslinjen för minst en effektvariabel.
Baslinje, vecka 24
Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Antal patienter med symtomatisk hypoglykemi och svår symtomatisk hypoglykemi
Tidsram: Första dosen av studieläkemedlet upp till 3 dagar efter den sista dosen
Symtomatisk hypoglykemi var en händelse med kliniska symtom som ansågs bero på en hypoglykemisk episod med åtföljande plasmaglukos mindre än 60 mg/dL (3,3 mmol/L) eller förknippad med omedelbar återhämtning efter oral administrering av kolhydrater, intravenös glukos eller glukagon om ingen plasmaglukosmätning var tillgänglig. Allvarlig symtomatisk hypoglykemi var en symptomatisk hypoglykemihändelse där patienten behövde hjälp av en annan person och var associerad med antingen en plasmaglukosnivå under 36 mg/dL (2,0 mmol/L) eller snabb återhämtning efter oral administrering av kolhydrater, intravenös glukos eller glukagon. , om ingen plasmaglukosmätning var tillgänglig.
Första dosen av studieläkemedlet upp till 3 dagar efter den sista dosen
Andel patienter med minst 5 % viktminskning från baslinjen vid vecka 24
Tidsram: Baslinje, vecka 24
Behandlingsperioden för denna effektvariabel är tiden från den första dosen av studieläkemedlet upp till 3 dagar efter den sista dosen av studieläkemedlet eller fram till införandet av räddningsterapi, beroende på vilket som är tidigast. För att en patient skulle inkluderas i mITT-populationen krävdes både baslinje och minst en bedömning efter baslinjen för minst en effektvariabel.
Baslinje, vecka 24

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Sanofi

Utredare

  • Studierektor: Clinical Study Operations, Sanofi

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2009

Primärt slutförande (Faktisk)

1 augusti 2011

Avslutad studie (Faktisk)

1 augusti 2011

Studieregistreringsdatum

Först inskickad

10 september 2009

Först inskickad som uppfyllde QC-kriterierna

10 september 2009

Första postat (Uppskatta)

11 september 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

11 oktober 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 augusti 2016

Senast verifierad

1 augusti 2016

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • EFC10781
  • EudraCT : 2008-007335-40

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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