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Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin (GetGoal-M-Asia)

18 sierpnia 2016 zaktualizowane przez: Sanofi

Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin (With or Without Sulfonylurea): a Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With 24-week Treatment Period

The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010) in comparison to placebo, as an add-on treatment to metformin with or without sulfonylurea, over a period of 24 weeks of treatment.

The primary objective is to assess the effects on glycemic control of lixisenatide (AVE0010) in comparison to placebo as an add-on treatment to metformin with or without sulfonylurea in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.

The secondary objectives are to assess the effects of lixisenatide over 24 weeks on percentage of patients reaching HbA1c less than (< ) 7 percent (%) or HbA1c less than or equal to (<=) 6.5%, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG) and glucose excursion during standardized meal test, body weight; to evaluate safety, tolerability, pharmacokinetic (PK) and anti-lixisenatide antibody development.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

The study duration for each patient is 27 weeks +/- 10 days (up to 2 weeks screening + 1 week run-in + 24 weeks double-blind treatment + 3 days follow-up).

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

391

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Chiny
      • Beijing, Chiny, 100034
        • Investigational Site Number 156011
      • Beijing, Chiny, 100101
        • Investigational Site Number 156012
      • Beijing, Chiny, 100191
        • Investigational Site Number 156019
      • Beijing, Chiny, 100700
        • Investigational Site Number 156002
      • Beijing, Chiny, 100730
        • Investigational Site Number 156003
      • Beijing, Chiny, 100730
        • Investigational Site Number 156009
      • Beijing, Chiny, 100853
        • Investigational Site Number 156001
      • Changchun, Chiny, 130041
        • Investigational Site Number 156036
      • Changsha, Chiny, 410008
        • Investigational Site Number 156016
      • Changsha, Chiny, 410011
        • Investigational Site Number 156015
      • Chengdu, Chiny, 610041
        • Investigational Site Number 156006
      • Chengdu, Chiny, 610072
        • Investigational Site Number 156032
      • Dalian, Chiny, 116027
        • Investigational Site Number 156010
      • Guangzhou, Chiny, 510080
        • Investigational Site Number 156004
      • Guangzhou, Chiny, 510080
        • Investigational Site Number 156008
      • Guangzhou, Chiny, 510630
        • Investigational Site Number 156025
      • Haikou, Chiny, 57028
        • Investigational Site Number 156031
      • Harbin, Chiny, 150001
        • Investigational Site Number 156014
      • Hefei, Chiny, 230022
        • Investigational Site Number 156029
      • Qingdao, Chiny, 266003
        • Investigational Site Number 156013
      • Shanghai, Chiny, 200003
        • Investigational Site Number 156007
      • Shanghai, Chiny, 200065
        • Investigational Site Number 156030
      • Shenyang, Chiny, 110004
        • Investigational Site Number 156020
      • Suzhou, Chiny, 215004
        • Investigational Site Number 156035
      • Taiyuan, Chiny, 030001
        • Investigational Site Number 156033
      • Tianjin, Chiny, 300052
        • Investigational Site Number 156037
      • Xi'An, Chiny, 710032
        • Investigational Site Number 156022
      • Xi'An, Chiny, 710061
        • Investigational Site Number 156023
  • Hongkong
      • Hong Kong, Hongkong
        • Investigational Site Number 344001
      • Hong Kong, Hongkong
        • Investigational Site Number 344003
      • Shatin, Nt, Hongkong
        • Investigational Site Number 344002
  • Malezja
      • Kelantan, Malezja, 16150
        • Investigational Site Number 458001
      • Kuala Lumpur, Malezja, 59100
        • Investigational Site Number 458003
      • Putrajaya, Malezja, 62250
        • Investigational Site Number 458002
  • Tajlandia
      • Bangkok, Tajlandia, 10400
        • Investigational Site Number 764002

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion criteria:

- Type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit, insufficiently controlled with metformin alone or metformin with sulfonylurea at the time of the screening visit

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
  • Treatment with metformin not at a stable dose of at least 1.0 gram per day or more than 1.5 gram per day for at least 3 months prior to screening visit
  • In case of treatment with sulfonylurea, if the sulfonylurea dosage is less than the maximum effective dose (that is, half of the maximum recommended dose according to local labeling), or is not at a stable (unchanged) dose for at least 3 months prior to screening
  • FPG at screening >250 milligram per deciliter (mg/dL) (>13.9 millimole per liter [mmol/L])
  • History of hypoglycemia unawareness
  • Body mass index <=20 kilogram per square meter (kg/m^2)
  • Weight change of >5 kg during the 3 months preceding the screening visit
  • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, or inflammatory bowel disease or patients considered by the investigator at high risk for acute pancreatitis (for example, with known history of biliary gallstone[s], or with very high triglyceride level [>=5.65 mmol/L]) at the time of screening
  • Personal or family history of medullary thyroid cancer or genetic conditions that predispose to medullary thyroid cancer (for example, multiple endocrine neoplasia syndromes);
  • History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
  • Hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products 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
  • Cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult, history or presence of clinically significant diabetic retinopathy, history 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 blood pressure (SBP) or diastolic blood pressure (DBP) >180 millimeter of mercury (mmHg) or >95 mmHg, respectively
  • Laboratory findings at the time of screening: amylase and/or lipase: >3 times upper limit of normal (ULN); hemoglobin <11 gram/deciliter and/or neutrophils <1500 per cubic millimeter (mm^3) and/or platelets <100 000/mm^3; calcitonin >20 picogram per milliliter (5.9 picomole per liter) ; and positive test for Hepatitis B surface antigen and/or Hepatitis C antibody
  • 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
  • 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 attending 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; investigator or any sub-investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol)
  • Use of oral or injectable antidiabetic or hypoglycemic agents other than metformin and sulfonylurea (for example, alpha-glucosidase inhibitor, thiazolidinedione, glucagon-like peptide -1 [GLP-1], receptor agonist, dipeptidyl-peptidase-4 inhibitors, insulin) within 3 months prior to the time of screening
  • Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to the time of screening
  • Use of any investigational drug within 3 months prior to screening;
  • Participation in a previous study with lixisenatide
  • Renal impairment defined with creatinine >1.4 mg/dL in women and creatinine >1.5 mg/dL in men
  • 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
  • Allergic reaction to any GLP-1 agonist in the past (for example, exenatide, liraglutide) or to metacresol
  • Additional exclusion criteria at the end of the run-in phase: informed consent withdrawal; lack of compliance during the single-blind placebo run-in phase (>2 injections missed); and patient with any adverse event which precludes the inclusion in the study, as assessed by the investigator

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Lixisenatide
1-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 2 weeks, followed by 20 mcg QD up to Week 24.
Lek: Liksysenatyd (AVE0010)
Samodzielne wstrzyknięcie podskórne raz dziennie w ciągu godziny poprzedzającej śniadanie.
Urządzenie: Automatyczny wstrzykiwacz do wstrzykiwacza
Inne nazwy:
  • OptiClik®
Lek: Metformin
Metformin to be continued at stable dose (at least 1.0 gram per day and not more than 1.5 gram per day) up to Week 24.
Lek: Sulfonylurea
Sulfonylurea if given at screening, to be continued up to Week 24. In patients with a screening HbA1c <8% the dose is decreased by 25% to 50% at randomization and then increased up to the screening dose between Week 4 and 12 as per fasting self-monitored plasma glucose (SMPG) values. In patients with a screening HbA1c >=8%, the dose is not to be changed at randomization. In any case, after Week 12, sulfonylurea is to be continued at a stable dose.
Komparator placebo: Placebo
1-step initiation regimen of volume matching placebo: 10 mcg QD for 2 weeks, followed by 20 mcg QD up to Week 24.
Urządzenie: Automatyczny wstrzykiwacz do wstrzykiwacza
Inne nazwy:
  • OptiClik®
Lek: Metformin
Metformin to be continued at stable dose (at least 1.0 gram per day and not more than 1.5 gram per day) up to Week 24.
Lek: Sulfonylurea
Sulfonylurea if given at screening, to be continued up to Week 24. In patients with a screening HbA1c <8% the dose is decreased by 25% to 50% at randomization and then increased up to the screening dose between Week 4 and 12 as per fasting self-monitored plasma glucose (SMPG) values. In patients with a screening HbA1c >=8%, the dose is not to be changed at randomization. In any case, after Week 12, sulfonylurea is to be continued at a stable dose.
Lek: Placebo
Samodzielne wstrzyknięcie podskórne raz dziennie w ciągu godziny poprzedzającej śniadanie.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Ramy czasowe: 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 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 on-treatment assessment for at least 1 efficacy variable, were required.
Baseline, Week 24

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Ramy czasowe: Baseline, Week 24
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 1 day 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 on-treatment assessment for at least 1 efficacy variable, were required.
Baseline, Week 24
Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24
Ramy czasowe: 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.
Baseline, Week 24
Change From Baseline in Body Weight at Week 24
Ramy czasowe: Baseline, Week 24
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 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 on-treatment 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
Ramy czasowe: Week 24
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 on-treatment 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
Ramy czasowe: Week 24
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 on-treatment assessment for at least 1 efficacy variable, were required.
Week 24
Change From Baseline in Glucose Excursion at Week 24
Ramy czasowe: 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.
Baseline, Week 24
Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period
Ramy czasowe: Baseline up to Week 24
Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) 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 after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >250 milligram/deciliter (mg/dL) (13.9 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >220 mg/dL (12.2 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.
Baseline up to Week 24

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24
Ramy czasowe: Baseline, Week 24
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 on-treatment assessment for at least 1 efficacy variable, were required.
Baseline, Week 24
Liczba pacjentów z hipoglikemią objawową i ciężką hipoglikemią objawową
Ramy czasowe: Pierwsza dawka badanego leku do 3 dni po podaniu ostatniej dawki
Objawowa hipoglikemia była zdarzeniem z objawami klinicznymi, które uznano za wynik epizodu hipoglikemii z towarzyszącym stężeniem glukozy w osoczu poniżej 60 mg/dl (3,3 mmol/l) lub związane z szybkim powrotem do zdrowia po doustnym podaniu węglowodanów, dożylnym podaniu glukozy lub glukagonu, jeśli nie był dostępny pomiar stężenia glukozy w osoczu. Ciężka objawowa hipoglikemia była objawowym zdarzeniem hipoglikemii, w którym pacjent wymagał pomocy innej osoby i wiązało się albo ze stężeniem glukozy w osoczu poniżej 36 mg/dl (2,0 mmol/l) albo szybkim powrotem do zdrowia po doustnym podaniu węglowodanów, dożylnym podaniu glukozy lub glukagonu , jeśli nie był dostępny pomiar stężenia glukozy w osoczu.
Pierwsza dawka badanego leku do 3 dni po podaniu ostatniej dawki

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Sanofi

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 lipca 2010

Zakończenie podstawowe (Rzeczywisty)

1 grudnia 2011

Ukończenie studiów (Rzeczywisty)

1 grudnia 2011

Daty rejestracji na studia

Pierwszy przesłany

23 lipca 2010

Pierwszy przesłany, który spełnia kryteria kontroli jakości

23 lipca 2010

Pierwszy wysłany (Oszacować)

26 lipca 2010

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

13 października 2016

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 sierpnia 2016

Ostatnia weryfikacja

1 sierpnia 2016

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • EFC11321
  • U1111-1116-8938 (Inny identyfikator: UTN)

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Cukrzyca typu 2

Badania kliniczne na Liksysenatyd (AVE0010)

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