Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin
12. juni 2015 opdateret af: Sanofi
A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Metformin
Primary Objective:
- To assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to basal insulin with or without metformin in terms of HbA1c reduction over a period of 24 weeks in insufficiently controlled type 2 diabetic patients.
Secondary Objectives:
To assess the effects of lixisenatide over 24 weeks on :
- percentage of patients reaching HbA1c<7% or ≤6.5%,
- 2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during standardized meal challenge test,
- fasting plasma glucose (FPG),
- change in 7-point self-monitored plasma glucose (SMPG) profile),
- body weight,
- change in daily basal insulin dose.
- To assess lixisenatide safety and tolerability.
- To assess anti-lixisenatide antibody development.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Maximum study duration of approximately 35 weeks ± 9 days (up to 2 weeks screening + 8 weeks run-in + 24 weeks double-blind treatment+ 3 days follow-up)
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
447
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Kirov, Den Russiske Føderation, 610014
- Investigational Site Number 643007
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Samara, Den Russiske Føderation, 443067
- Investigational Site Number 643006
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St-Petersburg, Den Russiske Føderation, 194354
- Investigational Site Number 643003
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St-Petersburg, Den Russiske Føderation, 194354
- Investigational Site Number 643004
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St-Petersburg, Den Russiske Føderation, 195112
- Investigational Site Number 643005
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Ahmedabad, Indien, 380008
- Investigational Site Number 356019
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Aligarh, Indien, 202 002
- Investigational Site Number 356018
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Bangalore, Indien, 560092
- Investigational Site Number 356026
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Bhubaneswar, Indien, 751005
- Investigational Site Number 356017
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Hyderabad, Indien, 500004
- Investigational Site Number 356002
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Hyderabad, Indien, 500063
- Investigational Site Number 356024
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Nagpur, Indien, 440012
- Investigational Site Number 356015
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Pune, Indien, 411001
- Investigational Site Number 356008
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Secunderabad, Indien, 500003
- Investigational Site Number 356021
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Visakhapatnam, Indien, 530002
- Investigational Site Number 356023
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Beijing, Kina, 100029
- Investigational Site Number 156001
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Beijing, Kina, 100034
- Investigational Site Number 156033
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Beijing, Kina, 100088
- Investigational Site Number 156006
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Beijing, Kina, 100700
- Investigational Site Number 156005
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Beijing, Kina, 100730
- Investigational Site Number 156004
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Beijing, Kina, 100853
- Investigational Site Number 156002
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Changchun, Kina, 130041
- Investigational Site Number 156016
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Changsha, Kina, 410011
- Investigational Site Number 156025
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Chengdu, Kina, 610041
- Investigational Site Number 156014
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Chengdu, Kina, 610072
- Investigational Site Number 156013
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Dalian, Kina, 116027
- Investigational Site Number 156034
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Fuzhou, Kina, 354200
- Investigational Site Number 156035
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Guangzhou, Kina, 510515
- Investigational Site Number 156021
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Haikou, Kina, 570311
- Investigational Site Number 156023
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Harbin, Kina, 150001
- Investigational Site Number 156017
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Jinan, Kina, 250012
- Investigational Site Number 156026
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Jinan, Kina, 250013
- Investigational Site Number 156029
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Nanjing, Kina, 210008
- Investigational Site Number 156019
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Nanjing, Kina, 210011
- Investigational Site Number 156020
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Qingdao, Kina, 266003
- Investigational Site Number 156018
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Shanghai, Kina, 200003
- Investigational Site Number 156028
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Shanghai, Kina, 200072
- Investigational Site Number 156007
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Shenyang, Kina, 110022
- Investigational Site Number 156032
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Shijiazhuang, Kina, 050051
- Investigational Site Number 156009
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Siping, Kina, 136000
- Investigational Site Number 156036
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Suzhou, Kina, 215004
- Investigational Site Number 156010
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Tianjin, Kina, 300052
- Investigational Site Number 156008
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Wuhan, Kina, 430030
- Investigational Site Number 156027
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Xi'An, Kina, 710032
- Investigational Site Number 156011
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Xi'An, Kina, 710061
- Investigational Site Number 156012
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Daegu, Korea, Republikken, 705-703
- Investigational Site Number 410003
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Goyang, Korea, Republikken, 411-706
- Investigational Site Number 410007
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Seoul, Korea, Republikken, 130-872
- Investigational Site Number 410006
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Seoul, Korea, Republikken, 136-705
- Investigational Site Number 410001
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Seoul, Korea, Republikken, 139-872
- Investigational Site Number 410005
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Wonju, Korea, Republikken, 220-701
- Investigational Site Number 410002
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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 :
- Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year at the time of the screening visit insufficiently controlled with basal insulin± metformin.
Exclusion criteria:
At screening:
- Age < legal age of adulthood.
- HbA1c<7% or >10.5%.
- Basal insulin treatment has not been at a stable regimen for at least 3 months and at a stable dose (± 20%) of at least 15 U/day for at least 2 months prior to screening visit.
- If metformin is given, metformin treatment has not been at a stable dose of at least 1.0 g/day for at least 3 months prior to screening visit.
- History of hypoglycemia unawareness.
- Body Mass Index (BMI) ≤20 kg/m².
- Use of other oral or injectable glucose-lowering agents other than basal insulin or metformin within 3 months prior to the time of screening.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Lixisenatide
24-week treatment with lixisenatide once daily on top of basal insulin with or without metformin (at least 1.0g/day)
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Pharmaceutical form:solution Route of administration: subcutaneous injection |
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Placebo komparator: Placebo
24-week treatment with placebo once daily on top of basal insulin with or without metformin (at least 1.0g/day)
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Pharmaceutical form:solution Route of administration: subcutaneous injection |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Ændring i HbA1c
Tidsramme: fra baseline til uge 24
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fra baseline til uge 24
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Percentage of patients with HbA1c <7%, =<6.5%
Tidsramme: at week 24
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at week 24
|
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Change in 2-hour postprandial plasma glucose and plasma glucose excursion
Tidsramme: from baseline to week 24
|
from baseline to week 24
|
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Change in fasting plasma glucose
Tidsramme: from baseline to week 24
|
from baseline to week 24
|
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Change in 7-point self monitoring plasma glucose profile (average and each point)
Tidsramme: from baseline to week 24
|
from baseline to week 24
|
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Change in body weight
Tidsramme: from baseline to week 24
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from baseline to week 24
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Change in daily basal insulin dose
Tidsramme: from baseline to week 24
|
from baseline to week 24
|
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Antal patienter med bivirkninger
Tidsramme: 24 uger
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24 uger
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Anti-lixisenatide antibody assessment
Tidsramme: from baseline to week 24
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from baseline to week 24
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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.
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 2012
Primær færdiggørelse (Faktiske)
1. maj 2015
Studieafslutning (Faktiske)
1. maj 2015
Datoer for studieregistrering
Først indsendt
26. juni 2012
Først indsendt, der opfyldte QC-kriterier
29. juni 2012
Først opslået (Skøn)
2. juli 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
15. juni 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. juni 2015
Sidst verificeret
1. juni 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EFC12382
- U1111-1124-1213 (Anden identifikator: UTN)
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 .