A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients
11. maj 2011 opdateret af: Eli Lilly and Company
A Prospective Randomized Trial to Compare Basal Bolus Therapies That Use Either Insulin Lispro Protamine Suspension or Insulin Glargine Together With Lispro Insulin in Patients With Type 2 Diabetes
This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension (ILPS) provides the same glycemic control as a basal bolus regimen of insulin glargine (when one basal bolus regimen is injected once daily together with insulin lispro injected 2-3 times daily).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
374
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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Genk, Belgien, 3600
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Leuven, Belgien, 3000
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Willebroek, Belgien, 2830
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Scotland
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Edinburgh, Scotland, Det Forenede Kongerige, EH3 9YW
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South Yorkshire
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Sheffield, South Yorkshire, Det Forenede Kongerige, S5 7AU
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Warwickshire
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Rugby, Warwickshire, Det Forenede Kongerige, CV22 5PX
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West Midlands
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West Bromwich, West Midlands, Det Forenede Kongerige, B71 4HJ
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Athens, Grækenland, 11526
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Larissa, Grækenland, 41221
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Thessaloniki, Grækenland, 56429
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Ancona, Italien, 60131
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Bari, Italien, 70124
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Milano, Italien, 20162
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Padova, Italien, 35143
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Pistoia, Italien, 51100
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Ravenna, Italien, 48100
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Rome, Italien, 00189
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Bornova, Kalkun, 35100
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Istanbul, Kalkun, 34662
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Izmir, Kalkun, 35360
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Gorzow Wielkopolski, Polen, 66-400
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Krakow, Polen, 31-159
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Lodz, Polen, 93-338
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Lubin, Polen, 59-301
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Mielec, Polen, 39-300
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Poznan, Polen, 61-696
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Warsaw, Polen, 02-577
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Wroclaw, Polen, 503-349
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Baia Mare, Rumænien, 430071
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Bucharest, Rumænien, 020475
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Cluj-Napoca, Rumænien, 400006
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Sf Gheorghe, Rumænien
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Banska Bystrica, Slovakiet, 97405
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Bratislava, Slovakiet, 821 06
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Modra, Slovakiet, 900 01
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Nitra, Slovakiet, 94901
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Holesov, Tjekkiet, 769 01
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Hranice I-Mesto, Tjekkiet, 753 01
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Olomouc, Tjekkiet, 77200
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Ostrava, Tjekkiet, 709 00
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Plzen, Tjekkiet, 301 66
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Prague, Tjekkiet, 149 00
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Bad Mergentheim, Tyskland, D-97980
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Berlin, Tyskland, D-12351
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Damme, Tyskland, D-49401
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Dresden, Tyskland, D-01219
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Hamburg, Tyskland, D-22177
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Hannover, Tyskland, 30519
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Pirna, Tyskland, 01796
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Rotenburg-Fulda, Tyskland, D-36199
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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:
- Diabetes Mellitus, Type 2
- Have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to Visit 1 (Screening)
- Hemoglobin A1C (HbA1c) greater than or equal to 7.5% and less than or equal to 11.0%
- Body Mass Index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m^2
- Capable and willing to follow the protocol
- Give written consent
Exclusion Criteria:
- Are taking any glucose-lowering agents (other than those listed in the inclusion criteria above)
- Have a history of severe hypoglycemia in the past 6 months
- Are pregnant or may become pregnant
- Women who are breastfeeding
- Have significant cardiac disease
- Have significant renal or liver disease
- Undergoing therapy for a malignancy
- Contraindications to the study medications
- Have an irregular sleep/wake cycle
- Have a serious disease or any condition considered by the investigator to be exclusionary
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Glargine
Glargine plus Insulin Lispro (2-3 injections)
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patient glucose-level dependent, injection, once daily in the evening, 24 weeks
subcutaneous injections prior to meals, 24 weeks
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Eksperimentel: ILPS
Insulin Lispro Protamine Suspension (ILPS) plus Insulin Lispro (2-3 injections)
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subcutaneous injections prior to meals, 24 weeks
patient glucose-level dependent, injection, once daily in the evening, 24 weeks
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24
Tidsramme: Baseline, Week 24
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Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value.
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Baseline, Week 24
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change From Baseline in HbA1c at Week 12 and Week 24
Tidsramme: Baseline, Week 12, Week 24
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LSMean values presented were controlled for treatment, country, baseline HbA1C value and week.
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Baseline, Week 12, Week 24
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Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint
Tidsramme: Week 24
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Week 24
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7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint
Tidsramme: 24 weeks
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LSMean values presented were controlled for treatment, country, and baseline HbA1C value.
SMBG at morning pre-meal, morning postprandial, midday pre-meal, midday postprandial, evening pre-meal, evening postprandial, 0300 hours.
Postprandial glucose is measured 2 hours after the start of the meal.
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24 weeks
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Glycemic Variability at Endpoint
Tidsramme: Week 24
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LSMeans were controlled for treatment and country grouping (Mediterranean, rest of Europe).
Glycemic variability was assessed as the standard deviations of 4 fasting SMBG samples, 4 post-breakfast measurements, 4 post-lunch measurements, 4 post-evening meal measurements.
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Week 24
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Rate Of All Self-reported Hypoglycemic Episodes
Tidsramme: Baseline through Week 24
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Rate of self-reported hypoglycemic episodes, all, non-nocturnal,and nocturnal, severe, documented ≤3.9 mmol/L and ≤3.0 mmol/L.
Rate=episodes/30 days/patient/.
Episode=any time a patient has a symptom associated with hypoglycemia or blood glucose level of ≤70 mg/dL,even if not associated with symptoms.Overall=any time post-randomization in the study period.
Nocturnal=Episode between bedtime and waking.
Non-Nocturnal=Episode between waking and bedtime.Severe:episode in which patient requires assistance,and has glucose <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
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Baseline through Week 24
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Percentage of Participants With Self-Reported Hypoglycemic Episodes
Tidsramme: Baseline through Week 24
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Episode=any time a patient feels that he/she is experiencing a sign or symptom associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if not associated with signs,symptoms, or treatment.
Overall=any time post-randomization visits in the study period.
Nocturnal=Episode that occurs between bedtime and waking.
Non-Nocturnal=Episode occurring between waking and bedtime.
Severe=episode with symptoms of neuroglycopenia in which patient requires assistance,and has blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.
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Baseline through Week 24
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Number of Participants With Adverse Events (AE)
Tidsramme: Baseline through Week 24
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A listing of adverse events is located in the Reported Adverse Event module.
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Baseline through Week 24
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Change in Body Weight From Baseline to Week 24
Tidsramme: Baseline, Week 24
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LSMean values presented were controlled for treatment, country, and baseline HbA1C value.
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Baseline, Week 24
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Total Daily Insulin Dose at Endpoint
Tidsramme: Week 24
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LSMean values presented were controlled for treatment, country, and baseline HbA1C value.
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Week 24
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Number of Injections of Insulin at Week 24
Tidsramme: Week 24
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Week 24
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. april 2008
Primær færdiggørelse (Faktiske)
1. februar 2010
Studieafslutning (Faktiske)
1. februar 2010
Datoer for studieregistrering
Først indsendt
23. april 2008
Først indsendt, der opfyldte QC-kriterier
23. april 2008
Først opslået (Skøn)
25. april 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. maj 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. maj 2011
Sidst verificeret
1. maj 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Sygdomme i det endokrine system
- Diabetes mellitus
- Diabetes mellitus, type 2
- Hypoglykæmiske midler
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Koagulanter
- Heparin-antagonister
- Insulin
- Insulin, Globin Zink
- Insulin Glargine
- Insulin Lispro
- Protaminer
Andre undersøgelses-id-numre
- 12047 (Registry Identifier: DAIDS-ES Registry Number)
- F3Z-EW-IOPJ (Anden identifikator: Eli Lilly and Company)
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 .