Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX) (IOOX)
4. december 2009 opdateret af: Eli Lilly and Company
Comparison of Two Approaches to Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control on Oral Therapy: Comparison of Premixed Insulin Lispro Mid Mixture With Separate Basal and Bolus Insulin Injections
A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
484
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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South Australia
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Keswick, South Australia, Australien, 5035
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Victoria
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Fitzroy, Victoria, Australien, 3065
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Western Australia
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Fremantle, Western Australia, Australien, 6160
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Ontario
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London, Ontario, Canada, N6A 4L2
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Quebec
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Granby, Quebec, Canada, J2G 1T7
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Sherbrooke, Quebec, Canada, J1G 5K2
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Saskatchewan
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Regina, Saskatchewan, Canada, S4P 0W5
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Arkhangelsk, Den Russiske Føderation, 163045
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Moscow, Den Russiske Føderation, 117036
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Saint Petersburg, Den Russiske Føderation, 193257
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Mantes La Jolie, Frankrig, 78200
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Menton, Frankrig, 06500
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Pau, Frankrig, 64000
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Poitiers, Frankrig, 86000
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Toulouse, Frankrig, 31082
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Goyang-Si/Kyunggi-Do, Korea, Republikken, 410-719
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Kwang Ju, Korea, Republikken, 501-757
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Seoul, Korea, Republikken, 110-746
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Chihuahua, Mexico, 31238
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Guadalajara, Mexico, 44620
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Alicante, Spanien, 03114
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Almeria, Spanien, 04001
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Barcelona, Spanien, 08017
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Bilbao, Spanien, 48013
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Malaga, Spanien, 29010
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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
30 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Have type 2 diabetes
- Have been receiving oral antihyperglycemic medications (OAM) without insulin including at least two of the following at maximally tolerated doses, AND meet the minimum dosing criteria shown: Metformin 1500 mg/day, Sulfonylurea 1/2 the maximum daily dose, according to package insert, Thiazolidinedione (TZD) 30 mg/day pioglitazone or 4 mg/day rosiglitazone. The OAMs also must be used in accordance with the product label
- Have a hemoglobin A1c greater than or equal to 7.5% and less than or equal to 12.0%.
Exclusion Criteria:
- Are taking a TZD dose greater than what is indicated in combination with insulin according to the TZD label.
- Are taking any other glucose-lowering agents not mentioned in Inclusion Criterion.
- Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks or for a total of 30 days or more in the last 24 weeks.
- Have a body mass index greater than 40 kg/m2.
- Have had more than one episode of severe hypoglycemia in the last24 weeks
- Are pregnant, intend to be pregnant during the course of the study or are breastfeeding
- Have clinically significant cardiac, renal, hematologic, oncologic, or hepatic disease
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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Eksperimentel: Insulin Lispro Mid Mixture
Insulin lispro mid mixture (MM) up to three times a day (TID)
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Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks
Andre navne:
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Aktiv komparator: Insulin Glargine
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
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Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Hemoglobin A1c (HbA1c) at 36 Week Endpoint
Tidsramme: 36 weeks
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Level of hemoglobin A1c at endpoint.
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36 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Hemoglobin A1c (HbA1c) at Interval Visits
Tidsramme: 12, 24, and 36 weeks
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Levels of HbA1c at 12 weeks and 24 weeks and 36 weeks.
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12, 24, and 36 weeks
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Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Tidsramme: 12-24-36 weeks
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12-24-36 weeks
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7-point Self-monitored Blood Glucose Profiles
Tidsramme: Baseline, 12-24-36 weeks
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Actual daily mean blood glucose levels at specified time points.
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Baseline, 12-24-36 weeks
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Glycemic Variability
Tidsramme: Baseline, 12-24-36 weeks
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Glycemic variability was measured by mean blood glucose value (M-value), which was the mean of the intra-days self-monitoring blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.
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Baseline, 12-24-36 weeks
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Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia
Tidsramme: Baseline to 36 Weeks
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Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level <70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines.
Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking.
Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime.
Overall episodes: those that occurred at any time during the post-randomization visits.
Endpoint: last visit interval based on LOCF.
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Baseline to 36 Weeks
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30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)
Tidsramme: Baseline to 36 Weeks
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Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level <70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines.
Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking.
Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime.
Overall episodes: those that occurred at any time during the post-randomization visits.
Endpoint: last visit interval based on LOCF.
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Baseline to 36 Weeks
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Number of Patients With at Least One Severe Hypoglycemia Episode
Tidsramme: Baseline to 36 Weeks
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Severe hypoglycemia was defined as hypoglycemic event that meets at least one of the following criteria: not capable of treating self and blood glucose <2.8 millimoles per liter (mmol/L); not capable of treating self, blood glucose is missing and prompt recovery after oral carbohydrate or glucagon or intravenous glucose; hypoglycemic event outcome was coma, hopitalization, emergency room visit, or automobile accident.
The overall category is a severe hypoglycemic event that occurred at any time during the post-randomization visits.
Endpoint: last visit interval based on LOCF.
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Baseline to 36 Weeks
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Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial
Tidsramme: 36 Weeks
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Total daily insulin dose adjusted for body weight (Units of insulin per kilogram per day [U/kg/day]) was assessed.
Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations.
Prandial insulin is taken at meal time.
Insulin glargine is a basal insulin and insulin lispro is a prandial insulin.
Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro.
Endpoint: last visit interval based on LOCF.
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36 Weeks
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Endpoint Insulin Dose; Total, Basal, and Prandial
Tidsramme: 36 Weeks
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Total daily insulin dose (Units of insulin per day [U/day]) was assessed.
Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations.
Prandial insulin is taken at meal time.
Insulin glargine is a basal insulin and insulin lispro is a prandial insulin.
Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro.
Endpoint: last visit interval based on LOCF.
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36 Weeks
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Number of Insulin Injections Per Day
Tidsramme: Weeks 12, 24, 30, 36
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Weeks 12, 24, 30, 36
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Change From Baseline in Absolute Body Weight at 36 Week Endpoint
Tidsramme: Baseline, 36 Weeks
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Change in body weight was calculated as weight at endpoint (last observation carried forward) minus weight at baseline.
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Baseline, 36 Weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
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. august 2006
Primær færdiggørelse (Faktiske)
1. september 2008
Studieafslutning (Faktiske)
1. september 2008
Datoer for studieregistrering
Først indsendt
11. september 2006
Først indsendt, der opfyldte QC-kriterier
14. september 2006
Først opslået (Skøn)
19. september 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
9. december 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. december 2009
Sidst verificeret
1. december 2009
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 10936 (Registry Identifier: DAIDS ES)
- F3Z-MC-IOOX
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 .