Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX) (IOOX)
4 dicembre 2009 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
484
Fase
- Fase 4
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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South Australia
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Keswick, South Australia, Australia, 5035
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Victoria
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Fitzroy, Victoria, Australia, 3065
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Western Australia
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Fremantle, Western Australia, Australia, 6160
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ontario
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London, Ontario, Canada, N6A 4L2
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Goyang-Si/Kyunggi-Do, Corea, Repubblica di, 410-719
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Kwang Ju, Corea, Repubblica di, 501-757
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Seoul, Corea, Repubblica di, 110-746
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Arkhangelsk, Federazione Russa, 163045
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Moscow, Federazione Russa, 117036
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Saint Petersburg, Federazione Russa, 193257
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mantes La Jolie, Francia, 78200
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Menton, Francia, 06500
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Pau, Francia, 64000
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Poitiers, Francia, 86000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Toulouse, Francia, 31082
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Chihuahua, Messico, 31238
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Guadalajara, Messico, 44620
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Alicante, Spagna, 03114
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Almeria, Spagna, 04001
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Barcelona, Spagna, 08017
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Bilbao, Spagna, 48013
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Malaga, Spagna, 29010
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 30 anni a 80 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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
Altri nomi:
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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Hemoglobin A1c (HbA1c) at 36 Week Endpoint
Lasso di tempo: 36 weeks
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Level of hemoglobin A1c at endpoint.
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36 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Hemoglobin A1c (HbA1c) at Interval Visits
Lasso di tempo: 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
Lasso di tempo: 12-24-36 weeks
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12-24-36 weeks
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7-point Self-monitored Blood Glucose Profiles
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: 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
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2006
Completamento primario (Effettivo)
1 settembre 2008
Completamento dello studio (Effettivo)
1 settembre 2008
Date di iscrizione allo studio
Primo inviato
11 settembre 2006
Primo inviato che soddisfa i criteri di controllo qualità
14 settembre 2006
Primo Inserito (Stima)
19 settembre 2006
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
9 dicembre 2009
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 dicembre 2009
Ultimo verificato
1 dicembre 2009
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 10936 (Identificatore di registro: DAIDS ES)
- F3Z-MC-IOOX
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .