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Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide

12 janvier 2011 mis à jour par: Eli Lilly and Company

A Randomized Trial Comparing Insulin Lispro Protamine Suspension With Insulin Glargine in Subjects With Type 2 Diabetes on Oral Antihyperglycemic Medications and Exenatide

This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.

Aperçu de l'étude

Statut

Complété

Les conditions

Diabète sucré, Type 2

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

339

Phase

Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Porto Rico
- - Ponce, Porto Rico, 00731
    - 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.
  - Toa Baja, Porto Rico, 00949
    - 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.
  - Yabucoa, Porto Rico, 00767
    - 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.
États-Unis
- Arizona
  - Phoenix, Arizona, États-Unis, 85028
    - 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.
- California
  - Concord, California, États-Unis, 94520
    - 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.
  - Escondido, California, États-Unis, 92026
    - 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.
  - Fresno, California, États-Unis, 93720
    - 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.
  - Modesto, California, États-Unis, 95355
    - 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.
  - Orange, California, États-Unis, 92869
    - 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.
- Florida
  - Inverness, Florida, États-Unis, 34452
    - 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.
  - Jacksonville, Florida, États-Unis, 32204
    - 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.
  - Lake Worth, Florida, États-Unis, 33461
    - 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.
  - Miami, Florida, États-Unis, 33183
    - 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.
  - Orlando, Florida, États-Unis, 32804
    - 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.
  - Palm Harbor, Florida, États-Unis, 34684
    - 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.
  - Pembroke Pines, Florida, États-Unis, 33029
    - 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.
  - Plantation, Florida, États-Unis, 33324
    - 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.
  - West Palm Beach, Florida, États-Unis, 33401
    - 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.
- Hawaii
  - Honolulu, Hawaii, États-Unis, 96813
    - 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.
- Idaho
  - Idaho Falls, Idaho, États-Unis, 83404
    - 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.
- Indiana
  - Avon, Indiana, États-Unis, 46123
    - 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.
  - Bloomington, Indiana, États-Unis, 47403
    - 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.
  - South Bend, Indiana, États-Unis, 46617
    - 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.
- Iowa
  - Des Moines, Iowa, États-Unis, 50314
    - 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.
- Kentucky
  - Lexington, Kentucky, États-Unis, 40503
    - 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.
- Louisiana
  - Baton Rouge, Louisiana, États-Unis, 70808
    - 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.
  - Lafayette, Louisiana, États-Unis, 70503
    - 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.
  - Metairie, Louisiana, États-Unis, 70006
    - 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.
- Maine
  - Biddeford, Maine, États-Unis, 04005
    - 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.
- Missouri
  - Chesterfield, Missouri, États-Unis, 63017
    - 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.
  - Jefferson City, Missouri, États-Unis, 65109
    - 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.
  - St Louis, Missouri, États-Unis, 63104
    - 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.
- Nebraska
  - Omaha, Nebraska, États-Unis, 68131
    - 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.
- Nevada
  - Las Vegas, Nevada, États-Unis, 89148
    - 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.
- New Hampshire
  - Nashua, New Hampshire, États-Unis, 03063
    - 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.
- New York
  - Rochester, New York, États-Unis, 14607
    - 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.
  - Syracuse, New York, États-Unis, 13210
    - 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.
- North Carolina
  - Morehead City, North Carolina, États-Unis, 28557
    - 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.
- Ohio
  - London, Ohio, États-Unis, 43140
    - 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.
  - Mason, Ohio, États-Unis, 45040
    - 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.
  - Toledo, Ohio, États-Unis, 43606
    - 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.
- South Carolina
  - Greer, South Carolina, États-Unis, 29651
    - 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.
  - Myrtle Beach, South Carolina, États-Unis, 29572
    - 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.
- Tennessee
  - Kingsport, Tennessee, États-Unis, 37660
    - 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.
  - Memphis, Tennessee, États-Unis, 38119
    - 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.
- Texas
  - Austin, Texas, États-Unis, 78731
    - 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.
  - Dallas, Texas, États-Unis, 75231
    - 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.
  - San Antonio, Texas, États-Unis, 78229
    - 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.
- Vermont
  - South Burlington, Vermont, États-Unis, 05403
    - 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.
- Virginia
  - Virginia Beach, Virginia, États-Unis, 23462
    - 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.
- Washington
  - Spokane, Washington, États-Unis, 99202
    - 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.
  - Vancouver, Washington, États-Unis, 98664
    - 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.

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 74 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

Must have type 2 diabetes
Must be at least 18 years of age and less than 75 years of age
Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months
Must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (TZD). Doses must be at or above the following: Metformin--1500 mg/day, Sulfonylurea--1/2 the maximum daily dose according to the product label, TZD--30 mg/day pioglitazone
Must have a hemoglobin A1C greater than or equal to 7.0% and less than or equal to 10.0%

Exclusion Criteria:

Must not have used insulin on a regular basis during the past 2 years
Must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months
Must not have had more than one episode of severe hypoglycemia in the past 6 months
Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease
Must not be pregnant or intend to get pregnant during the course of the study

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Objectif principal: Traitement
Répartition: Randomisé
Modèle interventionnel: Affectation parallèle
Masquage: Aucun (étiquette ouverte)

Nombre de bras

Armes et Interventions

Groupe de participants / Bras	Intervention / Traitement
Comparateur actif: ILPS Insulin Lispro Protamine Suspension (ILPS)	Médicament: Insulin Lispro Protamine Suspension Administered subcutaneously once a day at bedtime Autres noms: LY275585[P]
Comparateur actif: Glargine Insulin Glargine	Médicament: Insulin Glargine Administered subcutaneously once a day at bedtime Autres noms: Lantus

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF]) Délai: Baseline, Endpoint (LOCF) up to 24 weeks	Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.	Baseline, Endpoint (LOCF) up to 24 weeks

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF) Délai: 24 weeks, Endpoint (LOCF) up to 24 weeks	Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.	24 weeks, Endpoint (LOCF) up to 24 weeks
Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF) Délai: Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks	Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.	Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks
Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5% Délai: Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks		Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF) Délai: Baseline, Endpoint (LOCF) up to 24 weeks	SMBG at morning pre-meal, morning post-prandial, midday pre-meal, midday post-prandial, evening pre-meal, evening postprandial, 0300 hours. Post-prandial glucose is measured 2 hours after the start of the meal.	Baseline, Endpoint (LOCF) up to 24 weeks
Glycemic Variability at Baseline and Endpoint (LOCF) Délai: Baseline, Endpoint (LOCF) up to 24 weeks	Glycemic variability was defined as the standard deviation (SD) of a participant's intra-day 7-point, self-monitored, blood glucose. Mean SD was calculated based on the SD for each participant in the study.	Baseline, Endpoint (LOCF) up to 24 weeks
Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe) Délai: Baseline to Endpoint (LOCF) up to 24 weeks	Overall:any time after randomization.Episode:any time patient experienced sign/symptom associated with hypoglycemia, or had blood glucose level ≤70 mg/dL. Non-nocturnal:any episode that occurred between waking and bedtime. Nocturnal:any episode that occurred between bedtime and waking.Severe:episode with symptoms consistent with neuroglycopenia in which patient requires assistance,and is associated with:blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.Incidence(%)=(Number of patients experiencing episodes/number of patients in arm)*100.	Baseline to Endpoint (LOCF) up to 24 weeks
Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year) Délai: Baseline to Endpoint (LOCF) up to 24 weeks	Rate of self-reported hypoglycemic episodes, all, non-nocturnal, and nocturnal, at Endpoint (LOCF) and overall. Rate is reported as episodes/participant/365 days. Episode = any time participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if it was not associated with signs, symptoms, or treatment. Overall=any time during the post-randomization visits within the study period. Nocturnal=Any episode that occurs between bedtime and waking. Non-Nocturnal=Any episode that occurs between waking and bedtime.	Baseline to Endpoint (LOCF) up to 24 weeks
Actual Body Weight at Baseline and Endpoint (LOCF) Délai: Baseline, Endpoint (LOCF) up to 24 weeks		Baseline, Endpoint (LOCF) up to 24 weeks
Change From Baseline in Body Weight at Endpoint (LOCF) Délai: Baseline, Endpoint (LOCF) up to 24 weeks		Baseline, Endpoint (LOCF) up to 24 weeks
Total Daily Insulin Dose at Endpoint (LOCF) Délai: Endpoint (LOCF) up to 24 weeks		Endpoint (LOCF) up to 24 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Eli Lilly and Company

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 novembre 2007

Achèvement primaire (Réel)

1 décembre 2009

Achèvement de l'étude (Réel)

1 décembre 2009

Dates d'inscription aux études

Première soumission

15 novembre 2007

Première soumission répondant aux critères de contrôle qualité

15 novembre 2007

Première publication (Estimation)

19 novembre 2007

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

13 janvier 2011

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 janvier 2011

Dernière vérification

1 janvier 2011

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

11647
F3Z-US-IOPB (Autre identifiant: Eli Lilly and Company)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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Complété

Évaluation DigiDiab Soins infirmiers à domicile

Diabète de type 2 | Diabète sucré de type 2 (DT2) | Diabète de type 2, nécessitant de l'insuline

L'Autriche
Virginia Commonwealth University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recrutement

Intégration d'un programme de produits sur ordonnance dans un programme de prévention du diabète

Diabète de type 2

États-Unis

Essais cliniques sur Insulin Lispro Protamine Suspension

Eli Lilly and Company

Complété

Comparaison de l'efficacité et de l'innocuité de deux stratégies d'intensification de l'insuline

Diabète sucré, Type 2

Turquie, Argentine, Corée, République de, Brésil, Chine, Egypte, Inde, Espagne
Eli Lilly and Company

Complété

Effets de l'insuline sur les symptômes de l'humeur perçue chez les patients atteints de diabète de type 2

Diabète de type 2

États-Unis
Sanofi

Complété

Lantus Versus Humalog Mix en tant que traitement d'appoint chez les patients atteints de diabète de type échec du traitement associant sulfonylurée et metformine

Diabète sucré, Type 2

États-Unis
Eli Lilly and Company

Complété

Comparaison de deux thérapies à l'insuline basale pour les patients atteints de diabète de type 1 (IOOZ)

Diabète sucré, type 1

Fédération Russe, États-Unis, Australie, Grèce, Argentine, Hongrie, Brésil, Mexique, Roumanie

Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide

A Randomized Trial Comparing Insulin Lispro Protamine Suspension With Insulin Glargine in Subjects With Type 2 Diabetes on Oral Antihyperglycemic Medications and Exenatide

Aperçu de l'étude

Statut

Les conditions

Intervention / Traitement

Type d'étude

Inscription (Réel)

Phase

Contacts et emplacements

Lieux d'étude

Critères de participation

Critère d'éligibilité

Âges éligibles pour étudier

Accepte les volontaires sains

Sexes éligibles pour l'étude

La description

Plan d'étude

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de bras

Armes et Interventions

Groupe de participants / Bras

Intervention / Traitement

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats

Description de la mesure

Délai

Mesures de résultats secondaires

Mesure des résultats

Description de la mesure

Délai

Collaborateurs et enquêteurs

Parrainer

Dates d'enregistrement des études

Dates principales de l'étude

Début de l'étude

Achèvement primaire (Réel)

Achèvement de l'étude (Réel)

Dates d'inscription aux études

Première soumission

Première soumission répondant aux critères de contrôle qualité

Première publication (Estimation)

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

Dernière mise à jour soumise répondant aux critères de contrôle qualité

Dernière vérification

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

Essais cliniques sur Diabète sucré, Type 2

Essais cliniques sur Insulin Lispro Protamine Suspension

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Cyprus

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements