- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00941369
Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-Naive Type 2 Diabetes Patients
Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-naive Type 2 Diabetes Patients Uncontrolled on Oral Hypoglycemic Agent Treatment Initiating Basal Insulin Therapy With Either Insulin Glargine or NPH Insulin
Primary Objective:
To investigate the impact of insulin glargine versus Neutral Protamine Hagedorn basal insulin on a composite diabetes related quality of life score (DRQoL).
Secondary Objective:
A comparison of combination therapy with insulin glargine versus Neutral Protamine Hagedorn basal insulin from baseline to endpoint in terms of:
- Glycaemic parameters: 7 blood glucose profiles
- Incidence of confirmed symptomatic hypoglycemia as well as confirmed severe hypoglycemia
- Change in lipid status
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
-
-
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Berlin, Germania
- Sanofi-Aventis Administrative Office
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion criteria:
- Patients with type 2 diabetes mellitus (no history of ketoacidosis) according to ADA criteria.
- Treatment with a combination of maximum 2 substance classes on a stable dosage during the last 3 months: metformin and/or sulfonylurea.
- No pre-treatment with any insulin in the last 3 months before the study.
- Glycated Haemoglobin A1c (HbA1c) value between > or = 7.0 and > or = 9.5%
- Fasting Blood Glucose (FBG) > or = 120 mg/dl (6.7 mmol/l).
- Body mass index < 40 kg/m.
- Ability to read and understand German language.
- Ability and willingness to follow a tight antidiabetic therapy and to perform blood glucose self monitoring on a regular basis.
- Women of childbearing potential who will take adequate contraceptive protection.
Exclusion criteria:
- Patients with type 1 diabetes mellitus.
- Any history of ketoacidosis.
- Pregnancy.
- Prior treatment with insulin.
- Treatment with more than two oral agents within the last 3 months or continuous treatment with thiazolidinediones, GLP-1 receptor agonists or with Dipeptidyl-Peptidase IV (DPP-IV) inhibitors.
- History of drug or alcohol abuse.
- Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the last 3 months prior to study entry or which may require surgical treatment within 3 months of study entry.
- Following pancreatectomy.
- Impaired hepatic function.
- Impaired renal function.
- Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
- Evidence of an uncooperative attitude, including poor compliance to any (antidiabetic) treatment.
- Inability to attend follow-up visits.
- Current treatment because of a mental disorder according to ICD 10(F 5 Diagnoses).
- Patients that are in a relationship of dependance with the investigator(s) and/or the sponsor.
- Systemic corticoids > 7,5 mg prednisolon equivalent or <or=7,5 mg prednisolon equivalent for less than 2 months.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 1
Insulin glargine: Lantus® (100 U/ml) in TactiPen® re-usable pen
|
Arm 1: Subcutaneous injection of Insulin Glargine with the TactiPen® injector pen once daily at any time, but each day at the same time Arm 2: Subcutaneous injection of Protamine Hagedorn basal insulin with the TactiPen® injector pen once or twice daily at the discretion of the treating physician The starting dose is 10 I.U. (NPH basal insulin) resp. 10 U (insulin glargine) per day. The dose adjustments will be based on the results of self-monitoring. |
Comparatore attivo: 2
Neutral Protamine Hagedorn basal insulin: Insuman® Basal (100 I.U./ml) in TactiPen® re-usable pen
|
Arm 1: Subcutaneous injection of Insulin Glargine with the TactiPen® injector pen once daily at any time, but each day at the same time Arm 2: Subcutaneous injection of Protamine Hagedorn basal insulin with the TactiPen® injector pen once or twice daily at the discretion of the treating physician The starting dose is 10 I.U. (NPH basal insulin) resp. 10 U (insulin glargine) per day. The dose adjustments will be based on the results of self-monitoring. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Health Assessment, Patient treatment satisfaction and Quality-of-Life
Lasso di tempo: At baseline (visit 2: randomization), at 24 weeks after the randomization (visit 7: cross over visit) and 48 weeks after the randomization (visit 12: endpoint)
|
At baseline (visit 2: randomization), at 24 weeks after the randomization (visit 7: cross over visit) and 48 weeks after the randomization (visit 12: endpoint)
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Glycaemic parameters assessment
Lasso di tempo: At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)
|
At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)
|
Anteropometric data (Weight, waist circumference) assessment
Lasso di tempo: At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)
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At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)
|
Lipid assessment
Lasso di tempo: At 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)
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At 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)
|
Hypoglycemia assessment
Lasso di tempo: Throughout the study from starting until the week 48
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Throughout the study from starting until the week 48
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Heinz Riederer, Sanofi
Pubblicazioni e link utili
Pubblicazioni generali
- Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
- Hermanns N, Kulzer B, Kohlmann T, Jacob S, Landgraf W, Theobald K, Haak T. Treatment satisfaction and quality-of-life between type 2 diabetes patients initiating long- vs. intermediate-acting basal insulin therapy in combination with oral hypoglycemic agents--a randomized, prospective, crossover, open clinical trial. Health Qual Life Outcomes. 2015 Jun 9;13:77. doi: 10.1186/s12955-015-0279-4.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- LANTU_L_04079
- 2009-019013-59(EudraCT)
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 .
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