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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00762684
Efficacy and Safety Study of TAK-559 in Treating Subjects With Type 2 Diabetes Mellitus
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Study of the Safety and Efficacy of TAK-559 Compared to Placebo in the Treatment of Patients With Type 2 Diabetes Mellitus
Panoramica dello studio
Descrizione dettagliata
Insulin is a primary regulator of blood glucose concentrations. A subnormal response to circulating insulin levels at target tissues leads to a decrease in insulin-mediated glucose uptake. Insulin resistance is associated with normal to high insulin levels and is often accompanied by dyslipidemia, a disruption in lipid metabolism resulting in increased triglycerides and low-density lipoprotein levels as well as decreased high-density lipoprotein levels in patients with type 2 diabetes mellitus. In the early stages of insulin resistance, a compensatory mechanism of increased insulin secretion by the pancreas maintains normal to near-normal glucose levels. Once the pancreas fails to maintain the increased insulin output, overt type 2 diabetes mellitus occurs.
TAK-559 is a novel oxyiminoalkanoic acid under investigation for use as an oral agent in the treatment of patients with type 2 diabetes mellitus. TAK-559 has partial peroxisome proliferator-activated receptor-alpha agonist activity, potent peroxisome proliferator-activated receptor-alpha activity, and modest peroxisome proliferator-activated receptor-gamma activity at high concentrations in nonclinical models.
This study was designed to evaluate the safety and glycemic control of TAK-559 in patients with type 2 diabetes mellitus whose symptoms were managed by diet and exercise.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Was diagnosed with type 2 diabetes mellitus using American Diabetes Association diagnostic criteria, and on a stable dose of an oral anti-diabetic monotherapy prior to Screening A.
- Had a glycosylated hemoglobin level greater than or equal to 8.0% and less than or equal to 10.0% at Screening B.
- Had a fasting plasma glucose greater than or equal to 126 mg/dL (7.0 mmol/L) at Screening B.
- Was taking a stable dose of at least 10 mg of glyburide for at least 10 days prior to Screening B.
- Had a stable or worsening self-monitoring blood glucose level while taking glyburide.
- Had a low-density lipoprotein less than 160 mg/dL (4.1 mmol/L) at Screening A.
- Had a body mass index less than or equal to 45 kg/m2 at Screening A.
- Was willing to be counseled by the investigator or designee to follow an individualized, weight-maintaining diet during the study period.
- Had evidence of insulin secretory capacity as demonstrated by a C-peptide concentration of greater than or equal to 1.5 ng/mL (0.50 nmol/L) at Screening A, and if necessary, after a repeat at Screening B.
- Was able to perform daily self-monitoring blood glucose tests throughout the study.
- Had a normal thyroid-stimulating hormone level of less than 5.5 uIU/mL (5.5 mIU/L) and greater than or equal to 0.35 uIU/mL (0.35 mIU/L) at Screening A.
- Was in good health as determined by a physician (ie, via medical history and physical examination), other than a diagnosis of type 2 diabetes mellitus.
- Had fasting clinical laboratory evaluations within the normal reference range for the testing laboratory, or if not, the results must be deemed not clinically significant by the investigator prior to Randomization.
- Females were post menopausal, surgically sterile, or using adequate contraception.
Exclusion Criteria:
- Had been diagnosed with type 1 diabetes mellitus, hemochromatosis, or has a history of ketoacidosis.
- Had any condition known to invalidate glycosylated hemoglobin results (eg, hemolytic states, hemoglobinopathies).
Was required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
- Insulin
- Oral anti-diabetics other than TAK-559 (including sulfonylureas other than glyburide, alpha-glucosidase inhibitors, metformin)
- Systemic corticosteroids
- Warfarin
- Rifampin
- St. John's Wort.
- Thiazolidinediones
- Peroxisome proliferator-activated receptor agonists
- Nicotinic Acid
- Fibrates
- Had a history of myocardial infarction, coronary angioplasty or bypass graft, unstable angina pectoris, transient ischemic attacks, clinically significant abnormal electrocardiogram, or documented cerebrovascular accident within 6 months prior to Screening A.
- Had abdominal, thoracic, or vascular surgery within 6 months prior to Screening A that in the investigator's opinion would warrant exclusion from the study.
- Had a creatine phosphokinase value greater than 3 times the upper limit of normal at Screening A. The creatine phosphokinase value can be retested prior to Randomization if elevated.
- Had persistent unexplained microscopic or macroscopic hematuria or a history of bladder cancer.
- Had a triglyceride level greater than 500 mg/dL (5.6 mmol/L) at Screening A.
- Had any alteration in allowed lipid lowering medication (dose or drug) within 2 months of Randomization, if applicable.
- Had donated and/or received any blood or blood products within 3 months prior to Randomization.
- Had a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within 2 years prior to Randomization.
- Had a systolic BP greater than 140 mm Hg or a diastolic blood pressure of greater than 95 mm Hg at Screening B.
- Had significant cardiovascular disease including but not limited to, New York Heart Association Functional (Cardiac) Classification III or IV.
- Had a previous history of cancer, other than basal cell or stage 1 squamous cell carcinoma of the skin, that has not been in remission within 5 years prior to Randomization.
- Had an alanine transaminase or aspartate transaminase level greater than 3 times the upper limit of normal, active liver disease, or jaundice at Screening A.
- Had a positive human immunodeficiency virus, hepatitis B surface antigen, or hepatitis B e antigen test at Screening A.
- Had any other serious disease or condition at Screening A or at Randomization that might affect life expectancy or make it difficult to successfully manage and follow the patient according to the protocol.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore placebo: QD placebo
|
TAK-559 compresse corrispondenti al placebo, per via orale, una volta al giorno per un massimo di 26 settimane.
|
Sperimentale: TAK-559 32 mg QD
|
TAK-559 32 mg, compresse, per via orale, una volta al giorno fino a 26 settimane.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Variazione rispetto al basale dell'emoglobina glicosilata.
Lasso di tempo: Visita finale.
|
Visita finale.
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Variazione rispetto al basale della glicemia plasmatica a digiuno.
Lasso di tempo: Settimane 2, 4, 8, 12, 16, 20 e visita finale
|
Settimane 2, 4, 8, 12, 16, 20 e visita finale
|
Variazione rispetto al basale dell'insulina sierica.
Lasso di tempo: Settimane 4, 12, 16, 20 e visita finale.
|
Settimane 4, 12, 16, 20 e visita finale.
|
Variazione rispetto al basale del peptide C.
Lasso di tempo: Settimane 4, 12, 16, 20 e visita finale.
|
Settimane 4, 12, 16, 20 e visita finale.
|
Variazione rispetto al basale dei trigliceridi.
Lasso di tempo: Settimane 12, 16, 20 e visita finale.
|
Settimane 12, 16, 20 e visita finale.
|
Variazione rispetto al basale del colesterolo totale.
Lasso di tempo: Settimane 12, 16, 20 e visita finale.
|
Settimane 12, 16, 20 e visita finale.
|
Variazione rispetto al basale delle lipoproteine ad alta densità.
Lasso di tempo: Settimane 12, 16, 20 e visita finale.
|
Settimane 12, 16, 20 e visita finale.
|
Variazione rispetto al basale delle lipoproteine a bassa densità.
Lasso di tempo: Settimane 12, 16, 20 e visita finale.
|
Settimane 12, 16, 20 e visita finale.
|
Variazione rispetto al basale delle lipoproteine a densità molto bassa.
Lasso di tempo: Settimane 12, 16, 20 e visita finale.
|
Settimane 12, 16, 20 e visita finale.
|
Variazione rispetto al basale degli acidi grassi liberi.
Lasso di tempo: Settimane 12, 16, 20 e visita finale.
|
Settimane 12, 16, 20 e visita finale.
|
Variazione rispetto al basale del rapporto tra albumina urinaria e creatinina.
Lasso di tempo: Settimane 12, 16, 20 e visita finale
|
Settimane 12, 16, 20 e visita finale
|
Change from baseline in glycosylated hemoglobin.
Lasso di tempo: Weeks 4, 8, 12, 16 and 20
|
Weeks 4, 8, 12, 16 and 20
|
Change from base line in apolipoproteins A1 and B 100.
Lasso di tempo: Final Visit
|
Final Visit
|
Change from baseline in thrombosis marker (plasminogen activator inhibitor-1)
Lasso di tempo: Weeks 4, 12, 16, 20 and Final Visit
|
Weeks 4, 12, 16, 20 and Final Visit
|
Change from baseline in thrombosis marker (fibrinogen)
Lasso di tempo: Weeks 4, 12, 16, 20 and Final Visit
|
Weeks 4, 12, 16, 20 and Final Visit
|
Change from baseline in inflammation marker (Interleukin-6).
Lasso di tempo: Weeks 4, 12, 16, 20 and Final Visit
|
Weeks 4, 12, 16, 20 and Final Visit
|
Change from baseline in inflammation marker (C-reactive protein).
Lasso di tempo: Weeks 4, 12, 16, 20, and Final Visit
|
Weeks 4, 12, 16, 20, and Final Visit
|
Collaboratori e investigatori
Sponsor
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
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 01-04-TL-559-028
- U1111-1127-7965 (Identificatore di registro: WHO)
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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