- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02313220
Exploratory Study to Investigate the Effect of Dapagliflozin and Exenatide Combined on Body Weight (Dapalost)
A 24-week, Single Centre, Randomized, Parallel-group, Double-blind, Placebo Controlled Phase II Study With an Optional 28-week Open-label Extension to Evaluate the Efficacy on Body Weight of Dapagliflozin 10 mg Once Daily in Combination With Exenatide 2 mg Once Weekly in Obese Non-diabetic Subjects.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Uppsala, Svezia, 75185
- Dept of Medical Sciences, Clinical Diabetes and Metabolism, Uppsala University and Section for Diabetes and Endocrinology at the Uppsala University Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Provision of signed informed consent prior to any study specific procedures.
- Female and/or male aged 18 to 70 years with body mass index (BMI) (measured as body weight (kg)/(height (m))2) 30 to 45 kg/m2.
Female subjects must meet all of the following criteria:
- Not breastfeeding
- Negative pregnancy test result (human chorionic gonadotropin, beta subunit [beta hCG]) at Visit 1 (Enrolment) (not applicable to hysterectomized females).
If of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year), must practice and be willing to continue to practice one of the following highly effective birth control methods during the entire duration of the study:
Diaphragm or partner use of condom in combination with combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- Oral
- Intravaginal
- Transdermal
Diaphragm or partner use of condom in combination with progestogen-only hormonal contraception associated with inhibition of ovulation:
- Oral
- Injectable
- Implantable
- Placement of an intrauterine device
- Placement of an intrauterine hormone-releasing system
- Bilateral tubal occlusion
- Vasectomised partner (provided that the partner is the sole sexual partner of the female subject and that the vasectomised partner has received medical assessment of the surgical success)
- Sexual abstinence (defined as refraining from heterosexual intercourse)
- Must practice appropriate birth control as stated above for 10 weeks after the last dose of study medication
Exclusion Criteria:
- Involvement in the planning and/or conduct of the study.
- Previous enrolment in the present study.
- Participation in another clinical study with an Investigational Product during the last 3 months prior to Visit 1.
- History of any clinically significant disease, disorder or condition which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Previously diagnosed diabetes mellitus; or fasting P-glucose ≥7.0 mmol/L at Visit 1 confirmed by one more measurement; or P-glucose ≥11.1 mmol/L at 120 min of the oral glucose tolerance test (OGTT) at Visit 1 confirmed by one more measurement. Note: Subjects with a fasting P-glucose of ≥7.0 mmol/L at Visit 1 or ≥11.1 mmol/L at 120 min of the OGTT at Visit 1 may be offered an extra visit before Visit 2 for a second fasting P-glucose measurement. If P-glucose is still ≥7.0 mmol/L at the second measurement, the subject will be excluded.
Any clinically significant abnormalities in physical examination or clinical chemistry results as judged by the investigator. The following specific exclusion criteria apply to the selected Clinical Chemistry results:
- Creatinine clearance <60 mL/min (estimated with Cockcroft-Gault formula).
- Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN.
- Total bilirubin (TB) >2.0 mg/dL (34.2 µmol/L).
- Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody Immunoglobulin M (IgM), Hepatitis B surface antigen and Hepatitis C virus antibody.
- Volume depleted patients. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
- Acute Coronary Syndrome (ACS) within 2 months prior to Visit 1. Hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment. Acute Stroke or transient ischemic attack (TIA) within two months prior to Visit 1. Less than two months post coronary artery revascularization.
- History of gastroparesis or pancreatitis
- History of malignancy within the last 5 years, excluding successful treatment of basal or squamous cell skin cancer.
- Body weight loss greater than 5% within 3 months prior to Visit 1.
- Treatment with any drug known to affect body weight within the last month, e.g. systemic glucocorticoids, antipsychotics or orlistat.
- Multiple Endocrine Neoplasia syndrome type 2.
- Personal or family history of medullary thyroid carcinoma.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Dapagliflozin and exenatide
Dapagliflozin 10 mg film-coated tablet once daily and exenatide 2 mg once weekly injection combined treatment for 24 weeks
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Oral use
Altri nomi:
Powder and solvent for suspension for injection, prolonged release suspension.
Subcutaneous use.
Altri nomi:
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Comparatore placebo: Placebo
Placebo film-coated tablet once daily and placebo once weekly injection combined treatment for 24 weeks
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Oral and Subcutaneous use.
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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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Body weight (kg)
Lasso di tempo: From randomization to 24 weeks
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To assess the efficacy of dapagliflozin 10 mg once daily and exenatide 2 mg once weekly in combination compared to placebo on body weight after 24 weeks of treatment in obese subjects
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From randomization to 24 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Body weight (%)
Lasso di tempo: From randomization to 24 weeks
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To assess the efficacy of dapagliflozin 10 mg once daily and exenatide 2 mg once weekly in combination compared to placebo on body weight after 24 weeks of treatment in obese subjects
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From randomization to 24 weeks
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Proportion of subjects with at least 10% reduction in weight and proportion of subjects with at least 5% reduction in weight.
Lasso di tempo: From randomization to 24 weeks
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To assess the proportion of subjects responding to treatment with dapagliflozin 10 mg once daily and exenatide 2 mg once weekly in combination when compared to placebo, with respect to change in body weight
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From randomization to 24 weeks
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Changes in body fat (%), liver fat (%), liver volume (l), total liver fat (l), visceral adipose tissue (l), subcutaneous adipose tissue (l), total adipose tissue (l) and total lean tissue (l).
Lasso di tempo: From randomization to 24 weeks
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To assess the efficacy of dapagliflozin 10 mg once daily and exenatide 2 mg once weekly in combination compared to placebo on total body fat mass, total lean body mass, percentage liver fat, visceral fat mass and subcutaneous fat mass.
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From randomization to 24 weeks
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3 h oral glucose tolerance test, frequently sampled for insulin sensitivity and secretion indices. Changes in glucose, glucagon, glycerol, free fatty acids, insulin and C-peptide.
Lasso di tempo: From enrolment to 24 weeks
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To assess the efficacy of dapagliflozin 10 mg once daily and exenatide 2 mg once weekly in combination compared to placebo on glucose tolerance, insulin secretion, insulin sensitivity and lipolysis regulation.
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From enrolment to 24 weeks
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Changes in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, diastolic blood pressure, systolic blood pressure, pulse, waist circumference and waist-hip ratio.
Lasso di tempo: From enrolment to 24 weeks
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To assess the efficacy of dapagliflozin 10 mg once daily and exenatide 2 mg once weekly in combination compared to placebo on blood lipid profile, blood pressure and other anthropometric measurements.
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From enrolment to 24 weeks
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Obesity-related genotypes and pharmacogenetics.
Lasso di tempo: From enrolment to 24 weeks
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To collect and store DNA for future exploratory research of genes/genetic variation that is related to obesity or to treatment response to dapagliflozin in combination with exenatide.
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From enrolment to 24 weeks
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Adverse events /serious adverse events, vital signs and collection of clinical chemistry/haematology parameters.
Lasso di tempo: From enrolment to 24 weeks
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To evaluate the safety and tolerability of dapagliflozin 10 mg once daily and once weekly 2 mg exenatide in combination in obese non-diabetic subjects.
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From enrolment to 24 weeks
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Jan Eriksson, Prof., MD, Uppsala University
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
- D1690L00016
- 2014-003432-39 (Numero 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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