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12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin

8 febbraio 2019 aggiornato da: Daiichi Sankyo, Inc.

A Randomized, Double-Blind, Placebo-Controlled With Active Comparator, 12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin

The hypothesis of this Phase 2, 12-week study, is that DS-8500a will improve glycemic control relative to placebo, based on changes in HbA1c, with acceptable safety and tolerability, in patients with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

298

Fase

  • Fase 2

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

  • Canada
      • Quebec, Canada, G1W 4R4
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 4A1
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
      • London, Ontario, Canada, N5W 6A2
      • Newmarket, Ontario, Canada, L3Y 5GB
      • Toronto, Ontario, Canada, M9W 4L6
      • Toronto, Ontario, Canada, M9V 4B4
    • Quebec
      • Mirabel, Quebec, Canada, J7J 2K8
      • Montreal, Quebec, Canada, H4N 2W2
      • Sherbrooke, Quebec, Canada, J1H 1Z1
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35216
    • Arizona
      • Litchfield Park, Arizona, Stati Uniti, 85340
      • Tempe, Arizona, Stati Uniti, 85282
    • California
      • Anaheim, California, Stati Uniti, 92801
      • Chino, California, Stati Uniti, 91710
      • Chula Vista, California, Stati Uniti, 91911
      • Fresno, California, Stati Uniti, 93720
      • Gold River, California, Stati Uniti, 95670
      • Greenbrae, California, Stati Uniti, 94904
      • San Diego, California, Stati Uniti, 92103
    • Colorado
      • Colorado Springs, Colorado, Stati Uniti, 80920
      • Lakewood, Colorado, Stati Uniti, 80227
    • Florida
      • Hallandale Beach, Florida, Stati Uniti, 33009
      • Miami, Florida, Stati Uniti, 33126
      • Miami, Florida, Stati Uniti, 33135
      • Pembroke Pines, Florida, Stati Uniti, 33026
      • West Palm Beach, Florida, Stati Uniti, 33409
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30331
    • Idaho
      • Boise, Idaho, Stati Uniti, 83704
    • Indiana
      • Avon, Indiana, Stati Uniti, 46123
      • Evansville, Indiana, Stati Uniti, 47725
      • Franklin, Indiana, Stati Uniti, 46131
      • Greenfield, Indiana, Stati Uniti, 46140
    • Iowa
      • Council Bluffs, Iowa, Stati Uniti, 51503
    • Michigan
      • Troy, Michigan, Stati Uniti, 48098
    • Minnesota
      • Edina, Minnesota, Stati Uniti, 55435
    • Missouri
      • Washington, Missouri, Stati Uniti, 63090
    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68114
    • North Carolina
      • Mooresville, North Carolina, Stati Uniti, 28117
      • Morgantown, North Carolina, Stati Uniti, 28655
      • Winston-Salem, North Carolina, Stati Uniti, 27103
    • Ohio
      • Columbus, Ohio, Stati Uniti, 43213
    • Oregon
      • Medford, Oregon, Stati Uniti, 97504
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29425
      • Charleston, South Carolina, Stati Uniti, 29407
      • Greer, South Carolina, Stati Uniti, 29651
      • Mount Pleasant, South Carolina, Stati Uniti, 29464
      • Spartanburg, South Carolina, Stati Uniti, 29303
    • Texas
      • Austin, Texas, Stati Uniti, 78705
      • Dallas, Texas, Stati Uniti, 75231
      • Houston, Texas, Stati Uniti, 77036
      • Plano, Texas, Stati Uniti, 75024
      • San Antonio, Texas, Stati Uniti, 78229
      • San Antonio, Texas, Stati Uniti, 78228
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84121
      • Salt Lake City, Utah, Stati Uniti, 84102
      • South Jordan, Utah, Stati Uniti, 84095
    • Virginia
      • Burke, Virginia, Stati Uniti, 22015

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 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Able to provide written informed consent and adhere to the study visit schedule and treatment
  • Diagnosed with Type 2 diabetes mellitus as defined in the American Diabetes Association Standards of Medical Care in Diabetes 2015
  • Male or female ≥ 18 and ≤ 70 years of age
  • Screening fasting C-peptide > 0.5 ng/mL
  • Women of child bearing potential (WOCBP) must be willing to use double-barrier contraception for the entire study
  • WOCBP must have a negative pregnancy test (human chorionic gonadotropin, beta subunit [βhCG]) before entering the Lead-in Period
  • Body mass index ≥ 25 kg/m2 and ≤ 45 kg/m2 at the Screening Visit
  • On stable (≥ 8 weeks) metformin monotherapy ≥ 1000 mg/day
  • Screening HbA1c ≥ 7.0% and ≤ 10%
  • Taking ≥ 80% and ≤ 120% of both dispensed DS-8500a placebo tablets and sitagliptin placebo capsules during the Lead-in Period

Exclusion Criteria:

  • History of type 1 diabetes and/or history of ketoacidosis
  • History of insulin use for > 2 weeks within 2 months prior to the Screening Visit
  • Two or more readings of fasting Self-monitoring of Blood Glucose (SMBG) > 240 mg/dL or worsening symptoms of hyperglycemia with one SMBG level of > 240 mg/dL during the second week of Lead-in Period, confirmed by laboratory measurement
  • Screening hemoglobin <12 g/dL for males and <11 g/dL for females
  • Blood donation within 2 months prior to the Screening Visit or plans to donate blood or blood products during the study
  • Subjects after bariatric surgery or any gastric bypass
  • Screening thyroid stimulating hormone (TSH) levels not within normal range (based on reference laboratory values )
  • Screening Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 2.0 x upper limit of normal (ULN), and/or total bilirubin > 1.5 x ULN. If a subject has total bilirubin > 1.5 ULN, unconjugated and conjugated bilirubin fractions should be analyzed and only subjects documented to have Gilbert's syndrome may be enrolled
  • Screening Serum creatinine ≥ 1.5 mg/dL for males and ≥ 1.4 mg/dL for females, or creatinine clearance (CrCl) < 50 mL/min for both males and females
  • Screening Creatine kinase (CK) > 3.0 × ULN
  • History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, peripheral arterial event or any revascularization procedure during the 6 months prior to the Screening Visit or planned vascular procedures or surgery during study period
  • History of congestive heart failure (CHF)

  • Exclusionary concomitant medications:

    a. Eight weeks prior to screening and throughout the duration of the study:

  • Any diabetes medication other than metformin; any prescription or over the counter medication for weight-loss.
  • Systemic corticosteroids (including nasal and inhaled), with the exception of use of topical and ophthalmic corticosteroids.
  • Rosuvastatin > 20 mg daily. b. During treatment periods, additional medications will be prohibited based on potential drug-drug interaction (DDI) (see Section 5.6)
  • Subjects with anticipated interruption in metformin or study drug use during the course of the clinical trial (e.g., due to an imaging procedure involving iodinated contrast media)
  • Subjects in whom treatment with sitagliptin 100 mg is contraindicated ( e.g., known hypersensitivity or intolerance to sitagliptin) or may not be medically advisable (e.g., history of pancreatitis)
  • Abuse of or dependence on prescription medications, illicit drugs, or alcohol within the last 1 year
  • Any history of a malignancy other than basal cell carcinoma within the past 5 years
  • Pregnancy or breast-feeding, or intent to become pregnant during the study period
  • Known (or evidence of) infection with human immunodeficiency virus
  • Any condition, laboratory abnormality, or concomitant therapy which, in the opinion of the Investigator, might pose a risk to the subject or make participation not in the subject's best interest
  • Subject is currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug study or is receiving other investigational agents
  • A direct or familial relationship with the Sponsor, Investigator, or site personnel affiliated with the study

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: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: DS-8500a 25mg
One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose
Droga: DS-8500a 25mg
DS-8500a 25mg tablet for oral administration
Altri nomi:
  • Prodotto investigativo
Droga: Placebo Tablet
Placebo matching DS-8500a tablet for oral administration
Altri nomi:
  • Placebo
Droga: Placebo Capsule
Placebo matching sitagliptin over-capsule for oral administration
Altri nomi:
  • Placebo
Sperimentale: DS-8500a 50 mg
Two DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose
Droga: DS-8500a 25mg
DS-8500a 25mg tablet for oral administration
Altri nomi:
  • Prodotto investigativo
Droga: Placebo Tablet
Placebo matching DS-8500a tablet for oral administration
Altri nomi:
  • Placebo
Droga: Placebo Capsule
Placebo matching sitagliptin over-capsule for oral administration
Altri nomi:
  • Placebo
Sperimentale: DS-8500a 75 mg
Three DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose
Droga: DS-8500a 25mg
DS-8500a 25mg tablet for oral administration
Altri nomi:
  • Prodotto investigativo
Droga: Placebo Capsule
Placebo matching sitagliptin over-capsule for oral administration
Altri nomi:
  • Placebo
Comparatore placebo: Placebo
Three placebo tablets and one placebo capsule in a once-daily oral dose
Droga: Placebo Tablet
Placebo matching DS-8500a tablet for oral administration
Altri nomi:
  • Placebo
Droga: Placebo Capsule
Placebo matching sitagliptin over-capsule for oral administration
Altri nomi:
  • Placebo
Comparatore attivo: Sitagliptin 100 mg
Three placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose
Droga: Placebo Tablet
Placebo matching DS-8500a tablet for oral administration
Altri nomi:
  • Placebo
Droga: Sitagliptin 100 mg
Two sitagliptin 50 mg tablets, over-encapsulated to provide a once-daily dose of 100 mg, for oral administration
Altri nomi:
  • Januvia

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
Lasso di tempo: Baseline, Week 12
Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the three-month average glucose concentration in the blood. Target HbA1c for Type 2 diabetics was less than 7% at the time of this trial. Negative scores show improvement from baseline.
Baseline, Week 12

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Total Cholesterol (TC) at Week 12
Lasso di tempo: Baseline, Week 12
Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol.
Baseline, Week 12
Change From Baseline in LDL-C at Week 12
Lasso di tempo: Baseline, Week 12
LDL-C is known as the "bad" cholesterol, so a lower score (negative change) means improvement.
Baseline, Week 12
Change From Baseline in HDL-C at Week 12
Lasso di tempo: Baseline, Week 12
HDL-C is known as the "good" cholesterol, so a higher score (positive change) means improvement.
Baseline, Week 12
Change From Baseline in Non-HDL-C at Week 12
Lasso di tempo: Baseline, Week 12
Non-HDL-C is the measure of "bad" cholesterol in the blood, including triglycerides and LDL-C, so a negative change means improvement. The equation for Non-HDL-C = LDL-C + (triglycerides/5).
Baseline, Week 12
Change From Baseline in Triglycerides at Week 12
Lasso di tempo: Baseline, Week 12
Triglycerides are a type of fat found in the blood. The body uses them for energy. Some triglycerides are needed for good health. But high triglycerides might raise the risk of heart disease. Since Type 2 diabetics tend to have high triglycerides, a negative change means improvement.
Baseline, Week 12
Change From Baseline in Area-Under-the Curve 0-3 Hours (AUC0-3h) of Plasma Glucose (PG) in Response to the Mixed Meal Tolerance Test (MMTT) at Week 4
Lasso di tempo: Baseline, Week 4
The MMTT requires a participant to drink a "mixed meal," such as Boost or Ensure, that contains protein, carbohydrates, and fat. The goal of the test is to find out how much insulin the pancreas makes in response to food by measuring the level of glucose in the blood. The lower the level of glucose in the blood during the first three hours after the test (AUC0-3h), the more insulin the body has made in response to the test. This would mean a negative change shows improvement.
Baseline, Week 4
Change From Baseline in AUC0-3h of PG in Response to the MMTT at Week 12
Lasso di tempo: Baseline, Week 12
The MMTT requires a participant to drink a "mixed meal," such as Boost or Ensure, that contains protein, carbohydrates, and fat. The goal of the test is to find out how much insulin the pancreas makes in response to food by measuring the level of glucose in the blood. The lower the level of glucose in the blood during the first three hours after the test (AUC0-3h), the more insulin the body has made in response to the test. This would mean a negative change shows improvement.
Baseline, Week 12
Change From Baseline in Maximum Concentration (Cmax) of PG in Response to MMTT at Week 4
Lasso di tempo: Baseline, Week 4
Cmax measures the highest amount of glucose in the blood, so a negative change means improvement.
Baseline, Week 4
Change From Baseline in Cmax of PG in Response to MMTT at Week 12
Lasso di tempo: Baseline, Week 12
Cmax measures the highest amount of glucose in the blood, so a negative change means improvement.
Baseline, Week 12
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 2
Lasso di tempo: Baseline, Week 2
Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.
Baseline, Week 2
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4
Lasso di tempo: Baseline, Week 4
Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.
Baseline, Week 4
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 8
Lasso di tempo: Baseline, Week 8
Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.
Baseline, Week 8
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Lasso di tempo: Baseline, Week 12
Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.
Baseline, Week 12
Count of Participants With HbA1c Less Than 7.0% at Week 12
Lasso di tempo: Week 12
HbA1C less than 7% is the success goal for many Type 2 diabetics.
Week 12

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Daiichi Sankyo, Inc.

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 gennaio 2016

Completamento primario (Effettivo)

31 gennaio 2017

Completamento dello studio (Effettivo)

31 gennaio 2017

Date di iscrizione allo studio

Primo inviato

4 gennaio 2016

Primo inviato che soddisfa i criteri di controllo qualità

4 gennaio 2016

Primo Inserito (Stima)

6 gennaio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 febbraio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 febbraio 2019

Ultimo verificato

1 maggio 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • DS8500-A-U202

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Sì

Descrizione del piano IPD

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Periodo di condivisione IPD

Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

Criteri di accesso alla condivisione IPD

Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Tipo di informazioni di supporto alla condivisione IPD

  • Protocollo di studio
  • Piano di analisi statistica (SAP)
  • Relazione sullo studio clinico (CSR)

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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