TOFO Insulin Combination Trial
10 oktober 2017 uppdaterad av: Sanofi
A Randomized, Double Blind Placebo Controlled 2-Arm Parallel Group, Multicenter Study With A 16-Week Treatment Assessing The Efficacy And Safety, And 52-Week Long Term Safety Including 36-Week Open Label Extension Of Tofogliflozin With Insulin Treatment In Type 2 Diabetes Mellitus
Primary Objectives:
To assess the effects of tofogliflozin on glycemic control in comparison to placebo as an add-on treatment to insulin treatment in terms of glycated hemoglobin (HbA1c) reduction over a period of 16 weeks in patients with type 2 diabetes mellitus.
To assess the safety of tofogliflozin in combination with insulin treatment throughout 52 weeks.
Secondary Objectives:
To assess the effects of tofogliflozin in comparison to placebo on:
- Body weight
- Fasting plasma glucose (FPG)
- Postprandial plasma glucose (PPG) To assess the long term safety and tolerability of tofogliflozin.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The total study duration from screening for a patient can be approximately up to 1 year, including a screening period of 2 weeks, double-blinded placebo controlled treatment period of 16 weeks, an open-labeled extension period of 36 weeks, and a follow-up period of 3 days.
Studietyp
Interventionell
Inskrivning (Faktisk)
211
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Adachi-ku, Japan
- Investigational Site Number 392-028
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Atsugi-shi, Japan
- Investigational Site Number 392-007
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Chuoh-ku, Japan
- Investigational Site Number 392-026
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Fukuoka-shi, Japan
- Investigational Site Number 392-021
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Ichihara-shi, Japan
- Investigational Site Number 392-002
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Iruma-shi, Japan
- Investigational Site Number 392-012
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Kawaguchi-shi, Japan
- Investigational Site Number 392-003
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Kitakyusyu-shi, Japan
- Investigational Site Number 392-014
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Kobe-shi, Japan
- Investigational Site Number 392-027
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Koga-shi, Japan
- Investigational Site Number 392-004
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Kunitachi-shi, Japan
- Investigational Site Number 392-022
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Kurume-shi, Japan
- Investigational Site Number 392-019
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Kyoto-shi, Japan
- Investigational Site Number 392-001
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Kyoto-shi, Japan
- Investigational Site Number 392-024
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Matsudo-shi, Japan
- Investigational Site Number 392-006
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Mito-shi, Japan
- Investigational Site Number 392-008
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Musashino-shi, Japan
- Investigational Site Number 392-030
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Okayama-shi, Japan
- Investigational Site Number 392-029
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Otsu-shi, Japan
- Investigational Site Number 392-017
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Sagamihara-shi, Japan
- Investigational Site Number 392-011
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Sakai-shi, Japan
- Investigational Site Number 392-020
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Sapporo-shi, Japan
- Investigational Site Number 392-010
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Sendai-shi, Japan
- Investigational Site Number 392-016
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Shinjuku-ku, Japan
- Investigational Site Number 392-018
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Shizuoka-shi, Japan
- Investigational Site Number 392-005
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Suita-shi, Japan
- Investigational Site Number 392-031
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Sumida-ku, Japan
- Investigational Site Number 392-015
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Sunto-gun, Japan
- Investigational Site Number 392-023
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Tokorozawa-shi, Japan
- Investigational Site Number 392-013
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Yokohama-shi, Japan
- Investigational Site Number 392-025
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion criteria:
- Patients aged 20-75 years old with type 2 diabetes mellitus (T2DM).
- Hemoglobin A1c ≥7.5% - ≤10.5% and FPG ≤220 mg/dL.
- Basal bolus (BB), Bolus, Premix, Basal supported oral therapy (BOT) regimens used for more than 12 weeks before screening.
- Stable dose (-/+20%) of insulin and no change in the dose of oral hypoglycemic agents for more than 12 weeks before screening.
- Only Dipeptidyl peptidase-4 inhibitor is allowed for basal supported oral therapy (BOT) regimen.
- Body mass index (BMI) ≥18.5 kg/m^2 and <35.0 kg/m^2.
- No change of antihypertensive, anti-hypercholesterolemia and uric acid lowering drug 4 weeks before screening.
Exclusion criteria:
- Type 1 diabetes mellitus.
- Pregnancy or lactation.
- Severely uncontrolled glycemic situation.
- History of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening.
- History of myocardial infarction, stroke, or heart failure requiring hospitalization or drug or alcohol abuse within the previous 6 months.
- A measured serum creatinine level greater than 2.0 mg/dL for men and 1.5 mg/dL for women.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 times the upper limit of the reference range at the central laboratory test facility.
- Has previously received treatment with the investigational product.
- Has received treatment with another investigational product or non-approved drug within 3 months before tests for provisional enrolment.
- Corticosteroid therapy for 14 or more days in total within 8 weeks before tests for provisional enrolment (excluding those used for localized effects, such as drugs for topical [skin] application, eye drops and sprays).
- Patients who are frequently experiencing orthostatic hypotension.
- Required a change in the dosing regimen for the following drugs within 4 weeks before tests for provisional enrolment:
- Lipid-lowering drug
- Antihypertensive drug
- Thyroid hormone preparation
- Uric acid lowering drug
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: tofogliflozin
Tofogliflozin administered once daily for 52 weeks.
Insulin administered as base treatment.
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Pharmaceutical form:tablet Route of administration: oral
Andra namn:
Pharmaceutical form:solution Route of administration: subcutaneous
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Placebo-jämförare: placebo
Placebo administered once daily for 16 weeks.
After 16-weeks, Tofogliflozin administered once daily for 36 weeks.
Insulin administered as base treatment.
|
Pharmaceutical form:tablet Route of administration: oral
Andra namn:
Pharmaceutical form:solution Route of administration: subcutaneous
Pharmaceutical form:tablet Route of administration: oral
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Change in HbA1c from baseline
Tidsram: 16 weeks after first intake of investigational product
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16 weeks after first intake of investigational product
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Change of Body Weight (BW) from baseline
Tidsram: 16 weeks after first intake of investigational product
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16 weeks after first intake of investigational product
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Change of FPG from baseline
Tidsram: 16 weeks after first intake of investigational product
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16 weeks after first intake of investigational product
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Change of PPG from baseline
Tidsram: 16 weeks after first intake of investigational product
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16 weeks after first intake of investigational product
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Number of subjects with adverse events
Tidsram: Up to 52 weeks from the first intake of investigational medicinal product
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Up to 52 weeks from the first intake of investigational medicinal product
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2014
Primärt slutförande (Faktisk)
1 januari 2016
Avslutad studie (Faktisk)
1 oktober 2016
Studieregistreringsdatum
Först inskickad
23 juli 2014
Först inskickad som uppfyllde QC-kriterierna
23 juli 2014
Första postat (Uppskatta)
25 juli 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 oktober 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 oktober 2017
Senast verifierad
1 oktober 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Störningar i glukosmetabolism
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- Diabetes mellitus
- Diabetes mellitus, typ 2
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Andra studie-ID-nummer
- TOFOGL07061
- U1111-1159-5316 (UTN)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .