- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01658514
Assessing the Behavior of Met DR in Subjects With Kidney Dysfunction
25 november 2015 uppdaterad av: Elcelyx Therapeutics, Inc.
A Randomized, Crossover Study Assessing the Single Dose Pharmacokinetics of Delayed-Release Metformin in Subjects With Renal Dysfunction
This study evaluated how a single dose of delayed-release metformin (Met DR) behaves in subjects with normal kidney function, mild kidney dysfunction, moderate kidney dysfunction, or severe kidney dysfunction.
The safety and tolerability of Met DR was also examined.
In addition, this study compared the behavior of a single dose of Met DR with that of extended-release metformin (Met XR) and placebo in subjects with the varying levels of kidney function described above.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
39
Fas
- Fas 2
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
18 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- 18 to 80 (inclusive) years old at Visit 1 (Screening)
Male, or female and met all of the following criteria:
- Not breastfeeding
- Negative pregnancy test result at Visit 1 (Screening) (not applicable to postmenopausal or surgically sterile females)
- Surgically sterile, postmenopausal, or if of childbearing potential, practiced and was willing to continue to practice appropriate birth control during the entire duration of the study
- Body weight of ≥45 kg
- Body mass index (BMI) of 18.0 to 40.0 kg/m² (inclusive) at Visit 1 (Screening)
- Had type 2 diabetes mellitus and an HbA1c ≤10.0%
- Had a physical examination with no clinically significant abnormalities as judged by the investigator
- Estimated glomerular filtration rate (eGFR) ≥15 mL/min/1.73 m² based on the Modification of Diet in Renal Disease (MDRD) equation
- Ability to understand and willingness to adhere to protocol requirements
Exclusion Criteria:
- Had End Stage Renal Disease requiring dialysis or severe renal dysfunction with eGFR <15 mL/min/1.73 m²
- Was on dialysis or had been on dialysis within 12 months of Visit 1 (Screening)
- Had received or planned to receive any iodinated contrast dye within 1 week prior to Visit 1 (Screening) or after study medication administration
- Was taking or had taken within 1 week of Visit 1 cationic drugs that are eliminated by renal tubular secretion (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin)
Had a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions:
- Hepatic disease
- Gastrointestinal disease
- Endocrine disorder (type 2 diabetes mellitus was allowed)
- Cardiovascular disease
- Central nervous system diseases
- Psychiatric or neurological disorders
- Organ transplantation
- Chronic or acute infection
- Orthostatic hypotension, fainting spells or blackouts
- Allergy or hypersensitivity
- Had any chronic disease requiring medication that had been adjusted in the past 14 days (subjects could take acute intermittent over-the-counter medications such as Tylenol, if needed)
- Had major surgery of any kind within 6 months of Visit 1 (Screening)
- Had a clinically significant finding of an electrocardiogram (ECG) as assessed by the investigator at Visit 1 (Screening)
- Had clinical laboratory test (clinical chemistry, hematology, or urinalysis) abnormalities, other than those related to diabetes or renal disease and other stable diseases, judged by the investigator to be clinically significant at Visit 1 (Screening)
- Had a hemoglobin result <8 g/dL or a level indicating severe anemia of renal origin
- Had a physical, psychological, or historical finding that, in the investigator's opinion, would make the subject unsuitable for the study
- Had received Byetta® or short-acting insulin within 3 days of Visit 1 (Screening)
- Had received metformin within 4 weeks of Visit 1 (Screening)
- Had any drug treatment that affects gastrointestinal motility or gastric pH (prescription or over-the-counter), including any antacids or medications such as Rolaids or Pepcid, within 2 days of Visit 2
- Abused drugs or alcohol or had a history of abuse that in the investigator's opinion would cause the individual to be noncompliant with study procedures
- Smoked more than 10 cigarettes, 3 cigars, or 3 pipes per day
- Had donated blood within 2 months of Visit 1 (Screening) or was planning to donate blood during the study
- Had received any investigational drug within one month (or seven half-lives of the investigational drug, whichever was greater) of Visit 1 (Screening)
- Had known allergies or hypersensitivity to any component of study treatment
- Was employed by Elcelyx Therapeutics, Inc (that is an employee, temporary contract worker, or designee of the company)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Met DR
One dose of 1000 mg metformin delayed-release
|
metformin tabletter med fördröjd frisättning
|
Aktiv komparator: Met XR
One dose of 1000 mg metformin extended-release
|
metformin tabletter med förlängd frisättning
|
Placebo-jämförare: Placebo
One dose of Placebo
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
AUC (0-t) of Plasma Metformin
Tidsram: from the time of dosing (0 h) to 72 hours postdose
|
AUC (0-t) = Area under the curve from the time of dosing (0 h) to the time of the last quantifiable concentration following dose administration
|
from the time of dosing (0 h) to 72 hours postdose
|
Cmax of Plasma Metformin
Tidsram: from the time of dosing (0 h) to 72 hours postdose
|
Cmax = Maximum concentration from the time of dosing (0 h) to the time of the last quantifiable metformin concentration following dose administration
|
from the time of dosing (0 h) to 72 hours postdose
|
Correlation of Placebo-adjusted Change From Pre-dose Value in Lactate Versus Metformin Concentration
Tidsram: from the time of dosing (0 h) to 24 hours postdose
|
To determine the exposure-response relationship of metformin and plasma lactate concentrations
|
from the time of dosing (0 h) to 24 hours postdose
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Craig Curtis, MD, Compass Research
- Huvudutredare: George Canas, MD, Prism Research
- Huvudutredare: Kenneth Lasseter, MD, Clinical Pharmacology of Miami, Inc
- Huvudutredare: Alexander White, MD, Progressive Medical Research
- Huvudutredare: Harold Bays, MD, Louisville Metabolic and Atherosclerosis Research Center
- Huvudutredare: Prabir Roy-Chaudhury, Cincinnati Veterans Affairs Medical Center Department of Internal Medicine
- Huvudutredare: Sunder Mudaliar, San Diego Veterans Healthcare System
- Huvudutredare: Nelson Kopyt, Northeast Clinical Research Center
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.
Allmänna publikationer
- Bakris GL, Mudaliar, S, Kim T, Burns C, Skare S, Baron A, Fineman M. Effects of New Metformin Formulation in Stage 3 and 4 CKD: A Pilot Study. J Am Soc Nephrol. 2014; 25:549A.
- DeFronzo R, Fleming GA, Chen K, Bicsak TA. Metformin-associated lactic acidosis: Current perspectives on causes and risk. Metabolism. 2016 Feb;65(2):20-9. doi: 10.1016/j.metabol.2015.10.014. Epub 2015 Oct 9.
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 januari 2014
Primärt slutförande (Faktisk)
1 juni 2014
Avslutad studie (Faktisk)
1 juni 2014
Studieregistreringsdatum
Först inskickad
1 augusti 2012
Först inskickad som uppfyllde QC-kriterierna
2 augusti 2012
Första postat (Uppskatta)
7 augusti 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
30 december 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 november 2015
Senast verifierad
1 november 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- LCRM101
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 .
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