- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00501020
Comparison of the Efficacy and Tolerability of the Addition of AVANDIA to Submaximal Doses of Metformin
5. oktober 2017 oppdatert av: GlaxoSmithKline
A 24-Week Randomized, Double-blind, Double-Dummy, Multicenter Study to Compare the Efficacy of AVANDIA When Added to Submaximal Doses of Metformin and to Compare the Tolerability of the Combination to Metformin Monotherapy When Administered to Subjects With Type 2 Diabetes Mellitus
This was a randomized, double-blind, double dummy, multicenter study to assess the safety, efficacy and tolerability of the addition of RSG (rosiglitazone) to sub-maximal MET (metformin) combination relative to maximal MET monotherapy in subjects with type 2 DM (diabetes mellitus).
The total duration of the study was approximately 20 months.
The study consisted of a two-week washout period, a four to seven-week MET titration period, and a 24-week randomized treatment phase in which subjects, stratified by prior therapy, received either RSG + MET combination therapy or MET monotherapy.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering
750
Fase
- Fase 4
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Subjects with a diagnosis of Type 2 DM as defined by the criteria of the American Diabetes Association.
- Exceptions were granted to those subjects over the age of 75 on a case-by-case basis and only with the expressed permission of the study sponsor.
- Females who were post-menopausal (i.e., >6 months without a menstrual period), surgically sterile, or using acceptable contraceptive measures (oral contraceptive, Norplant, Depo-Provera, an IUD, a diaphragm with spermicide or condoms).
- Subjects previously treated by either diet and exercise or oral therapy. Any subjects who were receiving MET or MET plus Sulfonylurea (SU) must have been receiving no more than MET 1000mg/day for at least three months prior to study entry. Subjects must have stopped previous treatment with thiazolidinediones (TZDs) at least three months prior to screening.
- Subjects with a Body Mass Index (BMI) >=27 kg/m2.
- Subjects who signed the Informed Consent.
- Subjects who received monotherapy treatment within the last three months prior to study entry or drug-naives who had HbA1c levels between 7% and 10%, inclusive. Subjects who received prior combination treatment had HbA1c of at least 6.5% to 8.5%, inclusive.
- Subjects with FPG of <270 mg/dL at screening and visit 2, must have had a FPG >=126 mg/dL at either screening or at the MET titration period (visit 2, run-in) for entry into the treatment phase of the study.
Exclusion Criteria:
- Females who were lactating, pregnant, or planning to become pregnant.
- Any clinically significant abnormality identified on the chest X-ray, screening physical examination, laboratory tests, or electrocardiogram, which, in the judgment of the investigator, would preclude safe completion of the study.
- Use of TZDs or any investigational drug for glycemic control within three months prior to study entry irregardless of the treatment regimen, or use of any other investigational agent (not related to glycemic management) within 30 days or five half-lives (whichever is longer) preceding study entry.
- Subjects with FPG >=270 mg/dL at screening.
- Subjects with prior history of hepatocellular reaction to or severe edema associated with troglitazone or any current TZD.
- History of significant hypersensitivity to TZDs, biguanides, or compounds with similar chemical structures.
- Subjects currently using insulin or who discontinued its use for glycemic control within the last three months prior to study entry.
- History of acute or chronic metabolic acidosis.
- Presence of clinically significant renal or hepatic disease (i.e., male subjects with serum creatinine >1.5 mg/dL; female subjects with serum creatinine >1.4 mg/dL; ALT, AST, total bilirubin, GGT, or alkaline phosphatase >2.5 times the upper limit of the reference range).
- Anemia defined by hemoglobin concentration <11.0 g/dL for males or <10.0 g/dL for females.
- Presence of unstable or severe angina or coronary insufficiency, or any congestive heart failure requiring pharmacologic treatment.
- Systolic BP >170mmHg or diastolic BP >100mmHg while on anti-hypertensive treatment.
- Recent history or suspicion of current drug abuse or alcohol abuse (defined as the consumption of more than 35 units of alcohol per week.
- Non-compliance with study medication during MET titration period (run-in).
- Subjects, who received or anticipated receiving radiocontrast dye during the MET titration (run-in) or the randomized treatment period of the study.
- Subjects unwilling or unable to comply with the procedure described in the protocol.
- Subjects who were unable to read or understand the English language were excluded from the study due to the administration of the QOL assessments.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
The primary efficacy variable was HbA1c change from baseline (visit 3) after 24 weeks of treatment with either RSG+MET combination therapy or Metformin monotherapy.
Tidsramme: 24 Weeks
|
24 Weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Secondary efficacy variables included: the change from baseline (visit 3) at week 24 (visit) in FPG, immunoreactive insulin, HbA1c and FPG responders, Questionnaire-Tolerability of GI side-effects, and Questionnaire - Quality of Life.
Tidsramme: 24 Weeks
|
24 Weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Goldstein BJ, Cobitz AR, Hand LM, Chen H. Are the metabolic effects of rosiglitazone influenced by baseline glycaemic control? Curr Med Res Opin. 2003;19(3):192-9. doi: 10.1185/030079903125001695.
- Rosenstock J, Goldstein BJ, Wooddell MJ, Strow LJ, Waterhouse BR, Cobitz AR Greater benefits of rosiglitazone added to submaximal dose of metformin compared to maximizing metformin dose in type 2 diabetes mellitus patients. Diabetes 2004; 53 (Suppl 2): A144 Poster presented at ADA
- Weissman PW, Goldstein BJ, Campbell JC, Gould ER, Waterhouse BR, Strow LJ, Cobitz AR. Rosiglitazone plus metformin combination effects on CV risk markers suggest potential CV benefits in type 2 diabetes patients. Diabetes 2004;53(Suppl 2): A28 Oral presentation at ADA
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
5. juni 2001
Primær fullføring (Faktiske)
13. februar 2003
Studiet fullført (Faktiske)
13. februar 2003
Datoer for studieregistrering
Først innsendt
12. juli 2007
Først innsendt som oppfylte QC-kriteriene
12. juli 2007
Først lagt ut (Anslag)
13. juli 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. oktober 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. oktober 2017
Sist bekreftet
1. oktober 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 49653/284
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Ja
IPD-planbeskrivelse
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokumenter
-
Statistisk analyseplan
Informasjonsidentifikator: 49653/284Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Skjema for informert samtykke
Informasjonsidentifikator: 49653/284Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Klinisk studierapport
Informasjonsidentifikator: 49653/284Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Studieprotokoll
Informasjonsidentifikator: 49653/284Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Annotert saksrapportskjema
Informasjonsidentifikator: 49653/284Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Datasett for individuell deltaker
Informasjonsidentifikator: 49653/284Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Datasettspesifikasjon
Informasjonsidentifikator: 49653/284Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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