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Chronic Reduction of Fasting Glycaemia With Insulin Glargine Improves First and Second Phase Insulin Secretion in Patients With Type 2 Diabetes

29. november 2010 oppdatert av: Ruhr University of Bochum

Chronic Reduction of Fasting Gylcaemia With Insulin Glargine Improves First and Second Phase Insulin Secretion in Patients With Type 2 Diabetes

Glucose-induced insulin secretion is often diminished in hyperglycaemic patients with type 2 diabetes. The investigators examined, whether chronic basal insulin treatment with insulin glargine lead to improvements in glucose-induced insulin secretion.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

14 patients with type 2 diabetes on previous metformin therapy were examined before and after eight weeks of treatment with insulin glargine, aimed to normalize fasting glycaemia. Intravenous glucose tolerance tests were performed with and without previous adjustment of fasting glucose levels by means of a 3-hour intravenous insulin infusion.

Studietype

Intervensjonell

Registrering (Faktiske)

14

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Bochum, Tyskland
        • Department of Medicine I; University Hospital St. Josef Hospital

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:

  1. Age between 18 and 75 years, inclusive
  2. BMI-range 27-50 kg/m²
  3. patients with type 2 diabetes presenting with fasting hyperglycaemia (>126mg/dl) on metformin treatment

Exclusion Criteria:

1.Pre-existing insulin therapy, treatment with sulphonylureas, glitazones, 2.glinides, DPP-4-inhibitors or exenatide 3.patients with type 1 diabetes 4.Patients are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.

5. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner). A male subject who is sexually active and has not been surgically sterilised must be informed that he must either use a condom during intercourse, ensure that his partner practices contraception, or he must refrain from sexual intercourse during the trial and until 1 month after completion of the trial. This is to prevent the possibility of a pregnancy from spermatocytes that can potentially be damaged by trial medication. It is strongly recommended that the female partners use a highly effective contraception (Pearl Index < 1%).

6. Patients have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days prior to screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.

7. Patients have alcohol consumption (>20 g daily for males and >10 g daily for females) 8. Patients have alanine aminotransaminase (ALT) greater than ten times the upper limit of the reference range.

9.Patients are undergoing therapy for a malignancy, other than basal cell or squamous cell skin cancer.

10. Patients have cardiac disease that is Class III or IV, according to the New York Heart Association criteria.

11. Patients have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine >1.8 mg/dL for males and greater than or equal to >1.5 mg/dL for females. 12.Patients have known hemoglobinopathy or chronic anemia 13.Patients are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.

14. Patients have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes them from following and completing the protocol, in the opinion of the investigator.

15. Patients fail to satisfy the investigator of suitability to participate for any other reason.

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: insulin glargine
patients with type 2 diabetes on previous therapy with metformin were examined before and after eight weeks of treatment with insulin glargin, aimed to normalize fasting plasma glycaemia
14 patients with type 2 diabetes on previous metformin therapy were treated with insulin glargine, aimed to normalize fasting glycaemia.
Andre navn:
  • Lantus

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Improvements in first and second phase insulin secretion
Tidsramme: 8 weeks
Improvements in first and second phase insulin secretion after bedtime administration of insulin glargin, titrated to reach normal (90-100 mg/dl) fasting glucose levels
8 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

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.

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

1. januar 2009

Primær fullføring (Faktiske)

1. mai 2010

Studiet fullført (Faktiske)

1. mai 2010

Datoer for studieregistrering

Først innsendt

29. november 2010

Først innsendt som oppfylte QC-kriteriene

29. november 2010

Først lagt ut (Anslag)

30. november 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

30. november 2010

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. november 2010

Sist bekreftet

1. oktober 2008

Mer informasjon

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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