Sitagliptin Versus Insulin Dose Increase in Type 2 Diabetes on Insulin Treatment
Comparison Between Sitagliptin Add-on Therapy and Insulin Dose Increase Therapy for Uncontrolled Type 2 Diabetes on Insulin Therapy
It is well established that inhibition of dipeptidyl peptidase (DPP)-IV reduces glucose levels and preserves pancreatic beta cell function in patients with type 2 diabetes. DPP-IV inhibitors stimulate insulin secretion as well as insulin biosynthesis and inhibit glucagon secretion from pancreas by increasing incretin (GLP-1) levels. Recent studies reported that combination therapy with DPP-IV inhibitors and other oral antidiabetic medication have additive or synergistic effects in lowering glycose level, preserving beta-cell mass and function as well as enhancing insulin sensitivity. However, there have been few studies about the glucose lowering effect of DPP-IV inhibitors in patients with type 2 diabetes on insulin treatment.
The researchers hypothesized that DPP-IV inhibitor add-on therapy to insulin treatment may have favorable effects on glucose control and endogenous insulin secretory function in type 2 diabetic patients. The researchers plan to compare between sitagliptin (DPP-IV inhibitor) add-on therapy and insulin dose increase therapy in uncontrolled type 2 diabetes on insulin treatment.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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-
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Seongnam, Korea, Republikken
- Seoul National University Bundang Hospital
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Gyeonggi
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Seongnam, Gyeonggi, Korea, Republikken, 463-707
- Seoul National University Bundang Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Type 2 diabetes
- HbA1c ≥ 7%
- Age ≥ 18
- Insulin treatment with or without oral antidiabetic medication
Exclusion Criteria:
- Contraindication to sitagliptin
- Pregnant or breast feeding women
- Type 1 diabetes, gestational diabetes, or diabetes with secondary cause
- Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT > 3-fold the upper limit of normal)
- Renal failure (Cr > 2.0)
- Cancer within 5 years
- Not appropriate for oral antidiabetic agent
- Medication which affect glycemic control
- Disease which affect efficacy and safety of drugs
- Other clinical trial within 30 days
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: sitagliptin
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sitagliptin 100mg once daily, orally, for 24 weeks.
Andre navne:
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Aktiv komparator: insulin dose increase
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insulin dose increase
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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The change of HbA1C
Tidsramme: 24weeks
|
24weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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the number of patients in HbA1C <7% without hypoglycemia
Tidsramme: 24 weeks
|
24 weeks
|
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hypoglycemia(symptoms consistent with hypoglycemia and confirmed by plasma glucose < 72 mg/dL)
Tidsramme: 24 weeks
|
24 weeks
|
|
the change of C-peptide
Tidsramme: 24 weeks
|
24 weeks
|
|
the change of body weight and waist circumference
Tidsramme: 24 weeks
|
24 weeks
|
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the change of insulin dose
Tidsramme: 24 weeks
|
24 weeks
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Sygdomme i det endokrine system
- Diabetes mellitus
- Hypoglykæmiske midler
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Proteasehæmmere
- Inkretiner
- Dipeptidyl-Peptidase IV-hæmmere
- Insulin
- Insulin, Globin Zink
- Insulin, langtidsvirkende
- Sitagliptin fosfat
Andre undersøgelses-id-numre
- SNUBH_ENDO2
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Kliniske forsøg med sitagliptin
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National Institute on Aging (NIA)Afsluttet
-
Hawler Medical UniversityAfsluttetDiabetes mellitus, type 2Irak
-
Brigham and Women's HospitalAktiv, ikke rekrutterendeType 2 diabetesForenede Stater
-
Brigham and Women's HospitalAktiv, ikke rekrutterendeHjertefejl | Type 2 diabetesForenede Stater
-
Emory UniversityMerck Sharp & Dohme LLCAfsluttet
-
Brigham and Women's HospitalAfsluttetType 2 diabetes mellitus | Aterosklerotisk kardiovaskulær sygdomForenede Stater
-
Baylor College of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)AfsluttetType 1 diabetesForenede Stater
-
Shahid Beheshti University of Medical SciencesIsfahan University of Medical SciencesAfsluttet
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Afsluttet
-
Kafrelsheikh UniversityAfsluttetLeverskrumpe med diabetesEgypten