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A Study of Basal Insulin Analog and Insulin Analog Mid Mixture in Chinese Participants With Type 2 Diabetes Mellitus (CLASSIC)

6. marts 2020 opdateret af: Eli Lilly and Company

Comparison Between Basal Insulin Analog and Insulin Analog Mid Mixture AS Starter Insulin for Chinese Patients With Type 2 Diabetes Mellitus (CLASSIC Study)

The purpose of this study is to compare the effectiveness of basal insulin analog and insulin analog mid mixture in Chinese participants with type 2 diabetes mellitus.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

814

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
      • Beijing, Kina, 102206
        • Peking University International Hospital
      • Beijing, Kina
        • Beijing Hai Dian Hospital
      • Shanghai, Kina, 200090
        • Shanghai Yangpu District Central Hospital
    • Beijing
      • Beijing, Beijing, Kina, 100044
        • Peking University Peoples Hospital
      • Beijing, Beijing, Kina, 100016
        • Beijing Huaxin Hospital
      • Chaoyang, Beijing, Kina, 100028
        • China Meitan General Hospital
      • Fangshan, Beijing, Kina, 102500
        • Beijing Yanhua Hospital
    • Gansu
      • Lanzhou, Gansu, Kina, 730030
        • The 2nd Hospital of Lanzhou University
    • Guangdong
      • Shenzhen, Guangdong, Kina, 518020
        • Shenzhen City People Hospital
      • Yuexiu, Guangdong, Kina, 510080
        • The 1st Hospital with Guangdong Pharmaceutical University
    • Henan
      • Luoyang, Henan, Kina, 471003
        • The 1st Affiliated Hospital of Henan Science and technology
      • Zhengzhou, Henan, Kina, 450003
        • People's Hospital of Henan Province
    • Hubei
      • Wuhan, Hubei, Kina, 430022
        • Wuhan Union (Xiehe) Hospital
    • Jiangsu
      • Changzhou, Jiangsu, Kina, 213003
        • Changzhou No.2 People's Hospital
      • Nanjing, Jiangsu, Kina, 210001
        • Nanjing TCM hospital
      • Nanjing, Jiangsu, Kina, 210024
        • Jiang Su Province Official Hospital
      • Nanjing, Jiangsu, Kina, 210048
        • Nanjing Jiangbei Hospital
      • Nanjing, Jiangsu, Kina, 211100
        • Nanjing Jiangning Hospital
      • Taizhou, Jiangsu, Kina, 225300
        • Taizhou City People Hospital
      • Wuxi, Jiangsu, Kina, 214000
        • The Second People's Hospital of Wuxi
      • Xuzhou, Jiangsu, Kina, 221009
        • Xuzhou Central Hospital
    • Shandong
      • Qingdao, Shandong, Kina, 266071
        • Qingdao Municipal Hospital
      • Taian, Shandong, Kina, 271000
        • Taian City Central Hospital
    • Shanghai
      • Shanghai, Shanghai, Kina, 200135
        • Shanghai Pudong New Area Gongli Hospital
      • Shanghai, Shanghai, Kina, 201318
        • Shanghai Pudong New District Zhoupu Hospital
    • Shunqing
      • Nanchong, Shunqing, Kina, 637000
        • Affiliated Hospital of North Sichuan Medical College
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • The Third Affiliated Hospital of Chengdu University of TCM
      • Luzhou, Sichuan, Kina, 646000
        • Southwest Medical University Affiliated Hospital
    • Tianjin
      • Nankai, Tianjin, Kina, 300192
        • Tianjin First Central Hospital
    • Tongzhou
      • Beijing, Tongzhou, Kina, 101149
        • Beijing Luhe Hospital Capital Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310014
        • Zhejiang Provincial People's Hospital
      • Ningbo, Zhejiang, Kina, 315010
        • Ningbo First Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • have type 2 diabetes as defined by World Health Organization (WHO) criteria
  • are taking oral anti-hyperglycemic medications (OAMs) and are judged as OAM failure by the investigator
  • most recent HbA1c value ≥7.5% within 12 weeks of study entry
  • in the opinion of the investigator, require to initiate premix analog or basal insulin analog treatment
  • willing to start with insulin treatment

Exclusion Criteria:

  • have a diagnosis of type 1 diabetes
  • have received any type of insulin within 24 months of study entry (except for intermittent use of insulin of less than 1 month each time)
  • have serious preexisting medical or other conditions that, in the judgment of the investigator, would preclude participation in this study
  • are pregnant or breastfeeding, or intend to become pregnant during the course of the study
  • are currently enrolled or have participated, within the last 30 days in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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
Eksperimentel: Insulin Analog Mid Mixture
Insulin analog mid mixture given subcutaneously (SC).
Medicin: Insulin Analog Mid Mixture
Administered SC
Eksperimentel: Basal Insulin Analog
Basal insulin analog given SC.
Medicin: Basal Insulin Analog
Administered SC

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
Tidsramme: Baseline, 24 Weeks

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate.
Baseline, 24 Weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline to Week 48 in HbA1c
Tidsramme: Baseline, 48 Weeks

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

Least Squares (LS) mean was determined by ANCOVA model with LOCF and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate.
Baseline, 48 Weeks
Percentage of Participants Who Achieve HbA1c <7% at Week 24
Tidsramme: 24 Weeks
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
24 Weeks
Percentage of Participants Who Achieve HbA1c <7% at Week 48
Tidsramme: 48 Weeks
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
48 Weeks
Change From Baseline to Week 24 in Venous Fasting Plasma Glucose
Tidsramme: Baseline, 24 Weeks
Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.
Baseline, 24 Weeks
Change From Baseline to Week 48 in Venous Fasting Plasma Glucose
Tidsramme: Baseline, 48 Weeks
Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.
Baseline, 48 Weeks
Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
Tidsramme: Baseline, 24 Weeks
Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.
Baseline, 24 Weeks
Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
Tidsramme: Baseline, 48 Weeks
Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.
Baseline, 48 Weeks
Total Daily Insulin Dose at Week 24 and 48
Tidsramme: 24 Weeks, 48 Weeks
Total daily insulin dose in the basal insulin analog and in Insulin Analog Mid Mixture group at week 24 and 48.
24 Weeks, 48 Weeks
Change From Baseline to Week 24 in Body Weight
Tidsramme: Baseline, 24 Weeks
LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.
Baseline, 24 Weeks
Change From Baseline to Week 48 in Body Weight
Tidsramme: Baseline, 48 Weeks
LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.
Baseline, 48 Weeks
Rate of Hypoglycemia at Week 24 and 48
Tidsramme: 24 Weeks, 48 Weeks
Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). The overall yearly rates (events/participant/year) of those hypoglycemic events, calculated as, for each participant, the number of episodes times 365.25 and then divided by the participants treatment duration, will be summarized, and analyzed by a Negative-binomial regression model with treatment as fixed effects and log of (patient's treatment duration/365.25) as an offset variable.
24 Weeks, 48 Weeks
Number of Participants With Insulin Treatment Change at Week 48
Tidsramme: Baseline through 48 Weeks

Insulin treatment change can be insulin treatment discontinuation, switch, intensification or reduction in frequency.

  1. Discontinuation: Defined as stopping insulin treatment for 30 days or more.
  2. Switch: Defined as stop the initial insulin therapy and started another insulin therapy of different class.
  3. Intensification: Defined as any of the following: adding meal time insulin in basal insulin analog QD group; changing from BID to TID (Three times a day) in insulin analog mid mixture BID group
  4. Reduction in frequency: Defined as any of the following: changing from BID to QD; changing from TID to BID or QD.
Baseline through 48 Weeks
Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24
Tidsramme: 24 Weeks
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of <7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.
24 Weeks
Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48
Tidsramme: 48 Weeks
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of <7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.
48 Weeks
Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score
Tidsramme: Baseline, 48 Weeks
The SEITQ is designed to measure an individual's self-efficacy related to insulin therapy. The SEITQ consists of 5 items (that is, statements). The first 4 statements imply confidence in completing the tasks needed to take insulin correctly and avoid both hyperglycemia and hypoglycemia, whereas the last statement is an outcome expectation and implies that performance of these tasks will lead to avoidance of complications. Each item score ranges from 1 (strongly disagree) to 7 (strongly agree). The total SEITQ score is the sum of each item scores, with the range of 5 to 35. Higher SEITQ score indicates better outcome (higher self-efficacy). LS Mean was calculated using Mixed Models Analysis (MMRM) for repeated measures with all post-baseline SEITQ as responses, baseline SEITQ as a continuous covariate, treatment group, Visits, and treatment by visit interaction as fixed effects and participant as a random effect.
Baseline, 48 Weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Eli Lilly and Company

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. februar 2017

Primær færdiggørelse (Faktiske)

19. februar 2019

Studieafslutning (Faktiske)

12. juli 2019

Datoer for studieregistrering

Først indsendt

11. januar 2017

Først indsendt, der opfyldte QC-kriterier

11. januar 2017

Først opslået (Skøn)

12. januar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. marts 2020

Sidst verificeret

15. august 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 16507
  • F3Z-GH-IOQR (Anden identifikator: Eli Lilly and Company)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD-delingstidsramme

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD-delingsadgangskriterier

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Type 2 diabetes mellitus

Kliniske forsøg med Insulin Analog Mid Mixture

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mali

Betingelser

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Placeringer

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