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

perjantai 6. maaliskuuta 2020 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

814

Vaihe

  • Vaihe 4

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta - 80 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Insulin Analog Mid Mixture
Insulin analog mid mixture given subcutaneously (SC).
Lääke: Insulin Analog Mid Mixture
Administered SC
Kokeellinen: Basal Insulin Analog
Basal insulin analog given SC.
Lääke: Basal Insulin Analog
Administered SC

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change From Baseline to Week 48 in HbA1c
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

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Sponsori

Eli Lilly and Company

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

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Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Maanantai 6. helmikuuta 2017

Ensisijainen valmistuminen (Todellinen)

Tiistai 19. helmikuuta 2019

Opintojen valmistuminen (Todellinen)

Perjantai 12. heinäkuuta 2019

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 11. tammikuuta 2017

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Keskiviikko 11. tammikuuta 2017

Ensimmäinen Lähetetty (Arvio)

Torstai 12. tammikuuta 2017

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 18. maaliskuuta 2020

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Perjantai 6. maaliskuuta 2020

Viimeksi vahvistettu

Torstai 15. elokuuta 2019

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 16507
  • F3Z-GH-IOQR (Muu tunniste: Eli Lilly and Company)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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-jaon aikakehys

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-jaon käyttöoikeuskriteerit

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

IPD-jakamista tukeva tietotyyppi

  • STUDY_PROTOCOL
  • MAHLA
  • CSR

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Kliiniset tutkimukset Tyypin 2 diabetes mellitus

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