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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. března 2020 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

814

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 80 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Insulin Analog Mid Mixture
Insulin analog mid mixture given subcutaneously (SC).
Lék: Insulin Analog Mid Mixture
Administered SC
Experimentální: Basal Insulin Analog
Basal insulin analog given SC.
Lék: Basal Insulin Analog
Administered SC

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change From Baseline to Week 48 in HbA1c
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Eli Lilly and Company

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

6. února 2017

Primární dokončení (Aktuální)

19. února 2019

Dokončení studie (Aktuální)

12. července 2019

Termíny zápisu do studia

První předloženo

11. ledna 2017

První předloženo, které splnilo kritéria kontroly kvality

11. ledna 2017

První zveřejněno (Odhad)

12. ledna 2017

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

18. března 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. března 2020

Naposledy ověřeno

15. srpna 2019

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 16507
  • F3Z-GH-IOQR (Jiný identifikátor: Eli Lilly and Company)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.

Časový rámec sdílení IPD

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.

Kritéria přístupu pro sdílení IPD

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

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Diabetes mellitus 2. typu

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