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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 mars 2020 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

814

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Insulin Analog Mid Mixture
Insulin analog mid mixture given subcutaneously (SC).
Médicament: Insulin Analog Mid Mixture
Administered SC
Expérimental: Basal Insulin Analog
Basal insulin analog given SC.
Médicament: Basal Insulin Analog
Administered SC

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change From Baseline to Week 48 in HbA1c
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Eli Lilly and Company

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

6 février 2017

Achèvement primaire (Réel)

19 février 2019

Achèvement de l'étude (Réel)

12 juillet 2019

Dates d'inscription aux études

Première soumission

11 janvier 2017

Première soumission répondant aux critères de contrôle qualité

11 janvier 2017

Première publication (Estimation)

12 janvier 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 mars 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 mars 2020

Dernière vérification

15 août 2019

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 16507
  • F3Z-GH-IOQR (Autre identifiant: Eli Lilly and Company)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage 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.

Critères d'accès au partage IPD

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

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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