A Study of Basal Insulin Analog and Insulin Analog Mid Mixture in Chinese Participants With Type 2 Diabetes Mellitus (CLASSIC)
6 marzo 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
814
Fase
- Fase 4
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Beijing, Cina, 102206
- Peking University International Hospital
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Beijing, Cina
- Beijing Hai Dian Hospital
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Shanghai, Cina, 200090
- Shanghai Yangpu District Central Hospital
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Beijing
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Beijing, Beijing, Cina, 100044
- Peking University Peoples Hospital
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Beijing, Beijing, Cina, 100016
- Beijing Huaxin Hospital
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Chaoyang, Beijing, Cina, 100028
- China Meitan General Hospital
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Fangshan, Beijing, Cina, 102500
- Beijing Yanhua Hospital
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Gansu
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Lanzhou, Gansu, Cina, 730030
- The 2nd Hospital of Lanzhou University
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Guangdong
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Shenzhen, Guangdong, Cina, 518020
- Shenzhen City People Hospital
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Yuexiu, Guangdong, Cina, 510080
- The 1st Hospital with Guangdong Pharmaceutical University
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Henan
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Luoyang, Henan, Cina, 471003
- The 1st Affiliated Hospital of Henan Science and technology
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Zhengzhou, Henan, Cina, 450003
- People's Hospital of Henan Province
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Hubei
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Wuhan, Hubei, Cina, 430022
- Wuhan Union (Xiehe) Hospital
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Jiangsu
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Changzhou, Jiangsu, Cina, 213003
- Changzhou No.2 People's Hospital
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Nanjing, Jiangsu, Cina, 210001
- Nanjing TCM hospital
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Nanjing, Jiangsu, Cina, 210024
- Jiang Su Province Official Hospital
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Nanjing, Jiangsu, Cina, 210048
- Nanjing Jiangbei Hospital
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Nanjing, Jiangsu, Cina, 211100
- Nanjing Jiangning Hospital
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Taizhou, Jiangsu, Cina, 225300
- Taizhou City People Hospital
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Wuxi, Jiangsu, Cina, 214000
- The Second People's Hospital of Wuxi
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Xuzhou, Jiangsu, Cina, 221009
- Xuzhou Central Hospital
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Shandong
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Qingdao, Shandong, Cina, 266071
- Qingdao Municipal Hospital
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Taian, Shandong, Cina, 271000
- Taian City Central Hospital
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Shanghai
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Shanghai, Shanghai, Cina, 200135
- Shanghai Pudong New Area Gongli Hospital
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Shanghai, Shanghai, Cina, 201318
- Shanghai Pudong New District Zhoupu Hospital
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Shunqing
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Nanchong, Shunqing, Cina, 637000
- Affiliated Hospital of North Sichuan Medical College
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Sichuan
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Chengdu, Sichuan, Cina, 610041
- The Third Affiliated Hospital of Chengdu University of TCM
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Luzhou, Sichuan, Cina, 646000
- Southwest Medical University Affiliated Hospital
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Tianjin
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Nankai, Tianjin, Cina, 300192
- Tianjin First Central Hospital
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Tongzhou
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Beijing, Tongzhou, Cina, 101149
- Beijing Luhe Hospital Capital Medical University
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Zhejiang
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Hangzhou, Zhejiang, Cina, 310014
- Zhejiang Provincial People's Hospital
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Ningbo, Zhejiang, Cina, 315010
- Ningbo First Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 80 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Insulin Analog Mid Mixture
Insulin analog mid mixture given subcutaneously (SC).
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Administered SC
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Sperimentale: Basal Insulin Analog
Basal insulin analog given SC.
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Administered SC
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline to Week 48 in HbA1c
Lasso di tempo: 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
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Percentage of Participants Who Achieve HbA1c <7% at Week 24
Lasso di tempo: 24 Weeks
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Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
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24 Weeks
|
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Percentage of Participants Who Achieve HbA1c <7% at Week 48
Lasso di tempo: 48 Weeks
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Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
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48 Weeks
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Change From Baseline to Week 24 in Venous Fasting Plasma Glucose
Lasso di tempo: 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.
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Baseline, 24 Weeks
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Change From Baseline to Week 48 in Venous Fasting Plasma Glucose
Lasso di tempo: 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
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Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
Lasso di tempo: 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.
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Baseline, 24 Weeks
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Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
Lasso di tempo: 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.
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Baseline, 48 Weeks
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Total Daily Insulin Dose at Week 24 and 48
Lasso di tempo: 24 Weeks, 48 Weeks
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Total daily insulin dose in the basal insulin analog and in Insulin Analog Mid Mixture group at week 24 and 48.
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24 Weeks, 48 Weeks
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Change From Baseline to Week 24 in Body Weight
Lasso di tempo: 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.
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Baseline, 24 Weeks
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Change From Baseline to Week 48 in Body Weight
Lasso di tempo: Baseline, 48 Weeks
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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.
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Baseline, 48 Weeks
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Rate of Hypoglycemia at Week 24 and 48
Lasso di tempo: 24 Weeks, 48 Weeks
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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.
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24 Weeks, 48 Weeks
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Number of Participants With Insulin Treatment Change at Week 48
Lasso di tempo: Baseline through 48 Weeks
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Insulin treatment change can be insulin treatment discontinuation, switch, intensification or reduction in frequency.
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Baseline through 48 Weeks
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Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24
Lasso di tempo: 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
|
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Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48
Lasso di tempo: 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
|
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Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score
Lasso di tempo: 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.
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Baseline, 48 Weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
6 febbraio 2017
Completamento primario (Effettivo)
19 febbraio 2019
Completamento dello studio (Effettivo)
12 luglio 2019
Date di iscrizione allo studio
Primo inviato
11 gennaio 2017
Primo inviato che soddisfa i criteri di controllo qualità
11 gennaio 2017
Primo Inserito (Stima)
12 gennaio 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
18 marzo 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
6 marzo 2020
Ultimo verificato
15 agosto 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 16507
- F3Z-GH-IOQR (Altro identificatore: Eli Lilly and Company)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano 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.
Periodo di condivisione 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.
Criteri di accesso alla condivisione IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .