acd – -Translation – Keybot Dictionary

  Réponses aux questions ...  

Show textShow cached sourceOpen source URL

L'Association canadienne du diabète (ACD) n'est pas un organisme de Santé Canada; par conséquent, Santé Canada ne peut pas dire à l'ACD ce qu'elle devrait faire. Le Groupe convient que, même si Santé Canada peut faire des suggestions à l'ACD, tout le reste ne relève pas du mandat du Groupe.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

The Canadian Diabetes Association (CDA) is not an agency of Health Canada therefore Health Canada has no authority to direct the CDA as to what they should do. The Panel agreed that while Health Canada could make suggestions to the CDA, anything else is beyond the scope of this Panel. The Panel recognized that there is a process for evaluating evidence and a methodology for developing the Guidelines, and the process must be followed.

  Ligne directrice : Norm...  

Show textShow cached sourceOpen source URL

Le manque d'efficacité au cours des essais de longue durée peut faire en sorte que les sujets reçoivent un traitement sous-optimal pendant de longues périodes. Pour éviter ce problème, il faudrait resserrer les critères de retrait en les abaissant progressivement vers l'objectif des LDPC-ACD, soit un taux d'HbA1c ≤ 7 %.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

Lack of efficacy during long term trials may result in subjects being maintained on sub-optimal treatment for extended periods. To protect subjects against lack of efficacy, the withdrawal criteria should be tightened by progressive lowering of HbA1c towards the CDA-CPG target of ≤7%. After 12 weeks of treatment, the withdrawal criteria for FPG should be tightened and HbA1c should be increasingly used to determine the clinical trial endpoints. Dose escalation or the addition of other therapies should be instituted if the HbA1c >7% (≈FPG > 9.5 mmol/L) after 6 to 12 months of treatment. Criteria for dose escalation, the addition of other therapies, or subject withdrawal should be clearly defined in the protocol for subjects with a HbA1c ≥8% (≈FPG ≥11.5 mmol/L (IFCC: 11.8 mmol/L)) at 52 weeks.

  Ligne directrice : Norm...  

Show textShow cached sourceOpen source URL

Comme la majorité des patients souffrant de diabète de type 2 présentent un surpoids ou sont obèses, les interventions qui font appel à la fois à une modification de l'alimentation et à une augmentation de l'activité physique sont recommandées dans les LDPC-ACD.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

Lifestyle management with diet and exercise can improve glycemic control, and is an integral part of the treatment of diabetes mellitus and patient self-management. Because the majority of patients with type 2 diabetes are overweight or obese, lifestyle interventions that combine dietary modification, and increased and regular physical activity, are recommended in the CDA-CPG. Thus, it is expected that subjects in all clinical trials for type 2 diabetes will receive dietary and lifestyle counselling consistent with the CDA-CPG.

  Ligne directrice : Norm...  

Show textShow cached sourceOpen source URL

Comme la majorité des patients souffrant de diabète de type 2 présentent un surpoids ou sont obèses, les interventions qui font appel à la fois à une modification de l'alimentation et à une augmentation de l'activité physique sont recommandées dans les LDPC-ACD.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

Lifestyle management with diet and exercise can improve glycemic control, and is an integral part of the treatment of diabetes mellitus and patient self-management. Because the majority of patients with type 2 diabetes are overweight or obese, lifestyle interventions that combine dietary modification, and increased and regular physical activity, are recommended in the CDA-CPG. Thus, it is expected that subjects in all clinical trials for type 2 diabetes will receive dietary and lifestyle counselling consistent with the CDA-CPG.

  Réponses aux questions ...  

Show textShow cached sourceOpen source URL

Les lignes directrices de pratique clinique élaborées et périodiquement mises à jour par l'ACD constituent le meilleur moyen de transmettre l'information sur l'utilisation clinique des insulines au milieu médical et aux professionnels de la santé.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

The Clinical Practice Guidelines developed and updated at intervals by CDA provide the best available means of communicating information about the clinical use of insulins to the medical community and health professionals. The wide range of clinically approved insulins can provide for the needs of most people who have to use insulin to control their diabetes. However the Panel agreed, as above, that animal-sourced insulin should continue to be made available to people who need them, and therefore it is desirable that this information be effectively disseminated. The specific message that might be used in the guidelines to convey this information cannot be dictated by Health Canada or by this Panel, but suggestions and discussions with CDA regarding the guidelines could be undertaken.

  Ligne directrice : Norm...  

Show textShow cached sourceOpen source URL	Santé Canada diffuse la présente ligne directrice applicable aux essais cliniques sur le diabète de type 2 dans le but de clarifier l'interprétation des Lignes directrices de pratique clinique de l'Association canadienne du diabète (LDPC-ACD)1 en ce qui concerne les demandes d'essai clinique en vertu de la partie C, titre 5, du
Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain	Health Canada is issuing this guidance for clinical trials in type 2 diabetes to provide clarification on the interpretation of the Canadian Diabetes Association Clinical Practice Guidelines (CDA-CPG)1 in relation to clinical trial applications under Part C, Division 5 of the

  Ligne directrice : Norm...  

Show textShow cached sourceOpen source URL	Santé Canada diffuse la présente ligne directrice applicable aux essais cliniques sur le diabète de type 2 dans le but de clarifier l'interprétation des Lignes directrices de pratique clinique de l'Association canadienne du diabète (LDPC-ACD) en ce qui concerne les demandes d'essai clinique en vertu de la partie C, titre 5, du
Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain	Health Canada is issuing this guidance for clinical trials in type 2 diabetes to provide clarification on the interpretation of the Canadian Diabetes Association Clinical Practice Guidelines (CDA-CPG) in relation to clinical trial applications under Part C, Division 5 of the

  Réponses aux questions ...  

Show textShow cached sourceOpen source URL

L'Association canadienne du diabète (ACD) n'est pas un organisme de Santé Canada; par conséquent, Santé Canada ne peut pas dire à l'ACD ce qu'elle devrait faire. Le Groupe convient que, même si Santé Canada peut faire des suggestions à l'ACD, tout le reste ne relève pas du mandat du Groupe.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

The Canadian Diabetes Association (CDA) is not an agency of Health Canada therefore Health Canada has no authority to direct the CDA as to what they should do. The Panel agreed that while Health Canada could make suggestions to the CDA, anything else is beyond the scope of this Panel. The Panel recognized that there is a process for evaluating evidence and a methodology for developing the Guidelines, and the process must be followed.

  Groupe consultatif d'ex...  

Show textShow cached sourceOpen source URL

Le Dr Hunt a reçu sa formation sur le diabète, au King’s College Hospital de Londres en 1955 avec Dr R. D. Lawrence. Il a déménagé au Canada en 1957. Président de l’ACD de 1964 à 1966. Professeur agrégé de médecine clinique à l’UBC.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

Dr. George Fantus received his undergraduate degree in biochemistry and his MD at McGill University in Montreal. This was followed by clinical training in Internal Medicine at the Royal Victoria Hospital, McGill and then subspecialty research and clinical training in endocrinology, in the Diabetes Branch of the National Institutes of Diabetes, Digestive and Kidney Diseases at the National Institutes of Health in Bethesda, Maryland and at the University of Toronto. Dr. Fantus joined the faculty at McGill in the Department of Medicine as Assistant Professor and established his independent research lab in the Division of Endocrinology and Metabolism. In 1987, he was appointed Director of the Metabolic Day Centre at the Royal Victoria Hospital. In 1991, Dr. Fantus moved to the University of Toronto and is currently Professor of Medicine and Physiology and Associate Dean, Research in the Faculty of Medicine. He served as Director, Division of Endocrinology and Metabolism in the Department of Medicine from 2001 - 2008. He is a senior scientist at the Toronto General Research Institute, Director of the Core Laboratory of the Banting and Best Diabetes Centre, and Associate Scientist at the Samuel Lunenfeld Reseach Institute, Mount Sinai Hospital. His clinical work in Endocrinology and focusing on type 2 diabetes is located at the Mount Sinai Hospital/University Health Network, Division of Endocrinology and Metabolism. Dr. Fantus has served on grants panels at the CIHR, the Canadian Diabetes Association, the NIH and on the Editorial Board of several journals, e.g. Endocrinology, Amer J. of Physiology.

  Ligne directrice : Norm...  

Show textShow cached sourceOpen source URL

Les Lignes directrices de pratique clinique de l'Association canadienne du diabète (LDPC-ACD) publiées en décembre 2003 recommandaient une prise en charge plus dynamique du diabète. Les lignes directrices révisées sont fondées sur des études publiées révélant une association entre des concentrations supérieures d'hémoglobine glycosylée (HbA1c) et un risque accru de complications liées au diabète, notamment le décès, l'infarctus du myocarde, la microangiopathie et la macroangiopathie2 3 4.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

The Canadian Diabetes Association Clinical Practice Guidelines (CDA-CPG) published in December 2003 recommended more aggressive management of type 2 diabetes. The revised guidelines were based on published studies reporting an association between higher levels of glycosylated haemoglobin (HbA1c) and an increased risk of complications related to diabetes, including death, myocardial infarction, and micro- and macro-vascular disease2 3 4. Based on the available evidence, the CDA-CPG Expert Committee recommended targets for glycemic control of a HbA1c ≤7%, a fasting plasma glucose (FPG) of 4.0 - 7.0 mmol/L (International Federation of Clinical Chemistry and Laboratory Medicine (IFCC): 4.3 - 7.3 mmol/L) and a 2-hour postprandial plasma glucose of 5.0 - 10.0 mmol/L (IFCC: 5.3 - 10.3 mmol/L) in patients in whom these targets could be safely met. For type 2 diabetes mellitus it was recommended that the management regimen be tailored to aim for glycemic targets as close to normal as possible, and as early as possible, with the target HbA1c attained within 6 to 12 months.

  Ligne directrice : Norm...  

Show textShow cached sourceOpen source URL

Comme les LDPC-ACD recommandent de viser un taux d'HbA1c < 7 % dans un délai de 6 à 12 mois, le protocole de tout essai d'une durée de > 3 mois devrait prévoir des moyens d'atteindre l'objectif des LDPC-ACD et des critères de retrait en cas de contrôle inadéquat de la glycémie.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

Phase III trials are longer term, typically 6 months to 2 years in duration, and usually have an active control arm with an accepted treatment. The test arm, or arms, are placebo-controlled, add-on therapy to the accepted treatment, or direct comparisons to the accepted treatment. The objective is usually non-inferiority or equivalence to the accepted treatment. The CDA-CPG recommend a target HbA1c of <7% within 6 to 12 months, therefore the protocol for any trial of >3 months duration should contain procedures to meet the CDA-CPG target and withdrawal criteria for inadequate glycemic control. The procedures to meet the CDA-CPG target include dose escalation and the addition of other therapies.

  Ligne directrice : Norm...  

Show textShow cached sourceOpen source URL

L'interprétation cohérente des LDPC-ACD relativement à la prise en charge des sujets souffrant de diabète de type 2 qui participent aux essais cliniques sur de nouveaux médicaments pour le traitement du diabète de type 2 contribuera à assurer la sécurité des sujets.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

Clinical practice guidelines ensure the best standard of care based on current science and consensus in the medical and scientific communities. From the regulatory perspective, they are one of the measures against which the safety of the subjects is assessed during the review of clinical trial applications. The consistent interpretation of CDA-CPG in relation to the management of subjects with type 2 diabetes in clinical trials for new drugs for the treatment of type 2 diabetes will contribute to the safety of subjects.

  Ligne directrice : Norm...  

Show textShow cached sourceOpen source URL

Les LDPC-ACD recommandent que le taux d'HbA1c soit surveillé tous les 3 mois et que la plupart des patients atteints de diabète de type 2 assurent une auto-surveillance de leur glycémie au moins une fois par jour, et plus souvent au besoin.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

The CDA-CPG guidelines recommend that HbA1c be monitored every three months and that most patients with type 2 diabetes self monitor blood glucose at least once daily, with more frequent monitoring as needed. Health Canada is recommending that subjects enrolled in clinical trials in Canada self monitor blood glucose daily, with more frequent monitoring as needed. HbA1c should be monitored at a maximum of 3 month intervals.

  Ligne directrice : Norm...  

Show textShow cached sourceOpen source URL

Certains antihyperglycémiants ont été associés à un gain de poids et à une rétention d'eau entraînant une insuffisance cardiaque, il faudrait par conséquent conseiller aux sujets de vérifier souvent leur poids corporel et d'aviser le chercheur des augmentations soudaines ou constantes survenues à ce chapitre. Les intervalles maximaux pour la surveillance du poids corporel et d'autres mesures doivent être conformes aux intervalles prescrits dans l'exemple de plan de traitement des patients des LDPC-ACD.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

Some antihyperglycemic agents have been associated with weight gain and water retention leading to congestive heart failure, therefore subjects should be advised to self monitor body weight at frequent intervals and to inform the investigator of sudden or consistent increases in body weight. The maximum intervals for monitoring body weight and other measures should conform to the intervals prescribed in the sample patient care plan in the CDA-CPG.

  Réponses aux questions ...  

Show textShow cached sourceOpen source URL

Les lignes directrices de pratique clinique élaborées et périodiquement mises à jour par l'ACD constituent le meilleur moyen de transmettre l'information sur l'utilisation clinique des insulines au milieu médical et aux professionnels de la santé.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

The Clinical Practice Guidelines developed and updated at intervals by CDA provide the best available means of communicating information about the clinical use of insulins to the medical community and health professionals. The wide range of clinically approved insulins can provide for the needs of most people who have to use insulin to control their diabetes. However the Panel agreed, as above, that animal-sourced insulin should continue to be made available to people who need them, and therefore it is desirable that this information be effectively disseminated. The specific message that might be used in the guidelines to convey this information cannot be dictated by Health Canada or by this Panel, but suggestions and discussions with CDA regarding the guidelines could be undertaken.

  Groupe consultatif d'ex...  

Show textShow cached sourceOpen source URL

Il est arrivé au Canada en 1992, et a occupé un poste de professeur adjoint de médecine à l’Université Memorial de Terre-Neuve, à St. John’s, jusqu’en mai 1997. Il est membre du conseil d’administration de l’ACD et chef de la section clinique et scientifique. Il est aussi membre du conseil d’administration d’Obésité Canada.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

Silverman has received various honours including an Assistantship and an Associateship from the Arthritis Society of Canada. He is currently the only Canadian Advisor to the Arthritis Panel at the U.S. Food and Drug Administration. He coordinates the Northern Paediatric Clinic which travels throughout Northern Ontario. Dr. Silverman is an Associate Editor at the Journal of Rheumatology responsible for the paediatric section of the journal. Dr. Silverman has continually held peer reviewed research grants from both the Arthritis Society and Medical Research Council of Canada, now the Canadian Institutes of Health Research (CIHR).

  Ligne directrice : Norm...  

Show textShow cached sourceOpen source URL

Les LDPC-ACD recommandent que la plupart des patients atteints de diabète de type 2 assurent une auto-surveillance de leur glycémie au moins une fois par jour, et plus souvent au besoin. Santé Canada recommande que les sujets inscrits dans des essais cliniques assurent une auto-surveillance de leur glycémie au moins une fois par jour.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

The CDA-CPG guidelines recommend that most patients with type 2 diabetes self monitor blood glucose at least once daily, with more frequent monitoring as needed. Health Canada is recommending that subjects enrolled in clinical trials in Canada self monitor blood glucose at least once daily. HbA1c should be monitored by the investigator at 3 month intervals. Because some antihyperglycemic agents have been associated with weight gain and water retention, subjects should also be advised to self monitor body weight at frequent intervals and inform the investigator of sudden or consistent increases in body weight. The protocol should specify weight monitoring by the investigator at treatment visits.

  Ligne directrice : Norm...  

Show textShow cached sourceOpen source URL

Les Lignes directrices de pratique clinique de l'Association canadienne du diabète (LDPC-ACD) publiées en décembre 2003 recommandaient une prise en charge plus dynamique du diabète. Les lignes directrices révisées sont fondées sur des études publiées révélant une association entre des concentrations supérieures d'hémoglobine glycosylée (HbA1c) et un risque accru de complications liées au diabète, notamment le décès, l'infarctus du myocarde, la microangiopathie et la macroangiopathie2 3 4.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

The Canadian Diabetes Association Clinical Practice Guidelines (CDA-CPG) published in December 2003 recommended more aggressive management of type 2 diabetes. The revised guidelines were based on published studies reporting an association between higher levels of glycosylated haemoglobin (HbA1c) and an increased risk of complications related to diabetes, including death, myocardial infarction, and micro- and macro-vascular disease2 3 4. Based on the available evidence, the CDA-CPG Expert Committee recommended targets for glycemic control of a HbA1c ≤7%, a fasting plasma glucose (FPG) of 4.0 - 7.0 mmol/L (International Federation of Clinical Chemistry and Laboratory Medicine (IFCC): 4.3 - 7.3 mmol/L) and a 2-hour postprandial plasma glucose of 5.0 - 10.0 mmol/L (IFCC: 5.3 - 10.3 mmol/L) in patients in whom these targets could be safely met. For type 2 diabetes mellitus it was recommended that the management regimen be tailored to aim for glycemic targets as close to normal as possible, and as early as possible, with the target HbA1c attained within 6 to 12 months.

  Liste des membres et de...  

Show textShow cached sourceOpen source URL

Depuis huit ans, il travaille bénévolement pour l'Association canadienne du diabète (ACD). Il a aidé son épouse Jill à mettre sur pied un groupe de soutien pour les parents d'enfants atteints de diabète de type 1, il a participé à la collecte de fonds par le truchement du programme de marathon d'Équipe Diabète Canada, il présente des exposés dans le cadre du Programme Signature de l'ACD, il a été élu président régional de l'ACD pour le Nouveau-Brunswick et, finalement, il est membre et président du National Advocacy Council de l'Association canadienne du diabète.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

For the past eight years he has been an active volunteer with the Canadian Diabetes Association (CDA). He assisted his wife Jill in the formation of a local Type 1 Diabetes Parent Support Group, he became involved in fundraising through the Team Diabetes Canada marathon program, he has served as CDA Signature Programs presenter, he was elected as the CDA's regional chairperson for New Brunswick and, most recently, he has served as a member and as Chair of the CDA's National Advocacy Council.

  Compétences - Groupe co...  

Show textShow cached sourceOpen source URL

Fait partie du comité consultatif scientifique sur les traitements métaboliques et endocriniens de Santé Canada; membre de nombreuses sociétés et associations; notamment l'American Diabetes Society; membre actif et ancien président de l'ACD; nombreuses recherches dans des domaines connexes.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

University of British Columbia; Professor of Medicine and Head, Division of Endocrinology, St. Paul's Hospital and Vancouver General Hospital, Vancouver. Current grant and honoraria from regulated industry but not related to the mandate of the Panel. Member of the Health Canada Scientific Advisory Committee on Metabolic and Endocrine Therapies; Member of many societies and associations , including American Diabetes society; active member and past Chair, CDA; considerable research in related field.

  Compétences - Groupe co...  

Show textShow cached sourceOpen source URL

Professeur de médecine et de physiologie, chercheur scientifique au Robarts Research, University of Western Ontario (UWO); membre, Division d'endocrinologie et de métabolisme, département de médecine, UWO, London Health Science Centre; consultant auprès de sociétés connexes; membre d'associations professionnelles et de comités de rédaction liés au diabète, soit Association canadienne du diabète (ACD), American Diabetes Association; nombreuses publications dans des domaines connexes.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

Professor of Medicine & Physiology, Scientist at Robarts Research, University of Western Ontario (UWO); Member Division of Endocrinology and Metabolism, Department of Medicine, UWO, London Health Science Centre; Consultant to related industry; Member of professional associations and editorial boards related to diabetes, i.e., Canadian Diabetes Association (CDA), American Diabetes Association; Numerous publications in related field.

  Liste des membres et de...  

Show textShow cached sourceOpen source URL

Depuis huit ans, il travaille bénévolement pour l'Association canadienne du diabète (ACD). Il a aidé son épouse Jill à mettre sur pied un groupe de soutien pour les parents d'enfants atteints de diabète de type 1, il a participé à la collecte de fonds par le truchement du programme de marathon d'Équipe Diabète Canada, il présente des exposés dans le cadre du Programme Signature de l'ACD, il a été élu président régional de l'ACD pour le Nouveau-Brunswick et, finalement, il est membre et président du National Advocacy Council de l'Association canadienne du diabète.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

For the past eight years he has been an active volunteer with the Canadian Diabetes Association (CDA). He assisted his wife Jill in the formation of a local Type 1 Diabetes Parent Support Group, he became involved in fundraising through the Team Diabetes Canada marathon program, he has served as CDA Signature Programs presenter, he was elected as the CDA's regional chairperson for New Brunswick and, most recently, he has served as a member and as Chair of the CDA's National Advocacy Council.

  Ligne directrice : Norm...  

Show textShow cached sourceOpen source URL

Les LDPC-ACD recommandent que les patients qui n'atteignent pas les objectifs glycémiques au bout de 2 à 3 mois à l'aide d'une gestion du mode de vie soient traités au moyen d'un seul antihyperglycémiant si le taux d'HbA1c est < à 9 %.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

In short-term Phase II proof of concept studies, subjects are usually treatment naive or inadequately controlled type 2 diabetes patients with a HbA1c of 6.5 - 10%. The CDA-CPG recommend that patients who do not achieve glycemic targets within 2 - 3 months using lifestyle management should be treated with a single antihyperglycemic agent if the HbA1c <9%. An HbA1c ≥9% is considered marked hyperglycemia, and the CDA-CPG recommend that patients with an HbA1c ≥9%, despite lifestyle management, be treated with 2 antihyperglycemic agents from different classes, or with insulin. Thus, a HbA1c ≥9% should only be allowed if the subject has not previously attempted lifestyle management

  Ligne directrice : Norm...  

Show textShow cached sourceOpen source URL

Comme les LDPC-ACD recommandent de viser un taux d'HbA1c < 7 % dans un délai de 6 à 12 mois, le protocole de tout essai d'une durée de > 3 mois devrait prévoir des moyens d'atteindre l'objectif des LDPC-ACD et des critères de retrait en cas de contrôle inadéquat de la glycémie.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

Phase III trials are longer term, typically 6 months to 2 years in duration, and usually have an active control arm with an accepted treatment. The test arm, or arms, are placebo-controlled, add-on therapy to the accepted treatment, or direct comparisons to the accepted treatment. The objective is usually non-inferiority or equivalence to the accepted treatment. The CDA-CPG recommend a target HbA1c of <7% within 6 to 12 months, therefore the protocol for any trial of >3 months duration should contain procedures to meet the CDA-CPG target and withdrawal criteria for inadequate glycemic control. The procedures to meet the CDA-CPG target include dose escalation and the addition of other therapies.

  Ligne directrice : Norm...  

Show textShow cached sourceOpen source URL

Les LDPC-ACD recommandent que les patients qui n'atteignent pas les objectifs glycémiques au bout de 2 à 3 mois à l'aide d'une gestion du mode de vie soient traités au moyen d'un seul antihyperglycémiant si le taux d'HbA1c est < à 9 %.

Compare text pagesCompare HTM pagesOpen source URLOpen target URLDefine hc-sc.gc.ca as primary domain

In short-term Phase II proof of concept studies, subjects are usually treatment naive or inadequately controlled type 2 diabetes patients with a HbA1c of 6.5 - 10%. The CDA-CPG recommend that patients who do not achieve glycemic targets within 2 - 3 months using lifestyle management should be treated with a single antihyperglycemic agent if the HbA1c <9%. An HbA1c ≥9% is considered marked hyperglycemia, and the CDA-CPG recommend that patients with an HbA1c ≥9%, despite lifestyle management, be treated with 2 antihyperglycemic agents from different classes, or with insulin. Thus, a HbA1c ≥9% should only be allowed if the subject has not previously attempted lifestyle management