Scientific Advisory Committee on Metabolic and Endocrine Therapies (SAC-MET) - Announcement of Meeting and Invitation for Stakeholder Comments - Ottawa, Ontario - November 2007

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Contact: Policy Bureau Enquiries

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Scientific Advisory Committee on Metabolic and Endocrine Therapies (SAC-MET)

Announcement of meeting and invitation for stakeholder comments

Ottawa, Ontario
November 2007

This notice announces the first meeting of the Health Products and Food Branch's Scientific Advisory Committee on Metabolic and Endocrine Therapies (SAC-MET). The purpose of the meeting is to obtain external advice on definitions and clinical trial requirements for the prevention of Type 2 Diabetes Mellitus (T2DM) (See Questions for Discussion, outlined below).

Mandate of the SAC-MET

To provide on-going and timely scientific, medical and clinical advice on the evaluation of safety, efficacy and effectiveness of drugs used for the treatment of metabolic and endocrine conditions.

For more details, please refer to the Terms of Reference of the SAC-MET.

Agenda & Meeting format

A detailed agenda for the meeting will be posted at a later date on the Health Canada website.

Prior to the meeting, stakeholders are asked to consider the questions for discussion as outlined below. Written comments may be sent to the Committee Coordinator. During the meeting, the Committee will address the questions as outlined, along with the submitted stakeholder comments before making final recommendations to Health Canada. These deliberations will take place in a closed meeting format on November 15^th 2007.

Procedure for submitting comments

You may submit comments by mail or e-mail to the contact person identified below by November 9^th 2007.

Please Note: All comments must be submitted by close of business November 9^th 2007. There will be no extensions to the deadline for submission of written comments.

Contact Person

Jackie Moore
SAC-MET Coordinator
Therapeutic Products Directorate
Room 2014, Tower B, Holland Cross
A.L. 3102C3
1600 Scott Street
Ottawa, ON K1A 0K9

Telephone: (613) 941-9290
Facsimile: (613) 941-5035
Jackie_Lane_Moore@hc-sc.gc.ca

Questions for Discussion: Definitions & Clinical Trial Requirements for the Prevention of Type 2 Diabetes Mellitus (T2DM)

1. (a) For the purpose of evaluating pharmaceutical interventions for the prevention of Type 2 diabetes mellitus (T2DM), what should be the definition of "prevention"?
   
   (e.g. reduction of the frequency of T2DM in high risk individuals; delay of onset of T2DM; reduction of risk factors for T2DM, etc.)?
   
   (b) If delay of onset of T2DM is considered to be a valid "prevention" indication, what would be a clinically meaningful "delay"?
   
   
2. Based on the agreed-upon definition(s), how should clinical trials be designed in order to investigate the safety and efficacy of a drug for the "prevention" indication?
   
   In particular, the following features of the study design should be defined:
   
   
   • 2.1 study population (i.e. key inclusion and exclusion criteria)
   • 2.2 primary endpoint(s)
   • 2.3 important secondary endpoints
   • 2.4 study duration:
     • 2.4.1 placebo run-in, if any
     • 2.4.2 blinded treatment phase
     • 2.4.3 open-label extension, if any (e.g. to further assess safety and maintenance of efficacy)
     • 2.4.4 post-treatment washout period, if any (e.g. to evaluate sustainability of effect(s) after treatment withdrawal)
   • 2.5 standard therapy (e.g. lifestyle recommendations for all randomized subjects)
     
     
3. Depending on the nature and magnitude of the benefit, what level of risk is acceptable for an agent intended for a healthy population (i.e., not yet manifesting disease)?
   
   What safety information should be required:
   
   
   1. pre-approval?
   2. post-approval? (within what timeframe?)
      
      
4. Should drugs for the prevention of T2DM be approved in the absence of demonstrated reduction in cardiovascular, renal, retinal and other serious health consequences of diabetes? If so, should sponsors be required to provide studies establishing the long-term clinical benefits post-approval?
   
   
5. Based on the agreed-upon definition(s) of prevention of T2DM, what would be acceptable label claims for drug products with demonstrated safety and efficacy?