Type 1 Diabetes Study 117

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SymlinAmylin PharmaceuticalsNew Drug
Application (21-332)
Advisory Committee Meeting Bethesda,
Maryland (July 26, 2001)
Center for Drug Evaluation and Research
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• EFFICACY - Robert I Misbin, MD
• Type 1 diabetes
• Type 2 diabetes
• SAFETY - Dragos Roman, MD
• Hypoglycemia

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Type 1 Diabetes
8.2 8.9 8.8 8.9
9.0 8.9 8.9
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Trial 117 - Type 1 Diabetes

• Stable metabolic regimen
• HbA1c at least 8 at screening
• Patients to remain on their usual diet, type
  of insulin, insulin regimen and exercise regimen

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TYPE 1 DIABETESTRIAL 117

• Mean data at baseline
• 38 years old
• 16 years of diabetes
• BMI 25
• HbA1c 9.0
• 50 units insulin/day

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American Diabetes Association Recommendations

• HbA1c lt7 Goal of therapy
• HbA1c gt8 additional action
  suggested

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Trial 117 - Type 1 Diabetes

• Stable metabolic regimen
• HbA1c at least 8 at screening
• Patients to remain on their usual diet, type
  of insulin, insulin regimen and exercise regimen

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Type 1 Diabetes Study 117
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Type 1 Diabetes - Trial 117

• Early Glycemic Responder Subgroup
• Reduction in HbA1c at least 0.5 units at 4 weeks
• Show data at 4 and 26 weeks

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Early Glycemic Responders Study117
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Early Glycemic Responders 117
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Early Glycemic Responders 117
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(No Transcript)
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Pramlintide Treatment of Type 1 Diabetes

• 3-4 injections per day in addition to insulin
• More severe hypoglycemia than reducing HbA1c with
  insulin alone
• Weight loss relative to insulin alone

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Type 2 Diabetes
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TYPE 2 DIABETESTRIAL 123

• Mean data at baseline
• 58 years old
• 13 years of diabetes
• BMI 30.6
• HbA1c 9.4
• 56 units insulin/day

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Trial 123 - Type 2 Diabetes

• HbA1c at least 8 at screening
• Patients to remain on their usual diet,
  insulin regimen, and exercise regimen
• changes in insulin doses were not encouraged in
  order to limit the impact of alterations in
  insulin dosing on glycemic control.

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Type 2 Diabetes Study 123
ITT population
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Type 2 Diabetes Metformin
-0.9
Insulin Metformin
Insulin Placebo
Annals of Internal Medicine 1999 131185
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(No Transcript)
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Type 2 Diabetes Study 123
ITT population
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SAFETY REVIEW

• Dr Dragos Roman