Title: Type 1 Diabetes Study 117
1SymlinAmylin PharmaceuticalsNew Drug
Application (21-332)
Advisory Committee Meeting Bethesda,
Maryland (July 26, 2001)
Center for Drug Evaluation and Research
2- EFFICACY - Robert I Misbin, MD
- Type 1 diabetes
- Type 2 diabetes
- SAFETY - Dragos Roman, MD
- Hypoglycemia
3Type 1 Diabetes
8.2 8.9 8.8 8.9
9.0 8.9 8.9
4Trial 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
5TYPE 1 DIABETESTRIAL 117
- Mean data at baseline
- 38 years old
- 16 years of diabetes
- BMI 25
- HbA1c 9.0
- 50 units insulin/day
6American Diabetes Association Recommendations
- HbA1c lt7 Goal of therapy
- HbA1c gt8 additional action
suggested
7Trial 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
8Type 1 Diabetes Study 117
9Type 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
10Early Glycemic Responders Study117
11Early Glycemic Responders 117
12Early Glycemic Responders 117
13(No Transcript)
14Pramlintide 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
15Type 2 Diabetes
16TYPE 2 DIABETESTRIAL 123
- Mean data at baseline
- 58 years old
- 13 years of diabetes
- BMI 30.6
- HbA1c 9.4
- 56 units insulin/day
17Trial 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.
18Type 2 Diabetes Study 123
ITT population
19Type 2 Diabetes Metformin
-0.9
Insulin Metformin
Insulin Placebo
Annals of Internal Medicine 1999 131185
20(No Transcript)
21Type 2 Diabetes Study 123
ITT population
22SAFETY REVIEW