LEAD 2: Add-on to Metformin Vs. Glimepiride

Question 0

Why was LEAD 2 done?

Answer 0

To show Victoza’s ability to be used in combination with metformin compared to a SU+ MET therapy.

Question 1

What were the study arms for LEAD 2? (5)

Answer 1

A. Glimepiride + Metformin B. Placebo+ Metformin C. Lira 0.6 mg + MET D. Lira 1.2 mg + MET E. Lira 1.8 mg + MET

Question 2

In LEAD 2, what was the duration of: 1. The Study 2. The Extension

Answer 2

1. The 1st part of the study was a double-blind, double-dummy, active control, parallel-group trial for 26 weeks 2. The extension was a 78 week open-label extension

Question 3

In LEAD 2, how did previous OAD therapy impact enrollment?

Answer 3

If a patient had been previously treated with 2 OAD, the A1c criteria for enrollment was 7-10% If a patient had been previously treated with 1 OAD, the A1c criteria for enrollment was 7-11%

Question 4

What were the baseline characteristics for LEAD 2? 1. Average age 2. BMI 3. Duration of DM2 4. HgA1c 5. FPG

Answer 4

1. About 56- 57 years old 2. About 31 for BMI 3. About 7-8 years since the time of diagnosis for DM2 4. 8.3-8.4% were the baseline A1c 5. FPG was about 180 mg/dL

Question 5

LEAD 2 had the initial study period of 26 weeks and a 78 week extension. What can be said of the effect of the change in A1c from baseline in this study at 26 weeks and 104 weeks?

Answer 5

The lira 1.2 mg, lira 1.8 mg, and glimepiride doses plus metformin therapy significanltly reduced A1c by about 1% at 26 weeks compared to MET+Placebo At 104 weeks, only lira 1.2 mg and 1.8 mg and glimepiride significantly reduced A1c compared to the placebo

Question 6

In LEAD 2 what percentage of patients achieved a HgA1c of <7% at 26 weeks compared to MET + Placebo?

Answer 6

1. Lira 1.2 mg: about 35% 2. Lira 1.8 mg: about 42% 3. Glim: about 36% 4. Placebo: about 10.8%

Question 7

In LEAD 2 what percentage of patients achieved a HgA1c of <7% at 104 weeks compared to MET + Placebo?

Answer 7

1. Lira 1.2 mg: about 30% 2. Lira 1.8 mg: about 31% 3. Glim: about 23.5% 4. Placebo: about 11%

Question 8

In previous flashcards you were asked about the % of patients who achieved A1c of < 7% at 26 and 104 weeks. What is interesting about those the effects of Lira vs. Glimepiride when you look at those 2 time periods next to each other.

Answer 8

At 26 weeks, the effect of glimepiride was greater or at least comparable to the lira 1.2 mg dose. However, at 104 weeks the effect of lira 1.2 mg surpassed that of glimepiride