LEAD 3-Vict Vs. Glim Mono

Question 0

LEAD 3 Studied Victoza Vs. Glimepiride as monotherpy: 1. What was the length of the study? 2. What were the ages of the patients? 3. What were the A1c cutoffs

Answer 0

1. 52 week, RCT, double-blind, double dummy RCT 2. 18-80 years old, with DM2 3. If previously treated with lifestyle only 7-11%, if have a h/o OAD therapy then it was 7-10%

Question 1

In LEAD 3 what were the doses of Victoza and glimepiride studied?

Answer 1

Victoza 1.2 mg & 1.8 mg Glimepiride 8 mg

Question 2

In LEAD 3, what were the baseline characteristics for: 1. What were the average ages of the patients? 2. What proportion of the patients had been previously on an OAD? 3. What proportion of the patients were drug naive? 4. What was the baseline A1c for the groups? 5. About what was the FPG?

Answer 2

1. About 52-54 2. 2/3 3. 1/3 4. 8.2% 5. 167-171

Question 3

1. In LEAD 3, what was the primary efficacy outcome? 2a. Was it achieved at the 1.2 mg dose? 2b. Was it achieved at the 1.8 mg dose? 3. Were these effects maintained during the 104 week extension?

Answer 3

1. Reduction in A1c from the baseline at 52 weeks 2a. The Victoza 1.2 mg dose had a statistically significant reduction in A1c from baseline compared to glimepiride 2b. The Victoza 1.8 mg dose had a statistically significant reduction in A1c from baseline compared to glimepiride 3. Yes

Question 4

At 52 weeks, what was the a1c reduction seen in: 1. The 1.2 mg dose group 2. The 1.8 mg dose group 3. The glimepiride group

Answer 4

1. 0.8% 2. 1.1% 3. 0.5%

Question 5

In LEAD 3, what percentage of patients achieved a target A1c of < 7% at 52 weeks? 1. 1.2 mg dose 2. 1.8 mg dose 3. Glimepiride group

Answer 5

1. 42.8% of the 1.2 mg group 2. 50.9% of the 1.8 mg group 3. 27.8% of the glimepiride group

Question 6

In LEAD 3, what percentage of patients achieved a target A1c of < 6.5% at 52 weeks? 1. 1.2 mg dose 2. 1.8 mg dose 3. Glimepiride group

Answer 6

1. 28% of the 1.2 mg group 2. 37.6% of the 1.8 mg group 3. 16.2% of the glimepiride group

Question 7

How would you describe the effect Victoza had on FPG compared to glimepiride at 52 weeks and 104 week?

Answer 7

Victoza had a statistically significant greater reduction in FPG at both doses than glimepiride in both the RCT and safety extension

Question 8

What can be said about Victoza’s effects on weight loss compared to glimepiride’s at 52 and 104 weeks?

Answer 8

The 1.2 mg dose showed a loss of about 4-4.5 lbs and the 1.8 mg dose showed a loss of about 5-6 lbs. Patients on glimepiride gained about 2 lbs.

Question 9

What can be said of Victoza’s effect on Nausea over 26 weeks? a. What percentage of patients experienced it in both groups? b. What was the time course for the nausea?

Answer 9

a. About 30% of patients reported nausea during the 1st 26 weeks fo the study b. Patients are most likely to experience upon initiation of the medication, but the incidence goes down significantly at about 2-4 months

Question 10

In LEAD 3 what can be said of the incidence of minor hypoglycemia for Victoza compared to glimepiride?

Answer 10

Glimepiride was associated with a statistically significant greater risk of hypoglycemia compared to Victoza - 26% of glimepiride vs 10-12% of Victoza patients