* MK-3102 lowers blood glucose 0.71 pct at 25 mg in study
* Safety seen similar to placebo in Phase II trial
* Merck says begins Phase III MK-3102 program with 25 mg
Oct 3 An experimental once-a-week drug for type
2 diabetes being developed by Merck & Co proved
effective in lowering blood sugar levels in a mid-stage clinical
trial, according to data presented on Wednesday.
The pill, known as MK-3102, is from the same class of
medicines as Merck's successful daily diabetes drug Januvia,
known as DPP-4 inhibitors.
The 685-patient study tested MK-3102 at five doses - ranging
from 0.25 milligram to 25 mg - against a placebo, with the
primary goal being reduction in A1c, a common measure of blood
After 12 weeks of treatment with the Merck drug, A1c was
reduced 0.71 percent at 25 mg, 0.67 percent at 10 mg, 0.49
percent at 3 mg, 0.5 percent with 1 mg, and 0.28 percent for the
lowest 0.25 mg dose. The reductions compared with placebo for
all doses were deemed to be statistically significant, according
to Merck, which presented the data on Wednesday at the European
Association for the Study of Diabetes (EASD) meeting in Berlin.
Based on the encouraging Phase II results, Merck said it is
beginning larger Phase III trials of the drug -- typically the
final stage of human testing before seeking regulatory approval.
The company said it has chosen to advance only the 25 mg dose
for a Phase III program that will test MK-3102 against, and in
combination with, a variety of diabetes treatments.
The 0.71 reduction seen with the 25 mg dose in the study is
similar to the glucose reduction attained by Januvia, known
chemically as sitagliptin.
Januvia has been a bright spot for Merck. It and a related
combination diabetes pill called Janumet saw sales jump to $1.47
billion in the second quarter, putting the franchise on track
for nearly $6 billion in sales this year.
"We do anticipate the efficacy, safety and tolerability of
this will be comparable to sitagliptin," Nancy Thornberry,
Merck's head of diabetes and endocrinology, said in a telephone
interview from Berlin.
"We have almost six years of marketed use with sitagliptin,
and so the safety and tolerability of the class as a whole has
been extremely well established, as has the efficacy profile,"
However, she stressed that MK-3102 was a new compound and
not simply a new formulation of Januvia. As with all new
diabetes treatments since GlaxoSmithKine's Avandia was
linked to serious heart risks, Merck will be expected to
demonstrate the heart safety of MK-3102 in its Phase III trials.
Patients in the Phase II study began the trial with an A1c
level of about 8 percent. American Diabetes Association
guidelines call for A1c levels of 7 percent or lower.
The drug was generally well tolerated with a safety profile
similar to placebo, Merck said.
As with Januvia, the new drug is likely to work by itself or
in combination with other diabetes treatments, including
insulin, Merck said.
"We think this is going to be a very attractive choice for
patients who have a high pill burden. Any attempt to simplify
the regimen for those patients is helpful," Thornberry said.