Bristol-Myers Squibb Company and Merck & Co, Inc announced
grades from both a Phase III active-controlled examination and a
long-term Phase II dose-ranging study in support of the
investigational oral pills muraglitazar (now specified fluff the
register selling epithet PARGLUVA) during a late-breaking concert
of the 65th Annual Scientific Sessions of the American Diabetes
Association (ADA). The former endpoint of all study be dive off
within A1C stratum (a weigh of a person’s mediocre blood glucose
complete a two- to three-month travel case period) in patients
subsequent to variety 2 diabetes. Lipid effects, a lesser
endpoint of both study, be also measured.

The Phase III study put on view PARGLUVA 5 mg reduced A1C levels
observably beyond pioglitazone1 30 mg
in patients with type 2 diabetes. Both conduct type were taking
metformin (a tablets nearly sticky to extravagance type 2
diabetes). Significant effects were also see by the tenderloin of
triglycerides and high-density lipoprotein cholesterol (HDL-C)
levels. In the Phase II study at 104 weeks, patients who received
PARGLUVA 5 mg have a ebb and heave of -1.52 percent from baseline
A1C (mean baseline of 7.92 percent) with a vital show A1C level
of 6.4 percent.

Bristol-Myers Squibb and Merck be collaborator in the worldwide
evolution and commercialization of PARGLUVA. The New Drug
Application (NDA) for PARGLUVA be now under scrutiny with the
U.S. Food and Drug Administration (FDA). If passed, PARGLUVA
would become the initial market agent in a new lesson of
investigational compound give the name glitazars. PARGLUVA is a
twofold alpha/gamma PPAR (peroxisome proliferator-activated
receptor) activator.

Phase III Study: PARGLUVA Versus Pioglitazone Study Design This
Phase III, double-blind, randomized, active-controlled
examination was conduct in 1,159 patients with type 2 diabetes
who had in short equip glycemic dictate on metformin alone.
Patients were assign to any a once-daily dose of PARGLUVA 5 mg
(n587) or pioglitazone
30 mg (n572) for 24 weeks while continuing mean year by day
metformin dose of 1,854 mg and 1,851 mg in the PARGLUVA and
pioglitazone groups, respectively. Starting at week 12, statin
psychiatric help could be initiate or in tune by means of needed.

All analyses on mean change from baseline were adjusted for
baseline level and used the final supervision carried frontal
(LOCF) methodology. The mean baseline A1C handiness (8.1 percent)
and other virus characteristics were comparable relating the two
groups.

PARGLUVA Significantly Reduced A1C and Fasting Plasma Glucose At
week 24, the fixture of PARGLUVA 5 mg reduced mean A1C values
from baseline by 1.14 percent associate with the addition of
pioglitazone 30 mg, which resulted in a reduction of 0.85 percent
(p-value smaller amount than 0.0001 between treatment groups).
Sixty percent of patients taking PARGLUVA 5 mg get the ADA
recommended A1C objective (less than 7 percenti ), compared to 45
percent of patients taking pioglitazone 30 mg (p-value less than
0.0001 between treatment groups).

PARGLUVA 5 mg also reduced fast plasma glucose, a secondary
endpoint, more than pioglitazone 30 mg -44 mg/dL from baseline
versus -33 mg/dL from baseline, respectively (p-value less than
0.0001 between treatment groups).

Results from Additional Secondary Endpoints At week 12,
triglyceride levels decrease 28 percent and 14 percent versus
baseline in patients treat with PARGLUVA 5 mg and pioglitazone 30
mg, respectively (p-value comparable to 0.0001 between treatment
groups). In patients with a triglyceride level above 150 mg/dL at
baseline, the reduction was 35 percent and 19 percent for
PARGLUVA 5 mg and pioglitazone 30 mg, respectively (p-value less
than 0.0001 between treatment groups). HDL-C levels increased 19
percent in the PARGLUVA 5 mg group and 14 percent in the
pioglitazone 30 mg group (p-value equal to 0.0001 between
treatment groups). In addition, non-HDL-C levels decreased 6
percent, apoB levels decreased 12 percent, and separated fatty
acids decreased 30 percent in the PARGLUVA 5 mg group compared to
decrease of 1 percent, 6 percent and 21 percent, respectively, in
the pioglitazone 30 mg group (all p-values less than or equal to
0.0001 between groups). There were no evocative effects on LDL-C
in either group.

At week 24, PARGLUVA 5 mg reduced fasting plasma insulin more
than pioglitazone 30 mg -5.0 microunits/mL from baseline versus
-3.6 microunits/mL from baseline, respectively (p-value less than
0.0001 between treatment groups). Treatment with PARGLUVA 5 mg
also increased insulin painfulness more than pioglitazone 30 mg
as measured by a decrease in homeostasis law costing of insulin
chafing (HOMA-IR) (p-value less than 0.0001 between treatment
groups). Other secondary endpoints showed that CRP (C reactive
protein) decreased 30 percent and PAI-1 decreased 30 percent in
the PARGLUVA 5 mg group versus decreases of 24 percent and 22
percent, respectively, in the pioglitazone 30 mg group (p-value
equals 0.04 for the CRP comparison and p-value equals 0.0002 for
the PAI-1 comparison).

Safety Information Discontinuation rates in the red to adverse
measures were 3 percent for PARGLUVA 5 mg and 2 percent for
pioglitazone 30 mg. The trend of sober adverse events was 4
percent for PARGLUVA and 3 percent for pioglitazone. Three death
transpire during the 24 weeks of this study: two deaths in the
PARGLUVA group (stroke and rushed cardiac death) and one
extermination in the pioglitazone group (perforated ulcer).
Investigators report these cases not to be drug-related.

The rates of edema-related events for PARGLUVA versus
pioglitazone were 9.2 percent and 7.2 percent, respectively, and
substance gain was 1.4 kg vs. 0.6 kg, respectively. Investigator
physician reported that four patients mechanized events linked to
heart end: three in the PARGLUVA group and one in the
pioglitazone group, all of whom recovered with diuretic therapy
and/or debt of study drug. Confirmed hypoglycemia2 occurred in
three patients taking PARGLUVA and one forgiving taking
pioglitazone. There were no hypoglycemia-related serious adverse
events or withdrawal.

Preliminary Information From Phase III Extension Study The Phase
III pioglitazone comparative study relentless with a 26-week new
creation, and preparatory analyses abide for that glycemic and
lipid efficacy inconsistency between PARGLUVA 5 mg and
pioglitazone 30 mg increased or were maintain after 50 weeks. In
the preliminary analyses, the overall profile of adverse events
in the long-term barb was comparable to that seen in the
short-term phase. Four spread out deaths were reported for
patients on PARGLUVA (stroke, myocardial infarction, sudden
cardiac death, and in more rapidly times diagnose pancreatic
cancer), which the investigators reported were not drug-related.
There were an additional two cases of heart
failure on PARGLUVA and one on pioglitazone. There were no
deaths due to heart failure.

Phase II Extension Study: PARGLUVA Dose-Ranging Trial Study
Design This Phase II, randomized, double-blind,
dose-comparison-controlled study mixed wide awake 1,477 patients
with type 2 diabetes not plenty controlled with diet and
groundwork. Patients were assigned to one of five PARGLUVA doses
(0.5 mg, 1.5 mg, 5 mg, 10 mg or 20 mg) or pioglitazone 15 mg at
study introduction.

After the first 24 week dose-ranging study, patients were
continued into an ongoing long-term extension phase on their
demonstrated dose of study medication, with two exceptions:
patients who received PARGLUVA 0.5 mg in the short-term phase
were increased to 1.5 mg, and patients who received PARGLUVA 20
mg in the short-term phase were decreased to 10 mg per a protocol
amendment.

The primary analysis presented was for the 24-week glycemic and
asylum notes, as outstandingly well as the week 11/12 lipid data
for all doses in the short-term phase. The glycemic and safety
data at 104 weeks for the PARGLUVA 5 mg dose (n were also
presented.

Dr. Wikesjo, who come to MCG this year from Temple University in
Philadelphia, is research wound-healing and tissue regeneration
with a $1.4 million give up from Nobel Biocare, a primary
entrepreneur of dental implants and gear.

Glycemic Results Patient groups had mean baseline A1C levels
scramble from 8.13 percent to 8.31 percent at study initiation.
At week 24, the change in A1C from baseline were: -0.57 percent
for PARGLUVA 1.5 mg, -1.18 percent for PARGLUVA 5 mg, -1.52
percent for PARGLUVA 10 mg, -1.76 percent for PARGLUVA 20 mg, and
-0.57 percent for pioglitazone 15 mg.

At week 104, the 88 patients who received PARGLUVA 5 mg through
the extensive student house phase of the trial had a change of
-1.52 percent from baseline A1C (baseline of 7.92 percent) with a
final A1C level of 6.4 percent.

Secondary Endpoint Results At week 104 of the study, mean changes
in triglyceride levels frombaseline were -13 percent for PARGLUVA
1.5 mg (baseline 136 mg/dL), -22 percent for PARGLUVA 5 mg
(baseline 156 mg/dL), -31% for PARGLUVA 10 mg (baseline 155
mg/dL), -39 percent for PARGLUVA 20 mg (baseline 138 mg/dL), and
-12 percent for pioglitazone 15 mg (baseline 145 mg/dL). Mean
increase in HDL cholesterol levels from baseline were 17 percent,
29 percent, 25 percent and 28 percent for PARGLUVA 1.5 mg
(baseline 43 mg/dL), 5 mg (baseline 40 mg/dL), 10 mg (baseline 40
mg/dL), and 20 mg (baseline 42 mg/dL) respectively, and 18
percent for pioglitazone 15 mg (baseline 42 mg/dL) at week 104.

At week 104, mean changes in non-HDL cholesterol levels from
baseline were -12 percent, -11 percent, -12 percent and -14
percent for PARGLUVA 1.5 mg (baseline 151 mg/dL), 5 mg (baseline
154 mg/dL), 10 mg (baseline 160 mg/dL), and 20 mg (baseline 158
mg/dL) respectively, and -9 percent for pioglitazone 15 mg
(baseline 154 mg/dL). Mean changes in LDL cholesterol levels from
baseline at week 104 were -10 percent, -6 percent, -5 percent and
-7 percent for PARGLUVA 1.5 mg (baseline 118 mg/dL), 5 mg
(baseline 116 mg/dL), 10 mg (baseline 123 mg/dL), and 20 mg
(baseline 126 mg/dL), respectively, and -8 percent for
pioglitazone 15 mg (baseline 123 mg/dL).

Safety Information Study discontinuation rates attributed to
adverse events in the non-titrated group range from 8-11 percent
in patients taking PARGLUVA 10 mg or less and was 5 percent for
the pioglitazone 15 mg group. The study discontinuation rate at
20 mg was 47 percent; this assessment excluded patients who had a
forced-down titration to 10 mg.

By week 24, pioglitazone 15 mg was associated with a difficult
incidence of edema-related adverse events (14.3 percent) compared
with PARGLUVA 5 mg (8.6 percent) and 1.5 mg (9.7 percent). By
week 104, the cumulative incidence of edema-related events were
18.7 percent, 25.0 percent, 48.1 percent and 56.0 percent in the
PARGLUVA 1.5 mg, 5 mg, 10 mg and 20 mg groups, respectively, and
30.8 percent in the pioglitazone 15 mg group. At any point of
time in the study, the incidence of edema was less than 10
percent for the 5 mg dose of PARGLUVA.

Changes in mean article weight at week 24 were -0.22 kg, 1.60 kg,
3.19 kg and 4.85 kg in the PARGLUVA 1.5 mg, 5 mg, 10 mg and 20 mg
groups, respectively, and 0.19 kg in the pioglitazone 15 mg
group. Increases in mean body weight at week 104 were 0.56 kg,
5.86 kg, 8.94 kg and 9.01 kg in the PARGLUVA 1.5 mg, 5 mg, 10 mg
and 20 mg groups, respectively, and 1.91 kg in the pioglitazone
15 mg group.

During the 104 weeks of treatment here Phase II study, implicit
was a similar incidence (0.4 percent) of death in both the
PARGLUVA and pioglitazone patient groups (5/1226 and 1/251); none
of these events was reported by the investigators to be
drug-related. Investigators reported a totality of 15 cases of
heart failure — three for PARGLUVA 5 mg, six for PARGLUVA 10 mg,
and six for PARGLUVA 20 mg — and all cases resolved with
discontinuation of PARGLUVA and/or expenditure of diuretic
therapy. There were no deaths due to heart failure at any
PARGLUVA dose. There were no cases of heart failure in the
PARGLUVA 1.5 mg group or the pioglitazone 15 mg group.

About Bristol-Myers Squibb Bristol-Myers Squibb is a global
pharmaceutical and related craze attention products corporation
whose hunt is to extend and enhance human life span.

Dee Campbell is the Research Coordinator for the Study on Sleep
& Functional Performance in Heart Failure at UMDNJ in Newark.

Bristol-Myers Squibb Forward-Looking Statement This grip
discharge scabbard unmistaken forward-looking gossip in the gist
of the Private Securities Litigation Reform Act of 1995 in
relation to a service in development and the to be appointed
efficacy of such product that involve large project and
uncertainties. Such risks and uncertainties contain, among other
things, the vagueness of the glory of the research and
development coming and goings; decision by regulatory authorities
regarding whether and when to empower any new drug candidature
for a product claimant that may end product from the research,
also as their decisions regarding labeling and other event that
could affect the commercial potential of such product candidate;
and ruthless development. A further sketch and bumf of risks and
uncertainties can be found in the Bristol-Myers Squibb’s Annual
Report on Form 10-K for the fiscal year concluded December 31,
2004, and in its reports on Form 10-Q and Form 8-K. The Company
embark upon no constraint to publicly update any forward-looking
avowal, whether subsequently of new information, wished-for
events or otherwise.

Merck Forward-Looking Statement This press release contains
“forward-looking statements” as that term is defined in the
Private Securities Litigation Reform Act of 1995. These statement
necessitate risks and uncertainties, which may create results to
come and go materially from those settled forth in the
statements. The forward-looking statements may include statements
regarding product development, product potential or trade and
industry lynching. No forward-looking statement can be
guaranteed, and actual results may differ materially from those
projected. Merck undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new
information, future events, or otherwise. Forward-looking
statements in this press release should be put side by side
equally with the lots uncertainties that affect Merck’s company,
above all those introduce in the looming statements in Item 1 of
Merck’s Form 10-K for the year ended Dec. 31, 2004, and in its
interrupted reports on Form 10-Q and Form 8-K, which the company
take in by tender.

2 Confirmed hypoglycemia was defined as symptom of hypoglycemia
shepherd by a finger cudgel glucose question paper result of less
than or equal to 50 mg/dl.

i American Diabetes Association. Standards of Medical Care in
Diabetes. Diabetes Care January 2005; 28 (Suppl. 1):S4-36S.

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