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Senior Citizen Health & Medicine
Galvus Oral Diabetes Compound Shows Significant
Blood Sugar Reduction
Senior
citizens showed A1c drop of 2.3% from mean A1c baseline of 8.4%
June 13, 2006 - Galvus (vildagliptin), seeking to
become a new once-daily oral treatment option for type 2 diabetes, has
demonstrated impressive efficacy, especially in patients with poor
glycemic control, as well as weight loss benefits in obese patients,
according to a Phase III study reported today at the 66th Scientific
Sessions of the American Diabetes Association (ADA) meeting in
Washington, DC.
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The combination of Galvus, a member of the DPP-4
inhibitor class, and pioglitazone led to an overall 1.9% reduction in
HbA1c (a measure of blood sugar control also known as A1c).
Pioglitazone is an insulin sensitizer known as a
thiazolidinedione, or TZD.
Two-thirds of people (65%) on Galvus and
pioglitazone achieved the ADA-defined A1c goal of less than or equal to
7% versus 42% of those who achieved this goal on monotherapy (Galvus
42.5%, pioglitazone 42.9%).
More importantly, a reduction of up to 2.8% in A1c
was seen among patients with poor glycemic control who had the highest
mean baseline blood sugar levels (about 10%) as measured by A1c.
Also in this study, patients over age 65 who were
given Galvus and pioglitazone showed an A1c drop of 2.3% from a mean A1c
baseline of 8.4%.
In obese patients, with a Body Mass Index (BMI)
equal to or over 35, patients given Galvus and pioglitazone showed a
decline of 2.2% from a mean A1c baseline of 8.6%.
In a separate head-to-head comparison with
rosiglitazone, another insulin sensitizer, Galvus demonstrated
comparable efficacy. Among severely obese Galvus-treated patients, there
was a mean reduction of body weight greater than 1 kg, with an overall
mean difference of 2.8 kg between the Galvus and rosiglitazone treatment
groups.
"These new data underscore the significant efficacy
and good tolerability that have been consistently observed in the robust
Galvus clinical development program," said James Shannon, MD, Head of
Development at Novartis Pharma AG.
"The magnitude of A1c reductions seen with the
combination of Galvus and a TZD is encouraging for patients struggling
to reach and maintain their blood sugar levels. The trial results for
Galvus continue to reinforce the benefits of treating both islet
dysfunction and insulin resistance in type 2 diabetes," Shannon said.
Throughout the Phase III program, Galvus has shown
clinically significant and consistent A1c reductions both as monotherapy
and in combination with other oral and injectable anti-diabetic agents.
Galvus has demonstrated a good tolerability profile in these studies,
with no weight gain overall and an incidence of hypoglycemia
(excessively low blood sugar) and edema (fluid retention) similar to
placebo in monotherapy trials.
"As the diabetes epidemic continues to grow
worldwide, there is a very real and urgent need for new ways to help
control blood sugar levels in people with type 2 diabetes," said Julio
Rosenstock, MD, Director of Dallas Diabetes and Endocrine Center at
Medical City, Clinical Professor of Medicine, University of Texas,
Southwestern Medical School Dallas and a lead investigator in the Galvus/pioglitazone
trial.
"We were pleased to see the especially steep
reductions of glucose in the sub-analysis of patients with the highest
blood sugar levels. However, this high baseline population represents a
difficult to treat group and these patients usually require a multi-drug
strategy to reach glycemic goal."
Galvus was accepted for U.S. regulatory review
earlier in 2006. The submission includes data from clinical trials
involving more than 4,300 patients worldwide. Regulatory filings in the
EU are planned to be completed later in 2006.
About the trials
The two trials were highlighted at the ADA
late-breaker session as part of a broad overview of clinical data
summarizing the development as well as overall efficacy and tolerability
of Galvus.
The first was a six-month clinical trial evaluating
the combination of Galvus and pioglitazone (Pio) in patients with type 2
diabetes. The study evaluated 592 patients who had never been previously
treated for type 2 diabetes and who had a baseline A1c of between 7.5%
and 11%. It involved four treatment groups: (1) Galvus 100 mg; (2) Pio
30 mg; (3) Galvus 100 mg + Pio 30 mg; (4) Galvus 50 mg + Pio 15 mg.
Among patients with baseline A1c of 9% or greater,
the combination of Galvus and Pio produced a 2.8% reduction in A1c. In
the overall population, patients receiving Galvus 100 mg + Pio 30 mg saw
a statistically significant overall reduction in A1c compared to those
on Pio alone (1.9% vs. 1.4%, p < 0.001).
Adverse events were consistent with the individual
safety profiles of Galvus and TZDs. The patients treated with the
combination of Galvus and Pio experienced no significant additional
weight gain and less edema compared to patients taking Pio alone.
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About Diabetes |
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Diabetes currently affects about 195
million people worldwide and is estimated to grow to more than
330 million by 2025, according to the International Diabetes
Federation. The U.S. Centers for Disease Control estimates that
about 20 million Americans have diabetes.
Type 2 diabetes is a progressive disease
where control of blood sugar deteriorates over time.
It is the sixth leading cause of death in
the United States and a major contributor to heart disease,
stroke, blindness, kidney disease and vascular or neurological
problems that can result in amputation.
Islet dysfunction and insulin resistance
both contribute to diabetes.
Specifically, islet dysfunction can lead
to excess sugar production (via glucagon from the alpha-cells)
and reduced insulin production (from the beta-cells).
Even among people receiving diabetes
care, controlling blood sugar levels is difficult. More than
half of those currently taking medication to manage their
diabetes are still not reaching their blood sugar goals,
according to data from the National Health and Nutrition
Examination Survey (NHANES). |
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The second trial involved 700 patients in a
six-month head-to-head comparison of Galvus (100 mg daily) and
rosiglitazone (8 mg once/day). Galvus reduced blood sugar levels
significantly (-1.1%) as measured by A1c, with no difference between
treatment groups. Galvus treatment was not associated with weight gain
overall, while people in the rosiglitazone group gained on average 1.6
kg. Galvus-treated patients also experienced a lower incidence of edema
(2.5% vs. 4.9%).
The initial results from this trial were presented
at an ADA poster session at 10:00 am EDT on Saturday, June 10 (abstract
557-P).
In an additional subgroup analysis of severely
obese patients presented at the late-breaker session, there was a mean
reduction of body weight greater than 1 kg in the Galvus group, with a
mean difference between the Galvus and rosiglitazone groups of 2.8 kg.
Additional information from the company:
About the "GLORIOUS" mega-trial program
Novartis is committed to developing therapies
that will impact the progression of type 2 diabetes. This was confirmed
through the announcement at the ADA meeting of the "GLORIOUS" mega-trial
program, one of the largest series of outcomes-focused clinical programs
conducted among people with type 2 diabetes. Novartis intends to provide
additional details on the program later in 2006.
About Galvus
In clinical studies, Galvus has demonstrated
significant reductions in blood sugar that were sustained at one year.
Galvus is suitable for once-daily dosing and has been evaluated in
clinical trials both as monotherapy and in combination with other
anti-diabetes agents. Galvus is not associated with overall weight gain,
a key benefit for people with diabetes who struggle to keep their weight
under control. The overall incidence of side effects with Galvus
including hypoglycemia and edema was similar to placebo in monotherapy
trials. Overall, the most common side effects seen in the Galvus
clinical trial program were cold/flu-like symptoms, headaches and
dizziness. Galvus lowers blood sugar by targeting islet dysfunction: It
improves the ability of the islet's alpha- and beta-cells to
appropriately sense and respond to sugar in the blood.
About Novartis (company statement)
Novartis Pharmaceuticals Corporation researches,
develops, manufactures and markets leading innovative prescription drugs
used to treat a number of diseases and conditions, including those in
the cardiovascular, metabolic, cancer, organ transplantation, central
nervous system, dermatological, GI and respiratory areas. The company's
mission is to improve people's lives by pioneering novel healthcare
solutions.
Located in East Hanover, New Jersey, Novartis
Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE:NVS)
-- a world leader in offering medicines to protect health, treat disease
and improve well-being. Our goal is to discover, develop and
successfully market innovative products to treat patients, ease
suffering and enhance the quality of life. Novartis is the only company
with leadership positions in both patented and generic pharmaceuticals.
We are strengthening our medicine-based portfolio, which is focused on
strategic growth platforms in innovation-driven pharmaceuticals,
high-quality and low-cost generics, human vaccines and leading
self-medication OTC brands. In 2005, the Group's businesses achieved net
sales of USD 32.2 billion and net income of USD 6.1 billion.
Approximately USD 4.8 billion was invested in R&D. Headquartered in
Basel, Switzerland; Novartis Group companies employ approximately 96,000
people and operate in over 140 countries around the world. For more
information, please visit
http://www.novartis.com/.
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