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Novartis Data At ADA Demonstrate Galvus® Efficacy And Safety In Combination With Insulin

is presenting data at the ’s () 72nd Scientific Sessions in , that demonstrate the safety and of Galvus® (vildagliptin) in combination with insulin in patients with type 2 diabetes11.

Novartis is also announcing the launch of VERIFY, a five-year study that is intended to examine if vildagliptin has the potential to slow the progressive decline in blood sugar control in patients with type 2 diabetes when used in combination with metformin within two years of diagnosis2. VERIFY is the first early use study of its kind. Previous research has found that half of patients treated with only one therapy fail to maintain target blood sugar levels within three years3.

“The vildagliptin data presented at ADA and the launch of the VERIFY study demonstrate the Novartis commitment to diabetes research which helps to improve the lives of patients,” said David Morris, Global Head Development Primary Care Franchise, Novartis Pharmaceuticals. “We are particularly excited about the VERIFY study which will explore the potential long-term benefits of earlier use of vildagliptin in combination with metformin in patients with type 2 diabetes.”

A selection of other vildagliptin data from clinical studies and a pooled analysis were also featured at ADA through abstracts selected for publication, poster presentations and an oral presentation.

Among the data presented were results of a separate one-year study focused on patients with type 2 diabetes with moderate and severe renal impairment. This 369-patient study showed that when vildagliptin was added to an ongoing anti-diabetic therapy there were clinically relevant and statistically significant reductions in HbA1c levels compared to placebo in patients with moderate (0.57 vs. 0.14) and severe (0.81 vs. 0.08) renal impairment, with a similar safety profile4.

Novartis also presented baseline data from EDGE, one of the largest real-world studies of type 2 diabetes treatments conducted to date5. Initial results from this global, observational study of more than 45,000 patients suggest that the point at which physicians prescribe combination therapy varies greatly by region5. Full results of the study are planned to be published and presented later this year.

About the vildagliptin in combination with insulin study

In a 24-week study of 449 patients with type 2 diabetes who were unable to achieve target HbA1c levels with insulin alone or a combination of insulin and metformin, patients randomized to vildagliptin demonstrated substantially greater reductions in blood sugar levels than those randomized to placebo1. Overall, vildagliptin was well tolerated with no weight gain1.

About the VERIFY study

VERIFY (Vildagliptin Efficacy in combination with metfoRmIn For earlY treatment of type 2 diabetes) is a Novartis-sponsored five-year, randomized, double-blind, parallel-group, placebo-controlled study to compare vildagliptin and metformin, to metformin alone in patients with type 2 diabetes2. The study, launched in 2012, plans to enroll at least 2,000 recently-diagnosed patients at more than 260 sites in approximately 30 countries2.

The primary endpoints of the study are to assess time to initial treatment failure (HbA1c ≥ 7.0% at two consecutive visits) and the rate of loss of blood sugar control over time2. Secondary endpoints include evaluation of the progression and change in HbA1c levels, fasting plasma glucose (early morning blood sugar levels) and the safety and tolerability of the treatments2.

About the EDGE study

The Novartis-sponsored EDGE study (The observational Effectiveness of Diabetes control with vildaGliptin and vildagliptin/mEtformin), which enrolled patients in 27 countries, compared vildagliptin to other oral anti-diabetic agents in patients who failed to achieve target blood sugar levels with monotherapy5. Full results of the study are planned to be published and presented later this year.

About diabetes

Diabetes is one of the world’s greatest healthcare challenges, affecting 366 million people globally and killing one person every seven seconds6. The obesity epidemic and an aging world population are contributing to the escalating incidence of type 2 diabetes and by 2030 it is projected that more than half a billion people will be diagnosed with the disease6. Type 2 diabetes accounts for 90 percent of all cases of the disease7.

About Galvus®

Galvus® (vildagliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor, a class of oral diabetes medications that enhance the body’s natural ability to control blood sugar. Galvus safety and efficacy has been established in more than 11,500 vildagliptin-treated patients as part of a comprehensive clinical trial program8.

Galvus is approved in more than 100 countries across Europe, Asia Pacific, Africa and Latin America. It is indicated for the treatment of type 2 diabetes as a monotherapy and in combination with metformin, a sulphonylurea, a thiazolidinedione or insulin8. Specific indications vary by country.

Source

1. Lukashevich V et al. Vildagliptin combined with insulin reduces HbA1c without increasing risk of hypoglycemia and weight gain in patients with type 2 diabetes mellitus. ADA abstracts 2012.

2. ClinicalTrials.gov. A 5-year Study to Compare the Durability of Glycemic Control of a Combination Regimen With Vildagliptin & Metformin Versus Standard-of-care Monotherapy With Metformin, Initiated in Treatment-naïve Patients With Type 2 Diabetes Mellitus. Available here. Accessed June 06, 2012.

3. UK Prospective Diabetes Study (UKPDS) Group. Glycemic control with diet, sulphonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA 1999; 281:2005–2012.

4. Kothny W et al. One-year safety, tolerability and efficacy of vildagliptin in patients with type 2 diabetes mellitus and moderate or severe renal insufficiency. ADA abstracts 2012.

5. Bader G et al. Effectiveness of diabetes control with vildagliptin vs. other OADs: baseline characteristics of patients enrolled in the EDGE study. ADA abstracts 2012.

6. International Diabetes Federation. Global diabetes plan. Accessed May 30, 2012.

7. International Diabetes Federation. Types of diabetes. Accessed May 30, 2012.

8. Galvus Summary of Product Characteristics (SmPC).

Source: Novartis