viernes, 5 de enero de 2018

OZEMPIC: New Drug Trials Snapshot Posteddrug [OZEMPIC (semaglutide)]



A new  DRUG TRIALS SNAPSHOT is now available.
OZEMPIC is a drug that improves blood sugar control in adults with type 2 diabetes mellitus (DM) when used in addition to diet and exercise.
OZEMPIC is available as a liquid that comes in a prefilled pen. It is injected once weekly under the skin (subcutaneously) of the abdomen, thigh or upper arm. OZEMPIC may be used alone or in combination with other FDA-approved diabetes medications such as metformin, sulfonylureas, thiazolidinedione and insulin. In patients also using insulin injections, OZEMPIC and insulin should be injected separately and not mixed.
See more Drug Trials Snapshots  or contact us with questions at Snapshots@fda.hhs.gov.

Drug Trial Snapshot: Ozempic

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the OZEMPIC Package Insert for complete information.
OZEMPIC (semaglutide)
(oh-ZEM-pick) 
Novo Nordisk Inc. 
Approval date: December 5, 2017

DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

OZEMPIC is a drug that improves blood sugar control in adults with type 2 diabetes mellitus (DM) when used in addition to diet and exercise.

How is this drug used?

OZEMPIC is available as a liquid that comes in a prefilled pen. It is injected once weekly under the skin (subcutaneously) of the abdomen, thigh or upper arm. OZEMPIC may be used alone or in combination with other FDA-approved diabetes medications such as metformin, sulfonylureas, thiazolidinedione and insulin. In patients also using insulin injections, OZEMPIC and insulin should be injected separately and not mixed.

What are the benefits of this drug?

In patients with type 2 diabetes, treatment with OZEMPIC can lower HbA1c (hemoglobin A1c), which is a measure of blood sugar control.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: Overall, OZEMPIC worked similarly in men and women
  • Race: OZEMPIC worked similarly in White, Black/African American and Asian races. The number of patients of other races was small; therefore, differences in response could not be determined.
  • Age: OZEMPIC worked similarly in patients younger or older than 65 years of age.

What are the possible side effects?

OZEMPIC may cause serious side effects including low blood sugar, inflammation of the pancreas, complications of diabetes-related retina disease (diabetic retinopathy) and allergic reactions. In animal studies, mice and rats that received OZEMPIC were more likely to develop a certain kind of thyroid cancer. It is not known whether this may occur in humans.
The most common side effects in clinical trials included nausea, vomiting, diarrhea, abdominal pain and constipation.

Were there any differences in side effects among sex, race and age?

  • Sex: The risk of side effects was similar between men and women.
  • Race: The risk of side effects was similar between White, Black/African American and Asian races. The number of patients of other races was small; therefore, differences could not be determined.
  • Age: The risk of side effects was similar between patients younger or older than 65 years of age.

WHO WAS IN THE STUDIES?

Who participated in the clinical trials?

The FDA approved OZEMPIC based on evidence from seven clinical trials of 4087 patients with type 2 DM. The trials were conducted at 536 sites in 33 countries, including Canada, Mexico, Russian Federation, Ukraine, Turkey, India, South Africa, Japan, Hong Kong, multiple European countries, Argentina, and the United States.
The FDA also considered data from one separate trial of 3297 patients with type 2 DM who were at high risk for cardiovascular events. This trial was conducted in 20 countries in Europe, Russian Federation, Turkey, Brazil, Israel, Malaysia, Brazil, Mexico, Thailand, Taiwan, Canada, and the United States.
These two populations will be presented separately.
Figures 1, 2 and 3 summarize the number patients in the 7 clinical trials by sex, race, and age.
Figure 1: Baseline Demography by Sex – Safety Population
Pie chart summarizing how many men and women were in the clinical trials. In total, 2737 men (57%) and 2070 women (43%) participated in the clinical trials.
Clinical Trial Data
Figure 2: Baseline Demography by Race – Safety Population
Pie chart summarizing the percentage of patients by race in the clinical trials. In total, 2908 White (60%), 268 Black or African American (6%), 1497 Asian (31%), and 134 Other (3%) patients participa
Clinical Trial Data
Table 1: Baseline Demography by Race – Safety Population 
RaceNumber of PatientsPercentage
White290860
Black or African American2686
Asian149731
American Indian or Native Alaskan6less than 1
Hawaiian or Other Pacific Islander 3less than 1
Other631
Not reported621
Clinical Trial Data
Figure 3: Baseline Demography by Age – Safety Population
Alt-Tag: Pie charts summarizing how many individuals of certain age groups were in the clinical trials. In total, 3655 patients were younger than  65 years of age 76%), and 1152 were 65 and older (24%).
Clinical Trial Data
Figures 4, 5, and 6 summarize the patients at high risk for cardiovascular events by sex, race, and age.
Figure 4: Baseline Demography by Sex – Patients at High Risk for CV Event – Safety Population
Pie chart summarizing how many men and women were in the cardiovascular clinical trial. In total, 1994 men (61%) and 1292 women (39%) participated in the clinical trials.
Clinical Trial Data
Figure 5: Baseline Demography by Race – Patients at High Risk for CV Event – Safety Population
Pie chart summarizing the percentage of patients by race in the cardiovascular clinical trial. In total, 2725 White (83%), 221 Black or African American (7%), 273 Asian (8%), and 67 Other (2%) patients participated in the clinical trial
Clinical Trial Data
Table 2: Baseline Demography by Race – Patients at High Risk for CV Events – Safety Population
Race
Number of PatientsPercentage
White
272583
Black or African American
2217
Asian
2738
American Indian or Native Alaskan
10less than 1
Hawaiian or Other Pacific Islander 
3less than 1
Other
542
Clinical Trial Data
Figure 6: Baseline Demography by Age Category – Patients at High Risk for CV Events – Safety Population
Pie charts summarizing how many individuals of certain age groups were in the cardiovascular clinical trial. In total, 1697 patients were younger than  65 years of age 52%), and 1598 were 65 and older(48%).
Clinical Trial Data

How were the trials designed?

The benefits and side effects of OZEMPIC for the treatment of adult patients with type 2 DM were evaluated in seven clinical trials. In two of these trials (NCT #02054897 and NCT#02305381), patients were randomly assigned to receive either OZEMPIC or placebo injection weekly. Neither the patient nor the health care provider knew which treatment was being given until after the trials were completed. Treatment was given for 30 weeks.
In the other five trials (NCT #01930188, 01885208, 02128932, 02207374, 02254291), patients were randomly assigned to receive either OZEMPIC or another antidiabetic medication, and the patient and provider knew which medication was being given in four trials. Treatment was given for 30 weeks or 56 weeks.
In each trial, HbA1c was measured from the start of the trial to the end of the trial and compared between the OZEMPIC group and the other groups.
There was also an additional trial where patients with type 2 diabetes who were at high risk for cardiovascular events (NCT #01720446) were randomly assigned to receive OZEMPIC or placebo. Neither the patient nor the health care provider knew which treatment was being given. Treatment was given for 104 weeks (2 years), and the occurrence of cardiovascular events, including heart attacks, strokes and hospitalization due to unstable angina (near heart attack) were recorded and compared in the two groups of patients.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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