STEGALTRO is a drug that improves blood sugar control in adults with type 2 diabetes when used in addition to diet and exercise.
STEGLATRO is a tablet that is taken by mouth once daily in the morning.
Drug Trials Snapshots: STEGLATRO
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.
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 STEGLATRO Package Insert for complete information.
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 STEGLATRO Package Insert for complete information.
STEGLATRO (ertugliflozin)
Steh-GLA-troh
Merck Sharpe & Dohme Corp.
Approval date: December 19, 2017
Steh-GLA-troh
Merck Sharpe & Dohme Corp.
Approval date: December 19, 2017
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
STEGALTRO is a drug that improves blood sugar control in adults with type 2 diabetes when used in addition to diet and exercise.
How is this drug used?
STEGLATRO is a tablet that is taken by mouth once daily in the morning.
What are the benefits of this drug?
In patients with type 2 diabetes treatment with STEGLATRO can lower hemoglobin A1c (HbA1c). HbA1c is a measure of blood sugar control over the last 8-12 weeks.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: STEGLATRO worked similarly in men and women.
- Race: The majority of patients were White. The number of patients of other races was limited; therefore, differences in response among races could not be determined.
- Age: STEGLATRO worked similarly in patients below and above 65 years of age.
What are the possible side effects?
STEGALTRO may cause serious side effects such as decrease in blood pressure, kidney injury, surgery to remove lower limbs, increased cholesterol levels, and very low blood sugar levels when used in combination with insulin or medications that increase insulin, and serious urinary tract infection. Serious urinary tract infections can spread to the kidneys (pyeleonephritis) or cause a serious, potentially life-threatening blood infection (urosepsis).
STEGLATRO may also cause ketoacidosis. Diabetic ketoacidosis is a serious, potentially life-threatening complication that occurs when the body produces high levels of acids in the blood. The acids are called ketones.
The most common side effects with STEGLATRO are genital yeast infections.
Were there any differences in side effects among sex, race and age?
- Sex: More genital yeast infections were seen in women taking STEGLATRO compared to men taking STEGLATRO. In the trial, all patients (men and women) treated with STEGLATROI had more genital yeast infections compared to patients given placebo.
- Race: The majority of patients were White. The number of patients of other races was limited; therefore, differences in side effects among races could not be determined.
- Age: Patients above 65 years of age had more side effects related to dehydration compared to younger patients.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved STEGLATRO based on evidence from seven clinical trials (NCT01958671, NCT02033889, NCT02036515, NCT01986855, NCT01999218, NCT02099110, and NCT02226003) of 4,859 patients with type 2 diabetes. Trials were conducted at 387 centers in Asia, Australia/New Zealand, Europe, North America, South Africa, and South America.
Five of the trials (NCT02033889, NCT02036515, NCT01999218, NCT02099110, and NCT02226003) provided support for approval of two new combination drug products (Segluromet and Steglujan) that contain STEGLATRO in combination with the approved antidiabetic drugs metformin and sitagliptin, respectively.
Presented below is the population of 4,859 patients with type 2 diabetes that participated in all 7 trials together. Three of the trials (NCT01958671, NCT02036515, and NCT02033889) were used to evaluate the side effects of STEGLATRO and represent the safety population. Demographics of these patients are presented in Table 10 under MORE INFO section.
Figures 1 – 3 below summarize by sex, race and age how many patients participated in seven combined clinical trials.
Figure 1. Baseline Demographics by Sex
FDA Review
Figure 2 and Table 1 summarize the percentage of patients by race in clinical trials.
Figure 2. Baseline Demographics by Race
Table 1. Baseline Demographics by Race
| Race | Number of Patients | Percentage |
|---|---|---|
| White | 3732 | 77 |
| Black or African American | 241 | 5 |
| Asian | 648 | 13 |
| American Indian or Alaska Native | 59 | 1 |
| Native Hawaiian or Other Pacific Islander | 2 | less than 1 |
| Multiple | 177 | 4 |
FDA Review
Figure 3 summarizes the percentage of patients by age in clinical trials.
Figure 3. Baseline Demographics by Age
FDA Review
How were the trials designed?
The benefits and side effects of STEGLATRO were evaluated in seven clinical trials of adults with type 2 diabetes whose disease was not well controlled. All patients were required to follow diet and exercise recommendations, but the trials differed with respect to which other drugs patients were allowed to use for diabetes treatment.
In five trials, patients were randomly assigned to receive either STEGLATRO or placebo by mouth once daily; and, in two trials, they received either STEGLATRO or an active comparator. Neither the patients nor the healthcare providers knew which treatment patients received until after the trial was completed. Treatment was given for 26 weeks for six of the trials, and for 52 weeks for one trial.
The benefit of STEGLATRO was evaluated by the change in HbA1c between the STEGLATRO and the other treatment (either placebo or active comparator) at the end of the treatment period.
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.
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.
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