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For more than 7 years now, I've been practicing at Florida Hospital in a couple of roles. I see patients in clinic every week, including those with type 2 diabetes, but the majority of my time is spent designing and conducting clinical trials. Clinical trials are important to me because the data they provide may impact more patients than treating patients individually.

Conducting a head-to-head trial like SUSTAIN 7 has the potential to affect treatment decisions for some of the millions of adults with type 2 diabetes.

THE VALUE OF HEAD-TO-HEAD TRIALS

Understanding how medications compare across and within drug classes allows health care providers to make informed treatment decisions. There are many treatments for type 2 diabetes that reduce A1C, and some may result in weight reduction.1,2

Head-to-head clinical trials give health care providers useful information about how a treatment that they may already be familiar with compares to another treatment.

I choose Ozempic® for my appropriate adult patients with type 2 diabetes based on the results of the SUSTAIN 7 trial.

Ozempic® is not indicated for weight loss.

Scroll below to see SUSTAIN 7 design and results.

RICHARD E PRATLEY, MD

Medical Director
Florida Hospital Diabetes Institute

Senior Scientist
Diabetes Research

Orlando, Florida

SUSTAIN 7

OZEMPIC® VS TRULICITY®

For more than 7 years now, I've been practicing at Florida Hospital in a couple of roles. I see patients in clinic every week, including those with type 2 diabetes, but the majority of my time is spent designing and conducting clinical trials. Clinical trials are important to me because the data they provide may impact more patients than treating patients individually.

Conducting a head-to-head trial like SUSTAIN 7 has the potential to affect treatment decisions for some of the millions of adults with type 2 diabetes.

THE VALUE OF HEAD-TO-HEAD TRIALS

Understanding how medications compare across and within drug classes allows health care providers to make informed treatment decisions. There are many treatments for type 2 diabetes that reduce A1C, and some may result in weight reduction.1,2

Head-to-head clinical trials give health care providers useful information about how a treatment that they may already be familiar with compares to another treatment.

I choose Ozempic® for my appropriate adult patients with type 2 diabetes based on the results of the SUSTAIN 7 trial. 

Ozempic® is not indicated for weight loss.

Scroll below to see SUSTAIN 7 design and results.

RICHARD E PRATLEY, MD

Medical Director
Florida Hospital Diabetes Institute

Senior Scientist
Diabetes Research

Orlando
Florida

STUDY DESIGN

OZEMPIC® VS TRULICITY®
in a head-to-head trial

Why did we compare Ozempic® and Trulicity® in a head-to-head trial?

When designing a clinical trial to study treatments, I try to understand 2 things: First, what unmet need would it address for my patient? Second, I try to understand the broader perspective. How would it address the needs that other health care providers have in caring for their patients?

In designing SUSTAIN 7, my colleagues and I wanted to compare Ozempic® to a medication that was efficacious in A1C reduction and that had a similar dosing schedule.1

Trulicity® had never been studied against another once-weekly GLP-1 RA therapy, so it was important to determine if there were in‑class differences in efficacy between it and Ozempic®.1

To adequately compare the efficacy of these treatments, we used a study duration of 40 weeks.1 The primary endpoint was mean change in A1C, and select secondary endpoints included percent of patients achieving A1C <7% and mean change in weight.1

GLP-1 RA=glucagon-like peptide-1 receptor agonist.

primary_msg
STUDY DESIGN

OZEMPIC® VS
TRULICITY®

in a head-to-head trial

Why did we compare Ozempic® and Trulicity® in a head-to-head trial?

When designing a clinical trial to study treatments, I try to understand 2 things: First, what unmet need would it address for my patient? Second, I try to understand the broader perspective. How would it address the needs that other health care providers have in caring for their patients?

In designing SUSTAIN 7, my colleagues and I wanted to compare Ozempic® to a medication that was efficacious in A1C reduction and that had a similar dosing schedule.1

Trulicity® had never been studied against another once-weekly GLP-1 RA therapy, so it was important to determine if there were in‑class differences in efficacy between it and Ozempic®.1

To adequately compare the efficacy of these treatments, we used a study duration of 40 weeks.1 The primary endpoint was mean change in A1C, and select secondary endpoints included percent of patients achieving A1C <7% and mean change in weight.1

GLP-1 RA= glucagon-like peptide-1 receptor agonist.

Not an actual patient.

Adult type 2 diabetes patient

Hypothetical patient

Meet Nancy: a patient with type 2 diabetes

Nancy has been taking metformin for years, but her A1C level continues to increase little by little.

Nancy is taking Ozempic® 1 mg once weekly in addition to metformin.a

PATIENT PROFILE

aStart Ozempic® with a 0.25 mg subcutaneous injection once weekly for 4 weeks. The 0.25 mg dose is intended for treatment initiation and is not effective for glycemic control. After 4 weeks on the 0.25 mg dose, increase the dosage to 0.5 mg once weekly. If additional glycemic control is needed after at least 4 weeks on the 0.5 mg dose, the dosage may be increased to 1 mg once weekly. The maximum recommended dosage is 1 mg once weekly.

Adult type 2 diabetes patient

Hypothetical patient

Meet Nancy: a patient with type 2 diabetes

Nancy has been taking metformin for years, but her A1C level continues to increase little by little.

Nancy is taking Ozempic® 1 mg once weekly in addition to metformin.a

Not an actual patient.

aStart Ozempic® with a 0.25 mg subcutaneous injection once weekly for 4 weeks. The 0.25 mg dose is intended for treatment initiation and is not effective for glycemic control. After 4 weeks on the 0.25 mg dose, increase the dosage to 0.5 mg once weekly. If additional glycemic control is needed after at least 4 weeks on the 0.5 mg dose, the dosage may be increased to 1 mg once weekly. The maximum recommended dosage is 1 mg once weekly.

PATIENT PROFILE

PRIMARY ENDPOINT

In patients on metformin, for each dose comparison

Ozempic® outperformed Trulicity® in reducing A1C1


Study results
Hear from Dr Pratley
PRIMARY ENDPOINT
Mean reduction in A1C from baseline at Week 40
Alternate Text Alternate Text

Results based on a sensitivity analysis of retrieved dropout population: estimated mean.
*P=0.002
P=0.0004

Superior A1C reductions for each dose comparison vs Trulicity®1


Results are from a 40-week randomized, open-label, active-controlled trial in 1201 adult patients with type 2 diabetes comparing Ozempic® 0.5 mg to Trulicity® 0.75 mg and Ozempic® 1 mg to Trulicity® 1.5 mg.1

Superior A1C reductions in SUSTAIN 7

As an investigator in the SUSTAIN 7 trial, I had the benefit of seeing significant A1C reductions first-hand.1

I think one of the notable things about the SUSTAIN 7 trial was the change in A1C. Ozempic® had superior A1C reductions vs Trulicity®.1 That glycemic difference was preserved both at the lower and higher dose comparisons. In my clinical opinion, this difference is valuable information when prescribing a treatment.

I tell physicians who haven’t yet prescribed Ozempic® to try it in appropriate adults with type 2 diabetes who have had trouble achieving their glycemic goals. There are many treatments that help lower glucose levels, but the powerful A1C reductions of Ozempic® make it worth considering as an option for adults with T2D.1,2

SUSTAIN 7: Significant A1C reductions

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SECONDARY ENDPOINT

In patients on metformin, for each dose comparison

Ozempic® delivered superior A1C control vs Trulicity®1


Study results
Hear from Dr Pratley
SECONDARY ENDPOINT:
Percent of patients who achieved A1C <7% at Week 40
Alternate Text Alternate Text

Predefined secondary endpoint analyzed using post ad hoc analysis of retrieved dropout population.
*P<0.0001
P=0.02

~3 out of 4 patients achieved A1C <7% with Ozempic® 1 mg1


Results are from a 40-week randomized, open-label, active-controlled trial in 1201 adult patients with type 2 diabetes comparing Ozempic® 0.5 mg to Trulicity® 0.75 mg and Ozempic® 1 mg to Trulicity® 1.5 mg.1

Reaching A1C goal

Right now, there are millions of adults with type 2 diabetes with an A1C higher than 9%.3 While there are many available treatments for these patients, it is important to continue to evaluate their treatment plans.

Choosing too high of a glycemic control target may contribute to A1C levels slowly creeping up over time. Since type 2 diabetes is chronic and progressive, I strive to be vigilant about A1C increases, and keep this in mind when choosing reasonable goals for my individual patients.2

In the SUSTAIN 7 trial, we evaluated the percentage of patients achieving an A1C <7%, which the ADA recommends as a reasonable goal for most adults.1,2 Approximately 3 out of 4 patients were able to achieve A1C <7% with Ozempic® 1 mg.1

Regardless of the A1C goal for each patient, their treatment should be helping them achieve glycemic control. If their A1C remains high, they may need a different treatment. With superior glycemic control results vs Trulicity®, Ozempic® may be an appropriate treatment option for my adult patients with type 2 diabetes.

SUSTAIN 7: Significant glycemic control

ADA and AACE recommended A1C goals

ADA=American Diabetes Association.

tertiary_msg
SECONDARY ENDPOINT

In patients on metformin, for each dose comparison

Ozempic® demonstrated superior body weight reduction vs Trulicity®1

Ozempic® is not indicated for weight loss.


Study results
Hear from Dr Pratley
SECONDARY ENDPOINT:
Mean body weight change from baseline at Week 40
Alternate Text Alternate Text

*ETD=-4.7 lb
(95% CI; -6.5, -2.9)
vs Trulicity® 0.75 mg.

ETD=-6.7 lb
(95% CI; -8.5, -5.0)
vs Trulicity® 1.5 mg.

Results based on a sensitivity analysis of retrieved dropout population: estimated mean.

ETD=estimated treatment difference.

More than double the weight reduction for each dose comparison vs Trulicity®1


Results are from a 40-week randomized, open-label, active-controlled trial in 1201 adult patients with type 2 diabetes comparing Ozempic® 0.5 mg to Trulicity® 0.75 mg and Ozempic® 1 mg to Trulicity® 1.5 mg.1

How body weight impacts my treatment plan decision

In addition to glycemic control, weight reduction is an important part of the treatment plan for many of my patients with type 2 diabetes. Since increased body weight can negatively impact diabetes, I consider the effect of medications on body weight. I am more likely to choose a medicine that may also result in weight reduction.2,4

In the SUSTAIN 7 trial, both doses of Ozempic® resulted in significant reductions in weight as a secondary endpoint. Patients receiving Ozempic® had more than double the weight reduction in both the lower and the higher dose comparisons vs Trulicity®.1

SUSTAIN 7: Significant weight reduction

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ADVERSE EVENTS

Adverse events ≥5% in SUSTAIN 7

Adverse events (AEs) occurring in ≥5% of participants treated with Ozempic® in SUSTAIN 71

SUSTAIN 7 was not designed to evaluate relative safety between Ozempic® and Trulicity®

Ozempic® AEs ≥5% in SUSTAIN 7 trial

The AEs occurring in ≥5% of participants in SUSTAIN 7 taking Trulicity® 0.75 mg (n=299), Ozempic® 0.5 mg (n=301), Trulicity® 1.5 mg (n=299), and Ozempic® 1 mg (n=300), respectively, were:

Nausea (13%, 23%, 20%, 21%)
Diarrhea (8%, 14%, 18%, 14%)
Vomiting (4%, 10%, 10%, 10%)
Decreased appetite (3%, 8%, 10%, 9%)
Headache (4%, 8%, 6%, 7%)
Lipase increased (5%, 7%, 6%, 6%)
Nasopharyngitis (6%, 5%, 7%, 5%)
Upper respiratory tract infection (7%, 5%, 5%, 3%)
Constipation (3%, 5%, 5%, 5%)

GI AEs leading to treatment discontinuation were 2%, 5%, 5%, and 6% in Trulicity® 0.75 mg, Ozempic® 0.5 mg, Trulicity® 1.5 mg, and Ozempic® 1 mg, respectively.1

  • In placebo-controlled trials, the most common adverse reactions reported in ≥5% of patients treated with Ozempic® are nausea, vomiting, diarrhea, abdominal pain, and constipation5
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice5
  • Comparator adverse event rates are not an adequate basis for comparison of safety between products

Why I prescribe Ozempic®

In the SUSTAIN 7 trial, Ozempic® was proven superior to Trulicity® in A1C reduction, A1C control, and weight reduction in adults with type 2 diabetes.1 Ozempic® is not indicated for weight loss.

After about a year of treatment with Ozempic® 1 mg once weekly, Nancy reduced her A1C by 1.5%, getting her below an A1C of 7%, which was her A1C goal. She also experienced a weight reduction of 10 lb. Her results are similar to the results of many patients in the SUSTAIN 7 trial.1

Based on the SUSTAIN 7 results, Ozempic® provided significant and superior glycemic control vs Trulicity®, making it a treatment I strongly consider for my appropriate patients with type 2 diabetes, like Nancy.1

Nancy is not an actual patient. Individual results may vary.

Why I prescribe Ozempic®

In the SUSTAIN 7 trial, Ozempic® was proven superior to Trulicity® in A1C reduction, A1C control, and weight reduction in adults with type 2 diabetes.1 Ozempic® is not indicated for weight loss.

After about a year of treatment with Ozempic® 1 mg once weekly, Nancy reduced her A1C by 1.5%, getting her below an A1C of 7%, which was her A1C goal. She also experienced a weight reduction of 10 lb. Her results are similar to the results of many patients in the SUSTAIN 7 trial.1

Based on the SUSTAIN 7 results, Ozempic® provided significant and superior glycemic control vs Trulicity®, making it a treatment I strongly consider for my appropriate patients with type 2 diabetes, like Nancy.1

Nancy is not an actual patient. Individual results may vary.

quinary_msg
STUDY DESIGN

SUSTAIN 7: Head-to-head vs Trulicity® (dulaglutide)1

Study design: 40-week, multinational, multicenter, randomized, open-label, 4-armed, pair-wise, active-controlled, parallel-group trial to compare the efficacy and safety of Ozempic® vs dulaglutide.

Patients: A total of 1201 adult patients with type 2 diabetes inadequately controlled on metformin were randomized to receive Ozempic® 0.5 mg (n=301), Ozempic® 1 mg (n=300), dulaglutide 0.75 mg (n=299), or dulaglutide 1.5 mg (n=299) once weekly.

Primary endpoint: Mean change in A1C from baseline at Week 40.

Select secondary endpoints: Mean change in body weight from baseline at Week 40; proportion of patients achieving A1C <7% at Week 40.    

Help patients realize the potential with Ozempic®

Help patients realize the potential with Ozempic®

Once-weekly dosing


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Selected Important Safety Information

WARNING: RISK OF THYROID C-CELL TUMORS

  • In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether Ozempic® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.
  • Ozempic® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Ozempic® and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Ozempic®.

Ozempic® (semaglutide) injection 0.5 mg or 1 mg Indication and Limitations of Use

Ozempic® (semaglutide) injection 0.5 mg or 1 mg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

  • Ozempic® is not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans.
  • Ozempic® has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.
  • Ozempic® is not a substitute for insulin. Ozempic® is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis.

Important Safety Information

WARNING: RISK OF THYROID C-CELL TUMORS

  • In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether Ozempic® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.
  • Ozempic® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Ozempic® and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Ozempic®.

Contraindications

Ozempic® is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with known hypersensitivity to semaglutide or to any of the product components.

Warnings and Precautions

  • Risk of Thyroid C-Cell Tumors: Patients should be referred to an endocrinologist for further evaluation if serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging.
  • Pancreatitis: Acute and chronic pancreatitis have been reported in clinical studies. Observe patients carefully for signs and symptoms of pancreatitis (persistent severe abdominal pain, sometimes radiating to the back with or without vomiting). If pancreatitis is suspected, discontinue Ozempic® promptly, and if pancreatitis is confirmed, do not restart.
  • Diabetic Retinopathy Complications: In a 2-year trial involving patients with type 2 diabetes and high cardiovascular risk, more events of diabetic retinopathy complications occurred in patients treated with Ozempic® (3.0%) compared to placebo (1.8%). The absolute risk increase for diabetic retinopathy complications was larger among patients with a history of diabetic retinopathy at baseline than among patients without a known history of diabetic retinopathy.
    Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. The effect of long-term glycemic control with semaglutide on diabetic retinopathy complications has not been studied. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.
  • Never Share an Ozempic® Pen Between Patients: Ozempic® pens must never be shared between patients, even if the needle is changed. Pen-sharing poses a risk for transmission of blood-borne pathogens.
  • Hypoglycemia: The risk of hypoglycemia is increased when Ozempic® is used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin.
  • Acute Kidney Injury: There have been postmarketing reports of acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis, in patients treated with GLP-1 receptor agonists. Some of these events have been reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Monitor renal function when initiating or escalating doses of Ozempic® in patients reporting severe adverse gastrointestinal reactions.
  • Hypersensitivity: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with GLP-1 receptor agonists. If hypersensitivity reactions occur, discontinue use of Ozempic®; treat promptly per standard of care, and monitor until signs and symptoms resolve. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist.
  • Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Ozempic®.

Adverse Reactions

  • The most common adverse reactions, reported in ≥5% of patients treated with Ozempic® are nausea, vomiting, diarrhea, abdominal pain, and constipation.

Drug Interactions

  • The risk of hypoglycemia may be lowered by a reduction in the dose of the secretagogue or insulin.
  • Ozempic® causes a delay of gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications, so caution should be exercised.

Use in Specific Populations

  • There are limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Discontinue Ozempic® in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide.

Please click here for Prescribing Information, including Boxed Warning.

 

References:

  1. Pratley RE, Aroda VR, Lingvay I, et al, on behalf of the SUSTAIN 7 investigators. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018;6(4):275-286.
  2. American Diabetes Association. Standards of medical care in diabetes—2019. Diabetes Care. 2019;42(suppl 1):S1-S193.
  3. Centers for Disease Control and Prevention. National diabetes statistics report, 2017. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf. Accessed October 5, 2018.
  4. Anderson JW, Kendall CW, Jenkins DJ. Importance of weight management in type 2 diabetes: review with meta-analysis of clinical studies. J Am Coll Nutr. 2003;22(5):331-339.
  5. Ozempic [package insert]. Plainsboro, NJ: Novo Nordisk Inc; December 2017.