For more than 9 years now, I've been practicing at AdventHealth Orlando 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
AdventHealth Orlando Diabetes Institute
Senior Scientist
Diabetes Research
Orlando, Florida
SUSTAIN 7
OZEMPIC® VS TRULICITY®
For more than 9 years now, I've been practicing at AdventHealth Orlando 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
AdventHealth Orlando 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.
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.
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.
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
PRIMARY ENDPOINT:
Mean reduction in A1C from baseline at Week 40
| Trulicity® 0.75 mg (n=299); Baseline: 8.2% | ||
| Trulicity® 0.75 mg | -1.1%* | |
| (n=299); Baseline: 8.2% | ||
| Ozempic® 0.5 mg (n=301); Baseline: 8.3% | ||
| Ozempic® 0.5 mg | -1.4%* | |
| (n=301); Baseline: 8.3% | ||
| Trulicity® 1.5 mg (n=299); Baseline: 8.2% | ||
| Trulicity® 1.5 mg | -1.3%† | |
| (n=299); Baseline: 8.2% | ||
| Ozempic® 1 mg (n=300); Baseline: 8.2% | ||
| Ozempic® 1 mg | -1.6%† | |
| (n=300); Baseline: 8.2% | ||
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 firsthand.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
SECONDARY ENDPOINT
In patients on metformin, for each dose comparison
Ozempic® delivered superior A1C control vs Trulicity®1
SECONDARY ENDPOINT:
Percent of patients who achieved A1C <7% at Week 40
| Trulicity® 0.75 mg (n=299); Baseline: 8.2% | ||
| Trulicity® 0.75 mg | 51%* | |
| (n=299); Baseline: 8.2% | ||
| Ozempic® 0.5 mg (n=301); Baseline: 8.3% | ||
| Ozempic® 0.5 mg | 65%* | |
| (n=301); Baseline: 8.3% | ||
| Trulicity® 1.5 mg (n=299); Baseline: 8.2% | ||
| Trulicity® 1.5 mg | 63%† | |
| (n=299); Baseline: 8.2% | ||
| Ozempic® 1 mg (n=300); Baseline: 8.2% | ||
| Ozempic® 1 mg | 73%† | |
| (n=300); Baseline: 8.2% | ||
Predefined secondary endpoint analyzed using post 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=American Diabetes Association.
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.
SECONDARY ENDPOINT:
Mean body weight change from baseline at Week 40
| Trulicity® 0.75 mg (n=299); Baseline: 211 lb | ||
| Trulicity® 0.75 mg | -4.6 lb* | |
| (n=299); Baseline: 211 lb | ||
| Ozempic® 0.5 mg (n=301); Baseline: 213 lb | ||
| Ozempic® 0.5 mg | -9.3 lb* | |
| (n=301); Baseline: 213 lb | ||
| Trulicity® 1.5 mg (n=299); Baseline: 206 lb | ||
| Trulicity® 1.5 mg | -6.2 lb† | |
| (n=299); Baseline: 206 lb | ||
| Ozempic® 1 mg (n=300); Baseline: 211 lb | ||
| Ozempic® 1 mg | -12.8 lb† | |
| (n=300); Baseline: 211 lb | ||
*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
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®
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.
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
