In adult patients with type 2 diabetes on metformin
Primary endpoint: Mean change in A1C from baseline at Week 402,3
Ozempic®—the once-weekly injectable with unmatched glycemic control across trials
Superior results vs Trulicity® (in SUSTAIN 7) and as add-on to basal insulin and statistically significant results vs study-titrated Lantus®1,2
Ozempic® vs Trulicity®
Unmatched A1C reductions vs Trulicity®2
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.2
Ozempic® delivered superior A1C control vs Trulicity®2
In adult patients with type 2 diabetes on metformin
Secondary endpoint: Percent of patients who achieved A1C <7% at Week 402,3
Predefined secondary endpoint based on a post hoc analysis of retrieved dropout population.
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.2
Adverse events ≥5% in SUSTAIN 7
AEs occurring in ≥5% of participants treated with Ozempic® in SUSTAIN 72
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 discontinuation (2%, 5%, 5%, 6%)2
AE=adverse events; GI=gastrointestinal.
- In placebo-controlled trials, the most common adverse reactions reported in ≥5% of patients treated with Ozempic® are nausea, vomiting, diarrhea, abdominal pain, and constipation1
- 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 practice1
- Comparator adverse event rates are not an adequate basis for comparison of safety between products
Body weight change was studied as a secondary endpoint
Ozempic® is not indicated for weight loss.
Ozempic® vs Lantus®
Greater A1C reductions shown vs study‑titrated Lantus®, delivered in a once-weekly injection1
In insulin-naïve adult patients with type 2 diabetes on metformin ± sulfonylurea
Primary endpoint: Mean change in A1C from baseline at Week 301,3,4
Results based on a sensitivity analysis of retrieved dropout population.
26% of insulin patients titrated to goal by Week 30. Mean daily insulin dose: 29 U/day.1
Results are from a 30-week, randomized, open-label, active-controlled trial in 1089 insulin-naïve adult patients with type 2 diabetes comparing Ozempic® 0.5 mg and Ozempic® 1 mg with Lantus®.1,4
Ozempic® delivered greater A1C control vs study‑titrated Lantus®1,4
In insulin-naïve adult patients with type 2 diabetes on metformin ± sulfonylurea
Secondary endpoint: Percent of patients who achieved A1C <7% at Week 301,3,4
26% of insulin patients titrated to goal by Week 30. Mean daily insulin dose: 29 U/day.1
Predefined secondary endpoint based on a post hoc analysis of retrieved dropout population.
Results are from a 30-week, randomized, open-label, active-controlled trial in 1089 insulin-naïve adult patients with type 2 diabetes comparing Ozempic® 0.5 mg and Ozempic® 1 mg with Lantus®.1,4
Ozempic® lowered FPG and PPG1,3,4
In insulin-naïve adult patients with type 2 diabetes on metformin ± sulfonylurea
Secondary endpoint: Mean change in FPG at Week 301,3,4,a
Secondary endpoint: Mean change in PPG increment at Week 30a,b
26% of insulin patients titrated to goal by Week 30. Mean daily insulin dose: 29 U/day.1
Predefined secondary endpoint based on a post hoc analysis of retrieved dropout population.
aThe clinical relevance of FPG and PPG is unknown.
bBased on the 8-point self-measured plasma glucose (SMPG) profile, PPG increment is the overall mean difference between the postprandial glucose and the preprandial glucose overall values across the 3 main meals.4
Results are from a 30-week, randomized, open-label, active-controlled trial in 1089 insulin-naïve adult patients with type 2 diabetes comparing Ozempic® 0.5 mg and Ozempic® 1 mg with Lantus®.1,4
Adverse events ≥5% in SUSTAIN 4
AEs occurring in ≥5% of participants treated with Ozempic® in SUSTAIN 44
SUSTAIN 4 was not designed to evaluate relative safety between Ozempic® and Lantus®
The AEs occurring in ≥5% of participants in SUSTAIN 4 taking Lantus® (n=360), Ozempic® 0.5 mg (n=362), Ozempic® 1 mg (n=360), respectively, were:
Nausea (4%, 21%, 22%)
Diarrhea (4%, 16%, 19%)
Nasopharyngitis (12%, 12%, 8%)
Lipase increased (4%, 10%, 8%)
Decreased appetite (<1%, 7%, 6%)
Vomiting (3%, 7%, 10%)
Headache (6%, 5%, 6%)
Dyspepsia (1%, 3%, 7%)
Back pain (2%, 3%, 5%)
Gastro-esophageal reflux disease (1%, 1%, 5%)
GI AEs leading to discontinuation (0%, 3%, 5%)4
AE=adverse events; GI=gastrointestinal.
- In placebo-controlled trials, the most common adverse reactions reported in ≥5% of patients treated with Ozempic® are nausea, vomiting, diarrhea, abdominal pain, and constipation1
- 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 practice1
- Comparator adverse event rates are not an adequate basis for comparison of safety between products
- Incidence of severe hypoglycemia was ≤1.5% across all placebo-controlled trials1
- Incidence of severe hypoglycemia or blood glucose-confirmed hypoglycemia (% of patients) was 4% with Ozempic® 0.5 mg, 6% with Ozempic® 1 mg, and 11% with Lantus®4,a
aDefined as an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions or blood glucose-confirmed symptomatic hypoglycemia (plasma glucose ≤3.1 mmol/L [56 mg/dL]).4
Ozempic® has once-weekly dosing
Ozempic® as an add-on to basal insulin
Intensify with Ozempic® when patients are not getting the glycemic results they need from basal insulin1
In adult patients with type 2 diabetes on basal insulin ± metformin
Primary endpoint: Mean change in A1C from baseline at Week 301,3,5
Results based on a sensitivity analysis of retrieved dropout population.
Patients with A1C ≤8% at screening had their background basal insulin dose reduced by 20% at the start of the trial to limit potential risk of hypoglycemia.
Results are from a 30-week, randomized, double-blind, placebo-controlled, parallel-group trial in 397 adult patients with type 2 diabetes evaluating the addition of Ozempic® 0.5 mg and Ozempic® 1 mg to basal insulin ± metformin.1,5
Ozempic® as an add-on to basal insulin ± MET delivered superior A1C control vs basal insulin ± MET alone1
In adult patients with type 2 diabetes on basal insulin ± metformin
Secondary endpoint: Percent of patients who achieved A1C <7% at Week 301,3,5
Patients with A1C ≤8% at screening had their background basal insulin dose reduced by 20% at the start of the trial to limit potential risk of hypoglycemia.
Results based on post hoc analysis of retrieved dropout population.
Results are from a 30-week, randomized, double-blind, placebo-controlled, parallel-group trial in 397 adult patients with type 2 diabetes evaluating the addition of Ozempic® 0.5 mg and Ozempic® 1 mg to basal insulin ± metformin.1,5
When basal insulin ± metformin was not enough in adult patients with type 2 diabetes
Adding Ozempic® lowered both fasting and postmeal blood sugar1,3
Secondary endpoint: Mean change in FPG at Week 301,a
Mean change in PPG at Week 303,b
Patients with A1C ≤8% at screening had their background basal insulin dose reduced by 20% at the start of the trial to limit potential risk of hypoglycemia.
The clinical relevance of FPG and PPG is unknown.
aPredefined secondary endpoint using post hoc analysis of retrieved dropout population; not adjusted for multiplicity.
bMean change in 90-minute PPG from baseline at Week 30 was not a predefined endpoint. Post hoc analysis of absolute PPG means were calculated from the 7-point SMPG profile.
Results are from a 30-week, randomized, double-blind, placebo-controlled, parallel-group trial in 397 adult patients with type 2 diabetes evaluating the addition of Ozempic® 0.5 mg and Ozempic® 1 mg to basal insulin ± metformin.1,5
Adverse events ≥5% in SUSTAIN 5
AEs occurring in ≥5% of participants treated with Ozempic® in SUSTAIN 53,5
The AEs occurring in ≥5% of participants in SUSTAIN 5 taking placebo + basal insulin ± MET (n=133), Ozempic® 0.5 mg + basal insulin ± MET (n=132), and Ozempic® 1 mg + basal insulin ± MET (n=131), respectively, were:
Nausea (5%, 12%, 17%)
Vomiting (3%, 6%, 12%)
Diarrhea (2%, 5%, 7%)
Nasopharyngitis (11%, 8%, 5%)
Urinary tract infection (6%, 2%, 3%)
Upper respiratory tract infection (3%, 6%, <1%)
Lipase increased (3%, 9%, 5%)
Decreased appetite (<1%, 4%, 5%)
GI AEs leading to discontinuation (<1%, 5%, 6%)5
AE=adverse events; GI=gastrointestinal, MET=metformin.
- Incidence of severe hypoglycemia was ≤1.5% across all placebo-controlled trials1
- Incidence of severe hypoglycemia or blood glucose-confirmed hypoglycemia (% of patients) was5:
- 8.3% with Ozempic® 0.5 mg + basal insulin ± metformin
- 10.7% with Ozempic® 1 mg + basal insulin ± metformin
- 5.3% with placebo + basal insulin ± metformin
- The risk of hypoglycemia is increased when Ozempic® is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin1
Help patients realize the potential with Ozempic®
Help patients realize the potential with Ozempic®
Learn how Ozempic® works in the body to affect insulin response
Once-weekly dosing
STUDY DESIGNS
SUSTAIN 7: Head-to-head vs Trulicity® (dulaglutide)2
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.
Secondary endpoints: Mean change in body weight from baseline at Week 40; proportion of patients achieving A1C <7% at Week 40.
SUSTAIN 4: Head-to-head vs Lantus® (insulin glargine U-100)1,4
Study design: 30-week, randomized, open-label, active-controlled, parallel-group, multinational, multicenter trial to compare the efficacy and safety of Ozempic® vs insulin glargine U-100.
Patients: A total of 1089 insulin-naïve adult patients with type 2 diabetes inadequately controlled on metformin alone (48%) or in combination with a sulfonylurea (51%) were randomized to receive once-weekly Ozempic® 0.5 mg (n=362), once-weekly Ozempic® 1 mg (n=360), or once-daily insulin glargine U-100 (n=360). Patients assigned to insulin glargine had a baseline mean A1C of 8.1% and were started on a dose of 10 units once daily. Insulin glargine dose adjustments occurred throughout the trial period based on self-measured fasting plasma glucose before breakfast, targeting 71 to <100 mg/dL. In addition, investigators could titrate insulin glargine based on their discretion between study visits. Twenty-six percent of patients had been titrated to goal by the primary endpoint at Week 30, at which time the mean daily insulin dose was 29 units per day.
Primary endpoint: Mean change in A1C from baseline at Week 30.
Secondary endpoints: Mean change in body weight from baseline at Week 30; proportion of patients achieving A1C <7% at Week 30; change in mean fasting plasma glucose (FPG) at Week 30; change in PPG increment (difference between the postprandial and preprandial glucose values across the 3 main meals from an 8-point self-measured plasma glucose (SMPG) profile at Week 30).
SUSTAIN 5: As add-on to basal insulin vs placebo5
Study design: 30-week, randomized, double-blind, placebo-controlled, parallel-group, multinational, multicenter trial to compare the efficacy and safety of Ozempic® in combination with basal insulin vs volume-matched placebo in combination with basal insulin.
Patients: A total of 397 adult patients inadequately controlled on basal insulin with or without metformin were randomized to once-weekly Ozempic® 0.5 mg (n=132), Ozempic® 1 mg (n=131), or placebo (n=133). Randomization was stratified according to A1C at screening. Patients with A1C ≤8% at screening reduced the insulin dose by 20% at the start of the trial to reduce the risk of hypoglycemia.
Primary endpoint: Mean change in A1C from baseline at Week 30.
Secondary endpoints: Mean change in body weight from baseline at Week 30; proportion of patients achieving A1C <7% at Week 30; change in mean fasting plasma glucose (FPG) at Week 30.