Frequently asked questions about Ozempic® (semaglutide)
About Ozempic®
Ozempic® (pronounced Oh-ZEM-pick) is a GLP-1 RA available in a once-weekly pen and once-daily pill indicated1,2:
Ozempic® injection:
- To improve glycemic control, along with diet and exercise, in adults with T2D
- To reduce risk of MACE (CV death, nonfatal MI, or nonfatal stroke) in adults with T2D and established CVD
- To reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death for adults with T2D and CKD1
Ozempic® pill:
- To improve glycemic control, along with diet and exercise, in adults with T2D
- To reduce the risk of MACE (CV death, nonfatal MI, or nonfatal stroke) in adults with T2D who are at high risk of these events2
CKD=chronic kidney disease; CV=cardiovascular; CVD=cardiovascular disease; eGFR=estimated glomerular filtration rate; GLP-1 RA=glucagon-like peptide-1 receptor agonist; MACE=major adverse cardiovascular event; MI=myocardial infarction; T2D=type 2 diabetes.
Ozempic® lowers fasting and postprandial blood glucose by stimulating insulin secretion in a glucose-dependent manner.1,2
Ozempic® causes a minor delay in gastric emptying, thereby reducing the rate at which glucose appears in circulation postprandially.1,2
T2D=type 2 diabetes.
Ozempic® is not indicated for weight loss.1,2
While the primary endpoint in the majority of clinical trials was mean change in A1C, mean change in body weight was generally evaluated as a confirmatory secondary endpoint.1,2
See Ozempic® pen A1C and weight page for additional information and see the Ozempic® pen Prescribing Information.
See Ozempic® pill A1C and weight page for additional information and see the Ozempic® pill Prescribing Information.
The most common adverse reactions reported in ≥5% of patients taking Ozempic® are nausea, vomiting, diarrhea, abdominal pain, and constipation.1,2
Decreased appetite was also reported in ≥5% of patients taking semaglutide tablets.1
Learn about the safety profile for Ozempic®.
See how to prescribe a 1-month or 3-month supply of Ozempic® in your EHR systems for Ozempic® pen and Ozempic® pill
EHR=electronic health record.
Whether patients are commercially insured or are uninsured, there's a way to save on both formulations of Ozempic®.
Commercially covered patients pay as little as $25 for up to a 3-month prescription.a
aGovernment beneficiaries excluded. Pay as little as $25, subject to a maximum savings of $100/month. Eligibility and restrictions apply. Government beneficiaries excluded. One month defined as 1 box of 1 Ozempic® pen and 1 bottle of 30 tablets of Ozempic® pill. Novo Nordisk reserves the right to modify or cancel this program at any time. See full terms at www.savingscardeligibility.com and NovoCarePharmacyTerms.com.
Yes! Patients can download digital patient starter kits for Ozempic® at OzempicQuickResources.com. The kits include information on:
- Taking and storing Ozempic®
- Side effects
- Savings and support programs
Ozempic® pen
Ozempic® pen is available in the following doses1:
- A 0.25 mg starting dose and a maintenance dose of 0.5 mg, both available in a red-label pen
- A maintenance dose of 1 mg available in a blue-label pen
- A maximum maintenance dose of 2 mg available in a yellow-label pen
The 0.25 mg dose is intended for treatment initiation and is not effective for glycemic control.1
Ozempic® pen should be administered by a patient once weekly on the same day each week, at any time of the day, with or without meals.1
The day of weekly administration can be changed if necessary, as long as the time between 2 doses is at least 2 days (>48 hours).1
If a patient misses a dose, they should administer Ozempic® pen as soon as possible within 5 days after the missed dose. If more than 5 days have passed, the patient should skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once-weekly dosing schedule.1
Instructions for using the pen can be found here.
Ozempic® injection is supplied as a clear, colorless solution in a prefilled, disposable, single-patient-use pen in the following packaging configurations1:
Red-label pen:
- Contains 2 mg of semaglutide in a 3 mL (0.68 mg/mL) pen
- Delivers dose of 0.25 mg or 0.5 mg per injection
- Includes 6 NovoFine® Plus needles
- NDC: 0169-4181-13
Blue-label pen:
- Contains 4 mg of semaglutide in a 3 mL (1.34 mg/mL) pen
- Delivers doses of 1 mg per injection
- Includes 4 NovoFine® Plus needles
- NDC: 0169-4130-13
Yellow-label pen:
- Contains 8 mg of semaglutide in a 3 mL (2.68 mg/mL) pen
- Delivers doses of 2 mg per injection
- Includes 4 NovoFine® Plus needles
- NDC: 0169-4772-12
Prior to first use (until expiration date): Ozempic® pen should be refrigerated at 36 °F to 46 °F (2 °C to 8 °C).1
After first use (up to 56 days): Ozempic® pen should be stored at room temperature at 59 °F to 86 °F (15 °C to 30 °C) or refrigerated at 36 °F to 46 °F (2 °C to 8 °C).1
Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze Ozempic® pen and do not use Ozempic® pen if it has been frozen.1
Keep the pen cap on when not in use. Ozempic® pen should be protected from excessive heat and sunlight.1
Always remove and safely discard the needle after each injection and store the Ozempic® pen without an injection needle attached. Always use a new needle for each injection.
Basal insulin can be used along with once-weekly Ozempic® and titrated as needed.1 Review the A1C reductions of Ozempic® in combination with basal insulin.1
Patients receiving Ozempic® in combination with an insulin secretagogue (eg, sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia.1
Ozempic® pill
Ozempic® pill is available in the following once daily doses2:
- A 1.5 mg starting dose
- A 4 mg therapeutic dose
- A 9 mg dose
The 1.5 mg dose is intended for treatment initiation and is not effective for glycemic control.2
Ozempic® pill should be taken orally once daily, in the morning, on an empty stomach with up to 4 ounces of water.2
Swallow tablet whole. Do not split, crush, chew, or dissolve in any solution. Wait 30 minutes to eat, drink, or take other oral medications. Do not take more than 1 tablet per day.2
If the patient misses a dose, they should skip the missed dose and wait until the following day.2
See Ozempic® pill administration information
Ozempic® pill is supplied as a once-daily tablet in bottles containing 30 tablets for a 30-day supply in the following packaging configurations2:
Green label:
- Includes 1 Ozempic® pill bottle containing doses of 1.5 mg of semaglutide per tablet
- NDC: 0169-1715-30
Red label:
- Includes 1 Ozempic® pill bottle containing doses of 4 mg of semaglutide per tablet
- NDC: 0169-1704-30
Blue label:
- Includes 1 Ozempic® pill bottle containing doses of 9 mg of semaglutide per tablet
- NDC: 0169-1709-30
Ozempic® pill should not be refrigerated. It should be stored at room temperature between 68 °F and 77 °F (20 °C to 25 °C) in a dry place away from moisture. Store and dispense in the original bottle. Do not use a pill organizer or other container to store Ozempic® pill.2
You should discuss all the important storage information with your patients for Ozempic® pill to work as intended.
See Ozempic® pill storage information.
More ways to help your patients with T2D
T2D=type 2 diabetes.
Important Safety Information for Ozempic®
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 or 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 a prior serious hypersensitivity reaction to semaglutide or to any of the excipients in Ozempic®. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with Ozempic®
Warnings and Precautions
- Risk of Thyroid C-Cell Tumors: Patients should be further evaluated if serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging
- Acute Pancreatitis: Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including semaglutide. Observe patients carefully for signs and symptoms of acute pancreatitis, which may include persistent or severe abdominal pain (sometimes radiating to the back), with or without nausea or vomiting. If pancreatitis is suspected, discontinue Ozempic® and initiate appropriate management
- 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® injection (3%) compared to placebo (1.8%). In a pooled analysis of glycemic control trials, patients reported diabetic retinopathy related adverse reactions during the trial (4.2% with semaglutide tablets and 3.8% with comparator). 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.
Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. 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: Patients receiving Ozempic® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia
- Acute Kidney Injury Due to Volume Depletion: There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with semaglutide. The majority of reported events occurred in patients who experienced gastrointestinal reactions leading to dehydration such as nausea, vomiting, or diarrhea. Monitor renal function in patients reporting adverse reactions to Ozempic® that could lead to volume depletion, especially during dosage initiation and escalation
- Severe Gastrointestinal (GI) Adverse Reactions: Use of Ozempic® has been associated with GI adverse reactions, sometimes severe. In clinical trials, severe GI adverse reactions were reported more frequently among patients who received Ozempic® injection (0.5 mg 0.4%, 1 mg 0.8%) than placebo (0%); and severe GI adverse reactions were reported more frequently among patients who received semaglutide tablets (7 mg 0.6%, 14 mg 2%) than placebo (0.3%). Severe GI adverse reactions have also been reported postmarketing with GLP-1 receptor agonists. Ozempic® is not recommended in patients with severe gastroparesis
- Hypersensitivity: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported in patients treated with Ozempic®. 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
- Acute Gallbladder Disease: Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In placebo-controlled trials, cholelithiasis was reported in 1.5% and 0.4% of patients treated with Ozempic® injection 0.5 mg and 1 mg, respectively, and not reported in placebo-treated patients. In placebo-controlled trials to improve glycemic control, cholelithiasis was reported in 1% of patients treated with semaglutide tablets 7 mg. In a 4-year CV outcomes trial (Trial 7), cholelithiasis was reported in 1.1% of patients treated with semaglutide tablets 14 mg and in 0.9% of placebo-treated patients. In Trial 7, cholecystitis was reported in 1.1% treated with semaglutide tablets 14 mg and in 0.7% of placebo-treated patients. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated
- Pulmonary Aspiration During General Anesthesia or Deep Sedation: Ozempic® delays gastric emptying. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking Ozempic®
Adverse Reactions
- The most common adverse reactions reported in ≥5% of patients taking Ozempic® are nausea, vomiting, diarrhea, abdominal pain, and constipation. Decreased appetite was also reported in ≥5% of patients taking semaglutide tablets
Drug Interactions
- When initiating Ozempic®, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia
- Ozempic® causes a delay of gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. Monitor the effects of oral medications concomitantly administered with Ozempic®. Consider increased clinical or laboratory monitoring for medications that have a narrow therapeutic index or that require clinical monitoring
Use in Specific Populations
- Pregnancy: Available data with semaglutide use in pregnant women are not sufficient to determine a drug associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Discontinue Ozempic® in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide
- Lactation: A clinical lactation study reported semaglutide concentrations below the lower limit of quantification in human breast milk. However, salcaprozate sodium (SNAC) and/or its metabolites are present in human milk. Because of the unknown potential for serious adverse reactions in the breastfed infant due to the possible accumulation of SNAC, an absorption enhancer for Ozempic® tablets, and because there are alternative formulations of semaglutide that do not contain SNAC that can be used during lactation, advise patients that breastfeeding is not recommended during treatment with Ozempic® tablets
Please click here for Ozempic® injection Prescribing Information, including Boxed Warning.
Please click here for Ozempic® tablets Prescribing Information, including Boxed Warning.
Indications and Usage
Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg and Ozempic® (semaglutide) tablets 4 mg or 9 mg are indicated:
- as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
Ozempic® injection is indicated:
- to reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes and established CV disease
- to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease
Ozempic® tablets are indicated:
- to reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes who are at high risk for these events
Important Safety Information for Ozempic®
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 or 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®
Important Safety Information for Ozempic®
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 or 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 a prior serious hypersensitivity reaction to semaglutide or to any of the excipients in Ozempic®. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with Ozempic®
Warnings and Precautions
- Risk of Thyroid C-Cell Tumors: Patients should be further evaluated if serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging
- Acute Pancreatitis: Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including semaglutide. Observe patients carefully for signs and symptoms of acute pancreatitis, which may include persistent or severe abdominal pain (sometimes radiating to the back), with or without nausea or vomiting. If pancreatitis is suspected, discontinue Ozempic® and initiate appropriate management
- 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® injection (3%) compared to placebo (1.8%). In a pooled analysis of glycemic control trials, patients reported diabetic retinopathy related adverse reactions during the trial (4.2% with semaglutide tablets and 3.8% with comparator). 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.
Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. 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: Patients receiving Ozempic® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia
- Acute Kidney Injury Due to Volume Depletion: There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with semaglutide. The majority of reported events occurred in patients who experienced gastrointestinal reactions leading to dehydration such as nausea, vomiting, or diarrhea. Monitor renal function in patients reporting adverse reactions to Ozempic® that could lead to volume depletion, especially during dosage initiation and escalation
- Severe Gastrointestinal (GI) Adverse Reactions: Use of Ozempic® has been associated with GI adverse reactions, sometimes severe. In clinical trials, severe GI adverse reactions were reported more frequently among patients who received Ozempic® injection (0.5 mg 0.4%, 1 mg 0.8%) than placebo (0%); and severe GI adverse reactions were reported more frequently among patients who received semaglutide tablets (7 mg 0.6%, 14 mg 2%) than placebo (0.3%). Severe GI adverse reactions have also been reported postmarketing with GLP-1 receptor agonists. Ozempic® is not recommended in patients with severe gastroparesis
- Hypersensitivity: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported in patients treated with Ozempic®. 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
- Acute Gallbladder Disease: Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In placebo-controlled trials, cholelithiasis was reported in 1.5% and 0.4% of patients treated with Ozempic® injection 0.5 mg and 1 mg, respectively, and not reported in placebo-treated patients. In placebo-controlled trials to improve glycemic control, cholelithiasis was reported in 1% of patients treated with semaglutide tablets 7 mg. In a 4-year CV outcomes trial (Trial 7), cholelithiasis was reported in 1.1% of patients treated with semaglutide tablets 14 mg and in 0.9% of placebo-treated patients. In Trial 7, cholecystitis was reported in 1.1% treated with semaglutide tablets 14 mg and in 0.7% of placebo-treated patients. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated
- Pulmonary Aspiration During General Anesthesia or Deep Sedation: Ozempic® delays gastric emptying. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking Ozempic®
Adverse Reactions
- The most common adverse reactions reported in ≥5% of patients taking Ozempic® are nausea, vomiting, diarrhea, abdominal pain, and constipation. Decreased appetite was also reported in ≥5% of patients taking semaglutide tablets
Drug Interactions
- When initiating Ozempic®, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia
- Ozempic® causes a delay of gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. Monitor the effects of oral medications concomitantly administered with Ozempic®. Consider increased clinical or laboratory monitoring for medications that have a narrow therapeutic index or that require clinical monitoring
Use in Specific Populations
- Pregnancy: Available data with semaglutide use in pregnant women are not sufficient to determine a drug associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Discontinue Ozempic® in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide
- Lactation: A clinical lactation study reported semaglutide concentrations below the lower limit of quantification in human breast milk. However, salcaprozate sodium (SNAC) and/or its metabolites are present in human milk. Because of the unknown potential for serious adverse reactions in the breastfed infant due to the possible accumulation of SNAC, an absorption enhancer for Ozempic® tablets, and because there are alternative formulations of semaglutide that do not contain SNAC that can be used during lactation, advise patients that breastfeeding is not recommended during treatment with Ozempic® tablets
Please click here for Ozempic® injection Prescribing Information, including Boxed Warning.
Please click here for Ozempic® tablets Prescribing Information, including Boxed Warning.
Indications and Usage
Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg and Ozempic® (semaglutide) tablets 4 mg or 9 mg are indicated:
- as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
Ozempic® injection is indicated:
- to reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes and established CV disease
- to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease
Ozempic® tablets are indicated:
- to reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes who are at high risk for these events
References:
- Ozempic injection. Prescribing information. Novo Nordisk Inc.
- Ozempic tablets. Prescribing information. Novo Nordisk Inc.
- 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. doi:10.1016/S2213-8587(18)30024-X