Proven A1C efficacy in adults with type 2 diabetes.1
In 3 studies at 26 weeks and 1 study at 52 weeks evaluating Awiqli® in adults with type 2 diabetes (T2D), Awiqli® demonstrated proven A1C efficacy.1
Actor portrayal
Proven A1C efficacy in adults with T2D previously treated with daily basal insulin2
Awiqli® achieved the primary endpoint of noninferiority in mean change in HbA1C from baseline and demonstrated a statistically significant reduction in HbA1c compared with once-daily insulin degludec U-100 at week 26.1,2
Primary endpoint: mean change in HbA1c from baseline at week 26.2
Treatment with once-weekly Awiqli® for 26 weeks resulted in statistically significantly greater reduction in HbA1c compared with insulin degludec U-100 with an ETD of -0.19 (95% CI: -0.32, -0.06).1,c
aEstimated using an ANCOVA with treatment, personal CGM device use (yes/no) and region as fixed factors and baseline response as covariate.1
bMissing values were imputed by the baseline value adding a random term, using multiple imputation. There were 2.7% of patients in the Awiqli® arm and 3.8% in the degludec arm for whom HbA1c data was missing at week 26.1
cp=0.0032 (two-sided) for superiority, adjusted for multiplicity.1
ANCOVA=analysis of covariance; CGM=continuous glucose monitor; CI=confidence interval; ETD=estimated treatment difference; GLP-1 RA=glucagon-like peptide-1 receptor agonist; HbA1c=hemoglobin A1C; OAD=oral antidiabetic drug; U=units.
Study design
ONWARDS 2 (TRIAL C)
Across all 4 trials, insulin icodec-abae was titrated in 20-unit increments, and the fasting plasma glucose (FPG) glycemic target (based on the mean of the 3 most recent FPG values) was 80-130 mg/dL for both treatment arms.
The efficacy of Awiqli® was evaluated in a 26-week, randomized, open-label, active-controlled, parallel-group, multicenter, multinational, treat-to-target trial in 526 adult patients with type 2 diabetes mellitus treated with once- or twice-daily basal insulin with or without oral antidiabetic agents (OADs). Patients were randomized to Awiqli® once weekly or insulin degludec U-100 once daily according to the approved labeling. Pretrial noninsulin OADs/GLP-1 receptor agonist were continued as background therapy in both treatment arms throughout the entire trial except for sulfonylureas and glinides, which were discontinued at randomization.
Additional evidence in basal-bolus therapy
ONWARDS 4 achieved noninferiority in mean change in HbA1c from baseline as compared with insulin glargine U-100, both in combination with insulin aspart before each meal, at week 26.1,3
Primary endpoint: mean change in HbA1c from baseline at week 26.3
At Week 26, the difference in HbA1c reduction from baseline between Awiqli® and insulin glargine U-100 was 0.02% (95% CI: –0.11, ‑0.15) and met the prespecified noninferiority margin (0.3%).1
dEstimated using an ANCOVA with treatment, personal CGM device use (yes/no) and region as fixed factors and baseline response as covariate.1
eMissing values were imputed by the baseline value adding a random term, using multiple imputation. There were 5.5% of patients in the Awiqli® arm and 9.3% in the glargine arm for whom HbA1c data was missing at week 26.1
ANCOVA=analysis of covariance; CGM=continuous glucose monitor; CI=confidence interval; ETD=estimated treatment difference; GLP-1 RA=glucagon-like peptide-1 receptor agonist; HbA1c=hemoglobin A1C; OAD=oral antidiabetic drug; U=units.
Study design
ONWARDS 4 (TRIAL D)
Across all 4 trials, insulin icodec-abae was titrated in 20-unit increments, and the fasting plasma glucose (FPG) glycemic target (based on the mean of the 3 most recent FPG values) was 80-130 mg/dL for both treatment arms.
The efficacy of Awiqli® was evaluated in a 26-week, randomized, open-label, active-controlled, parallel-group, multicenter, multinational, treat-to-target trial in 582 adult patients with type 2 diabetes mellitus inadequately controlled on once-daily basal insulin in combination with mealtime rapid-acting insulin with or without oral antidiabetic agents (OADs) or GLP-1 receptor agonist. Patients were randomized to Awiqli® once weekly or insulin glargine U-100 once daily according to the approved labeling both in combination with insulin aspart before each meal. Pretrial noninsulin OADs or GLP-1 receptor agonist were continued as background therapy in both treatment arms throughout the entire trial except for sulfonylureas and glinides, which were discontinued at randomization.
Insulin-naïve adults with type 2 diabetes
ONWARDS 1 achieved the primary endpoint of noninferiority in mean change in HbA1c from baseline at week 52 with Awiqli® compared to insulin glargine U-100.1,4
Primary endpoint: mean change in HbA1c from baseline at week 52.4
Treatment with once-weekly Awiqli® for 52 weeks resulted in a statistically significant reduction in HbA1c compared with once-daily insulin glargine U-100 with an ETD of −0.18 (95% CI: −0.29, −0.08).1,h
fEstimated using an ANCOVA with treatment, and region as fixed factors and baseline response as covariate.1
gMissing values were imputed by the baseline value adding a random term, using multiple imputation. There were 2.6% of patients in the Awiqli® arm and 2.6% in the glargine arm for whom HbA1c data was missing at week 52.1
hp=0.0004 (two-sided) for superiority, adjusted for multiplicity.1
ANCOVA=analysis of covariance; CI=confidence interval; ETD=estimated treatment difference; GLP-1 RA=glucagon-like peptide-1 receptor agonist; HbA1c=hemoglobin A1C; OAD=oral antidiabetic drug; TIR=time in range; U=units.
Confirmatory secondary endpoint
More time in the target glucose range
- In ONWARDS 1, adults treated with Awiqli® + OAD(s)/GLP-1 RA spent approximately 1 hour longer per day in the target glucose range compared with insulin glargine U-100 + OAD(s)/GLP-1 RA.1,4
- From weeks 48–52, Awiqli® demonstrated a 4.27 percentage-point improvement in mean TIR (70–180 mg/dL) versus insulin glargine U-100 (71.3% vs 67.0%), exceeding the >70% target recommended by international consensus guidelines.1,4,5,i,j
iEstimated using an ANCOVA with treatment, and region as fixed factors. Missing values were imputed using multiple imputation based on patients in the insulin glargine arm who completed their randomized treatment.1
jp<0.001 (two-sided) for superiority, adjusted for multiplicity.1
Study design
ONWARDS 1 (TRIAL A)
Across all 4 trials, insulin icodec-abae was titrated in 20-unit increments, and the fasting plasma glucose (FPG) glycemic target (based on the mean of the 3 most recent FPG values) was 80-130 mg/dL for both treatment arms.
The efficacy of Awiqli® was evaluated in a 52-week, randomized, open-label, active-controlled, parallel-group, multicenter, multinational, treat-to-target trial that enrolled 984 insulin-naïve adult patients with type 2 diabetes mellitus inadequately controlled on one or more oral antidiabetic agents (OADs) or GLP-1 receptor agonist. Patients were randomized to Awiqli® once weekly or insulin glargine U-100 once daily according to the approved labeling. Pretrial noninsulin antidiabetic medications were continued as background therapy in both treatment arms throughout the entire trial except for sulfonylureas and glinides, which were discontinued at randomization.
ONWARDS 3 achieved the primary endpoint of noninferiority in mean change in HbA1c from baseline at week 26 in patients treated with Awiqli® compared to degludec U-100.1,6
Primary endpoint: mean change in HbA1c from baseline at week 26.6
Treatment with once-weekly Awiqli® for 26 weeks resulted in a statistically significantly greater reduction in HbA1c compared with once-daily insulin degludec U-100, with an ETD of −0.22 (95% CI: −0.35, −0.09).1,m
kEstimated using an ANCOVA with treatment, SU or glinide use (yes/no), and region as fixed factors and baseline response as covariate.
lMissing values were imputed by the baseline value adding a random term, using multiple imputation. There were 3.7% of patients in the Awiqli® arm and 3.1% in the degludec arm for whom HbA1c data was missing at week 26.1
mp=0.0007 (two-sided) for superiority, adjusted for multiplicity.1
ANCOVA=analysis of covariance; CI=confidence interval; ETD=estimated treatment difference; GLP-1 RA=glucagon-like peptide-1 receptor agonist; HbA1c=hemoglobin A1C; OAD=oral antidiabetic drug; SU=sulfonylurea; U=units.
Study design
ONWARDS 3 (TRIAL B)
Across all 4 trials, insulin icodec-abae was titrated in 20-unit increments, and the fasting plasma glucose (FPG) glycemic target (based on the mean of the 3 most recent FPG values) was 80-130 mg/dL for both treatment arms.
The efficacy of Awiqli® was evaluated in a 26-week, randomized, double-blind, active-controlled, parallel-group, multicenter, multinational, treat-to-target trial that enrolled 588 adult insulin-naïve patients with type 2 diabetes mellitus inadequately controlled on one or more oral antidiabetic agents (OADs) or GLP-1 receptor agonist. Patients were randomized to Awiqli® once weekly or insulin degludec U-100 once daily according to the approved labeling. Pretrial noninsulin antidiabetic medications were continued as background therapy in both treatment arms throughout the entire trial except for sulfonylureas and glinides, which were reduced at randomization by approximately 50% at the discretion of the investigator.
Safety
The safety of once-weekly Awiqli® was evaluated across 5 clinical trials involving 1880 adults with T2D, with a mean exposure duration of 26 to 52 weeks across the 5 trials.1
Hypoglycemia
Hypoglycemia was the most common adverse reaction observed in patients treated with Awiqli®. In clinical trials, events of severe hypoglycemia (level 3) were defined as an episode associated with severe cognitive impairment requiring external assistance for recovery. Hypoglycemia episodes with a glucose level below 54 mg/dL with or without associated symptoms (level 2 hypoglycemia) were also assessed in patients with type 2 diabetes.1
Proportion (%) of patients with T2D experiencing at least one episode of severe (level 3) or clinically significant (level 2) hypoglycemia in clinical trials1
nLevel 3 hypoglycemia is an episode associated with severe cognitive impairment requiring external assistance for recovery.
oLevel 2 hypoglycemia is a hypoglycemia episode with a self-measured blood glucose level below 54 mg/dL with or without associated symptoms.
pIn Trial E, Awiqli® arm titration was performed via a digital titration app.
qExcludes sulfonylureas and glinides.
rSulfonylurea and glinide dosage decreased by 50% at the discretion of the investigator.
Other common adverse reactions observed with Awiqli®1
- Hypersensitivity reactions (eg, urticaria, swelling face and lips)
- Injection site reactions
- Lipodystrophy
- Pruritus
- Rash
- Edema
- Weight gain
These are not all the serious and possible side effects of Awiqli®. Read the Awiqli® Important Safety Information and Prescribing Information here.
Evaluated across diverse patient populations
Patient characteristics
Age, sex, race, and ethnicity did not meaningfully affect the pharmacokinetics and pharmacodynamics of Awiqli®.1
Renal impairment
No clinically relevant differences in pharmacokinetics were observed in patients with renal impairment. Additional dose adjustment should not be necessary; however, glucose monitoring should be intensified and dosing individualized in these patients.1,s
Hepatic impairment
No differences in pharmacokinetics were observed in patients with hepatic impairment. Additional dose adjustment should not be necessary; however, glucose monitoring should be intensified and dosing individualized in these patients.1,s
For more information on use in specific populations, please see the full Prescribing Information.
sDose adjustments may be needed with changes in renal or hepatic function or during illness to minimize the risk of hypoglycemia or hyperglycemia. Due to the long half-life of Awiqli®, adjustment of dose is not advised during acute illness nor if patients make short-term changes in their physical activity level or usual diet. In these situations, consider other applicable adjustments, eg, glucose intake or changes to other glucose-lowering medication.
Dosing with Awiqli®
See how to initiate, titrate, and switch patients to Awiqli®.
Support for you and your patients
Access savings, support, and educational resources.
Important Safety Information for Awiqli®
Contraindications
- Awiqli® is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin icodec-abae or any of the excipients in Awiqli® FlexTouch®. Serious hypersensitivity reactions have included anaphylaxis.
Warnings and Precautions
- Hypoglycemia Due to Medication Errors and Accidental Overdose: Serious hypoglycemia requiring hospitalization has occurred due to accidental mix-ups between Awiqli® and other insulin products or once-weekly injectable antidiabetic medicines, incorrect dose selection, and dosing frequency errors.
To avoid dosing errors when switching patients from daily basal insulin to Awiqli®, follow the dosage recommendations as detailed in the prescribing information. Administer Awiqli® once weekly only.
Advise patients to always check the product label before each injection to confirm they are using Awiqli® and not another insulin or injectable antidiabetic medicine. Prior to initiation, train patients and their caregiver(s) on how to select their weekly Awiqli® dosage. Advise patients using other injectable medications for glycemic control that the dosage selection of Awiqli® differs. Instruct patients to visually verify the dialed units on the dose counter of the Awiqli® FlexTouch® prefilled pen before each injection to avoid dosing errors. Do not dial the maximum single dose (700 units) of Awiqli® unless this is the prescribed dose. Do not use a syringe to remove Awiqli® from the Awiqli® FlexTouch® disposable insulin prefilled pen.
Monitor patients for signs and symptoms of hypoglycemia, particularly during the first several weeks after initiation or dose escalation of Awiqli®. Ensure patients understand how to recognize and manage hypoglycemia. - Hypoglycemia: Hypoglycemia is the most common adverse reaction of insulin, including Awiqli®. Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). Awiqli®, or any insulin, should not be used during episodes of hypoglycemia.
Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., betablockers) or in patients who experience recurrent hypoglycemia. The longacting effect of Awiqli® may delay recovery from hypoglycemia compared to shorter-acting insulins.
Risk Factors for Hypoglycemia: The risk of hypoglycemia generally increases with intensity of glycemic control. The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. As with all insulins, the glucose lowering effect over time of Awiqli® may vary among different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature.
Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content or timing of meals), changes in level of physical activity, or changes to co-administered medications. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia.
Educate patients and caregivers to recognize and manage hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended. - Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia.
Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. Adjustments in concomitant anti-diabetic treatment may be needed. - Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including Awiqli®. If hypersensitivity reactions occur, discontinue Awiqli®; treat per standard of care and monitor until symptoms and signs resolve.
- Hypokalemia: All insulins, including Awiqli®, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated.
- Never Share an Awiqli® FlexTouch® Pen or Needle Between Patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens.
- Fluid Retention and Congestive Heart Failure with Concomitant Use of PPAR Gamma Agonists: Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including Awiqli®. Patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of the TZD must be considered.
Adverse Reactions
- Adverse reactions commonly associated with Awiqli® are: hypoglycemia, hypersensitivity reactions (e.g. urticaria, swelling face and lips), injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain
Drug Interactions
- There are certain drugs that may cause clinically significant drug interactions with Awiqli®:
- Drugs that may increase the risk of hypoglycemia: antidiabetic agents, ACE
inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors - Drugs that may decrease the blood glucose lowering effect: atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones
- Drugs that may increase or decrease the blood glucose lowering effect: alcohol, beta-blockers, clonidine, lithium salts, and pentamidine
- Drugs that may blunt the signs and symptoms of hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine
- Drugs that may increase the risk of hypoglycemia: antidiabetic agents, ACE
Please click here for Awiqli® Prescribing Information.
Important Safety Information for Awiqli®
Contraindications
- Awiqli® is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin icodec-abae or any of the excipients in Awiqli® FlexTouch®. Serious hypersensitivity reactions have included anaphylaxis.
Warnings and Precautions
- Hypoglycemia Due to Medication Errors and Accidental Overdose: Serious hypoglycemia requiring hospitalization has occurred due to accidental mix-ups between Awiqli® and other insulin products or once-weekly injectable antidiabetic medicines, incorrect dose selection, and dosing frequency errors.
To avoid dosing errors when switching patients from daily basal insulin to Awiqli®, follow the dosage recommendations as detailed in the prescribing information. Administer Awiqli® once weekly only.
Advise patients to always check the product label before each injection to confirm they are using Awiqli® and not another insulin or injectable antidiabetic medicine. Prior to initiation, train patients and their caregiver(s) on how to select their weekly Awiqli® dosage. Advise patients using other injectable medications for glycemic control that the dosage selection of Awiqli® differs. Instruct patients to visually verify the dialed units on the dose counter of the Awiqli® FlexTouch® prefilled pen before each injection to avoid dosing errors. Do not dial the maximum single dose (700 units) of Awiqli® unless this is the prescribed dose. Do not use a syringe to remove Awiqli® from the Awiqli® FlexTouch® disposable insulin prefilled pen.
Monitor patients for signs and symptoms of hypoglycemia, particularly during the first several weeks after initiation or dose escalation of Awiqli®. Ensure patients understand how to recognize and manage hypoglycemia. - Hypoglycemia: Hypoglycemia is the most common adverse reaction of insulin, including Awiqli®. Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). Awiqli®, or any insulin, should not be used during episodes of hypoglycemia.
Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., betablockers) or in patients who experience recurrent hypoglycemia. The longacting effect of Awiqli® may delay recovery from hypoglycemia compared to shorter-acting insulins.
Risk Factors for Hypoglycemia: The risk of hypoglycemia generally increases with intensity of glycemic control. The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. As with all insulins, the glucose lowering effect over time of Awiqli® may vary among different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature.
Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content or timing of meals), changes in level of physical activity, or changes to co-administered medications. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia.
Educate patients and caregivers to recognize and manage hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended. - Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia.
Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. Adjustments in concomitant anti-diabetic treatment may be needed. - Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including Awiqli®. If hypersensitivity reactions occur, discontinue Awiqli®; treat per standard of care and monitor until symptoms and signs resolve.
- Hypokalemia: All insulins, including Awiqli®, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated.
- Never Share an Awiqli® FlexTouch® Pen or Needle Between Patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens.
- Fluid Retention and Congestive Heart Failure with Concomitant Use of PPAR Gamma Agonists: Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including Awiqli®. Patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of the TZD must be considered.
Adverse Reactions
- Adverse reactions commonly associated with Awiqli® are: hypoglycemia, hypersensitivity reactions (e.g. urticaria, swelling face and lips), injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain
Drug Interactions
- There are certain drugs that may cause clinically significant drug interactions with Awiqli®:
- Drugs that may increase the risk of hypoglycemia: antidiabetic agents, ACE
inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors - Drugs that may decrease the blood glucose lowering effect: atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones
- Drugs that may increase or decrease the blood glucose lowering effect: alcohol, beta-blockers, clonidine, lithium salts, and pentamidine
- Drugs that may blunt the signs and symptoms of hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine
- Drugs that may increase the risk of hypoglycemia: antidiabetic agents, ACE
Please click here for Awiqli® Prescribing Information.
References
- Awiqli [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
- Philis-Tsimikas A, Asong M, Franek E, et al. Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open-label, multicentre, treat-to-target trial. Lancet Diabetes Endocrinol. 2023;11(6):414-425.
- Mathieu C, Ásbjörnsdóttir B, Bajaj HS, et al. Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial. Lancet. 2023;401(10392):1929-1940.
- Rosenstock J, Bain SC, Gowda A, et al. Weekly icodec versus daily glargine U100 in type 2 diabetes without previous insulin. N Engl J Med. 2023;389(4):297-308.
- Battelino T, Alexander CM, Amiel SA, et al. Continuous glucose monitoring and metrics for clinical trials: an international consensus statement. Lancet Diabetes Endocrinol. 2023;11(1):42-57.
- Lingvay I, Asong M, Desouza C, et al. Once-weekly insulin icodec vs once-daily insulin degludec in adults with insulin-naive type 2 diabetes: the ONWARDS 3 randomized clinical trial. JAMA. 2023;330(3):228-237.