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Endocrine Disorders, Contraception, and Hormone Therapy during Pregnancy
Published in “Bert” Bertis Britt Little, Drugs and Pregnancy, 2022
Dulaglutide is another GLP-1 inhibitor used to treat T2DM. The drug is not intended for treating type 1 diabetes, and should never be used for this disorder. It has not been studied in human pregnancy. The manufacturer reported increased embryonic loss and skeletal ossification abnormalities in pregnant rats given up to 44 times the usual human dose during organogenesis. Offspring of rabbits given 13 times the usual human dose of dulaglutide during embryogenesis had lung lobe agenesis and vertebral malformations. Under the old FDA category system, dulaglutide is pregnancy risk category C.
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Published in Caroline Ashley, Aileen Dunleavy, John Cunningham, The Renal Drug Handbook, 2018
Caroline Ashley, Aileen Dunleavy, John Cunningham
The pharmacokinetics of dulaglutide were found to be similar between healthy subjects and patients with mild to severe renal impairment (CRCL<30 mL/min), including end stage renal disease (requiring dialysis).
Is retatrutide (LY3437943), a GLP-1, GIP, and glucagon receptor agonist a step forward in the treatment of diabetes and obesity?
Published in Expert Opinion on Investigational Drugs, 2023
Unfortunately, the inappropriate comparison with dulaglutide in subjects with type 2 diabetes is being repeated in an ongoing clinical trial. Thus, a phase 2 study of once-weekly retatrutide compared with placebo and dulaglutide in participants with type 2 diabetes (NCT04867785) is using 4 doses of retatrutide for about 43 weeks in 281 subjects who have failed to achieve glycemic control despite diet and exercise or on a stable dose of metformin [16]. Retatrutide is also being studied in people living with obesity: phase 2 study of once-weekly retatrutide compared with placebo in participants who have obesity or are overweight with weight-related comorbidities (NCT04881760) is over 18 months [17]. In the phase 1b trial of retatrutide, 6 doses were used; 0.5, 1.5, 3, 6, 9, and 12 mg, and it would be useful to know which doses are being taken forward to the phase 2 stage. However, the 4 doses of retatrutide that are being used in the phase 2 clinical trials are not specified on the clinicaltrials.gov website, which I consider to be an omission.
Type 2 diabetes and cardiovascular disease: risk reduction and early intervention
Published in Postgraduate Medicine, 2023
Debbie Hinnen, Davida Kruger, Melissa Magwire
Gastrointestinal (GI) symptoms (including nausea, vomiting, diarrhea, and constipation) are the most common side effects of GLP-1RA therapy (predominantly nausea) (Table 3). In a pool of placebo-controlled trials for dulaglutide 0.75 mg and 1.5 mg, nausea was reported in 12.4% and 21.1% of patients compared with 5.3% of patients receiving placebo. In general, the incidence of nausea does not appear to occur in a dose-dependent manner. Comparable rates of nausea were reported in patients receiving higher doses of dulaglutide (15.6% of patients receiving dulaglutide 3.0 mg and 16.4% of patients receiving dulaglutide 4.5 mg) [8]. The proportions of patients reporting nausea were similar for liraglutide 1.2 mg and 1.8 mg (18.0% and 20.0%) [9], and semaglutide 0.5 mg and 1.0 mg (15.8% and 20.3%) [7] (Table 3). Furthermore, proportions of patients reporting nausea were similar with semaglutide 1.0 mg (14.6%) and 2.0 mg (14.4%) in SUSTAIN FORTE [36].
Stepwise approach to continuous glucose monitoring interpretation for internists and family physicians
Published in Postgraduate Medicine, 2022
Emily D. Szmuilowicz, Grazia Aleppo
Review of the daily glucose trends (examples shown in Figure 3(a)) showed postprandial hyperglycemia following most but not all meals. Of note, fasting hyperglycemia was noted on some days (red arrows); however, this followed elevated postprandial bedtime glucose on the preceding night, and glucose decreased by ≥50 mg/dL (≥2.8 mmol/L) overnight from bedtime to fasting the next morning. This pattern indicates that interventions targeting postprandial hyperglycemia were needed (Figure 2), and these measures would be expected to improve the fasting glucose on the next day as well. Indeed, fasting glucose levels were improved on days when postprandial hyperglycemia on the night prior was less severe (green arrows), indicating that the basal insulin dose was adequate. The therapeutic modification recommended was to increase dulaglutide to 3.0 mg once week to address the postprandial hyperglycemia. In addition, the daily glucose trends were reviewed with the patient to identify which meal choices were associated with larger versus smaller postprandial glucose increases, in order to guide meal choices. Following these interventions, there was significant improvement in TIR (increased from 65% to 86%) and TAR (decrease from 35% to 14%; Figure 3(b)).