Characteristics Associated with the Choice of First Injectable Therapy Among US Patients With Type 2 Diabetes

Yu, Maria; Mody, Reema; Landó, Laura Fernández; Shui, Amy; Kallenbach, Lee; Slipski, Lukas; Oliveira, Carolina Piras de

doi:10.1016/j.clinthera.2017.11.001

Cited by 15 publications

(23 citation statements)

References 25 publications

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“…29 Furthermore, all these studies were conducted using only one meal tolerance test following drug administration and not at repeated meals throughout the day. Based on these exploratory results and the inconsistent data from studies with meal tolerance tests performed for long-acting versus shortacting GLP-1 RAs, [23][24][25][26] there is not sufficient evidence to clinically justify a polarized classification of short-acting GLP-1 RAs as prandial specific and long-acting GLP-1 RAs as basal specific. Indeed, specific characteristics of different GLP-1 RAs including HbA1c and weight efficacy, cardiovascular benefits, frequency of administration and adherence could be more relevant when making treatment selection.…”

Section: Dulaglutide 15 Mg Versus Exenatide Bidmentioning

confidence: 99%

“…Finally, in a 24-week meal tolerance test study, long-acting taspoglutide QW (development discontinued) was evaluated against exenatide BID, and no difference was seen in pre-and 2-hour postbreakfast glucose levels and postbreakfast area under the glucose curve (AUC 0-3 h), suggesting a similar impact on postprandial glucose levels between long-and short-acting GLP-1 RAs 29. Based on these exploratory results and the inconsistent data from studies with meal tolerance tests performed for long-acting versus shortacting GLP-1 RAs,[23][24][25][26] there is not sufficient evidence to clinically justify a polarized classification of short-acting GLP-1 RAs as prandial specific and long-acting GLP-1 RAs as basal specific. Based on these exploratory results and the inconsistent data from studies with meal tolerance tests performed for long-acting versus shortacting GLP-1 RAs,[23][24][25][26] there is not sufficient evidence to clinically justify a polarized classification of short-acting GLP-1 RAs as prandial specific and long-acting GLP-1 RAs as basal specific.…”

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confidence: 99%

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Relative contribution of basal and postprandial hyperglycaemia stratified by HbA1c categories before and after treatment intensification with dulaglutide

Umpiérrez

Pantalone

Atisso

et al. 2019

Diabetes Obesity Metabolism

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Aim: To assess the effect of dulaglutide on the relative contribution of basal hyperglycaemia (BHG) and postprandial hyperglycaemia (PPHG) to overall hyperglycaemia across HbA1c categories in patients with type 2 diabetes.Methods: Data from five phase 3 studies (N = 673) were pooled to assess the change in relative contributions of BHG and PPHG to overall hyperglycaemia across different HbA1c categories after 6 months of treatment intensification with dulaglutide 1.5 mg as monotherapy or with 1 or 2 oral medication(s) in patients with type 2 diabetes. BHG and PPHG were calculated using the area under the curve (AUC) of 7-point self-monitored plasma glucose concentration profiles. As a secondary objective, relative contribution of BHG and PPHG for dulaglutide versus liraglutide, exenatide BID and insulin glargine was assessed by individual studies at 6 months. Results: In pooled data, after 6 months of treatment intensification with dulaglutide 1.5 mg, there was a significant reduction from baseline in overall hyperglycaemia (AUC overall ) [(mean ± SE) -466.31 ± 18.32 mg*h/dL (P < 0.001)], BHG (AUC basal ) [(mean ± SE) -371.46 ± 16.36 mg*h/dL (P < 0.001)] and PPHG (AUC postprandial ) [(mean ± SE) -94.84 ± 7.97 mg*h/dL (P < 0.001)]. At baseline, relative contributions of BHG increased and PPHG decreased with increasing HbA1c levels. This pattern was maintained at 6 months, even as overall glycaemia improved with decreasing HbA1c values. Conclusions: In patients with type 2 diabetes, dulaglutide reduces HbA1c by lowering both basal and postprandial hyperglycaemia across various HbA1c levels. K E Y W O R D S basal insulin, dulaglutide, GLP-1 RAs, glycaemic control, type 2 diabetes 1 | INTRODUCTION Widely accepted treatment guidelines recommend an individualized treatment approach towards target HbA1c for patients with type 2 diabetes, based upon cardiovascular disease, life expectancy, disease duration, comorbidities, micro-and macrovascular complications, adherence and other patient-related factors. 1-4 HbA1c is a measure of overall glucose exposure during both fasting and postprandial state, and this interrelationship between the "glucose triad" of HbA1c, fasting glucose and postprandial glucose level changes with progression of the disease. 5 Monnier et al., in a study of 290 patients with type 2 diabetes managed with diet, metformin and/or sulphonylurea, showed that the relative contribution of postprandial hyperglycaemia (PPHG) decreases with increase in HbA1c and the relationship is the opposite for relative contribution of basal hyperglycaemia (BHG) to overall hyperglycaemia. 6 Moreover, the relative contribution of BHG and PPHG to overall hyperglycaemia in patients across a range of HbA1c levels of 7.3-10.2% (56.3-83.0 mmol/mol) was~50%, highlighting the need for drugs that impact both BHG and PPHG for a large proportion of patients. 6 In another study conducted by Riddle et al., in patients with mean baseline HbA1c of 8.7% (71.6 mmol/mol) treated with insulin glargine, the mean relative contribution of BHG t...

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Section: Dulaglutide 15 Mg Versus Exenatide Bidmentioning

confidence: 99%

mentioning

confidence: 99%

Relative contribution of basal and postprandial hyperglycaemia stratified by HbA1c categories before and after treatment intensification with dulaglutide

Umpiérrez

Pantalone

Atisso

et al. 2019

Diabetes Obesity Metabolism

Self Cite

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“…From the 61 included articles, 56 studies assessed the phenotypic factors affecting diabetes progression, while only four studies investigated genotypic determinants of diabetes progression and one study assessed both phenotypic and genotypic factors . Before 2000, there were only four studies published and between 2000 and 2010; there were 20 studies published, with the remaining 37 studies published after 2010.…”

Section: Resultsmentioning

confidence: 99%

“…Before 2000, there were only four studies published and between 2000 and 2010; there were 20 studies published, with the remaining 37 studies published after 2010. The 61 studies were comprised of 35 retrospective cohort studies, 19 prospective cohort studies, three cross‐sectional studies, three case‐control studies studies and one randomized controlled trial (RCT) . The sample size ranged from 50 to 366 955 individuals, and most of the studies were from developed countries with European, American and Australian populations.…”

Section: Resultsmentioning

confidence: 99%

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The impact of phenotype, ethnicity and genotype on progression of type 2 diabetes mellitus

Nair

Donnelly

Dawed

et al. 2020

Endocrino Diabet & Metabol

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Aim:To conduct a comprehensive review of studies of glycaemic deterioration in type 2 diabetes and identify the major factors influencing progression. Methods:We conducted a systematic literature search with terms linked to type 2 diabetes progression. All the included studies were summarized based upon the factors associated with diabetes progression and how the diabetes progression was defined.Results: Our search yielded 2785 articles; based on title, abstract and full-text review, we included 61 studies in the review. We identified seven criteria for diabetes progression: 'Initiation of insulin', 'Initiation of oral antidiabetic drug', 'treatment intensification', 'antidiabetic therapy failure', 'glycaemic deterioration', 'decline in betacell function' and 'change in insulin dose'. The determinants of diabetes progression were grouped into phenotypic, ethnicity and genotypic factors. Younger age, poorer glycaemia and higher body mass index at diabetes diagnosis were the main phenotypic factors associated with rapid progression. The effect of genotypic factors on progression was assessed using polygenic risk scores (PRS); a PRS constructed from the genetic variants linked to insulin resistance was associated with rapid glycaemic deterioration. The evidence of impact of ethnicity on progression was inconclusive due to the small number of multi-ethnic studies. Conclusion:We have identified the major determinants of diabetes progressionyounger age, higher BMI, higher HbA1c and genetic insulin resistance. The impact of ethnicity is uncertain; there is a clear need for more large-scale studies of diabetes progression in different ethnic groups. K E Y W O R D S diabetes progression, glycaemic deterioration, insulin initiation, type 2 diabetes S U PP O RTI N G I N FO R M ATI O N Additional supporting information may be found online in the Supporting Information section. How to cite this article: Thakarakkattil Narayanan Nair A, Donnelly LA, Dawed AY, et al. The impact of phenotype, ethnicity and genotype on progression of type 2 diabetes mellitus. Endocrinol Diab Metab. 2020;3:e00108.

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Effect of Subcutaneous Tirzepatide vs Placebo Added to Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes

Dahl

Onishi

Norwood³

et al. 2022

JAMA

318

437

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The effects of tirzepatide, a dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist, as an addition to insulin glargine for treatment of type 2 diabetes have not been described. OBJECTIVE To assess the efficacy and safety of tirzepatide added to insulin glargine in patients with type 2 diabetes with inadequate glycemic control.DESIGN, SETTING, AND PARTICIPANTS Randomized phase 3 clinical trial conducted at 45 medical research centers and hospitals in 8 countries (enrollment from August 30, 2019, to March 20, 2020 follow-up completed January 13, 2021) in 475 adults with type 2 diabetes and inadequate glycemic control while treated with once-daily insulin glargine with or without metformin.INTERVENTIONS Patients were randomized in a 1:1:1:1 ratio to receive once-weekly subcutaneous injections of 5-mg (n = 116), 10-mg (n = 119), or 15-mg (n = 120) tirzepatide or volume-matched placebo (n = 120) over 40 weeks. Tirzepatide was initiated at 2.5 mg/week and escalated by 2.5 mg every 4 weeks until the assigned dose was achieved. MAIN OUTCOMES AND MEASURESThe primary end point was mean change from baseline in glycated hemoglobin A 1c (HbA 1c ) at week 40. The 5 key secondary end points included mean change in body weight and percentage of patients achieving prespecified HbA 1c levels. RESULTS Among 475 randomized participants (211 [44%] women; mean [SD] age, 60.6 [9.9] years; mean [SD] HbA 1c , 8.31% [0.85%]), 451 (94.9%) completed the trial. Treatment was prematurely discontinued by 10% of participants in the 5-mg tirzepatide group, 12% in the 10-mg tirzepatide group, 18% in the 15-mg tirzepatide group, and 3% in the placebo group. At week 40, mean HbA 1c change from baseline was −2.40% with 10-mg tirzepatide and −2.34% with 15-mg tirzepatide vs −0.86% with placebo (10 mg: difference vs placebo, −1.53% [97.5% CI, −1.80% to −1.27%]; 15 mg: difference vs placebo, −1.47% [97.5% CI, −1.75% to −1.20%]; P < .001 for both). Mean HbA 1c change from baseline was −2.11% with 5-mg tirzepatide (difference vs placebo, −1.24% [95% CI, −1.48% to −1.01%]; P < .001]). Mean body weight change from baseline was −5.4 kg with 5-mg tirzepatide, −7.5 kg with 10-mg tirzepatide, −8.8 kg with 15-mg tirzepatide and 1.6 kg with placebo (5 mg: difference, −7.1 kg [95% CI, −8.7 to −5.4]; 10 mg: difference, −9.1 kg [95% CI, −10.7 to −7.5]; 15 mg: difference, −10.5 kg [95% CI, −12.1 to −8.8]; P < .001 for all). Higher percentages of patients treated with tirzepatide vs those treated with placebo had HbA 1c less than 7% (85%-90% vs 34%; P < .001 for all). The most common treatment-emergent adverse events in the tirzepatide groups vs placebo group were diarrhea (12%-21% vs 10%) and nausea (13%-18% vs 3%).CONCLUSIONS AND RELEVANCE Among patients with type 2 diabetes and inadequate glycemic control despite treatment with insulin glargine, the addition of subcutaneous tirzepatide, compared with placebo, to titrated insulin glargine resulted in statistically significant improvements in glycemic control after 40 weeks.

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Characteristics Associated with the Choice of First Injectable Therapy Among US Patients With Type 2 Diabetes

Cited by 15 publications

References 25 publications

Relative contribution of basal and postprandial hyperglycaemia stratified by HbA1c categories before and after treatment intensification with dulaglutide

Relative contribution of basal and postprandial hyperglycaemia stratified by HbA1c categories before and after treatment intensification with dulaglutide

The impact of phenotype, ethnicity and genotype on progression of type 2 diabetes mellitus

Effect of Subcutaneous Tirzepatide vs Placebo Added to Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes

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