Characteristics of insulin-Naïve people with type 2 diabetes who successfully respond to insulin glargine U100 after 24 weeks of treatment: a meta-analysis of individual participant data from 3 randomized clinical trials
Abstract Background To identify baseline/clinical characteristics associated with clinically meaningful responses to insulin glargine 100 U/mL (IGlar) in insulin-naive people with type 2 diabetes mellitus (T2DM). Methods Individual participant data were pooled from 3 randomized trials to compare bas...
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| Format: | Article |
| Language: | English |
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BMC
2018-05-01
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| Series: | Clinical Diabetes and Endocrinology |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s40842-018-0059-2 |
| _version_ | 1818215979319033856 |
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| author | M. H. Cummings D. Cao I. Hadjiyianni L. L. Ilag M. H. Tan |
| author_facet | M. H. Cummings D. Cao I. Hadjiyianni L. L. Ilag M. H. Tan |
| author_sort | M. H. Cummings |
| collection | DOAJ |
| description | Abstract Background To identify baseline/clinical characteristics associated with clinically meaningful responses to insulin glargine 100 U/mL (IGlar) in insulin-naive people with type 2 diabetes mellitus (T2DM). Methods Individual participant data were pooled from 3 randomized trials to compare baseline characteristics and clinical outcomes associated with 24-week response to IGlar in combination with non-insulin antihyperglycemic agents in participants with T2DM. Responders were defined as achieving endpoint HbA1c target < 53 mmol/mol (< 7%) and/or ≥ 11 mmol/mol (≥ 1%) HbA1c reduction from baseline. Results Differences in baseline characteristics for responders versus nonresponders were higher HbA1c (99 vs 91 mmol/mol [9.1 vs 8.3%]; P < 0.001), higher fasting blood glucose (FBG; 10.4 vs 8.8 mmol/L [187 vs 159 mg/dL; P < 0.001), and fewer participants (94% vs 98%; P = 0.006) taking oral medications targeting postprandial blood glucose (BG). Most participants (80%) achieved one or both components of composite endpoint. 12-week response was a strong predictor of subsequent 24-week response (sensitivity, 85.9%; predictive positive value, 91.4%). At both 12 and 24 weeks, < 40% of responders and nonresponders reached target FBG ≤ 5.6 mmol/L (≤ 100 mg/dL). Responders at 24 weeks had higher incidence of hypoglycemia (total, 82.5% vs 70.4%; P < 0.001; nocturnal, 60.3% vs 50.5%; P = 0.002; documented symptomatic, 65.8% vs 55.6%; P < 0.001) than nonresponders. Conclusions Baseline characteristics associated with response were identified. The strong predictability of 12-week response suggests that the magnitude of early HbA1c reduction should be considered when assessing response to IGlar. More aggressive IGlar titration may be reasonable for nonresponders and responders who have not reached FBG and HbA1c targets, taking into account other BG timepoints. |
| first_indexed | 2024-12-12T06:44:41Z |
| format | Article |
| id | doaj.art-9cd60482c4244802858625681dbc1178 |
| institution | Directory Open Access Journal |
| issn | 2055-8260 |
| language | English |
| last_indexed | 2024-12-12T06:44:41Z |
| publishDate | 2018-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Clinical Diabetes and Endocrinology |
| spelling | doaj.art-9cd60482c4244802858625681dbc11782022-12-22T00:34:13ZengBMCClinical Diabetes and Endocrinology2055-82602018-05-014111110.1186/s40842-018-0059-2Characteristics of insulin-Naïve people with type 2 diabetes who successfully respond to insulin glargine U100 after 24 weeks of treatment: a meta-analysis of individual participant data from 3 randomized clinical trialsM. H. Cummings0D. Cao1I. Hadjiyianni2L. L. Ilag3M. H. Tan4Queen Alexandra HospitalEli Lilly and CompanyLilly Deutschland GmbHEli Lilly and CompanyUniversity of MichiganAbstract Background To identify baseline/clinical characteristics associated with clinically meaningful responses to insulin glargine 100 U/mL (IGlar) in insulin-naive people with type 2 diabetes mellitus (T2DM). Methods Individual participant data were pooled from 3 randomized trials to compare baseline characteristics and clinical outcomes associated with 24-week response to IGlar in combination with non-insulin antihyperglycemic agents in participants with T2DM. Responders were defined as achieving endpoint HbA1c target < 53 mmol/mol (< 7%) and/or ≥ 11 mmol/mol (≥ 1%) HbA1c reduction from baseline. Results Differences in baseline characteristics for responders versus nonresponders were higher HbA1c (99 vs 91 mmol/mol [9.1 vs 8.3%]; P < 0.001), higher fasting blood glucose (FBG; 10.4 vs 8.8 mmol/L [187 vs 159 mg/dL; P < 0.001), and fewer participants (94% vs 98%; P = 0.006) taking oral medications targeting postprandial blood glucose (BG). Most participants (80%) achieved one or both components of composite endpoint. 12-week response was a strong predictor of subsequent 24-week response (sensitivity, 85.9%; predictive positive value, 91.4%). At both 12 and 24 weeks, < 40% of responders and nonresponders reached target FBG ≤ 5.6 mmol/L (≤ 100 mg/dL). Responders at 24 weeks had higher incidence of hypoglycemia (total, 82.5% vs 70.4%; P < 0.001; nocturnal, 60.3% vs 50.5%; P = 0.002; documented symptomatic, 65.8% vs 55.6%; P < 0.001) than nonresponders. Conclusions Baseline characteristics associated with response were identified. The strong predictability of 12-week response suggests that the magnitude of early HbA1c reduction should be considered when assessing response to IGlar. More aggressive IGlar titration may be reasonable for nonresponders and responders who have not reached FBG and HbA1c targets, taking into account other BG timepoints.http://link.springer.com/article/10.1186/s40842-018-0059-2Type 2 diabetesInsulin glargineInsulin naïveRespondersHbA1c composite endpointBaseline characteristics |
| spellingShingle | M. H. Cummings D. Cao I. Hadjiyianni L. L. Ilag M. H. Tan Characteristics of insulin-Naïve people with type 2 diabetes who successfully respond to insulin glargine U100 after 24 weeks of treatment: a meta-analysis of individual participant data from 3 randomized clinical trials Clinical Diabetes and Endocrinology Type 2 diabetes Insulin glargine Insulin naïve Responders HbA1c composite endpoint Baseline characteristics |
| title | Characteristics of insulin-Naïve people with type 2 diabetes who successfully respond to insulin glargine U100 after 24 weeks of treatment: a meta-analysis of individual participant data from 3 randomized clinical trials |
| title_full | Characteristics of insulin-Naïve people with type 2 diabetes who successfully respond to insulin glargine U100 after 24 weeks of treatment: a meta-analysis of individual participant data from 3 randomized clinical trials |
| title_fullStr | Characteristics of insulin-Naïve people with type 2 diabetes who successfully respond to insulin glargine U100 after 24 weeks of treatment: a meta-analysis of individual participant data from 3 randomized clinical trials |
| title_full_unstemmed | Characteristics of insulin-Naïve people with type 2 diabetes who successfully respond to insulin glargine U100 after 24 weeks of treatment: a meta-analysis of individual participant data from 3 randomized clinical trials |
| title_short | Characteristics of insulin-Naïve people with type 2 diabetes who successfully respond to insulin glargine U100 after 24 weeks of treatment: a meta-analysis of individual participant data from 3 randomized clinical trials |
| title_sort | characteristics of insulin naive people with type 2 diabetes who successfully respond to insulin glargine u100 after 24 weeks of treatment a meta analysis of individual participant data from 3 randomized clinical trials |
| topic | Type 2 diabetes Insulin glargine Insulin naïve Responders HbA1c composite endpoint Baseline characteristics |
| url | http://link.springer.com/article/10.1186/s40842-018-0059-2 |
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