Association of Patient Profile with Glycemic Control and Hypoglycemia with Insulin Glargine 300 U/mL in Type 2 Diabetes : A Post Hoc Patient-Level Meta-Analysis
AIMS: To examine the association of baseline patient characteristics with study outcomes in people with type 2 diabetes receiving insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL (Gla-100), over a 6-month period.
METHODS: A post hoc patient-level meta-analysis using data from three multicenter, randomized, open-label, parallel-group, phase 3a studies of similar design, in people previously receiving either basal and prandial insulin, basal insulin + oral antihyperglycemic drugs, or no prior insulin (EDITION 1, 2 and 3, respectively). The endpoints, glycated hemoglobin (HbA1c), hypoglycemia, body weight change, and insulin dose were investigated by subgroups: age (< 65 and ≥ 65 years), body mass index (BMI; < 30 and ≥ 30 kg/m2), age at onset (< 40, 40-50, and > 50 years), and diabetes duration (< 10 and ≥ 10 years).
RESULTS: Reduction in HbA1c was comparable between insulins, regardless of subgroup. The lower risk of ≥ 1 nocturnal (00:00-05:59 h) confirmed (≤ 3.9 mmol/L [≤ 70 mg/dL]) or severe hypoglycemic event with Gla-300 versus Gla-100 was also unaffected by participant characteristics. While heterogeneity of treatment effect between diabetes duration subgroups was seen for the risk of ≥ 1 confirmed (≤ 3.9 mmol/L [≤ 70 mg/dL]) or severe hypoglycemic event at any time (24 h), treatment effect consistently favored Gla-300; no evidence of heterogeneity was observed for the other subgroups. Annualized rates of confirmed (≤ 3.9 mmol/L [≤ 70 mg/dL]) or severe hypoglycemia and body weight change were not influenced by participant characteristics; a similar pattern was observed with insulin dose.
CONCLUSIONS: Comparable glycemic control was observed with Gla-300 versus Gla-100, with less hypoglycemia, regardless of age, BMI, age at onset or diabetes duration.
FUNDING: Sanofi. Plain language summary available for this article.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2018 |
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| Erschienen: |
2018 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:9 |
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| Enthalten in: |
Diabetes therapy : research, treatment and education of diabetes and related disorders - 9(2018), 5 vom: 10. Okt., Seite 2043-2053 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Twigg, Stephen M [VerfasserIn] |
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| Links: |
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| Themen: |
Glycated Hemoglobin A |
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| Anmerkungen: |
Date Revised 22.05.2023 published: Print-Electronic Citation Status PubMed-not-MEDLINE |
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| doi: |
10.1007/s13300-018-0498-x |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM288405188 |
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| 100 | 1 | |a Twigg, Stephen M |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Association of Patient Profile with Glycemic Control and Hypoglycemia with Insulin Glargine 300 U/mL in Type 2 Diabetes |b A Post Hoc Patient-Level Meta-Analysis |
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| 500 | |a Date Revised 22.05.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a AIMS: To examine the association of baseline patient characteristics with study outcomes in people with type 2 diabetes receiving insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL (Gla-100), over a 6-month period | ||
| 520 | |a METHODS: A post hoc patient-level meta-analysis using data from three multicenter, randomized, open-label, parallel-group, phase 3a studies of similar design, in people previously receiving either basal and prandial insulin, basal insulin + oral antihyperglycemic drugs, or no prior insulin (EDITION 1, 2 and 3, respectively). The endpoints, glycated hemoglobin (HbA1c), hypoglycemia, body weight change, and insulin dose were investigated by subgroups: age (< 65 and ≥ 65 years), body mass index (BMI; < 30 and ≥ 30 kg/m2), age at onset (< 40, 40-50, and > 50 years), and diabetes duration (< 10 and ≥ 10 years) | ||
| 520 | |a RESULTS: Reduction in HbA1c was comparable between insulins, regardless of subgroup. The lower risk of ≥ 1 nocturnal (00:00-05:59 h) confirmed (≤ 3.9 mmol/L [≤ 70 mg/dL]) or severe hypoglycemic event with Gla-300 versus Gla-100 was also unaffected by participant characteristics. While heterogeneity of treatment effect between diabetes duration subgroups was seen for the risk of ≥ 1 confirmed (≤ 3.9 mmol/L [≤ 70 mg/dL]) or severe hypoglycemic event at any time (24 h), treatment effect consistently favored Gla-300; no evidence of heterogeneity was observed for the other subgroups. Annualized rates of confirmed (≤ 3.9 mmol/L [≤ 70 mg/dL]) or severe hypoglycemia and body weight change were not influenced by participant characteristics; a similar pattern was observed with insulin dose | ||
| 520 | |a CONCLUSIONS: Comparable glycemic control was observed with Gla-300 versus Gla-100, with less hypoglycemia, regardless of age, BMI, age at onset or diabetes duration | ||
| 520 | |a FUNDING: Sanofi. Plain language summary available for this article | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Glycated Hemoglobin A | |
| 650 | 4 | |a Hypoglycemia | |
| 650 | 4 | |a Insulin Glargine | |
| 650 | 4 | |a Type 2 Diabetes | |
| 700 | 1 | |a Escalada, Javier |e verfasserin |4 aut | |
| 700 | 1 | |a Stella, Peter |e verfasserin |4 aut | |
| 700 | 1 | |a Merino-Trigo, Ana |e verfasserin |4 aut | |
| 700 | 1 | |a Lavalle-Gonzalez, Fernando J |e verfasserin |4 aut | |
| 700 | 1 | |a Cariou, Bertrand |e verfasserin |4 aut | |
| 700 | 1 | |a Meneghini, Luigi F |e verfasserin |4 aut | |
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