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A Randomized Controlled Trial Comparing Efficacy and Safety of Insulin Glargine 300 Units/mL Versus 100 Units/mL in Older People With Type 2 Diabetes: Results From the SENIOR Study.
- Source :
-
Diabetes care [Diabetes Care] 2018 Aug; Vol. 41 (8), pp. 1672-1680. Date of Electronic Publication: 2018 Jun 12. - Publication Year :
- 2018
-
Abstract
- Objective: SENIOR compared the efficacy and safety of insulin glargine 300 units/mL (Gla-300) with glargine 100 units/mL (Gla-100) in older people (≥65 years old) with type 2 diabetes.<br />Research Design and Methods: SENIOR was an open-label, two-arm, parallel-group, multicenter phase 3b trial designed to enroll ∼20% of participants aged ≥75 years. Participants were randomized 1:1 to Gla-300 or Gla-100, titrated to a fasting self-monitored plasma glucose of 5.0-7.2 mmol/L (90-130 mg/dL).<br />Results: In total, 1,014 participants were randomized (mean age: 71 years). Comparable reductions in HbA <subscript>1c</subscript> were observed from baseline to week 26 for Gla-300 (-0.89%) and Gla-100 (-0.91%) in the overall population (least squares mean difference: 0.02% [95% CI -0.092 to 0.129]) and for participants aged ≥75 years (-0.11% [-0.330 to 0.106]). Incidence and rates of confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycemia events were low and similar between both treatment groups, with lower rates of documented symptomatic hypoglycemia with Gla-300. The lower risk of hypoglycemia with Gla-300 versus Gla-100 was more apparent in the subgroup aged ≥75 years versus the overall population. Significantly lower annualized rates of documented symptomatic (≤3.9 mmol/L [≤70 mg/dL]) hypoglycemia were observed (Gla-300: 1.12; Gla-100: 2.71; rate ratio: 0.45 [95% CI 0.25-0.83]).<br />Conclusions: Efficacy and safety of Gla-300 was demonstrated in older people (≥65 years of age) with type 2 diabetes, with comparable reductions in HbA <subscript>1c</subscript> and similarly low or lower risk of documented symptomatic hypoglycemia versus Gla-100. A significant benefit in hypoglycemia reduction was seen in participants aged ≥75 years.<br /> (© 2018 by the American Diabetes Association.)
- Subjects :
- Aged
Aged, 80 and over
Aging blood
Aging drug effects
Blood Glucose drug effects
Blood Glucose metabolism
Diabetes Mellitus, Type 2 blood
Diabetes Mellitus, Type 2 epidemiology
Dose-Response Relationship, Drug
Fasting blood
Female
Glycated Hemoglobin analysis
Glycated Hemoglobin drug effects
Humans
Hypoglycemia blood
Hypoglycemia epidemiology
Incidence
Male
Treatment Outcome
Diabetes Mellitus, Type 2 drug therapy
Hypoglycemic Agents administration & dosage
Hypoglycemic Agents adverse effects
Insulin Glargine administration & dosage
Insulin Glargine adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1935-5548
- Volume :
- 41
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- Diabetes care
- Publication Type :
- Academic Journal
- Accession number :
- 29895556
- Full Text :
- https://doi.org/10.2337/dc18-0168