Initiating Insulin Therapy in Type 2 Diabetes
Abstract
OBJECTIVE—Safety and efficacy of biphasic insulin aspart 70/30 (BIAsp 70/30, prebreakfast and presupper) were compared with once-daily insulin glargine in type 2 diabetic subjects inadequately controlled on oral antidiabetic drugs (OADs). RESEARCH DESIGN AND METHODS—This 28-week parallel-group study randomized 233 insulin-naive patients with HbA1c values ≥8.0% on >1,000 mg/day metformin alone or in combination with other OADs. Metformin was adjusted up to 2,550 mg/day before insulin therapy was initiated with 5–6 units BIAsp 70/30 twice daily or 10–12 units glargine at bedtime and titrated to target blood glucose (80–110 mg/dl) by algorithm-directed titration. RESULTS—A total of 209 subjects completed the study. At study end, the mean HbA1c value was lower in the BIAsp 70/30 group than in the glargine group (6.91 ± 1.17 vs. 7.41 ± 1.24%, P < 0.01). The HbA1c reduction was greater in the BIAsp 70/30 group than in the glargine group (−2.79 ± 0.11 vs. −2.36 ± 0.11%, respectively; P < 0.01), especially for subjects with baseline HbA1c >8.5% (−3.13 ± 1.63 vs. −2.60 ± 1.50%, respectively; P < 0.05). More BIAsp 70/30–treated subjects reached target HbA1c values than glargine-treated subjects (HbA1c ≤6.5%: 42 vs. 28%, P < 0.05; HbA1c <7.0%: 66 vs. 40%, P < 0.001). Minor hypoglycemia (episodes/year) was greater in the BIAsp 70/30 group than in the glargine group (3.4 ± 6.6 and 0.7 ± 2.0, respectively; P < 0.05). Weight gain and daily insulin dose at study end were greater for BIAsp 70/30–treated subjects than for glargine-treated subjects (weight gain: 5.4 ± 4.8 vs. 3.5 ± 4.5 kg, P < 0.01; insulin dose: 78.5 ± 39.5 and 51.3 ± 26.7 units/day, respectively). CONCLUSIONS—In subjects with type 2 diabetes poorly controlled on OADs, initiating insulin therapy with twice-daily BIAsp 70/30 was more effective in achieving HbA1c targets than once-daily glargine, especially in subjects with HbA1c >8.5%.
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The very rapid-acting and long-acting insulin analogues have not been shown to lower A1C levels more effectively than the older, rapid-acting or intermediate-acting formulations.
“The very rapid-acting and long-acting insulin analogues have not been shown to lower A1C levels more effectively than the older, rapid-acting or intermediate-acting formulations (71–73).”
From Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy (2009) · cites this paper as [72]
Glargine was also associated with a lower frequency of hypoglycemia than premixed insulins.
“Glargine was also associated with a lower frequency of hypoglycemia than premixed insulins (136,137).”
From Hypoglycemia in Type 2 Diabetes (2005) · cites this paper as [137]
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- Authors
- Raskin, P., Allen, E., Hollander, P., Lewin, A., Gabbay, R. A., Hu, P., Bode, B., Garber, A., & for the INITIATE Study Group
- Affiliations
- The University of Texas Southwestern Medical Center (US)
- Princeton University (US)
- Baylor University Medical Center (US)
- National Research Institute (US)
- Pennsylvania State University (US)
- Atlanta Diabetes Association, Atlanta, Georgia
- Baylor College of Medicine (US)
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2005-02-01
- Volume
- 28
- Issue
- 2
- Pages
- 260-265
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W2114369760
- Cited by
- 560
- References
- 20
- Citations by year
- 2026: 2 · 2025: 1 · 2024: 3 · 2023: 3 · 2022: 6 · 2021: 3 · 2020: 11 · 2019: 8 · 2018: 9 · 2017: 10 · 2016: 13 · 2015: 10 · 2014: 23 · 2013: 38 · 2012: 24
- FWCI
- 50.15
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Novo Nordisk
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- type 2 diabetes, insulin initiation, insulin glargine, multiple daily insulin injections, metformin, inadequate glycemic control, HbA1c reduction, hypoglycemia, insulin dose adjustment, oral antidiabetic drugs, insulin-naive patients, glycemic control
- MeSH terms
- Insulin Glargine, Adult, Blood Glucose, Body Weight, Diabetes Mellitus, Type 2, Drug Therapy, Combination, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Male, Metformin, Middle Aged, Treatment Outcome, Insulin, Long-Acting, Insulin Aspart
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