A 16-week comparison of the novel insulin analog insulin glargine (HOE 901) and NPH human insulin used with insulin lispro in patients with type 1 diabetes.
Open accessAbstract
OBJECTIVE: To determine the safety and efficacy of the long-acting insulin analog, insulin glargine, as a component of basal bolus therapy in patients with type 1 diabetes. RESEARCH DESIGN AND METHODS: Patients with type 1 diabetes receiving basal-bolus insulin treatment with NPH human insulin and insulin lispro were randomized to receive insulin glargine (HOE 901), a long-acting basal insulin analog, once a day (n = 310) or NPH human insulin (n = 309) as basal treatment with continued bolus insulin lispro for 16 weeks in an open-label study NPH insulin patients maintained their prior schedule of administration once or twice a day, whereas insulin glargine patients received basal insulin once a day at bedtime. RESULTS: Compared with all NPH insulin patients, insulin glargine patients had significant decreases in fasting blood glucose measured at home (means +/- SEM, -42.0 +/- 4.7 vs. -12.4 +/- 4.7 mg/dl [-2.33 +/- 0.26 vs. -0.69 +/- 0.26 mmol/l]; P = 0.0001). These differences were evident early and persisted throughout the study More patients in the insulin glargine group (29.6%) than in the NPH group (16.8%) reached a target fasting blood glucose of 119 mg/dl (< 6.6 mmol/l). However, there were no differences between the groups with respect to change in GHb. Insulin glargine treatment was also associated with a significant decrease in the variability of fasting blood glucose values (P = 0.0124). No differences in the occurrence of symptomatic hypoglycemia, including nocturnal hypoglycemia, were observed. Overall, adverse events were similar in the two treatment groups with the exception of injection site pain, which was more common in the insulin glargine group (6.1%) than in the NPH group (0.3%). Weight gain was 0.12 kg in insulin glargine patients and 0.54 kg in NPH insulin patients (P = 0.034). CONCLUSIONS: Basal insulin therapy with insulin glargine once a day appears to be as safe and at least as effective as using NPH insulin once or twice a day in maintaining glycemic control in patients with type 1 diabetes receiving basal-bolus insulin treatment with insulin lispro.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Physiologic regimens using basal insulin analogs may reduce hypoglycemia, and bolus insulin analogs may improve postprandial glucose excursions for most people with type 1 diabetes.
“Several trials have demonstrated that physiologic regimens using basal insulin analogs may reduce hypoglycemia, and bolus insulin analogs may result in better control of PPG excursions for most persons with T1D.1132–1137”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [1134]
The Safety discussion (p. 5) reports that an earlier glargine study found less severe and nocturnal hypoglycemia, but this trial found no significant difference from NPH insulin. The study used premeal insulin lispro for postprandial control (p. 1); it did not compare bolus insulins or demonstrate better postprandial glucose excursions for most people with type 1 diabetes. (LLM, conf=0.85)
Experimental — accuracy not yet measuredThe benefits of insulin analogs were first shown when first-generation analogs were compared with NPH insulin.
“These effects were demonstrated initially when comparing first-generation insulin analogs to NPH insulin.1132,1134,1138,1139”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [1134]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
The citation lists haven’t been fetched yet
References 7 · Cited by 250
- Authors
- Raskin, P., Klaff, L., Bergenstal, R., Hallé, J. P., Donley, D., & Mecca, T.
- Affiliations
- The University of Texas Southwestern Medical Center (US)
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2000-11-01
- Volume
- 23
- Issue
- 11
- Pages
- 1666-1671
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W2160880263
- Cited by
- 250
- References
- 7
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 1 · 2023: 2 · 2022: 7 · 2021: 3 · 2020: 1 · 2019: 1 · 2018: 5 · 2017: 7 · 2016: 2 · 2015: 8 · 2014: 5 · 2013: 7 · 2012: 2
- FWCI
- 14.05
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Keywords
- insulin glargine, NPH insulin, type 1 diabetes, multiple daily insulin injections, long-acting insulin analogues, fasting blood glucose, glycemic variability, HbA1c, hypoglycemia, weight gain, injection site pain, insulin dosing frequency, home blood glucose monitoring, comparative efficacy and safety, adverse events
- MeSH terms
- Insulin Glargine, Adult, Blood Glucose, C-Peptide, Diabetes Mellitus, Type 1, Drug Administration Schedule, Drug Therapy, Combination, Ethnicity, Fasting, Female, Humans, Hypoglycemia, Insulin, Insulin, Isophane, Male, United States, Insulin, Long-Acting, Insulin Lispro
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
