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Combination of oral antidiabetic agents with basal insulin versus premixed insulin alone in randomized elderly patients with type 2 diabetes mellitus.
J Am Geriatr Soc 2007; 55(2):182-8JA

Abstract

OBJECTIVES

To compare initiation of insulin therapy by adding once-daily insulin glargine to oral antidiabetic agents (OADs) with switching patients to premixed 30% regular, 70% human neutral protamine hagedorn insulin (70/30) without OADs.

DESIGN

A 24-week, multicenter, open, randomized (1:1), parallel study.

SETTING

Three hundred sixty-four poorly controlled patients with type 2 diabetes mellitus were treated with once-daily morning insulin glargine with continued OADs (glimepiride+metformin) (glargine+OAD) or twice-daily 70/30 alone. Insulin dosage in each group was titrated to target fasting blood glucose (FBG) of 100 mg/dL or less (<or=5.6 mmol/L) using a weekly titration algorithm.

PARTICIPANTS

This planned subgroup analysis of the original study was based on 130 insulin-naive patients aged 65 and older with FBG of 120 mg/dL or greater (>or=6.7 mmol/L) and hemoglobin (Hb)A(1c) levels between 7.5% and 10.5% on OADs (glargine+OAD, n=67; 70/30, n=63).

MEASUREMENTS

HbA(1c), FBG, hypoglycemia, insulin dose, and adverse events were recorded.

RESULTS

HbA(1c) decreased from baseline to endpoint for both glargine+OAD (from 8.8% to 7.0%) and 70/30 (from 8.9% to 7.4%); adjusted mean HbA(1c) decrease for glargine+OAD and 70/30 was -1.9% and -1.4%, respectively (P=.003). More patients reached HbA(1c) of 7.0% or less without confirmed nocturnal hypoglycemia with glargine+OAD (n=37, 55.2%) than with 70/30 (n=19, 30.2%) (P=.006). FBG decreased significantly more with glargine+OAD (-57 mg/dL (-3.2 mmol/L)) than with 70/30 (-40 mg/dL (-2.2 mmol/L)) (P=.002). Patients treated with glargine+OAD experienced fewer episodes of any hypoglycemia (3.68/patient-year) than did those treated with 70/30 (9.09/patient-year) (P=.008).

CONCLUSION

In elderly patients, addition of once-daily morning glargine+OAD is a simple regimen to initiate insulin therapy, restoring glycemic control more effectively and with less hypoglycemia than twice-daily 70/30 alone.

Authors+Show Affiliations

Klinikum Bremen-Nord, Bremen, Germany. Hans.Janka@klinikum-bremen-nord.deNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17302653

Citation

Janka, Hans U., et al. "Combination of Oral Antidiabetic Agents With Basal Insulin Versus Premixed Insulin Alone in Randomized Elderly Patients With Type 2 Diabetes Mellitus." Journal of the American Geriatrics Society, vol. 55, no. 2, 2007, pp. 182-8.
Janka HU, Plewe G, Busch K. Combination of oral antidiabetic agents with basal insulin versus premixed insulin alone in randomized elderly patients with type 2 diabetes mellitus. J Am Geriatr Soc. 2007;55(2):182-8.
Janka, H. U., Plewe, G., & Busch, K. (2007). Combination of oral antidiabetic agents with basal insulin versus premixed insulin alone in randomized elderly patients with type 2 diabetes mellitus. Journal of the American Geriatrics Society, 55(2), pp. 182-8.
Janka HU, Plewe G, Busch K. Combination of Oral Antidiabetic Agents With Basal Insulin Versus Premixed Insulin Alone in Randomized Elderly Patients With Type 2 Diabetes Mellitus. J Am Geriatr Soc. 2007;55(2):182-8. PubMed PMID: 17302653.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Combination of oral antidiabetic agents with basal insulin versus premixed insulin alone in randomized elderly patients with type 2 diabetes mellitus. AU - Janka,Hans U, AU - Plewe,Gerd, AU - Busch,Klaus, PY - 2007/2/17/pubmed PY - 2007/3/31/medline PY - 2007/2/17/entrez SP - 182 EP - 8 JF - Journal of the American Geriatrics Society JO - J Am Geriatr Soc VL - 55 IS - 2 N2 - OBJECTIVES: To compare initiation of insulin therapy by adding once-daily insulin glargine to oral antidiabetic agents (OADs) with switching patients to premixed 30% regular, 70% human neutral protamine hagedorn insulin (70/30) without OADs. DESIGN: A 24-week, multicenter, open, randomized (1:1), parallel study. SETTING: Three hundred sixty-four poorly controlled patients with type 2 diabetes mellitus were treated with once-daily morning insulin glargine with continued OADs (glimepiride+metformin) (glargine+OAD) or twice-daily 70/30 alone. Insulin dosage in each group was titrated to target fasting blood glucose (FBG) of 100 mg/dL or less (<or=5.6 mmol/L) using a weekly titration algorithm. PARTICIPANTS: This planned subgroup analysis of the original study was based on 130 insulin-naive patients aged 65 and older with FBG of 120 mg/dL or greater (>or=6.7 mmol/L) and hemoglobin (Hb)A(1c) levels between 7.5% and 10.5% on OADs (glargine+OAD, n=67; 70/30, n=63). MEASUREMENTS: HbA(1c), FBG, hypoglycemia, insulin dose, and adverse events were recorded. RESULTS: HbA(1c) decreased from baseline to endpoint for both glargine+OAD (from 8.8% to 7.0%) and 70/30 (from 8.9% to 7.4%); adjusted mean HbA(1c) decrease for glargine+OAD and 70/30 was -1.9% and -1.4%, respectively (P=.003). More patients reached HbA(1c) of 7.0% or less without confirmed nocturnal hypoglycemia with glargine+OAD (n=37, 55.2%) than with 70/30 (n=19, 30.2%) (P=.006). FBG decreased significantly more with glargine+OAD (-57 mg/dL (-3.2 mmol/L)) than with 70/30 (-40 mg/dL (-2.2 mmol/L)) (P=.002). Patients treated with glargine+OAD experienced fewer episodes of any hypoglycemia (3.68/patient-year) than did those treated with 70/30 (9.09/patient-year) (P=.008). CONCLUSION: In elderly patients, addition of once-daily morning glargine+OAD is a simple regimen to initiate insulin therapy, restoring glycemic control more effectively and with less hypoglycemia than twice-daily 70/30 alone. SN - 0002-8614 UR - https://www.unboundmedicine.com/medline/citation/17302653/Combination_of_oral_antidiabetic_agents_with_basal_insulin_versus_premixed_insulin_alone_in_randomized_elderly_patients_with_type_2_diabetes_mellitus_ L2 - https://doi.org/10.1111/j.1532-5415.2007.01043.x DB - PRIME DP - Unbound Medicine ER -