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Prandial insulin substitution with insulin lispro or insulin lispro mid mixture vs. basal therapy with insulin glargine: a randomized controlled trial in patients with type 2 diabetes beginning insulin therapy.
J Diabetes Complications. 2006 May-Jun; 20(3):145-52.JD

Abstract

PURPOSE

To compare the effects of prandial insulin therapy focusing on postprandial glucose control vs. basal insulin therapy focusing on fasting glucose control in patients with type 2 diabetes.

METHODS

This was an open-label, randomized, parallel, three-arm multicenter trial in patients with type 2 diabetes starting insulin treatment. Patients (n=159) were randomly assigned to 24-week treatment with 3x daily insulin lispro, 3x daily lispro mid mixture (MidMix; 50% lispro, 50% protaminated lispro), or 1x daily insulin glargine; oral antihyperglycemic agents were discontinued. Primary end point was the postprandial glucose excursion 2 h after breakfast at the end of study. Secondary outcomes included HbA1c, self-monitored blood glucose profiles, hypoglycemic episodes, body weight, and patient satisfaction.

RESULTS

At the end of study, glucose excursions 2 h after breakfast were significantly lower with lispro and MidMix than with glargine (P<.001 for each vs. glargine): lispro, -0.6+/-2.0 mmol/l; MidMix, +0.8+/-2.4 mmol/l; glargine, +2.5+/-2.4 mmol/l. Fasting glucose decreases were significantly greater with glargine (-2.6+/-2.4 mmol/l) than with lispro or MidMix (-0.9+/-2.2 mmol/l; +0.9+/-1.8 mmol/l). Nevertheless, HbA1c decreased by 1.1% (lispro) and 1.2% (MidMix), vs. 0.3% with glargine. Hypoglycemic episodes were rare with 1-1.5 self-reported episodes per 100 patient-days.

CONCLUSIONS

In patients with type 2 diabetes starting insulin, 3x daily prandial treatment with a rapid-acting analog focusing on postprandial glucose values enabled better control of postprandial and circadian blood glucose profiles than once-daily glargine, in spite suboptimal fasting glucose levels, which targets fasting glucose values. These results support studies suggesting that control of postprandial hyperglycemia plays a key role in achieving HbA1c targets.

Authors+Show Affiliations

Lilly Deutschland GmbH, Bad Homburg, Germany. kazda_christof@lilly.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo 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

16632233

Citation

Kazda, Christof, et al. "Prandial Insulin Substitution With Insulin Lispro or Insulin Lispro Mid Mixture Vs. Basal Therapy With Insulin Glargine: a Randomized Controlled Trial in Patients With Type 2 Diabetes Beginning Insulin Therapy." Journal of Diabetes and Its Complications, vol. 20, no. 3, 2006, pp. 145-52.
Kazda C, Hülstrunk H, Helsberg K, et al. Prandial insulin substitution with insulin lispro or insulin lispro mid mixture vs. basal therapy with insulin glargine: a randomized controlled trial in patients with type 2 diabetes beginning insulin therapy. J Diabetes Complicat. 2006;20(3):145-52.
Kazda, C., Hülstrunk, H., Helsberg, K., Langer, F., Forst, T., & Hanefeld, M. (2006). Prandial insulin substitution with insulin lispro or insulin lispro mid mixture vs. basal therapy with insulin glargine: a randomized controlled trial in patients with type 2 diabetes beginning insulin therapy. Journal of Diabetes and Its Complications, 20(3), 145-52.
Kazda C, et al. Prandial Insulin Substitution With Insulin Lispro or Insulin Lispro Mid Mixture Vs. Basal Therapy With Insulin Glargine: a Randomized Controlled Trial in Patients With Type 2 Diabetes Beginning Insulin Therapy. J Diabetes Complicat. 2006;20(3):145-52. PubMed PMID: 16632233.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prandial insulin substitution with insulin lispro or insulin lispro mid mixture vs. basal therapy with insulin glargine: a randomized controlled trial in patients with type 2 diabetes beginning insulin therapy. AU - Kazda,Christof, AU - Hülstrunk,Hiltrud, AU - Helsberg,Karin, AU - Langer,Frank, AU - Forst,Thomas, AU - Hanefeld,Markolf, PY - 2005/04/18/received PY - 2005/09/01/revised PY - 2005/09/19/accepted PY - 2006/4/25/pubmed PY - 2006/11/7/medline PY - 2006/4/25/entrez SP - 145 EP - 52 JF - Journal of diabetes and its complications JO - J. Diabetes Complicat. VL - 20 IS - 3 N2 - PURPOSE: To compare the effects of prandial insulin therapy focusing on postprandial glucose control vs. basal insulin therapy focusing on fasting glucose control in patients with type 2 diabetes. METHODS: This was an open-label, randomized, parallel, three-arm multicenter trial in patients with type 2 diabetes starting insulin treatment. Patients (n=159) were randomly assigned to 24-week treatment with 3x daily insulin lispro, 3x daily lispro mid mixture (MidMix; 50% lispro, 50% protaminated lispro), or 1x daily insulin glargine; oral antihyperglycemic agents were discontinued. Primary end point was the postprandial glucose excursion 2 h after breakfast at the end of study. Secondary outcomes included HbA1c, self-monitored blood glucose profiles, hypoglycemic episodes, body weight, and patient satisfaction. RESULTS: At the end of study, glucose excursions 2 h after breakfast were significantly lower with lispro and MidMix than with glargine (P<.001 for each vs. glargine): lispro, -0.6+/-2.0 mmol/l; MidMix, +0.8+/-2.4 mmol/l; glargine, +2.5+/-2.4 mmol/l. Fasting glucose decreases were significantly greater with glargine (-2.6+/-2.4 mmol/l) than with lispro or MidMix (-0.9+/-2.2 mmol/l; +0.9+/-1.8 mmol/l). Nevertheless, HbA1c decreased by 1.1% (lispro) and 1.2% (MidMix), vs. 0.3% with glargine. Hypoglycemic episodes were rare with 1-1.5 self-reported episodes per 100 patient-days. CONCLUSIONS: In patients with type 2 diabetes starting insulin, 3x daily prandial treatment with a rapid-acting analog focusing on postprandial glucose values enabled better control of postprandial and circadian blood glucose profiles than once-daily glargine, in spite suboptimal fasting glucose levels, which targets fasting glucose values. These results support studies suggesting that control of postprandial hyperglycemia plays a key role in achieving HbA1c targets. SN - 1056-8727 UR - https://www.unboundmedicine.com/medline/citation/16632233/Prandial_insulin_substitution_with_insulin_lispro_or_insulin_lispro_mid_mixture_vs__basal_therapy_with_insulin_glargine:_a_randomized_controlled_trial_in_patients_with_type_2_diabetes_beginning_insulin_therapy_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1056-8727(05)00124-8 DB - PRIME DP - Unbound Medicine ER -