Mealtime 50/50 basal + prandial insulin analogue mixture with a basal insulin analogue, both plus metformin, in the achievement of target HbA1c and pre- and postprandial blood glucose levels in patients with type 2 diabetes: A multinational, 24-week, randomized, open-label, parallel-group comparison

David C. Robbins, Paul J. Beisswenger, Antonio Ceriello, Ronald B. Goldberg, Robert G. Moses, Emmanuil M. Pagkalos, Zvonko Milicevic, Cate A. Jones, Samiha Sarwat, Meng H. Tan

Research output: Contribution to journalArticle

Abstract

Background: In people without diabetes, ∼50% of daily insulin secretion is basal and the remainder is postprandial. Hence, it would be expected that insulin replacement therapy in a 50/50 ratio with each meal would mimic physiologic insulin secretion better than treatment with once-daily basal insulin in patients with diabetes mellitus. Using lispro mix (LM) 50/50 before meals may be a logical approach to achieving glycemic targets (glycosylated hemoglobin [HbAlc] and pre- and postprandial blood glucose [BG] concentrations) in these patients. Objective: The aim of this study was to test the hypothesis that treatment with a premixed insulin analogue containing 50/50 basal + prandial insulins administered before each meal would achieve lower overall and mealtime glycemic control than once-daily basal insulin analogue, both plus metformin (Met), in patients with type 2 diabetes mellitus. Methods: This 24-week, randomized, open-label, parallel-group trial was conducted at 38 sites across Australia, Greece, India, The Netherlands, Poland, Puerto Rico, and the United States. Male and female patients aged 35 to 75 years with type 2 diabetes mellitus and an HbA1c level of 6.5% to 11.0%, who were receiving metformin and/or a sulfonylurea with a stable dose of 0 to 2 daily insulin injections over the previous 3 months were eligible. Patients were randomly assigned to receive LM50/50 (50% insulin lispro protamine suspension [ILPS] and 50% lispro) TID plus metformin (to a maximally tolerated daily dosage of 500-1000 mg BID) (LM50/50 + Met) or insulin glar-gine QD at bedtime plus metformin (500-1000 mg BID) (G + Met) for 24 weeks. With LM50/50 + Met, the insulin dose was titrated to target a fasting BG (FBG) level of

Original languageEnglish
Pages (from-to)2349-2364
Number of pages16
JournalClinical Therapeutics
Volume29
Issue number11
DOIs
Publication statusPublished - Nov 2007

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Biphasic Insulins
Metformin
Type 2 Diabetes Mellitus
Meals
Blood Glucose
Insulin
Insulin Lispro
Insulins
glycosylated pre-hemoglobin A
Puerto Rico
Protamines
Greece
Glycosylated Hemoglobin A
Poland
Netherlands
India
Fasting
Suspensions
Diabetes Mellitus
Therapeutics

ASJC Scopus subject areas

  • Pharmacology

Cite this

Mealtime 50/50 basal + prandial insulin analogue mixture with a basal insulin analogue, both plus metformin, in the achievement of target HbA1c and pre- and postprandial blood glucose levels in patients with type 2 diabetes : A multinational, 24-week, randomized, open-label, parallel-group comparison. / Robbins, David C.; Beisswenger, Paul J.; Ceriello, Antonio; Goldberg, Ronald B.; Moses, Robert G.; Pagkalos, Emmanuil M.; Milicevic, Zvonko; Jones, Cate A.; Sarwat, Samiha; Tan, Meng H.

In: Clinical Therapeutics, Vol. 29, No. 11, 11.2007, p. 2349-2364.

Research output: Contribution to journalArticle

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title = "Mealtime 50/50 basal + prandial insulin analogue mixture with a basal insulin analogue, both plus metformin, in the achievement of target HbA1c and pre- and postprandial blood glucose levels in patients with type 2 diabetes: A multinational, 24-week, randomized, open-label, parallel-group comparison",
abstract = "Background: In people without diabetes, ∼50{\%} of daily insulin secretion is basal and the remainder is postprandial. Hence, it would be expected that insulin replacement therapy in a 50/50 ratio with each meal would mimic physiologic insulin secretion better than treatment with once-daily basal insulin in patients with diabetes mellitus. Using lispro mix (LM) 50/50 before meals may be a logical approach to achieving glycemic targets (glycosylated hemoglobin [HbAlc] and pre- and postprandial blood glucose [BG] concentrations) in these patients. Objective: The aim of this study was to test the hypothesis that treatment with a premixed insulin analogue containing 50/50 basal + prandial insulins administered before each meal would achieve lower overall and mealtime glycemic control than once-daily basal insulin analogue, both plus metformin (Met), in patients with type 2 diabetes mellitus. Methods: This 24-week, randomized, open-label, parallel-group trial was conducted at 38 sites across Australia, Greece, India, The Netherlands, Poland, Puerto Rico, and the United States. Male and female patients aged 35 to 75 years with type 2 diabetes mellitus and an HbA1c level of 6.5{\%} to 11.0{\%}, who were receiving metformin and/or a sulfonylurea with a stable dose of 0 to 2 daily insulin injections over the previous 3 months were eligible. Patients were randomly assigned to receive LM50/50 (50{\%} insulin lispro protamine suspension [ILPS] and 50{\%} lispro) TID plus metformin (to a maximally tolerated daily dosage of 500-1000 mg BID) (LM50/50 + Met) or insulin glar-gine QD at bedtime plus metformin (500-1000 mg BID) (G + Met) for 24 weeks. With LM50/50 + Met, the insulin dose was titrated to target a fasting BG (FBG) level of",
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T1 - Mealtime 50/50 basal + prandial insulin analogue mixture with a basal insulin analogue, both plus metformin, in the achievement of target HbA1c and pre- and postprandial blood glucose levels in patients with type 2 diabetes

T2 - A multinational, 24-week, randomized, open-label, parallel-group comparison

AU - Robbins, David C.

AU - Beisswenger, Paul J.

AU - Ceriello, Antonio

AU - Goldberg, Ronald B.

AU - Moses, Robert G.

AU - Pagkalos, Emmanuil M.

AU - Milicevic, Zvonko

AU - Jones, Cate A.

AU - Sarwat, Samiha

AU - Tan, Meng H.

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