Comparison of insulin lispro protamine suspension versus insulin glargine once daily added to oral antihyperglycaemic medications and exenatide in type 2 diabetes: a prospective randomized open-label trial.

Arakaki RF, Blevins TC, Wise JK, Liljenquist DR, Jiang HH, Jacobson JG, Martin SA, Jackson JA

Diabetes, obesity & metabolism29 Dec 2013Cited by 11 (Europe PMC)

PMID24298995PMCIDPMC4237556DOI10.1111/dom.12242PepBankPUB-24298995

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study8

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone8

In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Exenatide (exendin-4).

01HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
With background exenatide and OAMs, ILPS met HbA1c noninferiority versus glargine.
In plain wordsWith exenatide and oral medicines, ILPS met the study's HbA1c noninferiority criterion compared with glargine.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableHbA1c noninferiority
Study
n = 339
Comparator
Insulin glargine with OAMs and exenatide
Outcome group
Glycemic control · Metabolic and weight
Measurements
HbA1c least-squares mean between-treatment difference (ILPS minus glargine)
0.22%
ILPS vs glargine
95% CI of HbA1c between-treatment difference
0.06 to 0.38%
ILPS minus glargine
Source sentences
Summary
Non-inferiority of ILPS versus glargine was demonstrated: least-squares mean between-treatment difference (ILPS minus glargine) (95% CI) was 0.22% (0.06, 0.38).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare efficacy and safety of two, once-daily basal insulin formulations [insulin lispro protamine suspension (ILPS) vs. insulin glargine (glargine)] added to oral antihyperglycaemic medications (OAMs) and exenatide BID in suboptimally controlled type 2 diabetes (T2D) patients.
Summary · context
This 24-week, open-label, multicentre trial randomized patients to bedtime ILPS (n = 171) or glargine (n = 168).
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Report a problemFND-2429899501
02HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
With background exenatide and OAMs, ILPS reduced HbA1c less than glargine.
In plain wordsWith exenatide and oral medicines, ILPS lowered HbA1c less than glargine.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c reduction
Study
n = 339
Comparator
Insulin glargine with OAMs and exenatide
Outcome group
Glycemic control · Metabolic and weight
Measurements
HbA1c change
−1.16%
ILPS
HbA1c change
−1.4%
glargine
Source sentences
Summary
Mean HbA1c reduction was less for ILPS- versus glargine-treated patients (-1.16 ± 0.84 vs. -1.40 ± 0.97%, p = 0.008).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare efficacy and safety of two, once-daily basal insulin formulations [insulin lispro protamine suspension (ILPS) vs. insulin glargine (glargine)] added to oral antihyperglycaemic medications (OAMs) and exenatide BID in suboptimally controlled type 2 diabetes (T2D) patients.
Summary · context
This 24-week, open-label, multicentre trial randomized patients to bedtime ILPS (n = 171) or glargine (n = 168).
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Report a problemFND-2429899502
03HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
With background exenatide and OAMs, HbA1c target attainment did not differ significantly between ILPS and glargine.
In plain wordsWith exenatide and oral medicines, HbA1c target attainment was similar with ILPS and glargine.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHbA1c below target
Study
n = 339
Comparator
Insulin glargine with OAMs and exenatide
Outcome group
Glycemic control · Metabolic and weight
Measurements
Patients with endpoint HbA1c < 7.0%
53.7%
ILPS
Patients with endpoint HbA1c < 7.0%
61.7%
glargine
Source sentences
Summary
Endpoint HbA1c < 7.0% was achieved by 53.7% (ILPS) and 61.7% (glargine) (p = NS).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare efficacy and safety of two, once-daily basal insulin formulations [insulin lispro protamine suspension (ILPS) vs. insulin glargine (glargine)] added to oral antihyperglycaemic medications (OAMs) and exenatide BID in suboptimally controlled type 2 diabetes (T2D) patients.
Summary · context
This 24-week, open-label, multicentre trial randomized patients to bedtime ILPS (n = 171) or glargine (n = 168).
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Report a problemFND-2429899503
04HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialSafety outcome
With background exenatide and OAMs, overall hypoglycaemia rates were similar with ILPS and glargine.
In plain wordsWith exenatide and oral medicines, overall low blood sugar rates were similar with ILPS and glargine.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeOverall hypoglycaemia
Study
n = 339
Comparator
Insulin glargine with OAMs and exenatide
Outcome group
Adverse events · Metabolic and weight
Source sentences
Summary
Overall hypoglycaemia rates (p = NS) and severe hypoglycaemia incidence (p = NS) were similar.
2 context sentences(design, population, supporting numbers)
Summary · context
To compare efficacy and safety of two, once-daily basal insulin formulations [insulin lispro protamine suspension (ILPS) vs. insulin glargine (glargine)] added to oral antihyperglycaemic medications (OAMs) and exenatide BID in suboptimally controlled type 2 diabetes (T2D) patients.
Summary · context
This 24-week, open-label, multicentre trial randomized patients to bedtime ILPS (n = 171) or glargine (n = 168).
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Report a problemFND-2429899504
05HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialSafety outcome
With background exenatide and OAMs, severe hypoglycaemia incidence was similar with ILPS and glargine.
In plain wordsWith exenatide and oral medicines, severe low blood sugar incidence was similar with ILPS and glargine.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeSevere hypoglycaemia
Study
n = 339
Comparator
Insulin glargine with OAMs and exenatide
Outcome group
Adverse events · Metabolic and weight
Source sentences
Summary
Overall hypoglycaemia rates (p = NS) and severe hypoglycaemia incidence (p = NS) were similar.
2 context sentences(design, population, supporting numbers)
Summary · context
To compare efficacy and safety of two, once-daily basal insulin formulations [insulin lispro protamine suspension (ILPS) vs. insulin glargine (glargine)] added to oral antihyperglycaemic medications (OAMs) and exenatide BID in suboptimally controlled type 2 diabetes (T2D) patients.
Summary · context
This 24-week, open-label, multicentre trial randomized patients to bedtime ILPS (n = 171) or glargine (n = 168).
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Report a problemFND-2429899505
06HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialSafety outcome
With background exenatide and OAMs, nocturnal hypoglycaemia was higher with ILPS than glargine.
In plain wordsWith exenatide and oral medicines, nighttime low blood sugar was more frequent with ILPS than glargine.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseNocturnal hypoglycaemia
Study
n = 339
Comparator
Insulin glargine with OAMs and exenatide
Outcome group
Adverse events · Metabolic and weight
Source sentences
Summary
Nocturnal hypoglycaemia rate was higher in patients treated with ILPS versus glargine (p = 0.004).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare efficacy and safety of two, once-daily basal insulin formulations [insulin lispro protamine suspension (ILPS) vs. insulin glargine (glargine)] added to oral antihyperglycaemic medications (OAMs) and exenatide BID in suboptimally controlled type 2 diabetes (T2D) patients.
Summary · context
This 24-week, open-label, multicentre trial randomized patients to bedtime ILPS (n = 171) or glargine (n = 168).
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Report a problemFND-2429899506
07HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
With background exenatide and OAMs, weight gain was similar with ILPS and glargine.
In plain wordsWith exenatide and oral medicines, weight gain was similar with ILPS and glargine.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeWeight gain
Study
n = 339
Comparator
Insulin glargine with OAMs and exenatide
Outcome group
Body weight · Metabolic and weight
Measurements
Weight gain
0.27 kg
ILPS
Weight gain
0.66 kg
glargine
Source sentences
Summary
Weight gain was similar between groups (ILPS: 0.27 ± 3.38 kg; glargine: 0.66 ± 3.93 kg, p = NS).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare efficacy and safety of two, once-daily basal insulin formulations [insulin lispro protamine suspension (ILPS) vs. insulin glargine (glargine)] added to oral antihyperglycaemic medications (OAMs) and exenatide BID in suboptimally controlled type 2 diabetes (T2D) patients.
Summary · context
This 24-week, open-label, multicentre trial randomized patients to bedtime ILPS (n = 171) or glargine (n = 168).
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Report a problemFND-2429899507
08HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
With background exenatide and OAMs, endpoint total insulin dose was lower with ILPS than glargine.
In plain wordsWith exenatide and oral medicines, final insulin doses were lower with ILPS than glargine.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseTotal insulin dose
Study
n = 339
Comparator
Insulin glargine with OAMs and exenatide
Outcome group
Glycemic control · Metabolic and weight
Measurements
Endpoint total insulin dose
0.3 IU/kg/day
ILPS
Endpoint total insulin dose
0.37 IU/kg/day
glargine
Source sentences
Summary
Endpoint total insulin doses were lower in patients treated with ILPS versus glargine (0.30 ± 0.17 vs. 0.37 ± 0.17 IU/kg/day, p < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
To compare efficacy and safety of two, once-daily basal insulin formulations [insulin lispro protamine suspension (ILPS) vs. insulin glargine (glargine)] added to oral antihyperglycaemic medications (OAMs) and exenatide BID in suboptimally controlled type 2 diabetes (T2D) patients.
Summary · context
This 24-week, open-label, multicentre trial randomized patients to bedtime ILPS (n = 171) or glargine (n = 168).
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Report a problemFND-2429899508

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Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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Comparison of insulin lispro protamine suspension versus insulin glargine once daily added to oral antihyperglycaemic medications and exenatide in type 2 diabetes: a prospective randomized open-label trial.

Summary

Results from this study8

Studies that did not test the peptide alone8

Version history

Subjects

Publication types

MeSH terms

Keywords