Efficacy and safety profile of exenatide once weekly compared with insulin once daily in Japanese patients with type 2 diabetes treated with oral antidiabetes drug(s): results from a 26-week, randomized, open-label, parallel-group, multicenter, noninferiority study.

Inagaki N, Atsumi Y, Oura T, Saito H, Imaoka T

Clinical therapeutics9 Aug 2012Cited by 72 (Europe PMC)

PMID22884767DOI10.1016/j.clinthera.2012.07.007PepBankPUB-22884767

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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: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In Japanese patients with type 2 diabetes, exenatide was noninferior to insulin glargine for HbA1c change, with a negative between-group difference.
In plain wordsIn Japanese patients with diabetes, exenatide met the noninferiority criterion for blood sugar control compared with insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c change
Study
n = 427
Comparator
insulin glargine
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly · 26 weeksAs given in this study (human).
Measurements
HbA1c least squares mean difference
−0.43%
exenatide versus insulin glargine
Source sentences
Summary
Exenatide QW was statistically noninferior to insulin glargine for the change in HbA(1c) from baseline to end point (least squares mean difference, -0.43% [95% CI, -0.59 to -0.26]; P < 0.001), with the 95% CI upper limit less than the predefined noninferiority margin (0.4%).
1 context sentence(design, population, supporting numbers)
Summary · context
In this open-label, parallel-group, multicenter, noninferiority registration study, patients were randomized (1:1) to add exenatide QW (2 mg) or once-daily insulin glargine (starting dose, 4 U) to their current oral antidiabetes drug treatment.
Report a problemFND-2288476701
02HumanRandomized controlled trialEfficacy outcome
In Japanese patients with type 2 diabetes, exenatide reduced weight compared with insulin glargine.
In plain wordsIn Japanese patients with diabetes, exenatide reduced weight compared with insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseBody weight
Study
n = 427
Comparator
insulin glargine
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg once weekly · 26 weeksAs given in this study (human).
Measurements
Weight least squares mean difference
−2.01 kg
exenatide versus insulin glargine
Source sentences
Summary
Patient weight was reduced with exenatide QW compared with insulin glargine at end point (least squares mean difference, -2.01 kg [95% CI, -2.46 to -1.56]; P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
Secondary analyses (a priori) included analysis of superiority for between-group comparisons of change in weight and the proportion of patients reaching HbA(1c) target levels of ≤7.0% or ≤6.5%.
Summary · context
In this open-label, parallel-group, multicenter, noninferiority registration study, patients were randomized (1:1) to add exenatide QW (2 mg) or once-daily insulin glargine (starting dose, 4 U) to their current oral antidiabetes drug treatment.
Report a problemFND-2288476704
03HumanRandomized controlled trialEfficacy outcome
In Japanese patients with type 2 diabetes, more exenatide than insulin glargine recipients achieved HbA1c at most 6.5%.
In plain wordsIn Japanese patients with diabetes, more exenatide than insulin glargine recipients achieved HbA1c at most 6.5%.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseHbA1c at most 6.5%
Study
n = 426
Comparator
insulin glargine
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly · 26 weeksAs given in this study (human).
Measurements
Responders
20.6%
exenatide
Responders
4.2%
insulin glargine
Source sentences
Summary
A significantly greater proportion of patients receiving exenatide QW compared with insulin glargine achieved HbA(1c) target levels of ≤7.0% (89 of 211 [42.2%] vs 44 of 210 [21.0%]) or ≤6.5% (44 of 214 [20.6%] vs 9 of 212 [4.2%]) at end point (P < 0.001 for both).
2 context sentences(design, population, supporting numbers)
Summary · context
Secondary analyses (a priori) included analysis of superiority for between-group comparisons of change in weight and the proportion of patients reaching HbA(1c) target levels of ≤7.0% or ≤6.5%.
Summary · context
In this open-label, parallel-group, multicenter, noninferiority registration study, patients were randomized (1:1) to add exenatide QW (2 mg) or once-daily insulin glargine (starting dose, 4 U) to their current oral antidiabetes drug treatment.
Report a problemFND-2288476703
04HumanRandomized controlled trialEfficacy outcome
In Japanese patients with type 2 diabetes, more exenatide than insulin glargine recipients achieved HbA1c at most 7.0%.
In plain wordsIn Japanese patients with diabetes, more exenatide than insulin glargine recipients achieved HbA1c at most 7.0%.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseHbA1c at most 7.0%
Study
n = 421
Comparator
insulin glargine
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly · 26 weeksAs given in this study (human).
Measurements
Responders
42.2%
exenatide
Responders
21%
insulin glargine
Source sentences
Summary
A significantly greater proportion of patients receiving exenatide QW compared with insulin glargine achieved HbA(1c) target levels of ≤7.0% (89 of 211 [42.2%] vs 44 of 210 [21.0%]) or ≤6.5% (44 of 214 [20.6%] vs 9 of 212 [4.2%]) at end point (P < 0.001 for both).
2 context sentences(design, population, supporting numbers)
Summary · context
Secondary analyses (a priori) included analysis of superiority for between-group comparisons of change in weight and the proportion of patients reaching HbA(1c) target levels of ≤7.0% or ≤6.5%.
Summary · context
In this open-label, parallel-group, multicenter, noninferiority registration study, patients were randomized (1:1) to add exenatide QW (2 mg) or once-daily insulin glargine (starting dose, 4 U) to their current oral antidiabetes drug treatment.
Report a problemFND-2288476702
05HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes, exenatide had lower hypoglycemia risk than insulin glargine.
In plain wordsIn Japanese patients with diabetes, exenatide had lower low-blood-sugar risk than insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHypoglycemia risk
Study
n = 427
Comparator
insulin glargine
Outcome group
Adverse events · Metabolic and weight
Studied dose
2 mg once weekly · 26 weeksAs given in this study (human).
Source sentences
Summary
Exenatide QW was well tolerated, with a lower risk of hypoglycemia compared with insulin glargine but a higher incidence of injection-site induration.
1 context sentence(design, population, supporting numbers)
Summary · context
In this open-label, parallel-group, multicenter, noninferiority registration study, patients were randomized (1:1) to add exenatide QW (2 mg) or once-daily insulin glargine (starting dose, 4 U) to their current oral antidiabetes drug treatment.
Report a problemFND-2288476705
06HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes, exenatide had higher injection-site induration incidence than insulin glargine.
In plain wordsIn Japanese patients with diabetes, exenatide caused more injection-site hardening than insulin glargine.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseInjection-site induration
Study
n = 427
Comparator
insulin glargine
Outcome group
Adverse events · Skin and wound
Studied dose
2 mg once weekly · 26 weeksAs given in this study (human).
Source sentences
Summary
Exenatide QW was well tolerated, with a lower risk of hypoglycemia compared with insulin glargine but a higher incidence of injection-site induration.
1 context sentence(design, population, supporting numbers)
Summary · context
In this open-label, parallel-group, multicenter, noninferiority registration study, patients were randomized (1:1) to add exenatide QW (2 mg) or once-daily insulin glargine (starting dose, 4 U) to their current oral antidiabetes drug treatment.
Report a problemFND-2288476706

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00935532

Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus

AstraZenecan = 427Jul 2009 to Jul 2011

Type 2 Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 15 Jun 2015

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

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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