Safety of exenatide once weekly in patients with type 2 diabetes mellitus treated with a thiazolidinedione alone or in combination with metformin for 2 years.

Norwood P, Liutkus JF, Haber H, Pintilei E, Boardman MK, Trautmann ME

Clinical therapeutics29 Sept 2012Cited by 21 (Europe PMC)

PMID23031623DOI10.1016/j.clinthera.2012.09.007PepBankPUB-23031623

Publisher page PubMedAsk about this study

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 study12

12 results from studies that gave the peptide. 12 results from people.

01HumanNon-randomized trialSafety outcome
In patients with type 2 diabetes, nausea occurred in 17% during exenatide treatment.
In plain wordsIn patients with type 2 diabetes, 17% reported nausea during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableNausea
Study
n = 134
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
2 mg once weekly · up to 104 or 117 weeksAs given in this study (human).
Measurements
Nausea
17%
patients
Source sentences
Summary
The most common AEs were nausea (17% of patients) and injection-site nodule (12% of patients).
2 context sentences(design, population, supporting numbers)
Summary · context
In this single-arm, open-label trial with treatment up to 104 or 117 weeks, patients received 2 mg exenatide once weekly while continuing treatment with a TZD with or without metformin.
Summary · context
Patients were on a stable dosage of TZD (rosiglitazone or pioglitazone) and, if applicable, metformin.
Report a problemFND-2303162301
02HumanNon-randomized trialSafety outcome
In patients with type 2 diabetes, injection-site nodules occurred in 12% during exenatide treatment.
In plain wordsIn patients with type 2 diabetes, 12% reported injection-site nodules during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableInjection-site nodule
Study
n = 134
Outcome group
Adverse events · Skin and wound
Studied dose
2 mg once weekly · up to 104 or 117 weeksAs given in this study (human).
Measurements
Injection-site nodule
12%
patients
Source sentences
Summary
The most common AEs were nausea (17% of patients) and injection-site nodule (12% of patients).
2 context sentences(design, population, supporting numbers)
Summary · context
In this single-arm, open-label trial with treatment up to 104 or 117 weeks, patients received 2 mg exenatide once weekly while continuing treatment with a TZD with or without metformin.
Summary · context
Patients were on a stable dosage of TZD (rosiglitazone or pioglitazone) and, if applicable, metformin.
Report a problemFND-2303162302
03HumanNon-randomized trialSafety outcome
In patients with type 2 diabetes, serious adverse events occurred in 14%, without an identifiable pattern.
In plain wordsIn patients with type 2 diabetes, 14% reported serious adverse events during exenatide treatment, without an identifiable pattern.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableSerious adverse events
Study
n = 134
Outcome group
Adverse events · Whole body
Studied dose
2 mg once weekly · up to 104 or 117 weeksAs given in this study (human).
Measurements
Serious adverse events
14%
patients
Source sentences
Summary
Serious AEs were reported in 14% of patients and 5% withdrew because of a treatment-emergent AE.
3 context sentences(design, population, supporting numbers)
Summary · context
No identifiable pattern of serious AEs was observed.
Summary · context
In this single-arm, open-label trial with treatment up to 104 or 117 weeks, patients received 2 mg exenatide once weekly while continuing treatment with a TZD with or without metformin.
Summary · context
Patients were on a stable dosage of TZD (rosiglitazone or pioglitazone) and, if applicable, metformin.
Report a problemFND-2303162303
04HumanNon-randomized trialSafety outcome
In patients with type 2 diabetes, 5% withdrew due to treatment-emergent adverse events during exenatide treatment.
In plain wordsIn patients with type 2 diabetes, 5% stopped exenatide treatment because of adverse events.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableWithdrawal due to adverse events
Study
n = 134
Outcome group
Adverse events · Whole body
Studied dose
2 mg once weekly · up to 104 or 117 weeksAs given in this study (human).
Measurements
Withdrawal
5%
treatment-emergent AE
Source sentences
Summary
Serious AEs were reported in 14% of patients and 5% withdrew because of a treatment-emergent AE.
2 context sentences(design, population, supporting numbers)
Summary · context
In this single-arm, open-label trial with treatment up to 104 or 117 weeks, patients received 2 mg exenatide once weekly while continuing treatment with a TZD with or without metformin.
Summary · context
Patients were on a stable dosage of TZD (rosiglitazone or pioglitazone) and, if applicable, metformin.
Report a problemFND-2303162304
05HumanNon-randomized trialSafety outcome
In patients with type 2 diabetes, four edema reports occurred during exenatide treatment.
In plain wordsIn patients with type 2 diabetes, edema was reported during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableEdema
Study
n = 134
Outcome group
Adverse events · Whole body
Studied dose
2 mg once weekly · up to 104 or 117 weeksAs given in this study (human).
Measurements
Edema reports
4 reports
exenatide
Source sentences
Summary
There were 4 reports of edema and no reports of heart failure.
2 context sentences(design, population, supporting numbers)
Summary · context
In this single-arm, open-label trial with treatment up to 104 or 117 weeks, patients received 2 mg exenatide once weekly while continuing treatment with a TZD with or without metformin.
Summary · context
Patients were on a stable dosage of TZD (rosiglitazone or pioglitazone) and, if applicable, metformin.
Report a problemFND-2303162305
06HumanNon-randomized trialSafety outcome
In patients with type 2 diabetes, no heart failure was reported during exenatide treatment.
In plain wordsIn patients with type 2 diabetes, no heart failure was reported during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableHeart failure
Study
n = 134
Outcome group
Adverse events · Cardiovascular
Studied dose
2 mg once weekly · up to 104 or 117 weeksAs given in this study (human).
Source sentences
Summary
There were 4 reports of edema and no reports of heart failure.
2 context sentences(design, population, supporting numbers)
Summary · context
In this single-arm, open-label trial with treatment up to 104 or 117 weeks, patients received 2 mg exenatide once weekly while continuing treatment with a TZD with or without metformin.
Summary · context
Patients were on a stable dosage of TZD (rosiglitazone or pioglitazone) and, if applicable, metformin.
Report a problemFND-2303162306
07HumanNon-randomized trialSafety outcome
In patients with type 2 diabetes, no major hypoglycemia was reported during exenatide treatment.
In plain wordsIn patients with type 2 diabetes, no major low blood sugar episodes were reported during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableMajor hypoglycemia
Study
n = 134
Outcome group
Adverse events · Metabolic and weight
Studied dose
2 mg once weekly · up to 104 or 117 weeksAs given in this study (human).
Source sentences
Summary
No major hypoglycemia was reported; minor hypoglycemia was reported in 4% of patients.
2 context sentences(design, population, supporting numbers)
Summary · context
In this single-arm, open-label trial with treatment up to 104 or 117 weeks, patients received 2 mg exenatide once weekly while continuing treatment with a TZD with or without metformin.
Summary · context
Patients were on a stable dosage of TZD (rosiglitazone or pioglitazone) and, if applicable, metformin.
Report a problemFND-2303162307
08HumanNon-randomized trialSafety outcome
In patients with type 2 diabetes, minor hypoglycemia occurred in 4% during exenatide treatment.
In plain wordsIn patients with type 2 diabetes, 4% reported minor low blood sugar episodes during exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableMinor hypoglycemia
Study
n = 134
Outcome group
Adverse events · Metabolic and weight
Studied dose
2 mg once weekly · up to 104 or 117 weeksAs given in this study (human).
Measurements
Minor hypoglycemia
4%
patients
Source sentences
Summary
No major hypoglycemia was reported; minor hypoglycemia was reported in 4% of patients.
2 context sentences(design, population, supporting numbers)
Summary · context
In this single-arm, open-label trial with treatment up to 104 or 117 weeks, patients received 2 mg exenatide once weekly while continuing treatment with a TZD with or without metformin.
Summary · context
Patients were on a stable dosage of TZD (rosiglitazone or pioglitazone) and, if applicable, metformin.
Report a problemFND-2303162308
09HumanNon-randomized trialEfficacy outcome
In patients switching from twice-daily to weekly exenatide, HbA1c decreased from baseline.
In plain wordsIn patients switching from twice-daily to weekly exenatide, long-term blood sugar decreased from baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c after switching from twice-daily exenatide
Study
n = 90
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly · up to 104 or 117 weeksAs given in this study (human).
Measurements
HbA1c change
−0.4%
previous exenatide exposure
SE
0.1%
previous exenatide exposure
Source sentences
Summary
Exenatide-naïve patients experienced mean (SE) HbA(1c) reductions of -0.7% (0.2%) and weight reductions of -2.7 (0.8) kg, whereas patients with prior exposure to exenatide twice daily experienced a reduction of -0.4% (0.1%) in HbA(1c) and no change in weight.
3 context sentences(design, population, supporting numbers)
Summary · context
In this single-arm, open-label trial with treatment up to 104 or 117 weeks, patients received 2 mg exenatide once weekly while continuing treatment with a TZD with or without metformin.
Summary · context
Patients were on a stable dosage of TZD (rosiglitazone or pioglitazone) and, if applicable, metformin.
Summary · context
Of 134 patients in the intent-to-treat population (baseline mean [SD] HbA(1c),7.2% [1.0%]), 44 were exenatide-naïve (baseline HbA(1c), 7.8% [1.0%]) and 90 switched from exenatide twice daily (baseline HbA(1c), 7.0% [0.8%]).
Report a problemFND-2303162311
10HumanNon-randomized trialEfficacy outcome
In patients switching from twice-daily to weekly exenatide, weight did not change from baseline.
In plain wordsIn patients switching from twice-daily to weekly exenatide, weight did not change from baseline.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeWeight after switching from twice-daily exenatide
Study
n = 90
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg once weekly · up to 104 or 117 weeksAs given in this study (human).
Source sentences
Summary
Exenatide-naïve patients experienced mean (SE) HbA(1c) reductions of -0.7% (0.2%) and weight reductions of -2.7 (0.8) kg, whereas patients with prior exposure to exenatide twice daily experienced a reduction of -0.4% (0.1%) in HbA(1c) and no change in weight.
3 context sentences(design, population, supporting numbers)
Summary · context
In this single-arm, open-label trial with treatment up to 104 or 117 weeks, patients received 2 mg exenatide once weekly while continuing treatment with a TZD with or without metformin.
Summary · context
Patients were on a stable dosage of TZD (rosiglitazone or pioglitazone) and, if applicable, metformin.
Summary · context
Of 134 patients in the intent-to-treat population (baseline mean [SD] HbA(1c),7.2% [1.0%]), 44 were exenatide-naïve (baseline HbA(1c), 7.8% [1.0%]) and 90 switched from exenatide twice daily (baseline HbA(1c), 7.0% [0.8%]).
Report a problemFND-2303162312
11HumanNon-randomized trialEfficacy outcome
In exenatide-naive patients with type 2 diabetes, weekly exenatide reduced HbA1c from baseline.
In plain wordsIn patients new to exenatide, weekly treatment reduced long-term blood sugar from baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c in exenatide-naive patients
Study
n = 44
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly · up to 104 or 117 weeksAs given in this study (human).
Measurements
HbA1c change
−0.7%
exenatide-naive
SE
0.2%
exenatide-naive
Source sentences
Summary
Exenatide-naïve patients experienced mean (SE) HbA(1c) reductions of -0.7% (0.2%) and weight reductions of -2.7 (0.8) kg, whereas patients with prior exposure to exenatide twice daily experienced a reduction of -0.4% (0.1%) in HbA(1c) and no change in weight.
3 context sentences(design, population, supporting numbers)
Summary · context
In this single-arm, open-label trial with treatment up to 104 or 117 weeks, patients received 2 mg exenatide once weekly while continuing treatment with a TZD with or without metformin.
Summary · context
Patients were on a stable dosage of TZD (rosiglitazone or pioglitazone) and, if applicable, metformin.
Summary · context
Of 134 patients in the intent-to-treat population (baseline mean [SD] HbA(1c),7.2% [1.0%]), 44 were exenatide-naïve (baseline HbA(1c), 7.8% [1.0%]) and 90 switched from exenatide twice daily (baseline HbA(1c), 7.0% [0.8%]).
Report a problemFND-2303162309
12HumanNon-randomized trialEfficacy outcome
In exenatide-naive patients with type 2 diabetes, weekly exenatide reduced weight from baseline.
In plain wordsIn patients new to exenatide, weekly treatment reduced weight from baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseWeight in exenatide-naive patients
Study
n = 44
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg once weekly · up to 104 or 117 weeksAs given in this study (human).
Measurements
Weight change
−2.7 kg
exenatide-naive
SE
0.8 kg
exenatide-naive
Source sentences
Summary
Exenatide-naïve patients experienced mean (SE) HbA(1c) reductions of -0.7% (0.2%) and weight reductions of -2.7 (0.8) kg, whereas patients with prior exposure to exenatide twice daily experienced a reduction of -0.4% (0.1%) in HbA(1c) and no change in weight.
3 context sentences(design, population, supporting numbers)
Summary · context
In this single-arm, open-label trial with treatment up to 104 or 117 weeks, patients received 2 mg exenatide once weekly while continuing treatment with a TZD with or without metformin.
Summary · context
Patients were on a stable dosage of TZD (rosiglitazone or pioglitazone) and, if applicable, metformin.
Summary · context
Of 134 patients in the intent-to-treat population (baseline mean [SD] HbA(1c),7.2% [1.0%]), 44 were exenatide-naïve (baseline HbA(1c), 7.8% [1.0%]) and 90 switched from exenatide twice daily (baseline HbA(1c), 7.0% [0.8%]).
Report a problemFND-2303162310

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 postedNCT00753896

Safety of Exenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Treated With Thiazolidinedione Alone or Thiazolidinedione in Combination With Metformin

AstraZenecan = 134Oct 2008 to Nov 2009

Type 2 Diabetes

Trial page ClinicalTrials.govUpdated 21 Apr 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

Subjects

Terms as the source lists them.

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