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Study · Other design · n = 128 · 2012

15 results

Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment.

Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME

Diabetes, obesity & metabolism10 Feb 2012Cited by 117 (Europe PMC)

PMID22236356 (opens in a new tab)DOI10.1111/j.1463-1326.2012.01561.x (opens in a new tab)PepBankPUB-22236356
Publisher pagePubMedAsk about this study
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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 study15

13 results from studies that gave the peptide. 13 results from people.

  1. 01HumanOther designSafety outcome

    In exenatide QW patients, antibodies declined to 45.4% positive at 52 weeks, including 9.2% higher titres.

    In plain wordsIn exenatide QW patients, antibody frequency declined to 45.4% at 52 weeks.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseQW antibodies at 52 weeks
    Study

    n = 128

    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    Dose not stated

    Measurements

    Antibody-positive
    45.4%
    exenatide QW, 52 weeks
    Higher-titre antibody-positive
    9.2%
    exenatide QW, 52 weeks

    Source sentences

    Summary
    Similarly, 56.8% of exenatide QW patients were antibody-positive (45.0% low/11.8% higher titre) at 24-30 weeks, declining to 45.4% positive (9.2% higher titre) at 52 weeks.
  2. 02HumanOther designSafety outcome

    In exenatide trial patients, mean antibody titres peaked early and then declined.

    In plain wordsIn exenatide trial patients, antibody levels peaked early and then declined.

    Peptide
    Exenatide (exendin-4)
    Outcome
    MixedAntibody titre time course
    Study

    n: not reported in source

    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    Dose not stated

    Measurements

    Time to peak mean antibody titre
    6 to 22 weeks
    exenatide trials

    Source sentences

    Summary
    Mean titres peaked early (6-22 weeks) and subsequently declined.
  3. 03HumanOther designSafety outcome

    In exenatide BID patients, 36.7% were antibody-positive at 30 weeks, including 31.7% low titres and 5.0% higher titres.

    In plain wordsIn exenatide BID patients, 36.7% had antibodies at 30 weeks.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableBID antibodies at 30 weeks
    Study

    n: not reported in source

    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    Dose not stated

    Measurements

    Antibody-positive
    36.7%
    exenatide BID, 30 weeks
    Low-titre antibody-positive
    31.7%
    exenatide BID, 30 weeks
    Higher-titre antibody-positive
    5%
    exenatide BID, 30 weeks

    Source sentences

    Summary
    At 30 weeks, 36.7% of exenatide BID patients were antibody-positive; 31.7% exhibited low titres (≤125) and 5.0% had higher titres (≥625).
  4. 04HumanOther designSafety outcome

    In exenatide BID patients, antibody incidence declined to 16.9% at 3 years, including 1.4% with higher titres.

    In plain wordsIn exenatide BID patients, antibody frequency declined to 16.9% at 3 years.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseBID antibodies at three years
    Study

    n: not reported in source

    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    Dose not stated

    Measurements

    Antibody-positive
    16.9%
    exenatide BID, 3 years
    Higher-titre antibody-positive
    1.4%
    exenatide BID, 3 years

    Source sentences

    Summary
    Antibody incidence declined to 16.9% (1.4% higher titre) at 3 years.
  5. 05HumanOther designSafety outcome

    In exenatide QW patients, 56.8% were antibody-positive at 24-30 weeks, including 45.0% low and 11.8% higher titres.

    In plain wordsIn exenatide QW patients, 56.8% had antibodies at 24-30 weeks.

    Peptide
    Exenatide (exendin-4)
    Outcome
    Not applicableQW antibodies at 24-30 weeks
    Study

    n: not reported in source

    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    Dose not stated

    Measurements

    Antibody-positive
    56.8%
    exenatide QW, 24-30 weeks
    Low-titre antibody-positive
    45%
    exenatide QW, 24-30 weeks
    Higher-titre antibody-positive
    11.8%
    exenatide QW, 24-30 weeks

    Source sentences

    Summary
    Similarly, 56.8% of exenatide QW patients were antibody-positive (45.0% low/11.8% higher titre) at 24-30 weeks, declining to 45.4% positive (9.2% higher titre) at 52 weeks.
  6. 06HumanOther designSafety outcome

    In exenatide patients, adverse event rates were similar by antibody status, except for injection-site reactions.

    In plain wordsIn exenatide patients, side effect rates were similar with and without antibodies, except injection-site reactions.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeAdverse events by antibody status
    Study

    n: not reported in source

    Comparator
    Antibody-negative patients
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Other than injection-site reactions, adverse event rates in antibody-positive and antibody-negative patients were similar.
  7. 07HumanOther designEfficacy outcome

    In exenatide BID patients, mean HbA1c changes were -1.0% without antibodies and -0.9% with antibodies.

    In plain wordsIn exenatide BID patients, HbA1c decreased both with and without antibodies.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseBID HbA1c by antibody status
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    HbA1c change
    −1%
    exenatide BID, antibody-negative
    HbA1c change
    −0.9%
    exenatide BID, antibody-positive

    Source sentences

    Summary
    Efficacy was robust in both antibody-negative and antibody-positive patients (mean HbA1c change: -1.0 and -0.9%, respectively, exenatide BID; -1.6% and -1.3% exenatide QW).
  8. 08HumanOther designEfficacy outcome

    In exenatide QW patients, mean HbA1c changes were -1.6% without antibodies and -1.3% with antibodies.

    In plain wordsIn exenatide QW patients, HbA1c decreased both with and without antibodies.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseQW HbA1c by antibody status
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    HbA1c change
    −1.6%
    exenatide QW, antibody-negative
    HbA1c change
    −1.3%
    exenatide QW, antibody-positive

    Source sentences

    Summary
    Efficacy was robust in both antibody-negative and antibody-positive patients (mean HbA1c change: -1.0 and -0.9%, respectively, exenatide BID; -1.6% and -1.3% exenatide QW).
  9. 09HumanOther designOther

    In exenatide BID patients, antibody titre did not correlate with HbA1c change overall.

    In plain wordsIn exenatide BID patients, antibody levels were not linked to HbA1c change overall.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeBID HbA1c correlation with titre
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated

    Source sentences

    Summary
    No correlation between change in HbA1c and titre was observed for exenatide BID, although mean reductions were attenuated in the small subset of patients (5%) with higher titres.
  10. 10HumanOther designEfficacy outcome

    In exenatide BID patients with higher antibody titres, mean HbA1c reductions were attenuated.

    In plain wordsIn exenatide BID patients, those with high antibody levels had smaller average HbA1c reductions.

    Peptide
    Exenatide (exendin-4)
    Outcome
    MixedBID high-titre HbA1c response
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated

    Source sentences

    Summary
    No correlation between change in HbA1c and titre was observed for exenatide BID, although mean reductions were attenuated in the small subset of patients (5%) with higher titres.
  11. 11HumanOther designOther

    In exenatide QW patients, antibody titre correlated significantly with HbA1c response.

    In plain wordsIn exenatide QW patients, antibody levels were linked to HbA1c response.

    Peptide
    Exenatide (exendin-4)
    Outcome
    MixedQW HbA1c correlation with titre
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated

    Source sentences

    Summary
    A significant correlation was observed for exenatide QW with no difference between antibody-negative and low-titre patients, but an attenuated mean reduction in the subset of patients (12%) with higher titres.
  12. 12HumanOther designEfficacy outcome

    In exenatide QW patients, HbA1c responses did not differ between antibody-negative and low-titre patients.

    In plain wordsIn exenatide QW patients, HbA1c responses were similar without antibodies and with low antibody levels.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeQW low-titre HbA1c response
    Study

    n: not reported in source

    Comparator
    Antibody-negative patients
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated

    Source sentences

    Summary
    A significant correlation was observed for exenatide QW with no difference between antibody-negative and low-titre patients, but an attenuated mean reduction in the subset of patients (12%) with higher titres.
  13. 13HumanOther designEfficacy outcome

    In exenatide QW patients with higher antibody titres, mean HbA1c reductions were attenuated.

    In plain wordsIn exenatide QW patients, those with high antibody levels had smaller average HbA1c reductions.

    Peptide
    Exenatide (exendin-4)
    Outcome
    MixedQW high-titre HbA1c response
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated

    Source sentences

    Summary
    A significant correlation was observed for exenatide QW with no difference between antibody-negative and low-titre patients, but an attenuated mean reduction in the subset of patients (12%) with higher titres.

Studies that did not test the peptide alone2

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).

  1. 14LabNot a test of Exenatide (exendin-4) aloneIn vitro (cell-free)Activity measurement

    In tested exenatide patients, treatment-emergent antibodies did not cross-react with human GLP-1.

    In plain wordsIn lab tests, treatment-emergent exenatide antibodies did not cross-react with GLP-1.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeAntibody cross-reactivity with GLP-1
    Study

    n: not reported in source

    Outcome group
    Immune response · Immune and inflammation

    Source sentences

    Summary
    Treatment-emergent anti-exenatide antibodies from a subset of patients tested did not cross-react with human GLP-1 or glucagon.

    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).

  2. 15LabNot a test of Exenatide (exendin-4) aloneIn vitro (cell-free)Activity measurement

    In tested exenatide patients, treatment-emergent antibodies did not cross-react with glucagon.

    In plain wordsIn lab tests, treatment-emergent exenatide antibodies did not cross-react with glucagon.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeAntibody cross-reactivity with glucagon
    Study

    n: not reported in source

    Outcome group
    Immune response · Immune and inflammation

    Source sentences

    Summary
    Treatment-emergent anti-exenatide antibodies from a subset of patients tested did not cross-react with human GLP-1 or glucagon.

    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).

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

Registered trials19

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

19 trials · 19 completed · 8 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2Results postedNCT04431713

Exenatide Once-weekly as a Treatment for Multiple System Atrophy

University College, Londonn = 5016 Sept 2020 to 22 Mar 2024

Multiple System Atrophy

Trial pageClinicalTrials.govUpdated 27 Jun 2025
CompletedPhase 3Results postedNCT00877890

A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)

AstraZenecan = 254Mar 2009 to Jan 2010

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 7 Apr 2015
CompletedPhase 3Results postedNCT00641056

Efficacy of Exenatide Once Weekly and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea (DURATION - 3)

AstraZenecan = 467Apr 2008 to Nov 2009

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 15 Jun 2015
CompletedPhase 3Results postedNCT00637273

A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)

AstraZenecan = 514Jan 2008 to Jul 2009

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 7 Apr 2015
CompletedPhase 2NCT00382239

A Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 In Japanese Patients With Type 2 Diabetes

AstraZenecan = 153Sept 2006 to May 2007

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 23 Feb 2015
CompletedPhase 3NCT00381342

Safety and Efficacy of Exenatide as Monotherapy

AstraZenecan = 233Sept 2006 to Sept 2007

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 23 Feb 2015
CompletedPhase 3Results postedNCT00308139

Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)

AstraZenecan = 303Apr 2006 to Aug 2014

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 26 Aug 2015
CompletedPhase 3NCT00324363

Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin

AstraZenecan = 466Jan 2006 to Apr 2007

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 23 Feb 2015
CompletedPhase 3Results postedNCT00135330

An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus

AstraZenecan = 137Oct 2005 to Jul 2008

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 7 Apr 2015
CompletedPhase 3NCT00099619

Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy

AstraZenecan = 138Sept 2004 to Aug 2005

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 23 Feb 2015
CompletedPhase 3NCT00099320

Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin

AstraZenecan = 182May 2004 to Aug 2005

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 23 Feb 2015
CompletedPhase 2NCT00099333

Study of the Safety of Substituting Exenatide for Insulin in Patients Using Insulin and Oral Antidiabetic Agents

AstraZenecan = 49Feb 2004 to Aug 2005

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 23 Feb 2015
CompletedPhase 3Results postedNCT00082407

Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin

AstraZenecan = 505Nov 2003 to Jul 2008

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 7 Apr 2015
CompletedPhase 3Results postedNCT00082381

Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin

AstraZenecan = 551Jun 2003 to Jul 2008

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 7 Apr 2015
CompletedPhase 3NCT00111540

Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes

AstraZenecan = 456Nov 2002 to Sept 2006

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 23 Feb 2015
CompletedPhase 3NCT00044668

Evaluation of the Effect on Glucose Control and Safety of AC2993 in Patients With Type 2 Diabetes Treated With Metformin, Sulfonylurea, or Metformin and Sulfonylurea Combination

AstraZenecan = 155Aug 2002 to Sept 2005

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 20 Feb 2015
CompletedPhase 3NCT00035984

Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus

AstraZenecan = 734May 2002 to Aug 2003

Diabetes Mellitus, Non-Insulin-Dependent

Trial pageClinicalTrials.govUpdated 24 Feb 2015
CompletedPhase 3NCT00039013

Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With Metformin

AstraZenecan = 336Mar 2002 to Jun 2003

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 24 Feb 2015
CompletedPhase 3NCT00039026

Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With a Sulfonylurea

AstraZenecan = 377Feb 2002 to Aug 2003

Diabetes Mellitus, Non-Insulin-Dependent

Trial pageClinicalTrials.govUpdated 24 Feb 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.

  1. Version 2Current

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. 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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