Efficacy and Tolerability of Exenatide Once Weekly Over 6 Years in Patients with Type 2 Diabetes: An Uncontrolled Open-Label Extension of the DURATION-1 Study.

Henry RR, Klein EJ, Han J, Iqbal N

Diabetes technology & therapeutics15 Aug 2016Cited by 39 (Europe PMC)

PMID27525540PMCIDPMC5124747DOI10.1089/dia.2016.0107PepBankPUB-27525540

Read at source 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: CC BY-NC. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanNon-randomized trialEfficacy outcome
In type 2 diabetes patients completing exenatide treatment, HbA1c decreased by 1.6% from baseline at 6 years.
In plain wordsIn patients with diabetes who completed treatment, exenatide lowered HbA1c by 1.6% from baseline at 6 years.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c change
Study
n = 136
Comparator
Baseline
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly · 6 yearsAs given in this study (human).
Measurements
HbA1c change
−1.6%
six-year completers
Source sentences
Summary
Six-year completers had sustained significant improvements from baseline in glycated hemoglobin (HbA1c; least-squares mean [LSM] change, -1.6%), with 46.3% achieving HbA1c <7.0%, 33.1% achieving HbA1c ≤6.5%, and significant improvements from baseline in fasting plasma glucose (-28 mg/dL) and body we…
2 context sentences(design, population, supporting numbers)
Summary · context
The study enrolled patients aged ≥16 years with T2D treated primarily with metformin and sulfonylureas.
Summary · context
Following 30 weeks of randomized treatment with exenatide QW 2 mg or exenatide twice daily 10 μg, patients entered an uncontrolled, open-label, open-ended study phase in which all patients received exenatide QW 2 mg.
Report a problemFND-2752554001
02HumanNon-randomized trialEfficacy outcome
In type 2 diabetes patients completing exenatide treatment, 46.3% achieved HbA1c below 7.0% at 6 years.
In plain wordsIn patients with diabetes who completed exenatide treatment, 46.3% achieved HbA1c below 7.0% at 6 years.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableHbA1c below 7.0%
Study
n = 136
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly · 6 yearsAs given in this study (human).
Measurements
HbA1c below 7.0%
46.3%
six-year completers
Source sentences
Summary
Six-year completers had sustained significant improvements from baseline in glycated hemoglobin (HbA1c; least-squares mean [LSM] change, -1.6%), with 46.3% achieving HbA1c <7.0%, 33.1% achieving HbA1c ≤6.5%, and significant improvements from baseline in fasting plasma glucose (-28 mg/dL) and body we…
2 context sentences(design, population, supporting numbers)
Summary · context
The study enrolled patients aged ≥16 years with T2D treated primarily with metformin and sulfonylureas.
Summary · context
Following 30 weeks of randomized treatment with exenatide QW 2 mg or exenatide twice daily 10 μg, patients entered an uncontrolled, open-label, open-ended study phase in which all patients received exenatide QW 2 mg.
Report a problemFND-2752554002
03HumanNon-randomized trialEfficacy outcome
In type 2 diabetes patients completing exenatide treatment, 33.1% achieved HbA1c at or below 6.5% at 6 years.
In plain wordsIn patients with diabetes who completed exenatide treatment, 33.1% achieved HbA1c at or below 6.5% at 6 years.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableHbA1c at or below 6.5%
Study
n = 136
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly · 6 yearsAs given in this study (human).
Measurements
HbA1c at or below 6.5%
33.1%
six-year completers
Source sentences
Summary
Six-year completers had sustained significant improvements from baseline in glycated hemoglobin (HbA1c; least-squares mean [LSM] change, -1.6%), with 46.3% achieving HbA1c <7.0%, 33.1% achieving HbA1c ≤6.5%, and significant improvements from baseline in fasting plasma glucose (-28 mg/dL) and body we…
2 context sentences(design, population, supporting numbers)
Summary · context
The study enrolled patients aged ≥16 years with T2D treated primarily with metformin and sulfonylureas.
Summary · context
Following 30 weeks of randomized treatment with exenatide QW 2 mg or exenatide twice daily 10 μg, patients entered an uncontrolled, open-label, open-ended study phase in which all patients received exenatide QW 2 mg.
Report a problemFND-2752554003
04HumanNon-randomized trialEfficacy outcome
In type 2 diabetes patients completing exenatide treatment, fasting plasma glucose decreased by 28 mg/dL from baseline at 6 years.
In plain wordsIn patients with diabetes who completed exenatide treatment, fasting blood sugar decreased by 28 mg/dL from baseline at 6 years.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseFasting plasma glucose change
Study
n = 136
Comparator
Baseline
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly · 6 yearsAs given in this study (human).
Measurements
Fasting plasma glucose change
−28 mg/dL
six-year completers
Source sentences
Summary
Six-year completers had sustained significant improvements from baseline in glycated hemoglobin (HbA1c; least-squares mean [LSM] change, -1.6%), with 46.3% achieving HbA1c <7.0%, 33.1% achieving HbA1c ≤6.5%, and significant improvements from baseline in fasting plasma glucose (-28 mg/dL) and body we…
2 context sentences(design, population, supporting numbers)
Summary · context
The study enrolled patients aged ≥16 years with T2D treated primarily with metformin and sulfonylureas.
Summary · context
Following 30 weeks of randomized treatment with exenatide QW 2 mg or exenatide twice daily 10 μg, patients entered an uncontrolled, open-label, open-ended study phase in which all patients received exenatide QW 2 mg.
Report a problemFND-2752554004
05HumanNon-randomized trialEfficacy outcome
In type 2 diabetes patients completing exenatide treatment, body weight decreased by 4.2 kg from baseline at 6 years.
In plain wordsIn patients with diabetes who completed exenatide treatment, weight decreased by 4.2 kg from baseline at 6 years.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseBody weight change
Study
n = 136
Comparator
Baseline
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg once weekly · 6 yearsAs given in this study (human).
Measurements
Body weight change
−4.2 kg
six-year completers
Source sentences
Summary
Six-year completers had sustained significant improvements from baseline in glycated hemoglobin (HbA1c; least-squares mean [LSM] change, -1.6%), with 46.3% achieving HbA1c <7.0%, 33.1% achieving HbA1c ≤6.5%, and significant improvements from baseline in fasting plasma glucose (-28 mg/dL) and body we…
2 context sentences(design, population, supporting numbers)
Summary · context
The study enrolled patients aged ≥16 years with T2D treated primarily with metformin and sulfonylureas.
Summary · context
Following 30 weeks of randomized treatment with exenatide QW 2 mg or exenatide twice daily 10 μg, patients entered an uncontrolled, open-label, open-ended study phase in which all patients received exenatide QW 2 mg.
Report a problemFND-2752554005
06HumanNon-randomized trialEfficacy outcome
In exenatide-treated diabetes patients without added glucose-lowering drugs, weight fell by 6.1 kg from baseline, numerically more than the overall cohort.
In plain wordsIn patients without added diabetes drugs, weight fell by 6.1 kg during exenatide treatment, numerically more than in the overall cohort.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseWeight change without added glucose-lowering medication
Study
n = 78
Comparator
Baseline
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg once weekly · 6 yearsAs given in this study (human).
Measurements
Body weight change
−6.1 kg
completers without added medication
Source sentences
Summary
The 78 completers who added no glucose-lowering medications had numerically greater body weight reductions than the overall cohort (6-year LSM change, -6.1 kg) with more stability over time.
2 context sentences(design, population, supporting numbers)
Summary · context
The study enrolled patients aged ≥16 years with T2D treated primarily with metformin and sulfonylureas.
Summary · context
Following 30 weeks of randomized treatment with exenatide QW 2 mg or exenatide twice daily 10 μg, patients entered an uncontrolled, open-label, open-ended study phase in which all patients received exenatide QW 2 mg.
Report a problemFND-2752554006
07HumanNon-randomized trialSafety outcome
In type 2 diabetes patients receiving exenatide, no unexpected adverse events occurred during 1202.4 patient-years of exposure.
In plain wordsIn patients with diabetes, no unexpected adverse events occurred during exenatide exposure.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableUnexpected adverse events
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
2 mg once weekly · 6 yearsAs given in this study (human).
Source sentences
Summary
No unexpected adverse events were observed during 1202.4 patient-years of exposure.
2 context sentences(design, population, supporting numbers)
Summary · context
The study enrolled patients aged ≥16 years with T2D treated primarily with metformin and sulfonylureas.
Summary · context
Following 30 weeks of randomized treatment with exenatide QW 2 mg or exenatide twice daily 10 μg, patients entered an uncontrolled, open-label, open-ended study phase in which all patients received exenatide QW 2 mg.
Report a problemFND-2752554007
08HumanNon-randomized trialSafety outcome
In exenatide-treated type 2 diabetes patients, most minor hypoglycemia events occurred during concomitant sulfonylurea use.
In plain wordsIn patients with diabetes receiving exenatide, most minor low blood sugar events occurred during sulfonylurea use.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableMinor hypoglycemia with sulfonylureas
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
2 mg once weekly · 6 yearsAs given in this study (human).
Source sentences
Summary
Most minor hypoglycemia events occurred with concomitant sulfonylurea use.
2 context sentences(design, population, supporting numbers)
Summary · context
The study enrolled patients aged ≥16 years with T2D treated primarily with metformin and sulfonylureas.
Summary · context
Following 30 weeks of randomized treatment with exenatide QW 2 mg or exenatide twice daily 10 μg, patients entered an uncontrolled, open-label, open-ended study phase in which all patients received exenatide QW 2 mg.
Report a problemFND-2752554008

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 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 page ClinicalTrials.govUpdated 26 Aug 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.

Publication types

MeSH terms

PepBank is a research reference. Talk to a doctor before you use any peptide.