DURATION-2: efficacy and safety of switching from maximum daily sitagliptin or pioglitazone to once-weekly exenatide.

Wysham C, Bergenstal R, Malloy J, Yan P, Walsh B, Malone J, Taylor K

Diabetic medicine : a journal of the British Diabetic Association1 Jun 2011Cited by 91 (Europe PMC)

PMID21434995PMCIDPMC3123706DOI10.1111/j.1464-5491.2011.03301.xPepBankPUB-21434995

Summary

AimsIn the initial 26-week, double-blind, double-dummy assessment period of the DURATION-2 trial in patients with Type 2 diabetes on metformin, the once-weekly glucagon-like peptide 1 (GLP-1) receptor agonist exenatide once-weekly resulted in greater HbA(1c) improvement and weight reduction compared with maximum approved daily doses of sitagliptin or pioglitazone. This subsequent, 26-week, open-label, uncontrolled assessment period evaluated the safety and efficacy of (i) continued exenatide once-weekly treatment and (ii) switching from sitagliptin or pioglitazone to exenatide once-weekly.MethodsRandomised oral medications were discontinued and all patients received exenatide once-weekly. Of the 364 patients [original baseline HbA(1c) 8.5 ± 1.1% (70 mmol/mol), fasting plasma glucose 9.0 ± 2.5 mmol/l, weight 88 ± 20 kg) who continued into the open-label period, 319 patients (88%) completed 52 weeks.ResultsEvaluable patients who received only exenatide once-weekly demonstrated significant 52-week improvements (least square mean ± se) in HbA(1c) (-1.6 ± 0.1%), fasting plasma glucose (-1.8 ± 0.3 mmol/l) and weight (-1.8 ± 0.5 kg). Evaluable patients who switched from sitagliptin to exenatide once-weekly demonstrated significant incremental improvements in HbA(1c) (-0.3 ± 0.1%), fasting plasma glucose (-0.7 ± 0.2 mmol/l) and weight (-1.1 ± 0.3 kg). Patients who switched from pioglitazone to exenatide once-weekly maintained HbA(1c) and fasting plasma glucose improvements (week 52: -1.6 ± 0.1%, -1.7 ± 0.3 mmol/l), with significant weight reduction (-3.0 ± 0.3 kg). Exenatide once-weekly was generally well tolerated and adverse events were predominantly mild or moderate in intensity. Nausea was the most frequent adverse event in this assessment period (intent-to-treat: exenatide once-weekly-only 5%; sitagliptin→exenatide once-weekly 11%; pioglitazone→exenatide once-weekly 10%). No major hypoglycaemia was observed.ConclusionsPatients who switched to once-weekly exenatide from daily sitagliptin or pioglitazone had improved or sustained glycaemic control, with weight loss.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study14

14 results from studies that gave the peptide. 14 results from people.

01HumanNon-randomized trialEfficacy outcome
In T2D patients continuing weekly exenatide, HbA1c improved significantly over 52 weeks.
In plain wordsIn T2D patients continuing weekly exenatide, HbA1c improved significantly compared with baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseContinued exenatide HbA1c
Study
n: not reported in source
Comparator
Original baseline
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 52 weeksAs given in this study (human).
Measurements
HbA1c change
−1.6%
continued exenatide
Source sentences
Summary
Evaluable patients who received only exenatide once-weekly demonstrated significant 52-week improvements (least square mean ± se) in HbA(1c) (-1.6 ± 0.1%), fasting plasma glucose (-1.8 ± 0.3 mmol/l) and weight (-1.8 ± 0.5 kg).
2 context sentences(design, population, supporting numbers)
Summary · context
This subsequent, 26-week, open-label, uncontrolled assessment period evaluated the safety and efficacy of (i) continued exenatide once-weekly treatment and (ii) switching from sitagliptin or pioglitazone to exenatide once-weekly.
Summary · context
Randomised oral medications were discontinued and all patients received exenatide once-weekly.
Show in the study text Report a problemFND-2143499501
02HumanNon-randomized trialEfficacy outcome
In T2D patients continuing weekly exenatide, fasting glucose improved significantly over 52 weeks.
In plain wordsIn T2D patients continuing weekly exenatide, fasting blood sugar improved significantly compared with baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseContinued exenatide fasting glucose
Study
n: not reported in source
Comparator
Original baseline
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 52 weeksAs given in this study (human).
Measurements
Fasting glucose change
−1.8 mmol/l
continued exenatide
Source sentences
Summary
Evaluable patients who received only exenatide once-weekly demonstrated significant 52-week improvements (least square mean ± se) in HbA(1c) (-1.6 ± 0.1%), fasting plasma glucose (-1.8 ± 0.3 mmol/l) and weight (-1.8 ± 0.5 kg).
2 context sentences(design, population, supporting numbers)
Summary · context
This subsequent, 26-week, open-label, uncontrolled assessment period evaluated the safety and efficacy of (i) continued exenatide once-weekly treatment and (ii) switching from sitagliptin or pioglitazone to exenatide once-weekly.
Summary · context
Randomised oral medications were discontinued and all patients received exenatide once-weekly.
Show in the study text Report a problemFND-2143499502
03HumanNon-randomized trialEfficacy outcome
In T2D patients continuing weekly exenatide, weight decreased significantly over 52 weeks.
In plain wordsIn T2D patients continuing weekly exenatide, weight decreased significantly compared with baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseContinued exenatide weight
Study
n: not reported in source
Comparator
Original baseline
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated · 52 weeksAs given in this study (human).
Measurements
Weight change
−1.8 kg
continued exenatide
Source sentences
Summary
Evaluable patients who received only exenatide once-weekly demonstrated significant 52-week improvements (least square mean ± se) in HbA(1c) (-1.6 ± 0.1%), fasting plasma glucose (-1.8 ± 0.3 mmol/l) and weight (-1.8 ± 0.5 kg).
2 context sentences(design, population, supporting numbers)
Summary · context
This subsequent, 26-week, open-label, uncontrolled assessment period evaluated the safety and efficacy of (i) continued exenatide once-weekly treatment and (ii) switching from sitagliptin or pioglitazone to exenatide once-weekly.
Summary · context
Randomised oral medications were discontinued and all patients received exenatide once-weekly.
Show in the study text Report a problemFND-2143499503
04HumanNon-randomized trialEfficacy outcome
In T2D patients switching from sitagliptin to weekly exenatide, HbA1c showed significant incremental improvement.
In plain wordsIn T2D patients, HbA1c improved further after switching from sitagliptin to weekly exenatide compared with before the switch.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseSitagliptin switch HbA1c
Study
n: not reported in source
Comparator
Before switch from sitagliptin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 26-week extensionAs given in this study (human).
Measurements
Incremental HbA1c change
−0.3%
sitagliptin switch
Source sentences
Summary
Evaluable patients who switched from sitagliptin to exenatide once-weekly demonstrated significant incremental improvements in HbA(1c) (-0.3 ± 0.1%), fasting plasma glucose (-0.7 ± 0.2 mmol/l) and weight (-1.1 ± 0.3 kg).
2 context sentences(design, population, supporting numbers)
Summary · context
This subsequent, 26-week, open-label, uncontrolled assessment period evaluated the safety and efficacy of (i) continued exenatide once-weekly treatment and (ii) switching from sitagliptin or pioglitazone to exenatide once-weekly.
Summary · context
Randomised oral medications were discontinued and all patients received exenatide once-weekly.
Show in the study text Report a problemFND-2143499504
05HumanNon-randomized trialEfficacy outcome
In T2D patients switching from sitagliptin to weekly exenatide, fasting glucose showed significant incremental improvement.
In plain wordsIn T2D patients, fasting blood sugar improved further after switching from sitagliptin to weekly exenatide compared with before the switch.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseSitagliptin switch fasting glucose
Study
n: not reported in source
Comparator
Before switch from sitagliptin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 26-week extensionAs given in this study (human).
Measurements
Incremental fasting glucose change
−0.7 mmol/l
sitagliptin switch
Source sentences
Summary
Evaluable patients who switched from sitagliptin to exenatide once-weekly demonstrated significant incremental improvements in HbA(1c) (-0.3 ± 0.1%), fasting plasma glucose (-0.7 ± 0.2 mmol/l) and weight (-1.1 ± 0.3 kg).
2 context sentences(design, population, supporting numbers)
Summary · context
This subsequent, 26-week, open-label, uncontrolled assessment period evaluated the safety and efficacy of (i) continued exenatide once-weekly treatment and (ii) switching from sitagliptin or pioglitazone to exenatide once-weekly.
Summary · context
Randomised oral medications were discontinued and all patients received exenatide once-weekly.
Show in the study text Report a problemFND-2143499505
06HumanNon-randomized trialEfficacy outcome
In T2D patients switching from sitagliptin to weekly exenatide, weight showed significant incremental reduction.
In plain wordsIn T2D patients, weight decreased further after switching from sitagliptin to weekly exenatide compared with before the switch.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseSitagliptin switch weight
Study
n: not reported in source
Comparator
Before switch from sitagliptin
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated · 26-week extensionAs given in this study (human).
Measurements
Incremental weight change
−1.1 kg
sitagliptin switch
Source sentences
Summary
Evaluable patients who switched from sitagliptin to exenatide once-weekly demonstrated significant incremental improvements in HbA(1c) (-0.3 ± 0.1%), fasting plasma glucose (-0.7 ± 0.2 mmol/l) and weight (-1.1 ± 0.3 kg).
2 context sentences(design, population, supporting numbers)
Summary · context
This subsequent, 26-week, open-label, uncontrolled assessment period evaluated the safety and efficacy of (i) continued exenatide once-weekly treatment and (ii) switching from sitagliptin or pioglitazone to exenatide once-weekly.
Summary · context
Randomised oral medications were discontinued and all patients received exenatide once-weekly.
Show in the study text Report a problemFND-2143499506
07HumanNon-randomized trialEfficacy outcome
In T2D patients switching from pioglitazone to weekly exenatide, HbA1c improvements were maintained.
In plain wordsIn T2D patients, HbA1c improvements remained after switching from pioglitazone to weekly exenatide compared with before the switch.
Peptide
Exenatide (exendin-4)
Outcome
No significant changePioglitazone switch HbA1c
Study
n: not reported in source
Comparator
Before switch from pioglitazone
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 26-week extensionAs given in this study (human).
Measurements
Week 52 HbA1c change
−1.6%
pioglitazone switch, week 52
Source sentences
Summary
Patients who switched from pioglitazone to exenatide once-weekly maintained HbA(1c) and fasting plasma glucose improvements (week 52: -1.6 ± 0.1%, -1.7 ± 0.3 mmol/l), with significant weight reduction (-3.0 ± 0.3 kg).
2 context sentences(design, population, supporting numbers)
Summary · context
This subsequent, 26-week, open-label, uncontrolled assessment period evaluated the safety and efficacy of (i) continued exenatide once-weekly treatment and (ii) switching from sitagliptin or pioglitazone to exenatide once-weekly.
Summary · context
Randomised oral medications were discontinued and all patients received exenatide once-weekly.
Show in the study text Report a problemFND-2143499507
08HumanNon-randomized trialEfficacy outcome
In T2D patients switching from pioglitazone to weekly exenatide, fasting glucose improvements were maintained.
In plain wordsIn T2D patients, fasting blood sugar improvements remained after switching from pioglitazone to weekly exenatide compared with before the switch.
Peptide
Exenatide (exendin-4)
Outcome
No significant changePioglitazone switch fasting glucose
Study
n: not reported in source
Comparator
Before switch from pioglitazone
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 26-week extensionAs given in this study (human).
Measurements
Week 52 fasting glucose change
−1.7 mmol/l
pioglitazone switch, week 52
Source sentences
Summary
Patients who switched from pioglitazone to exenatide once-weekly maintained HbA(1c) and fasting plasma glucose improvements (week 52: -1.6 ± 0.1%, -1.7 ± 0.3 mmol/l), with significant weight reduction (-3.0 ± 0.3 kg).
2 context sentences(design, population, supporting numbers)
Summary · context
This subsequent, 26-week, open-label, uncontrolled assessment period evaluated the safety and efficacy of (i) continued exenatide once-weekly treatment and (ii) switching from sitagliptin or pioglitazone to exenatide once-weekly.
Summary · context
Randomised oral medications were discontinued and all patients received exenatide once-weekly.
Show in the study text Report a problemFND-2143499508
09HumanNon-randomized trialEfficacy outcome
In T2D patients who switched from pioglitazone to weekly exenatide, weight decreased significantly.
In plain wordsIn T2D patients switching from pioglitazone to weekly exenatide, weight decreased significantly.
Peptide
Exenatide (exendin-4)
Outcome
DecreasePioglitazone switch weight
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated · 26-week extensionAs given in this study (human).
Measurements
Weight change
−3 kg
pioglitazone switch
Source sentences
Summary
Patients who switched from pioglitazone to exenatide once-weekly maintained HbA(1c) and fasting plasma glucose improvements (week 52: -1.6 ± 0.1%, -1.7 ± 0.3 mmol/l), with significant weight reduction (-3.0 ± 0.3 kg).
2 context sentences(design, population, supporting numbers)
Summary · context
This subsequent, 26-week, open-label, uncontrolled assessment period evaluated the safety and efficacy of (i) continued exenatide once-weekly treatment and (ii) switching from sitagliptin or pioglitazone to exenatide once-weekly.
Summary · context
Randomised oral medications were discontinued and all patients received exenatide once-weekly.
Show in the study text Report a problemFND-2143499509
10HumanNon-randomized trialSafety outcome
In the T2D extension, weekly exenatide was generally well tolerated and adverse events were predominantly mild or moderate.
In plain wordsIn the T2D extension, weekly exenatide was generally well tolerated, with mostly mild or moderate adverse events.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableTolerability and event severity
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated · 26-week extensionAs given in this study (human).
Source sentences
Summary
Exenatide once-weekly was generally well tolerated and adverse events were predominantly mild or moderate in intensity.
2 context sentences(design, population, supporting numbers)
Summary · context
This subsequent, 26-week, open-label, uncontrolled assessment period evaluated the safety and efficacy of (i) continued exenatide once-weekly treatment and (ii) switching from sitagliptin or pioglitazone to exenatide once-weekly.
Summary · context
Randomised oral medications were discontinued and all patients received exenatide once-weekly.
Show in the study text Report a problemFND-2143499510
11HumanNon-randomized trialSafety outcome
In the T2D open-label extension, nausea was the most frequent adverse event (intent-to-treat: 5% exenatide once-weekly only, 11% after sitagliptin, 10% after pioglitazone).
In plain wordsIn T2D patients in the extension, nausea was the most frequent side effect: 5% with continued exenatide, 11% after switching from sitagliptin, 10% from pioglitazone.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableNausea during the open-label period
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · 26-week extensionAs given in this study (human).
Measurements
Nausea
5%
exenatide once-weekly only
Nausea
11%
sitagliptin to exenatide once-weekly
Nausea
10%
pioglitazone to exenatide once-weekly
Source sentences
Summary
Nausea was the most frequent adverse event in this assessment period (intent-to-treat: exenatide once-weekly-only 5%; sitagliptin→exenatide once-weekly 11%; pioglitazone→exenatide once-weekly 10%).
2 context sentences(design, population, supporting numbers)
Summary · context
This subsequent, 26-week, open-label, uncontrolled assessment period evaluated the safety and efficacy of (i) continued exenatide once-weekly treatment and (ii) switching from sitagliptin or pioglitazone to exenatide once-weekly.
Summary · context
Randomised oral medications were discontinued and all patients received exenatide once-weekly.
Show in the study text Report a problemFND-2143499511
12HumanNon-randomized trialSafety outcome
In T2D patients switching from sitagliptin to weekly exenatide, nausea occurred in 11% during the extension.
In plain wordsIn T2D patients switching from sitagliptin to weekly exenatide, 11% reported nausea during the extension.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableNausea after sitagliptin switch
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · 26-week extensionAs given in this study (human).
Measurements
Nausea
11%
sitagliptin switch
Source sentences
Summary
Nausea was the most frequent adverse event in this assessment period (intent-to-treat: exenatide once-weekly-only 5%; sitagliptin→exenatide once-weekly 11%; pioglitazone→exenatide once-weekly 10%).
2 context sentences(design, population, supporting numbers)
Summary · context
This subsequent, 26-week, open-label, uncontrolled assessment period evaluated the safety and efficacy of (i) continued exenatide once-weekly treatment and (ii) switching from sitagliptin or pioglitazone to exenatide once-weekly.
Summary · context
Randomised oral medications were discontinued and all patients received exenatide once-weekly.
Show in the study text Report a problemFND-2143499512
13HumanNon-randomized trialSafety outcome
In T2D patients switching from pioglitazone to weekly exenatide, nausea occurred in 10% during the extension.
In plain wordsIn T2D patients switching from pioglitazone to weekly exenatide, 10% reported nausea during the extension.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableNausea after pioglitazone switch
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · 26-week extensionAs given in this study (human).
Measurements
Nausea
10%
pioglitazone switch
Source sentences
Summary
Nausea was the most frequent adverse event in this assessment period (intent-to-treat: exenatide once-weekly-only 5%; sitagliptin→exenatide once-weekly 11%; pioglitazone→exenatide once-weekly 10%).
2 context sentences(design, population, supporting numbers)
Summary · context
This subsequent, 26-week, open-label, uncontrolled assessment period evaluated the safety and efficacy of (i) continued exenatide once-weekly treatment and (ii) switching from sitagliptin or pioglitazone to exenatide once-weekly.
Summary · context
Randomised oral medications were discontinued and all patients received exenatide once-weekly.
Show in the study text Report a problemFND-2143499513
14HumanNon-randomized trialSafety outcome
In T2D patients receiving weekly exenatide during the extension, no major hypoglycaemia was observed.
In plain wordsIn T2D patients receiving weekly exenatide during the extension, no major low blood sugar was observed.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableMajor hypoglycaemia
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated · 26-week extensionAs given in this study (human).
Source sentences
Summary
No major hypoglycaemia was observed.
2 context sentences(design, population, supporting numbers)
Summary · context
This subsequent, 26-week, open-label, uncontrolled assessment period evaluated the safety and efficacy of (i) continued exenatide once-weekly treatment and (ii) switching from sitagliptin or pioglitazone to exenatide once-weekly.
Summary · context
Randomised oral medications were discontinued and all patients received exenatide once-weekly.
Show in the study text Report a problemFND-2143499514

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 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 page ClinicalTrials.govUpdated 7 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

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