Safety and Efficacy of Exenatide Once Weekly Plus Dapagliflozin Once Daily Versus Exenatide or Dapagliflozin Alone in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy: 52-Week Results of the DURATION-8 Randomized Controlled Trial.

Jabbour SA, Frías JP, Hardy E, Ahmed A, Wang H, Öhman P, Guja C

Diabetes care6 Aug 2018Cited by 81 (Europe PMC)

PMID30082326PMCIDPMC6150435DOI10.2337/dc18-0680PepBankPUB-30082326

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

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In metformin-treated adults with type 2 diabetes, adding exenatide to dapagliflozin reduced HbA1c more than dapagliflozin alone at 52 weeks.
In plain wordsIn adults with type 2 diabetes, adding exenatide to dapagliflozin lowered HbA1c more than dapagliflozin alone.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c change versus dapagliflozin
Study
n: not reported in source
Comparator
dapagliflozin alone
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly · subcutaneous · 52 weeksAs given in this study (human).
Measurements
HbA1c change
−1.75%
combination
HbA1c change
−1.23%
dapagliflozin alone
Source sentences
Summary
At 52 weeks, HbA_1c reductions were greater with exenatide QW plus dapagliflozin (least squares mean change -1.75% [-19.1 mmol/mol]) versus exenatide QW (-1.38% [-15.1 mmol/mol]; P = 0.006) or dapagliflozin (-1.23% [-13.4 mmol/mol]; P < 0.001)
1 context sentence(design, population, supporting numbers)
Summary · context
Extension-period P values were nominal.
Report a problemFND-3008232602
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, mean HbA1c was 7.2% after 52 weeks of exenatide alone.
In plain wordsIn adults with type 2 diabetes, mean HbA1c was 7.2% with exenatide alone.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableMean HbA1c with exenatide alone
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Mean HbA1c
7.2%
exenatide alone
Source sentences
Summary
mean HbA_1c values were 6.9% (52 mmol/mol), 7.2% (55 mmol/mol), and 7.4% (57 mmol/mol), respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
At 52 weeks, HbA_1c reductions were greater with exenatide QW plus dapagliflozin (least squares mean change -1.75% [-19.1 mmol/mol]) versus exenatide QW (-1.38% [-15.1 mmol/mol]; P = 0.006) or dapagliflozin (-1.23% [-13.4 mmol/mol]; P < 0.001)
Summary · context
Extension-period P values were nominal.
Report a problemFND-3008232604
03HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, adding exenatide to dapagliflozin produced similar weight reductions to dapagliflozin alone at 52 weeks.
In plain wordsIn adults with type 2 diabetes, weight reductions were similar with exenatide plus dapagliflozin and dapagliflozin alone.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeWeight change versus dapagliflozin
Study
n: not reported in source
Comparator
dapagliflozin alone
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg once weekly · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Weight change
−3.31 kg
combination
Weight change
−2.28 kg
dapagliflozin alone
Source sentences
Summary
Weight and SBP reductions were greater with exenatide QW plus dapagliflozin (-3.31 kg and -4.5 mmHg) versus exenatide QW (-1.51 kg and -0.7 mmHg; both P < 0.001) but similar to those with dapagliflozin (-2.28 kg and -2.7 mmHg; P = 0.057 and P = 0.100, respectively).
1 context sentence(design, population, supporting numbers)
Summary · context
Extension-period P values were nominal.
Report a problemFND-3008232607
04HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, adding exenatide to dapagliflozin produced similar systolic blood pressure reductions to dapagliflozin alone.
In plain wordsIn adults with type 2 diabetes, blood pressure reductions were similar with exenatide plus dapagliflozin and dapagliflozin alone.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeSystolic blood pressure versus dapagliflozin
Study
n: not reported in source
Comparator
dapagliflozin alone
Outcome group
Blood pressure · Cardiovascular
Studied dose
2 mg once weekly · subcutaneous · 52 weeksAs given in this study (human).
Measurements
SBP change
−4.5 mmHg
combination
SBP change
−2.7 mmHg
dapagliflozin alone
Source sentences
Summary
Weight and SBP reductions were greater with exenatide QW plus dapagliflozin (-3.31 kg and -4.5 mmHg) versus exenatide QW (-1.51 kg and -0.7 mmHg; both P < 0.001) but similar to those with dapagliflozin (-2.28 kg and -2.7 mmHg; P = 0.057 and P = 0.100, respectively).
1 context sentence(design, population, supporting numbers)
Summary · context
Extension-period P values were nominal.
Report a problemFND-3008232608
05HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, no major hypoglycemia occurred in the trial, including the exenatide-alone arm.
In plain wordsIn adults with type 2 diabetes, no major hypoglycemia occurred, including with exenatide alone.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableMajor hypoglycemia with exenatide alone
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
2 mg once weekly · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
No major hypoglycemia occurred.
1 context sentence(design, population, supporting numbers)
Summary · context
Extension-period P values were nominal.
Report a problemFND-3008232612

Studies that did not test the peptide alone7

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).

06HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
In metformin-treated adults with type 2 diabetes, exenatide plus dapagliflozin reduced HbA1c more than exenatide alone at 52 weeks.
In plain wordsIn adults with type 2 diabetes, exenatide plus dapagliflozin lowered HbA1c more than exenatide alone.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c change versus exenatide
Study
n: not reported in source
Comparator
exenatide alone
Outcome group
Glycemic control · Metabolic and weight
Measurements
HbA1c change
−1.75%
combination
HbA1c change
−1.38%
exenatide alone
Source sentences
Summary
At 52 weeks, HbA_1c reductions were greater with exenatide QW plus dapagliflozin (least squares mean change -1.75% [-19.1 mmol/mol]) versus exenatide QW (-1.38% [-15.1 mmol/mol]; P = 0.006) or dapagliflozin (-1.23% [-13.4 mmol/mol]; P < 0.001)
1 context sentence(design, population, supporting numbers)
Summary · context
Extension-period P values were nominal.
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).
Report a problemFND-3008232601
07HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, mean HbA1c was 6.9% after 52 weeks of exenatide plus dapagliflozin.
In plain wordsIn adults with type 2 diabetes, mean HbA1c was 6.9% with exenatide plus dapagliflozin.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableMean HbA1c with combination
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Measurements
Mean HbA1c
6.9%
combination
Source sentences
Summary
mean HbA_1c values were 6.9% (52 mmol/mol), 7.2% (55 mmol/mol), and 7.4% (57 mmol/mol), respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
At 52 weeks, HbA_1c reductions were greater with exenatide QW plus dapagliflozin (least squares mean change -1.75% [-19.1 mmol/mol]) versus exenatide QW (-1.38% [-15.1 mmol/mol]; P = 0.006) or dapagliflozin (-1.23% [-13.4 mmol/mol]; P < 0.001)
Summary · context
Extension-period P values were nominal.
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).
Report a problemFND-3008232603
08HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, exenatide plus dapagliflozin reduced weight more than exenatide alone at 52 weeks.
In plain wordsIn adults with type 2 diabetes, exenatide plus dapagliflozin reduced weight more than exenatide alone.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseWeight change versus exenatide
Study
n: not reported in source
Comparator
exenatide alone
Outcome group
Body weight · Metabolic and weight
Measurements
Weight change
−3.31 kg
combination
Weight change
−1.51 kg
exenatide alone
Source sentences
Summary
Weight and SBP reductions were greater with exenatide QW plus dapagliflozin (-3.31 kg and -4.5 mmHg) versus exenatide QW (-1.51 kg and -0.7 mmHg; both P < 0.001) but similar to those with dapagliflozin (-2.28 kg and -2.7 mmHg; P = 0.057 and P = 0.100, respectively).
1 context sentence(design, population, supporting numbers)
Summary · context
Extension-period P values were nominal.
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).
Report a problemFND-3008232605
09HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, exenatide plus dapagliflozin reduced systolic blood pressure more than exenatide alone at 52 weeks.
In plain wordsIn adults with type 2 diabetes, exenatide plus dapagliflozin lowered systolic blood pressure more than exenatide alone.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseSystolic blood pressure versus exenatide
Study
n: not reported in source
Comparator
exenatide alone
Outcome group
Blood pressure · Cardiovascular
Measurements
SBP change
−4.5 mmHg
combination
SBP change
−0.7 mmHg
exenatide alone
Source sentences
Summary
Weight and SBP reductions were greater with exenatide QW plus dapagliflozin (-3.31 kg and -4.5 mmHg) versus exenatide QW (-1.51 kg and -0.7 mmHg; both P < 0.001) but similar to those with dapagliflozin (-2.28 kg and -2.7 mmHg; P = 0.057 and P = 0.100, respectively).
1 context sentence(design, population, supporting numbers)
Summary · context
Extension-period P values were nominal.
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).
Report a problemFND-3008232606
10HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes, exenatide plus dapagliflozin was well tolerated with no unexpected safety findings.
In plain wordsIn adults with type 2 diabetes, exenatide plus dapagliflozin was well tolerated, with no unexpected safety findings.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableCombination tolerability
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Source sentences
Summary
The exenatide QW plus dapagliflozin regimen was well tolerated with no unexpected safety findings; more patients treated with exenatide QW experienced gastrointestinal and injection site-related adverse events.
1 context sentence(design, population, supporting numbers)
Summary · context
Extension-period P values were nominal.
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).
Report a problemFND-3008232609
11HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes, more patients treated with once-weekly exenatide experienced gastrointestinal adverse events, without an arm-specific comparison.
In plain wordsIn adults with type 2 diabetes, more exenatide recipients had digestive adverse events, but the abstract does not identify specific treatment arms.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseGastrointestinal adverse events
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Source sentences
Summary
The exenatide QW plus dapagliflozin regimen was well tolerated with no unexpected safety findings; more patients treated with exenatide QW experienced gastrointestinal and injection site-related adverse events.
1 context sentence(design, population, supporting numbers)
Summary · context
Extension-period P values were nominal.
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).
Report a problemFND-3008232610
12HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialSafety outcome
In adults with type 2 diabetes, more patients treated with once-weekly exenatide experienced injection-site adverse events, without an arm-specific comparison.
In plain wordsIn adults with type 2 diabetes, more exenatide recipients had injection-site adverse events, but the abstract does not identify specific treatment arms.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseInjection-site adverse events
Study
n: not reported in source
Outcome group
Adverse events · Skin and wound
Source sentences
Summary
The exenatide QW plus dapagliflozin regimen was well tolerated with no unexpected safety findings; more patients treated with exenatide QW experienced gastrointestinal and injection site-related adverse events.
1 context sentence(design, population, supporting numbers)
Summary · context
Extension-period P values were nominal.
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).
Report a problemFND-3008232611

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 postedNCT02229396

Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo

AstraZenecan = 6954 Sept 2014 to 28 Dec 2017

Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 31 Dec 2018

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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