Exenatide once weekly treatment maintained improvements in glycemic control and weight loss over 2 years.

Taylor K, Gurney K, Han J, Pencek R, Walsh B, Trautmann M

BMC endocrine disorders29 Apr 2011Cited by 48 (Europe PMC)

PMID21529363PMCIDPMC3112417DOI10.1186/1472-6823-11-9PepBankPUB-21529363

Summary

BackgroundThe once-weekly (QW) formulation of the glucagon-like peptide-1 receptor agonist exenatide has been demonstrated to improve A1C, fasting plasma glucose (FPG), body weight, serum lipid profiles, and blood pressure in patients with type 2 diabetes through 52 weeks of treatment. In this report, we describe the 2-year results of the open-label, open-ended extension to the DURATION-1 trial of exenatide QW for type 2 diabetes.MethodsA 2-stage protocol was used: patients received either exenatide QW (2 mg) or exenatide twice daily for 30 weeks (5 μg for the first 4 weeks and 10 μg thereafter), followed by 1.5 years of treatment with exenatide QW (2 mg), for a total of 2 years (104 weeks) of exenatide treatment. Of the 295 (intent-to-treat [ITT]) patients who entered the trial, 73% (n = 216) completed 2 years of treatment (completer population). Baseline characteristics (mean ± SE) for these patients were: A1C, 8.2 ± 0.1%; FPG, 168.4 ± 43.0 mg/dL; body weight, 101.1 ± 18.7 kg; and diabetes duration, 7 ± 5 years.ResultsIn the completer population, significant improvements (LS mean ± SE [95% CI]) were maintained after 2 years of treatment in A1C (-1.71 ± 0.08% [-1.86 to -1.55%]), FPG (-40.1 ± 2.9 mg/dL [-45.7 to -34.5 mg/dL]), and body weight (-2.61 ± 0.52 kg [-3.64 to -1.58 kg]) compared with baseline. The percentages of patients who achieved an A1C of <7.0% and ≤6.5% at 2 years were 60% and 39%, respectively. A significant reduction in systolic blood pressure (SBP; -3.0 ± 1.0 mmHg [-4.9 to -1.1 mmHg]) was maintained through 2 years of treatment. Serum lipid profiles were also significantly improved, including triglycerides (geometric LS mean change from baseline, -15 ± 2.7% [-21% to -10%]), total cholesterol (-8.6 ± 2.8 mg/dL [-14.0 to -3.1 mg/dL]), and low-density lipoproteins (-4.5 ± 2.2 mg/dL [-8.9 to -0.01 mg/dL]). Changes in A1C, body weight, FPG, SBP, and lipids in the ITT population were similar to those seen in the completer population. Nausea (predominantly mild in intensity) was the most common adverse event, although the frequency and intensity of nausea decreased over time. No severe hypoglycemia was observed.ConclusionsExenatide QW was well tolerated during the 2-year treatment period. This study demonstrated sustained glucose control and weight loss throughout 2 years of treatment with exenatide QW.Trial registrationClinicalTrials.gov NCT00308139.

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

Results from this study12

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

01HumanNon-randomized trialEfficacy outcome
In type 2 diabetes, ITT changes in A1C, weight, glucose, blood pressure, and lipids resembled completer results with exenatide.
In plain wordsIn type 2 diabetes, ITT metabolic changes resembled completer results with exenatide.
Peptide
Exenatide (exendin-4)
Outcome
Direction not reportedITT metabolic changes
Study
n = 295
Comparator
baseline
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly after initial once-weekly or twice-daily treatment · 104 weeksAs given in this study (human).
Source sentences
Summary
Changes in A1C, body weight, FPG, SBP, and lipids in the ITT population were similar to those seen in the completer population.
2 context sentences(design, population, supporting numbers)
Summary · context
In this report, we describe the 2-year results of the open-label, open-ended extension to the DURATION-1 trial of exenatide QW for type 2 diabetes.
Summary · context
A 2-stage protocol was used: patients received either exenatide QW (2 mg) or exenatide twice daily for 30 weeks (5 μg for the first 4 weeks and 10 μg thereafter), followed by 1.5 years of treatment with exenatide QW (2 mg), for a total of 2 years (104 weeks) of exenatide treatment.
Show in the study text Report a problemFND-2152936310
02HumanNon-randomized trialEfficacy outcome
In trial completers with type 2 diabetes, exenatide reduced A1C from baseline after two years.
In plain wordsIn trial completers with type 2 diabetes, exenatide reduced A1C from baseline after two years.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseA1C change
Study
n = 216
Comparator
baseline
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly after initial once-weekly or twice-daily treatment · 104 weeksAs given in this study (human).
Measurements
A1C change
−1.71%
completers
Source sentences
Summary
In the completer population, significant improvements (LS mean ± SE [95% CI]) were maintained after 2 years of treatment in A1C (-1.71 ± 0.08% [-1.86 to -1.55%]), FPG (-40.1 ± 2.9 mg/dL [-45.7 to -34.5 mg/dL]), and body weight (-2.61 ± 0.52 kg [-3.64 to -1.58 kg]) compared with baseline.
2 context sentences(design, population, supporting numbers)
Summary · context
In this report, we describe the 2-year results of the open-label, open-ended extension to the DURATION-1 trial of exenatide QW for type 2 diabetes.
Summary · context
A 2-stage protocol was used: patients received either exenatide QW (2 mg) or exenatide twice daily for 30 weeks (5 μg for the first 4 weeks and 10 μg thereafter), followed by 1.5 years of treatment with exenatide QW (2 mg), for a total of 2 years (104 weeks) of exenatide treatment.
Show in the study text Report a problemFND-2152936301
03HumanNon-randomized trialEfficacy outcome
In trial completers with type 2 diabetes, exenatide reduced fasting plasma glucose from baseline.
In plain wordsIn trial completers with type 2 diabetes, exenatide reduced fasting blood glucose from baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseFasting plasma glucose change
Study
n = 216
Comparator
baseline
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly after initial once-weekly or twice-daily treatment · 104 weeksAs given in this study (human).
Measurements
FPG change
−40.1 mg/dL
completers
Source sentences
Summary
In the completer population, significant improvements (LS mean ± SE [95% CI]) were maintained after 2 years of treatment in A1C (-1.71 ± 0.08% [-1.86 to -1.55%]), FPG (-40.1 ± 2.9 mg/dL [-45.7 to -34.5 mg/dL]), and body weight (-2.61 ± 0.52 kg [-3.64 to -1.58 kg]) compared with baseline.
2 context sentences(design, population, supporting numbers)
Summary · context
In this report, we describe the 2-year results of the open-label, open-ended extension to the DURATION-1 trial of exenatide QW for type 2 diabetes.
Summary · context
A 2-stage protocol was used: patients received either exenatide QW (2 mg) or exenatide twice daily for 30 weeks (5 μg for the first 4 weeks and 10 μg thereafter), followed by 1.5 years of treatment with exenatide QW (2 mg), for a total of 2 years (104 weeks) of exenatide treatment.
Show in the study text Report a problemFND-2152936302
04HumanNon-randomized trialEfficacy outcome
In trial completers with type 2 diabetes, exenatide reduced body weight from baseline.
In plain wordsIn trial completers with type 2 diabetes, exenatide reduced body weight from baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseBody weight change
Study
n = 216
Comparator
baseline
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg once weekly after initial once-weekly or twice-daily treatment · 104 weeksAs given in this study (human).
Measurements
Weight change
−2.61 kg
completers
Source sentences
Summary
In the completer population, significant improvements (LS mean ± SE [95% CI]) were maintained after 2 years of treatment in A1C (-1.71 ± 0.08% [-1.86 to -1.55%]), FPG (-40.1 ± 2.9 mg/dL [-45.7 to -34.5 mg/dL]), and body weight (-2.61 ± 0.52 kg [-3.64 to -1.58 kg]) compared with baseline.
2 context sentences(design, population, supporting numbers)
Summary · context
In this report, we describe the 2-year results of the open-label, open-ended extension to the DURATION-1 trial of exenatide QW for type 2 diabetes.
Summary · context
A 2-stage protocol was used: patients received either exenatide QW (2 mg) or exenatide twice daily for 30 weeks (5 μg for the first 4 weeks and 10 μg thereafter), followed by 1.5 years of treatment with exenatide QW (2 mg), for a total of 2 years (104 weeks) of exenatide treatment.
Show in the study text Report a problemFND-2152936303
05HumanNon-randomized trialEfficacy outcome
In trial completers with type 2 diabetes, 60% achieved A1C below 7.0% after two years of exenatide.
In plain wordsIn trial completers with type 2 diabetes, 60% achieved A1C below 7.0% after two years of exenatide.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableA1C below 7.0%
Study
n = 216
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly after initial once-weekly or twice-daily treatment · 104 weeksAs given in this study (human).
Measurements
Responders
60%
A1C <7.0%
Source sentences
Summary
The percentages of patients who achieved an A1C of <7.0% and ≤6.5% at 2 years were 60% and 39%, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
In this report, we describe the 2-year results of the open-label, open-ended extension to the DURATION-1 trial of exenatide QW for type 2 diabetes.
Summary · context
A 2-stage protocol was used: patients received either exenatide QW (2 mg) or exenatide twice daily for 30 weeks (5 μg for the first 4 weeks and 10 μg thereafter), followed by 1.5 years of treatment with exenatide QW (2 mg), for a total of 2 years (104 weeks) of exenatide treatment.
Show in the study text Report a problemFND-2152936304
06HumanNon-randomized trialEfficacy outcome
In trial completers with type 2 diabetes, 39% achieved A1C at most 6.5% after two years of exenatide.
In plain wordsIn trial completers with type 2 diabetes, 39% achieved A1C at most 6.5% after two years of exenatide.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableA1C at most 6.5%
Study
n = 216
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly after initial once-weekly or twice-daily treatment · 104 weeksAs given in this study (human).
Measurements
Responders
39%
A1C ≤6.5%
Source sentences
Summary
The percentages of patients who achieved an A1C of <7.0% and ≤6.5% at 2 years were 60% and 39%, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
In this report, we describe the 2-year results of the open-label, open-ended extension to the DURATION-1 trial of exenatide QW for type 2 diabetes.
Summary · context
A 2-stage protocol was used: patients received either exenatide QW (2 mg) or exenatide twice daily for 30 weeks (5 μg for the first 4 weeks and 10 μg thereafter), followed by 1.5 years of treatment with exenatide QW (2 mg), for a total of 2 years (104 weeks) of exenatide treatment.
Show in the study text Report a problemFND-2152936305
07HumanNon-randomized trialEfficacy outcome
In trial completers with type 2 diabetes, exenatide reduced systolic blood pressure from baseline.
In plain wordsIn trial completers with type 2 diabetes, exenatide reduced systolic blood pressure from baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseSystolic blood pressure
Study
n = 216
Comparator
baseline
Outcome group
Blood pressure · Cardiovascular
Studied dose
2 mg once weekly after initial once-weekly or twice-daily treatment · 104 weeksAs given in this study (human).
Measurements
SBP change
−3 mmHg
completers
Source sentences
Summary
A significant reduction in systolic blood pressure (SBP; -3.0 ± 1.0 mmHg [-4.9 to -1.1 mmHg]) was maintained through 2 years of treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
In this report, we describe the 2-year results of the open-label, open-ended extension to the DURATION-1 trial of exenatide QW for type 2 diabetes.
Summary · context
A 2-stage protocol was used: patients received either exenatide QW (2 mg) or exenatide twice daily for 30 weeks (5 μg for the first 4 weeks and 10 μg thereafter), followed by 1.5 years of treatment with exenatide QW (2 mg), for a total of 2 years (104 weeks) of exenatide treatment.
Show in the study text Report a problemFND-2152936306
08HumanNon-randomized trialEfficacy outcome
In trial completers with type 2 diabetes, exenatide reduced triglycerides from baseline.
In plain wordsIn trial completers with type 2 diabetes, exenatide reduced triglycerides from baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseTriglycerides
Study
n = 216
Comparator
baseline
Outcome group
Lipids · Metabolic and weight
Studied dose
2 mg once weekly after initial once-weekly or twice-daily treatment · 104 weeksAs given in this study (human).
Measurements
Triglyceride change
−15%
completers
Source sentences
Summary
Serum lipid profiles were also significantly improved, including triglycerides (geometric LS mean change from baseline, -15 ± 2.7% [-21% to -10%]), total cholesterol (-8.6 ± 2.8 mg/dL [-14.0 to -3.1 mg/dL]), and low-density lipoproteins (-4.5 ± 2.2 mg/dL [-8.9 to -0.01 mg/dL]).
2 context sentences(design, population, supporting numbers)
Summary · context
In this report, we describe the 2-year results of the open-label, open-ended extension to the DURATION-1 trial of exenatide QW for type 2 diabetes.
Summary · context
A 2-stage protocol was used: patients received either exenatide QW (2 mg) or exenatide twice daily for 30 weeks (5 μg for the first 4 weeks and 10 μg thereafter), followed by 1.5 years of treatment with exenatide QW (2 mg), for a total of 2 years (104 weeks) of exenatide treatment.
Show in the study text Report a problemFND-2152936307
09HumanNon-randomized trialEfficacy outcome
In trial completers with type 2 diabetes, exenatide reduced total cholesterol from baseline.
In plain wordsIn trial completers with type 2 diabetes, exenatide reduced total cholesterol from baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseTotal cholesterol
Study
n = 216
Comparator
baseline
Outcome group
Lipids · Metabolic and weight
Studied dose
2 mg once weekly after initial once-weekly or twice-daily treatment · 104 weeksAs given in this study (human).
Measurements
Cholesterol change
−8.6 mg/dL
completers
Source sentences
Summary
Serum lipid profiles were also significantly improved, including triglycerides (geometric LS mean change from baseline, -15 ± 2.7% [-21% to -10%]), total cholesterol (-8.6 ± 2.8 mg/dL [-14.0 to -3.1 mg/dL]), and low-density lipoproteins (-4.5 ± 2.2 mg/dL [-8.9 to -0.01 mg/dL]).
2 context sentences(design, population, supporting numbers)
Summary · context
In this report, we describe the 2-year results of the open-label, open-ended extension to the DURATION-1 trial of exenatide QW for type 2 diabetes.
Summary · context
A 2-stage protocol was used: patients received either exenatide QW (2 mg) or exenatide twice daily for 30 weeks (5 μg for the first 4 weeks and 10 μg thereafter), followed by 1.5 years of treatment with exenatide QW (2 mg), for a total of 2 years (104 weeks) of exenatide treatment.
Show in the study text Report a problemFND-2152936308
10HumanNon-randomized trialEfficacy outcome
In trial completers with type 2 diabetes, exenatide reduced low-density lipoproteins from baseline.
In plain wordsIn trial completers with type 2 diabetes, exenatide reduced low-density lipoproteins from baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseLow-density lipoproteins
Study
n = 216
Comparator
baseline
Outcome group
Lipids · Metabolic and weight
Studied dose
2 mg once weekly after initial once-weekly or twice-daily treatment · 104 weeksAs given in this study (human).
Measurements
LDL change
−4.5 mg/dL
completers
Source sentences
Summary
Serum lipid profiles were also significantly improved, including triglycerides (geometric LS mean change from baseline, -15 ± 2.7% [-21% to -10%]), total cholesterol (-8.6 ± 2.8 mg/dL [-14.0 to -3.1 mg/dL]), and low-density lipoproteins (-4.5 ± 2.2 mg/dL [-8.9 to -0.01 mg/dL]).
2 context sentences(design, population, supporting numbers)
Summary · context
In this report, we describe the 2-year results of the open-label, open-ended extension to the DURATION-1 trial of exenatide QW for type 2 diabetes.
Summary · context
A 2-stage protocol was used: patients received either exenatide QW (2 mg) or exenatide twice daily for 30 weeks (5 μg for the first 4 weeks and 10 μg thereafter), followed by 1.5 years of treatment with exenatide QW (2 mg), for a total of 2 years (104 weeks) of exenatide treatment.
Show in the study text Report a problemFND-2152936309
11HumanNon-randomized trialSafety outcome
In patients with type 2 diabetes receiving exenatide, nausea was the most common adverse event and decreased in frequency and intensity.
In plain wordsIn patients with type 2 diabetes receiving exenatide, nausea was the most common side effect and became less frequent and intense.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseNausea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
2 mg once weekly after initial once-weekly or twice-daily treatment · 104 weeksAs given in this study (human).
Source sentences
Summary
Nausea (predominantly mild in intensity) was the most common adverse event, although the frequency and intensity of nausea decreased over time.
2 context sentences(design, population, supporting numbers)
Summary · context
In this report, we describe the 2-year results of the open-label, open-ended extension to the DURATION-1 trial of exenatide QW for type 2 diabetes.
Summary · context
A 2-stage protocol was used: patients received either exenatide QW (2 mg) or exenatide twice daily for 30 weeks (5 μg for the first 4 weeks and 10 μg thereafter), followed by 1.5 years of treatment with exenatide QW (2 mg), for a total of 2 years (104 weeks) of exenatide treatment.
Show in the study text Report a problemFND-2152936311
12HumanNon-randomized trialSafety outcome
In patients with type 2 diabetes receiving exenatide, no severe hypoglycemia occurred.
In plain wordsIn patients with type 2 diabetes receiving exenatide, no severe low blood sugar occurred.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableSevere hypoglycemia
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
2 mg once weekly after initial once-weekly or twice-daily treatment · 104 weeksAs given in this study (human).
Source sentences
Summary
No severe hypoglycemia was observed.
2 context sentences(design, population, supporting numbers)
Summary · context
In this report, we describe the 2-year results of the open-label, open-ended extension to the DURATION-1 trial of exenatide QW for type 2 diabetes.
Summary · context
A 2-stage protocol was used: patients received either exenatide QW (2 mg) or exenatide twice daily for 30 weeks (5 μg for the first 4 weeks and 10 μg thereafter), followed by 1.5 years of treatment with exenatide QW (2 mg), for a total of 2 years (104 weeks) of exenatide treatment.
Show in the study text Report a problemFND-2152936312

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

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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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