Efficacy and Safety of Multiple Doses of Exenatide Once-Monthly Suspension in Patients With Type 2 Diabetes: A Phase II Randomized Clinical Trial.

Wysham CH, MacConell L, Hardy E

Diabetes care19 Jul 2016Cited by 12 (Europe PMC)

PMID27436275DOI10.2337/dc16-0238PepBankPUB-27436275

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 study14

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

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, weekly exenatide reduced HbA1c from baseline by 1.54% at week 20.
In plain wordsIn adults with diabetes, weekly exenatide lowered HbA1c by 1.54% from baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c change, weekly 2 mg
Study
n: not reported in source
Comparator
Baseline
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly · subcutaneous · 20 weeksAs given in this study (human).
Measurements
HbA1c change
−1.54%
weekly exenatide
Source sentences
Summary
At week 20, mean ± SD HbA1c reductions were -1.54% ± 1.26% with exenatide QW and -1.29% ± 1.07%, -1.31% ± 1.66%, and -1.45% ± 0.93% with exenatide QMS 5, 8, and 11 mg, respectively (evaluable population: n = 110).
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase II, randomized, controlled, single-blind study, 121 adults (∼30/arm) with type 2 diabetes and HbA1c 7.1-11.0% (54-97 mmol/mol) were randomized 1:1:1:1 to subcutaneous exenatide QW 2 mg (self-administered) or exenatide QMS 5, 8, or 11 mg (caregiver-administered) for 20 weeks.
Report a problemFND-2743627501
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, monthly exenatide 5 mg reduced HbA1c from baseline by 1.29%.
In plain wordsIn adults with diabetes, monthly exenatide 5 mg lowered HbA1c by 1.29% from baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c change, monthly 5 mg
Study
n: not reported in source
Comparator
Baseline
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 mg once monthly · subcutaneous · 20 weeksAs given in this study (human).
Measurements
HbA1c change
−1.29%
monthly 5 mg
Source sentences
Summary
At week 20, mean ± SD HbA1c reductions were -1.54% ± 1.26% with exenatide QW and -1.29% ± 1.07%, -1.31% ± 1.66%, and -1.45% ± 0.93% with exenatide QMS 5, 8, and 11 mg, respectively (evaluable population: n = 110).
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase II, randomized, controlled, single-blind study, 121 adults (∼30/arm) with type 2 diabetes and HbA1c 7.1-11.0% (54-97 mmol/mol) were randomized 1:1:1:1 to subcutaneous exenatide QW 2 mg (self-administered) or exenatide QMS 5, 8, or 11 mg (caregiver-administered) for 20 weeks.
Report a problemFND-2743627502
03HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, monthly exenatide 8 mg reduced HbA1c from baseline by 1.31%.
In plain wordsIn adults with diabetes, monthly exenatide 8 mg lowered HbA1c by 1.31% from baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c change, monthly 8 mg
Study
n: not reported in source
Comparator
Baseline
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
8 mg once monthly · subcutaneous · 20 weeksAs given in this study (human).
Measurements
HbA1c change
−1.31%
monthly 8 mg
Source sentences
Summary
At week 20, mean ± SD HbA1c reductions were -1.54% ± 1.26% with exenatide QW and -1.29% ± 1.07%, -1.31% ± 1.66%, and -1.45% ± 0.93% with exenatide QMS 5, 8, and 11 mg, respectively (evaluable population: n = 110).
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase II, randomized, controlled, single-blind study, 121 adults (∼30/arm) with type 2 diabetes and HbA1c 7.1-11.0% (54-97 mmol/mol) were randomized 1:1:1:1 to subcutaneous exenatide QW 2 mg (self-administered) or exenatide QMS 5, 8, or 11 mg (caregiver-administered) for 20 weeks.
Report a problemFND-2743627503
04HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, monthly exenatide 11 mg reduced HbA1c from baseline by 1.45%.
In plain wordsIn adults with diabetes, monthly exenatide 11 mg lowered HbA1c by 1.45% from baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c change, monthly 11 mg
Study
n: not reported in source
Comparator
Baseline
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
11 mg once monthly · subcutaneous · 20 weeksAs given in this study (human).
Measurements
HbA1c change
−1.45%
monthly 11 mg
Source sentences
Summary
At week 20, mean ± SD HbA1c reductions were -1.54% ± 1.26% with exenatide QW and -1.29% ± 1.07%, -1.31% ± 1.66%, and -1.45% ± 0.93% with exenatide QMS 5, 8, and 11 mg, respectively (evaluable population: n = 110).
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase II, randomized, controlled, single-blind study, 121 adults (∼30/arm) with type 2 diabetes and HbA1c 7.1-11.0% (54-97 mmol/mol) were randomized 1:1:1:1 to subcutaneous exenatide QW 2 mg (self-administered) or exenatide QMS 5, 8, or 11 mg (caregiver-administered) for 20 weeks.
Report a problemFND-2743627504
05HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, body weight decreased from baseline with all exenatide regimens.
In plain wordsIn adults with diabetes, weight decreased from baseline with all exenatide regimens.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseBody weight
Study
n = 121
Comparator
Baseline
Outcome group
Body weight · Metabolic and weight
Studied dose
2 mg weekly or 5, 8 or 11 mg monthly · subcutaneous · 20 weeksAs given in this study (human).
Source sentences
Summary
Weight decreased with all treatments.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase II, randomized, controlled, single-blind study, 121 adults (∼30/arm) with type 2 diabetes and HbA1c 7.1-11.0% (54-97 mmol/mol) were randomized 1:1:1:1 to subcutaneous exenatide QW 2 mg (self-administered) or exenatide QMS 5, 8, or 11 mg (caregiver-administered) for 20 weeks.
Report a problemFND-2743627510
06HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, no major hypoglycemia occurred with the exenatide regimens.
In plain wordsIn adults with diabetes, no major low blood sugar events occurred with the exenatide regimens.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableMajor hypoglycemia
Study
n = 121
Outcome group
Adverse events · Metabolic and weight
Studied dose
2 mg once weekly or 5, 8 or 11 mg once monthly · subcutaneous · 20 weeksAs given in this study (human).
Source sentences
Summary
No major or minor hypoglycemia occurred.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase II, randomized, controlled, single-blind study, 121 adults (∼30/arm) with type 2 diabetes and HbA1c 7.1-11.0% (54-97 mmol/mol) were randomized 1:1:1:1 to subcutaneous exenatide QW 2 mg (self-administered) or exenatide QMS 5, 8, or 11 mg (caregiver-administered) for 20 weeks.
Report a problemFND-2743627513
07HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, no minor hypoglycemia occurred with the exenatide regimens.
In plain wordsIn adults with diabetes, no minor low blood sugar events occurred with the exenatide regimens.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableMinor hypoglycemia
Study
n = 121
Outcome group
Adverse events · Metabolic and weight
Studied dose
2 mg once weekly or 5, 8 or 11 mg once monthly · subcutaneous · 20 weeksAs given in this study (human).
Source sentences
Summary
No major or minor hypoglycemia occurred.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase II, randomized, controlled, single-blind study, 121 adults (∼30/arm) with type 2 diabetes and HbA1c 7.1-11.0% (54-97 mmol/mol) were randomized 1:1:1:1 to subcutaneous exenatide QW 2 mg (self-administered) or exenatide QMS 5, 8, or 11 mg (caregiver-administered) for 20 weeks.
Report a problemFND-2743627514
08HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, HbA1c reductions did not differ significantly among monthly exenatide doses.
In plain wordsIn adults with diabetes, HbA1c reductions did not differ significantly between monthly exenatide doses.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHbA1c differences among monthly doses
Study
n: not reported in source
Comparator
Other monthly exenatide doses
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5, 8 or 11 mg once monthly · subcutaneous · 20 weeksAs given in this study (human).
Source sentences
Summary
There were no significant differences in HbA1c reductions among the exenatide QMS doses.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase II, randomized, controlled, single-blind study, 121 adults (∼30/arm) with type 2 diabetes and HbA1c 7.1-11.0% (54-97 mmol/mol) were randomized 1:1:1:1 to subcutaneous exenatide QW 2 mg (self-administered) or exenatide QMS 5, 8, or 11 mg (caregiver-administered) for 20 weeks.
Report a problemFND-2743627505
09HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, weekly exenatide reduced fasting plasma glucose by 34 mg/dL from baseline.
In plain wordsIn adults with diabetes, weekly exenatide lowered fasting blood sugar by 34 mg/dL from baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseFasting plasma glucose change, weekly 2 mg
Study
n: not reported in source
Comparator
Baseline
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly · subcutaneous · 20 weeksAs given in this study (human).
Measurements
FPG change
−34 mg/dL
weekly exenatide
Source sentences
Summary
FPG reductions were -34 ± 48 mg/dL with exenatide QW and -25 ± 43, -30 ± 52, and -49 ± 49 mg/dL with exenatide QMS 5, 8, and 11 mg, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase II, randomized, controlled, single-blind study, 121 adults (∼30/arm) with type 2 diabetes and HbA1c 7.1-11.0% (54-97 mmol/mol) were randomized 1:1:1:1 to subcutaneous exenatide QW 2 mg (self-administered) or exenatide QMS 5, 8, or 11 mg (caregiver-administered) for 20 weeks.
Report a problemFND-2743627506
10HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, monthly exenatide 5 mg reduced fasting plasma glucose by 25 mg/dL from baseline.
In plain wordsIn adults with diabetes, monthly exenatide 5 mg lowered fasting blood sugar by 25 mg/dL from baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseFasting plasma glucose change, monthly 5 mg
Study
n: not reported in source
Comparator
Baseline
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 mg once monthly · subcutaneous · 20 weeksAs given in this study (human).
Measurements
FPG change
−25 mg/dL
monthly 5 mg
Source sentences
Summary
FPG reductions were -34 ± 48 mg/dL with exenatide QW and -25 ± 43, -30 ± 52, and -49 ± 49 mg/dL with exenatide QMS 5, 8, and 11 mg, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase II, randomized, controlled, single-blind study, 121 adults (∼30/arm) with type 2 diabetes and HbA1c 7.1-11.0% (54-97 mmol/mol) were randomized 1:1:1:1 to subcutaneous exenatide QW 2 mg (self-administered) or exenatide QMS 5, 8, or 11 mg (caregiver-administered) for 20 weeks.
Report a problemFND-2743627507
11HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, monthly exenatide 8 mg reduced fasting plasma glucose by 30 mg/dL from baseline.
In plain wordsIn adults with diabetes, monthly exenatide 8 mg lowered fasting blood sugar by 30 mg/dL from baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseFasting plasma glucose change, monthly 8 mg
Study
n: not reported in source
Comparator
Baseline
Outcome group
Glycemic control · Metabolic and weight
Studied dose
8 mg once monthly · subcutaneous · 20 weeksAs given in this study (human).
Measurements
FPG change
−30 mg/dL
monthly 8 mg
Source sentences
Summary
FPG reductions were -34 ± 48 mg/dL with exenatide QW and -25 ± 43, -30 ± 52, and -49 ± 49 mg/dL with exenatide QMS 5, 8, and 11 mg, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase II, randomized, controlled, single-blind study, 121 adults (∼30/arm) with type 2 diabetes and HbA1c 7.1-11.0% (54-97 mmol/mol) were randomized 1:1:1:1 to subcutaneous exenatide QW 2 mg (self-administered) or exenatide QMS 5, 8, or 11 mg (caregiver-administered) for 20 weeks.
Report a problemFND-2743627508
12HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, monthly exenatide 11 mg reduced fasting plasma glucose by 49 mg/dL from baseline.
In plain wordsIn adults with diabetes, monthly exenatide 11 mg lowered fasting blood sugar by 49 mg/dL from baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseFasting plasma glucose change, monthly 11 mg
Study
n: not reported in source
Comparator
Baseline
Outcome group
Glycemic control · Metabolic and weight
Studied dose
11 mg once monthly · subcutaneous · 20 weeksAs given in this study (human).
Measurements
FPG change
−49 mg/dL
monthly 11 mg
Source sentences
Summary
FPG reductions were -34 ± 48 mg/dL with exenatide QW and -25 ± 43, -30 ± 52, and -49 ± 49 mg/dL with exenatide QMS 5, 8, and 11 mg, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase II, randomized, controlled, single-blind study, 121 adults (∼30/arm) with type 2 diabetes and HbA1c 7.1-11.0% (54-97 mmol/mol) were randomized 1:1:1:1 to subcutaneous exenatide QW 2 mg (self-administered) or exenatide QMS 5, 8, or 11 mg (caregiver-administered) for 20 weeks.
Report a problemFND-2743627509
13HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, nausea occurred in 16.7-23.3% with monthly exenatide.
In plain wordsIn adults with diabetes, 16.7-23.3% reported nausea during monthly exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableNausea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
5, 8 or 11 mg once monthly · subcutaneous · 20 weeksAs given in this study (human).
Measurements
Nausea incidence
16.7 to 23.3%
monthly exenatide
Source sentences
Summary
For exenatide QMS, nausea (16.7-23.3%) and headache (16.7-26.7%) were the most common adverse events.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase II, randomized, controlled, single-blind study, 121 adults (∼30/arm) with type 2 diabetes and HbA1c 7.1-11.0% (54-97 mmol/mol) were randomized 1:1:1:1 to subcutaneous exenatide QW 2 mg (self-administered) or exenatide QMS 5, 8, or 11 mg (caregiver-administered) for 20 weeks.
Report a problemFND-2743627511
14HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, headache occurred in 16.7-26.7% with monthly exenatide.
In plain wordsIn adults with diabetes, 16.7-26.7% reported headache during monthly exenatide treatment.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableHeadache
Study
n: not reported in source
Outcome group
Adverse events · Nervous system and cognition
Studied dose
5, 8 or 11 mg once monthly · subcutaneous · 20 weeksAs given in this study (human).
Measurements
Headache incidence
16.7 to 26.7%
monthly exenatide
Source sentences
Summary
For exenatide QMS, nausea (16.7-23.3%) and headache (16.7-26.7%) were the most common adverse events.
1 context sentence(design, population, supporting numbers)
Summary · context
In this phase II, randomized, controlled, single-blind study, 121 adults (∼30/arm) with type 2 diabetes and HbA1c 7.1-11.0% (54-97 mmol/mol) were randomized 1:1:1:1 to subcutaneous exenatide QW 2 mg (self-administered) or exenatide QMS 5, 8, or 11 mg (caregiver-administered) for 20 weeks.
Report a problemFND-2743627512

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 2Results postedNCT01104701

A Study to Examine the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension

AstraZenecan = 121May 2010 to Dec 2010

Type 2 Diabetes

Trial page ClinicalTrials.govUpdated 20 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

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