Efficacy and safety of exenatide administered before the two largest daily meals of Latin American patients with type 2 diabetes.

Forti A, Garcia EG, Yu MB, Jimenez MC, Brodows RG, Oliveira JH

Current medical research and opinion24 Jul 2008Cited by 14 (Europe PMC)

PMID18662495DOI10.1185/03007990802282398PepBankPUB-18662495

Publisher page 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: Publisher copyright. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
In Latin American patients with type 2 diabetes, exenatide before breakfast and dinner was non-inferior to lunch and dinner for HbA1c reduction.
In plain wordsIn people with diabetes, exenatide before breakfast and dinner met the non-inferiority criterion versus lunch and dinner for A1c reduction.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHbA1c non-inferiority by meal timing
Study
n = 377
Comparator
Exenatide before lunch and dinner
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5-mug for 4 weeks, then 10-microg for 8 weeks · 4 weeks, then 8 weeksAs given in this study (human).
Measurements
HbA1c difference
0.14%
lunch/dinner minus breakfast/dinner
95% CI lower
−0.04%
difference
95% CI upper
0.32%
difference
Source sentences
Summary
HbA(1c) reduction with exenatide administration before BD was non-inferior to administration before LD (mean difference between (LD-BD) treatments: 0.14%; 95% CI -0.04 to 0.32%, p=0.120).
2 context sentences(design, population, supporting numbers)
Summary · context
In this open-label, 2-arm study, patients taking metformin, sulfonylureas, and/or thiazolidinediones were randomized to exenatide before BD or before LD (5-mug exenatide for 4 weeks, then 10-microg exenatide for 8 weeks).
Summary · context
Patients were eligible for study inclusion if they consumed <15% of their total caloric intake at breakfast.
Report a problemFND-1866249501
02HumanRandomized controlled trialEfficacy outcome
In Latin American patients with type 2 diabetes, exenatide before breakfast and dinner significantly reduced HbA1c from baseline.
In plain wordsIn people with diabetes, exenatide before breakfast and dinner reduced A1c compared with baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c change before breakfast and dinner
Study
n: not reported in source
Comparator
Baseline
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5-mug for 4 weeks, then 10-microg for 8 weeks · 4 weeks, then 8 weeksAs given in this study (human).
Measurements
HbA1c change
−1.2%
breakfast/dinner
Source sentences
Summary
Both treatments resulted in statistically significant HbA(1c) reductions at endpoint (BD -1.2% and LD -1.1%, respectively, p<0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
In this open-label, 2-arm study, patients taking metformin, sulfonylureas, and/or thiazolidinediones were randomized to exenatide before BD or before LD (5-mug exenatide for 4 weeks, then 10-microg exenatide for 8 weeks).
Summary · context
Patients were eligible for study inclusion if they consumed <15% of their total caloric intake at breakfast.
Report a problemFND-1866249502
03HumanRandomized controlled trialEfficacy outcome
In Latin American patients with type 2 diabetes, exenatide before lunch and dinner significantly reduced HbA1c from baseline.
In plain wordsIn people with diabetes, exenatide before lunch and dinner reduced A1c compared with baseline.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c change before lunch and dinner
Study
n: not reported in source
Comparator
Baseline
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5-mug for 4 weeks, then 10-microg for 8 weeks · 4 weeks, then 8 weeksAs given in this study (human).
Measurements
HbA1c change
−1.1%
lunch/dinner
Source sentences
Summary
Both treatments resulted in statistically significant HbA(1c) reductions at endpoint (BD -1.2% and LD -1.1%, respectively, p<0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
In this open-label, 2-arm study, patients taking metformin, sulfonylureas, and/or thiazolidinediones were randomized to exenatide before BD or before LD (5-mug exenatide for 4 weeks, then 10-microg exenatide for 8 weeks).
Summary · context
Patients were eligible for study inclusion if they consumed <15% of their total caloric intake at breakfast.
Report a problemFND-1866249503
04HumanRandomized controlled trialEfficacy outcome
In Latin American patients with type 2 diabetes, fasting serum glucose change did not differ significantly between exenatide meal-timing arms.
In plain wordsIn people with diabetes, fasting glucose changes did not differ significantly between the two exenatide meal schedules.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeFasting serum glucose change
Study
n = 377
Comparator
Exenatide before lunch and dinner
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5-mug for 4 weeks, then 10-microg for 8 weeks · 4 weeks, then 8 weeksAs given in this study (human).
Measurements
FSG change difference
0.5 mmol/L
meal-timing arms
Source sentences
Summary
At endpoint, there were no statistical significant differences between the BD and LD arms in mean change in FSG (0.50 mmol/L; CI -0.02 to 1.02 mmol/L, p=0.058) and daily mean change in SMBG (0.19 mmol/L; CI -0.17 to 0.54 mmol/L, p=0.295).
2 context sentences(design, population, supporting numbers)
Summary · context
In this open-label, 2-arm study, patients taking metformin, sulfonylureas, and/or thiazolidinediones were randomized to exenatide before BD or before LD (5-mug exenatide for 4 weeks, then 10-microg exenatide for 8 weeks).
Summary · context
Patients were eligible for study inclusion if they consumed <15% of their total caloric intake at breakfast.
Report a problemFND-1866249506
05HumanRandomized controlled trialEfficacy outcome
In Latin American patients with type 2 diabetes, daily mean SMBG change did not differ significantly between exenatide meal-timing arms.
In plain wordsIn people with diabetes, average daily self-measured glucose changes did not differ significantly between the two exenatide meal schedules.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeDaily mean SMBG change
Study
n = 377
Comparator
Exenatide before lunch and dinner
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5-mug for 4 weeks, then 10-microg for 8 weeks · 4 weeks, then 8 weeksAs given in this study (human).
Measurements
SMBG change difference
0.19 mmol/L
meal-timing arms
Source sentences
Summary
At endpoint, there were no statistical significant differences between the BD and LD arms in mean change in FSG (0.50 mmol/L; CI -0.02 to 1.02 mmol/L, p=0.058) and daily mean change in SMBG (0.19 mmol/L; CI -0.17 to 0.54 mmol/L, p=0.295).
2 context sentences(design, population, supporting numbers)
Summary · context
In this open-label, 2-arm study, patients taking metformin, sulfonylureas, and/or thiazolidinediones were randomized to exenatide before BD or before LD (5-mug exenatide for 4 weeks, then 10-microg exenatide for 8 weeks).
Summary · context
Patients were eligible for study inclusion if they consumed <15% of their total caloric intake at breakfast.
Report a problemFND-1866249507
06HumanRandomized controlled trialSafety outcome
In Latin American patients with type 2 diabetes, symptomatic hypoglycemia rates were similar between exenatide meal-timing arms.
In plain wordsIn people with diabetes, symptomatic hypoglycemia rates were similar between the two exenatide meal schedules.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeSymptomatic hypoglycemia rate
Study
n = 377
Comparator
Exenatide before lunch and dinner
Analysis
Secondary
Outcome group
Adverse events · Metabolic and weight
Studied dose
5-mug for 4 weeks, then 10-microg for 8 weeks · 4 weeks, then 8 weeksAs given in this study (human).
Measurements
Symptomatic hypoglycemia
5.2 events/patient-year
breakfast/dinner
Symptomatic hypoglycemia
6.1 events/patient-year
lunch/dinner
Source sentences
Summary
The rates of symptomatic hypoglycemia (5.2 events/patient-year vs. 6.1 events/patient-year) and nausea (23% vs. 25%), were similar between the BD and LD arms, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
In this open-label, 2-arm study, patients taking metformin, sulfonylureas, and/or thiazolidinediones were randomized to exenatide before BD or before LD (5-mug exenatide for 4 weeks, then 10-microg exenatide for 8 weeks).
Summary · context
Patients were eligible for study inclusion if they consumed <15% of their total caloric intake at breakfast.
Report a problemFND-1866249508
07HumanRandomized controlled trialSafety outcome
In Latin American patients with type 2 diabetes, nausea rates were similar between exenatide meal-timing arms.
In plain wordsIn people with diabetes, nausea rates were similar between the two exenatide meal schedules.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeNausea rate
Study
n = 377
Comparator
Exenatide before lunch and dinner
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
5-mug for 4 weeks, then 10-microg for 8 weeks · 4 weeks, then 8 weeksAs given in this study (human).
Measurements
Nausea
23%
breakfast/dinner
Nausea
25%
lunch/dinner
Source sentences
Summary
The rates of symptomatic hypoglycemia (5.2 events/patient-year vs. 6.1 events/patient-year) and nausea (23% vs. 25%), were similar between the BD and LD arms, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
In this open-label, 2-arm study, patients taking metformin, sulfonylureas, and/or thiazolidinediones were randomized to exenatide before BD or before LD (5-mug exenatide for 4 weeks, then 10-microg exenatide for 8 weeks).
Summary · context
Patients were eligible for study inclusion if they consumed <15% of their total caloric intake at breakfast.
Report a problemFND-1866249509
08HumanRandomized controlled trialEfficacy outcome
In Brazilian patients with type 2 diabetes, exenatide meal-timing arms met the non-inferiority criteria for HbA1c reduction.
In plain wordsIn Brazilian people with diabetes, the exenatide meal schedules met the non-inferiority criteria for A1c reduction.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHbA1c non-inferiority in Brazil
Study
n: not reported in source
Comparator
Exenatide before lunch and dinner
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5-mug for 4 weeks, then 10-microg for 8 weeks · 4 weeks, then 8 weeksAs given in this study (human).
Measurements
HbA1c difference
−0.12%
Brazil
CI lower
−0.37%
Brazil
CI upper
0.13%
Brazil
Source sentences
Summary
In Brazil, the non-inferiority criteria were met for HbA(1c) reduction between treatment arms (-0.12%; CI -0.37 to 0.13%, p=0.344),
2 context sentences(design, population, supporting numbers)
Summary · context
In this open-label, 2-arm study, patients taking metformin, sulfonylureas, and/or thiazolidinediones were randomized to exenatide before BD or before LD (5-mug exenatide for 4 weeks, then 10-microg exenatide for 8 weeks).
Summary · context
Patients were eligible for study inclusion if they consumed <15% of their total caloric intake at breakfast.
Report a problemFND-1866249504
09HumanRandomized controlled trialEfficacy outcome
In Mexican patients with type 2 diabetes, HbA1c reduction favored exenatide before breakfast and dinner over lunch and dinner.
In plain wordsIn Mexican people with diabetes, exenatide before breakfast and dinner reduced A1c more than lunch and dinner.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c timing difference in Mexico
Study
n: not reported in source
Comparator
Exenatide before lunch and dinner
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5-mug for 4 weeks, then 10-microg for 8 weeks · 4 weeks, then 8 weeksAs given in this study (human).
Measurements
HbA1c difference
0.41%
Mexico
CI lower
0.16%
Mexico
CI upper
0.66%
Mexico
Source sentences
Summary
whereas in Mexico, there was a difference favoring exenatide administration before BD (0.41%; CI 0.16 to 0.66%, p=0.002).
2 context sentences(design, population, supporting numbers)
Summary · context
In this open-label, 2-arm study, patients taking metformin, sulfonylureas, and/or thiazolidinediones were randomized to exenatide before BD or before LD (5-mug exenatide for 4 weeks, then 10-microg exenatide for 8 weeks).
Summary · context
Patients were eligible for study inclusion if they consumed <15% of their total caloric intake at breakfast.
Report a problemFND-1866249505

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 · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT00359879

Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes

AstraZenecan = 377Sept 2006 to Jul 2007

Type 2 Diabetes

Trial page ClinicalTrials.govUpdated 23 Feb 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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