Pharmacology and tolerability of a single dose of exenatide in adolescent patients with type 2 diabetes mellitus being treated with metformin: a randomized, placebo-controlled, single-blind, dose-escalation, crossover study.

Malloy J, Capparelli E, Gottschalk M, Guan X, Kothare P, Fineman M

Clinical therapeutics1 Apr 2009Cited by 29 (Europe PMC)

PMID19446153DOI10.1016/j.clinthera.2009.04.005PepBankPUB-19446153

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 study11

11 results from studies that gave the peptide. 11 results from people.

01HumanRandomized controlled trialSafety outcome
In adolescents with type 2 diabetes, no hypoglycemic events occurred during the exenatide crossover study.
In plain wordsIn adolescents with diabetes, no low blood sugar events occurred during the exenatide study.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableHypoglycemic events
Study
n = 13
Analysis
Primary
Outcome group
Adverse events · Metabolic and weight
Studied dose
2.5 and 5 microg · subcutaneous · single doseAs given in this study (human).
Source sentences
Summary
Exenatide was generally well tolerated, with no hypoglycemic events recorded during the study.
3 context sentences(design, population, supporting numbers)
Summary · context
The study enrolled 13 adolescent patients with T2DM (7 females, 6 males; mean [SD] age, 15 [1] years; body mass index, 32.5 [5.0] kg/m(2); glycosylated hemoglobin, 8.2% [1.5%]).
Summary · context
This was a randomized, single-blind, dose-escalation, crossover study in adolescent (age 10-16 years) patients with T2DM who were being treated with diet and exercise or a stable dose of metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea for at least 3 months before screening.
Summary · context
Eligible patients were allocated to receive single subcutaneous doses of exenatide 2.5 microg, exenatide 5 microg, and placebo, each followed by a standardized meal, on 3 separate days (maximum interval between first and third doses, 5 weeks).
Report a problemFND-1944615311
02HumanRandomized controlled trialPharmacokinetics
In adolescents with type 2 diabetes, a single exenatide dose produced the reported plasma exposure.
In plain wordsIn adolescents with diabetes, a single exenatide dose produced measurable blood exposure.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableExenatide AUC
Study
n = 12
Analysis
Primary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
5 microg · subcutaneous · single doseAs given in this study (human).
Measurements
AUC(0-infinity)
339.5 pg * h/mL
5 microg
Source sentences
Summary
After administration of exenatide 5 microg, the geometric mean (SE) exenatide AUC(0-infinity) and C(max) were 339.5 (39.6) pg * h/mL and 85.1 (11.5) pg/mL, respectively (n = 12).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, single-blind, dose-escalation, crossover study in adolescent (age 10-16 years) patients with T2DM who were being treated with diet and exercise or a stable dose of metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea for at least 3 months before screening.
Summary · context
Eligible patients were allocated to receive single subcutaneous doses of exenatide 2.5 microg, exenatide 5 microg, and placebo, each followed by a standardized meal, on 3 separate days (maximum interval between first and third doses, 5 weeks).
Report a problemFND-1944615301
03HumanRandomized controlled trialPharmacokinetics
In adolescents with type 2 diabetes, exenatide reached the reported peak plasma concentration.
In plain wordsIn adolescents with diabetes, exenatide reached the reported peak blood concentration.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableExenatide Cmax
Study
n = 12
Analysis
Primary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
5 microg · subcutaneous · single doseAs given in this study (human).
Measurements
Cmax
85.1 pg/mL
5 microg
Source sentences
Summary
After administration of exenatide 5 microg, the geometric mean (SE) exenatide AUC(0-infinity) and C(max) were 339.5 (39.6) pg * h/mL and 85.1 (11.5) pg/mL, respectively (n = 12).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, single-blind, dose-escalation, crossover study in adolescent (age 10-16 years) patients with T2DM who were being treated with diet and exercise or a stable dose of metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea for at least 3 months before screening.
Summary · context
Eligible patients were allocated to receive single subcutaneous doses of exenatide 2.5 microg, exenatide 5 microg, and placebo, each followed by a standardized meal, on 3 separate days (maximum interval between first and third doses, 5 weeks).
Report a problemFND-1944615302
04HumanRandomized controlled trialPharmacokinetics
In adolescents with type 2 diabetes, the lower exenatide dose reached the reported peak plasma concentration.
In plain wordsIn adolescents with diabetes, the lower exenatide dose reached the reported peak blood concentration.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableExenatide Cmax
Study
n = 9
Analysis
Primary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
2.5 microg · subcutaneous · single doseAs given in this study (human).
Measurements
Cmax
56.3 pg/mL
2.5 microg
Source sentences
Summary
after administration of exenatide 2.5-microg, the geometric mean AUC(0-infinity)) was 159.2 (23.1) pg * h/mL (n = 6) and the geometric mean C(max) was 56.3 (10.1) pg/mL (n = 9).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, single-blind, dose-escalation, crossover study in adolescent (age 10-16 years) patients with T2DM who were being treated with diet and exercise or a stable dose of metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea for at least 3 months before screening.
Summary · context
Eligible patients were allocated to receive single subcutaneous doses of exenatide 2.5 microg, exenatide 5 microg, and placebo, each followed by a standardized meal, on 3 separate days (maximum interval between first and third doses, 5 weeks).
Report a problemFND-1944615304
05HumanRandomized controlled trialPharmacokinetics
In adolescents with type 2 diabetes, the lower exenatide dose produced the reported plasma exposure.
In plain wordsIn adolescents with diabetes, the lower exenatide dose produced measurable blood exposure.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableExenatide AUC
Study
n = 6
Analysis
Primary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
2.5 microg · subcutaneous · single doseAs given in this study (human).
Measurements
AUC(0-infinity)
159.2 pg * h/mL
2.5 microg
Source sentences
Summary
after administration of exenatide 2.5-microg, the geometric mean AUC(0-infinity)) was 159.2 (23.1) pg * h/mL (n = 6) and the geometric mean C(max) was 56.3 (10.1) pg/mL (n = 9).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, single-blind, dose-escalation, crossover study in adolescent (age 10-16 years) patients with T2DM who were being treated with diet and exercise or a stable dose of metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea for at least 3 months before screening.
Summary · context
Eligible patients were allocated to receive single subcutaneous doses of exenatide 2.5 microg, exenatide 5 microg, and placebo, each followed by a standardized meal, on 3 separate days (maximum interval between first and third doses, 5 weeks).
Report a problemFND-1944615303
06HumanRandomized controlled trialPharmacokinetics
In adolescents with type 2 diabetes, exenatide plasma exposure appeared dose dependent.
In plain wordsIn adolescents with diabetes, exenatide blood exposure appeared to increase with dose.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseDose dependence of AUC
Study
n: not reported in source
Analysis
Primary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
2.5 and 5 microg · subcutaneous · single doseAs given in this study (human).
Source sentences
Summary
The exenatide AUC appeared to be dose dependent, although exenatide was not quantifiable in all patients at the 2.5-microg dose;
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, single-blind, dose-escalation, crossover study in adolescent (age 10-16 years) patients with T2DM who were being treated with diet and exercise or a stable dose of metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea for at least 3 months before screening.
Summary · context
Eligible patients were allocated to receive single subcutaneous doses of exenatide 2.5 microg, exenatide 5 microg, and placebo, each followed by a standardized meal, on 3 separate days (maximum interval between first and third doses, 5 weeks).
Report a problemFND-1944615305
07HumanRandomized controlled trialEfficacy outcome
In adolescents with type 2 diabetes, low-dose exenatide reduced postprandial glucose excursions versus placebo.
In plain wordsIn adolescents with diabetes, low-dose exenatide reduced glucose rises after meals compared with placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreasePostprandial glucose excursion
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.5 microg · subcutaneous · single doseAs given in this study (human).
Measurements
Incremental glucose AUC
−3465.6 mg * min/dL
lower exenatide dose
Incremental glucose AUC
3457.4 mg * min/dL
placebo
Source sentences
Summary
Both exenatide doses were associated with significant reductions in postprandial plasma glucose excursions compared with placebo (P < 0.01); the incremental mean (SE) AUC(15-360min) was -3465.6 (1587.3) mg * min/dL for exenatide 2.5 pg, -4422.2 (2434.4) mg * min/dL for exenatide 5 microg, and 3457.4…
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, single-blind, dose-escalation, crossover study in adolescent (age 10-16 years) patients with T2DM who were being treated with diet and exercise or a stable dose of metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea for at least 3 months before screening.
Summary · context
Eligible patients were allocated to receive single subcutaneous doses of exenatide 2.5 microg, exenatide 5 microg, and placebo, each followed by a standardized meal, on 3 separate days (maximum interval between first and third doses, 5 weeks).
Report a problemFND-1944615306
08HumanRandomized controlled trialEfficacy outcome
In adolescents with type 2 diabetes, higher-dose exenatide reduced postprandial glucose excursions versus placebo.
In plain wordsIn adolescents with diabetes, higher-dose exenatide reduced glucose rises after meals compared with placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreasePostprandial glucose excursion
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 microg · subcutaneous · single doseAs given in this study (human).
Measurements
Incremental glucose AUC
−4422.2 mg * min/dL
5 microg exenatide
Incremental glucose AUC
3457.4 mg * min/dL
placebo
Source sentences
Summary
Both exenatide doses were associated with significant reductions in postprandial plasma glucose excursions compared with placebo (P < 0.01); the incremental mean (SE) AUC(15-360min) was -3465.6 (1587.3) mg * min/dL for exenatide 2.5 pg, -4422.2 (2434.4) mg * min/dL for exenatide 5 microg, and 3457.4…
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, single-blind, dose-escalation, crossover study in adolescent (age 10-16 years) patients with T2DM who were being treated with diet and exercise or a stable dose of metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea for at least 3 months before screening.
Summary · context
Eligible patients were allocated to receive single subcutaneous doses of exenatide 2.5 microg, exenatide 5 microg, and placebo, each followed by a standardized meal, on 3 separate days (maximum interval between first and third doses, 5 weeks).
Report a problemFND-1944615307
09HumanRandomized controlled trialEfficacy outcome
In adolescents with type 2 diabetes, low-dose exenatide reduced postprandial glucagon versus placebo.
In plain wordsIn adolescents with diabetes, low-dose exenatide reduced glucagon after meals compared with placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreasePostprandial glucagon
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.5 microg · subcutaneous · single doseAs given in this study (human).
Measurements
Incremental glucagon AUC
125.5 pg * min/mL
2.5 microg exenatide
Incremental glucagon AUC
1843.1 pg * min/mL
placebo
Source sentences
Summary
The 2 exenatide doses were also associated with significant reductions in postprandial plasma glucagon concentrations compared with placebo (P < 0.01); the respective incremental mean values for AUC(15-180min) were 125.5 (658.4), -1403.8 (632.1), and 1843.1 (540.6) pg * min/mL.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, single-blind, dose-escalation, crossover study in adolescent (age 10-16 years) patients with T2DM who were being treated with diet and exercise or a stable dose of metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea for at least 3 months before screening.
Summary · context
Eligible patients were allocated to receive single subcutaneous doses of exenatide 2.5 microg, exenatide 5 microg, and placebo, each followed by a standardized meal, on 3 separate days (maximum interval between first and third doses, 5 weeks).
Report a problemFND-1944615308
10HumanRandomized controlled trialEfficacy outcome
In adolescents with type 2 diabetes, higher-dose exenatide reduced postprandial glucagon versus placebo.
In plain wordsIn adolescents with diabetes, higher-dose exenatide reduced glucagon after meals compared with placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreasePostprandial glucagon
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 microg · subcutaneous · single doseAs given in this study (human).
Measurements
Incremental glucagon AUC
−1403.8 pg * min/mL
5 microg exenatide
Incremental glucagon AUC
1843.1 pg * min/mL
placebo
Source sentences
Summary
The 2 exenatide doses were also associated with significant reductions in postprandial plasma glucagon concentrations compared with placebo (P < 0.01); the respective incremental mean values for AUC(15-180min) were 125.5 (658.4), -1403.8 (632.1), and 1843.1 (540.6) pg * min/mL.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, single-blind, dose-escalation, crossover study in adolescent (age 10-16 years) patients with T2DM who were being treated with diet and exercise or a stable dose of metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea for at least 3 months before screening.
Summary · context
Eligible patients were allocated to receive single subcutaneous doses of exenatide 2.5 microg, exenatide 5 microg, and placebo, each followed by a standardized meal, on 3 separate days (maximum interval between first and third doses, 5 weeks).
Report a problemFND-1944615309
11HumanRandomized controlled trialEfficacy outcome
In adolescents with type 2 diabetes, serum insulin did not differ significantly between exenatide and placebo.
In plain wordsIn adolescents with diabetes, insulin levels did not differ significantly between exenatide and placebo.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeSerum insulin
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.5 and 5 microg · subcutaneous · single doseAs given in this study (human).
Source sentences
Summary
There were no significant differences in serum insulin concentrations between exenatide and placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a randomized, single-blind, dose-escalation, crossover study in adolescent (age 10-16 years) patients with T2DM who were being treated with diet and exercise or a stable dose of metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea for at least 3 months before screening.
Summary · context
Eligible patients were allocated to receive single subcutaneous doses of exenatide 2.5 microg, exenatide 5 microg, and placebo, each followed by a standardized meal, on 3 separate days (maximum interval between first and third doses, 5 weeks).
Report a problemFND-1944615310

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 1 completed · 1 stopped early · source ClinicalTrials.gov (opens in a new tab)

WithdrawnPhase 1/2NCT01573806

Pharmacology of Exenatide in Pediatric Sepsis

Seattle Children's Hospitaln = 0Oct 2012 to est. Oct 2014

Septic Shock · Inflammation · Glucose Homeostasis · Organ Dysfunction · Health-related Quality of Life

Trial page ClinicalTrials.govUpdated 5 Oct 2017

CompletedPhase 2NCT00254254

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus

AstraZenecan = 13Feb 2006 to Feb 2007

Type 2 Diabetes Mellitus

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

Subjects

Terms as the source lists them.

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