Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Study to Compare Methodologies for Assessing Glucose-Dependent Insulin Secretion (0000-104)(COMPLETED)

NCTNCT00782418Other id0000-104Other id2008_568

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 27 participants (actual)
Sponsor: Merck Sharp & Dohme LLC · Industry
Design: Randomized · Double masking
Countries: Not stated
Start: Sept 2008
Primary completion: Feb 2009
Completion: Mar 2009
First posted: 31 Oct 2008 (estimated)
Last update posted: 21 Dec 2016 (estimated)
Conditions: The Methodology Assessment of Glucose Dependent Insulin Secretion

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200820092010

Ph 1
A Study to Compare Methodologies for Assessing Glucose-Dependent Insulin Secretion (0000-104)(COMPLETED)
NCT00782418
Sept 2008 to Mar 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study will compare graded glucose infusion (GGI) to the hyperglycemic clamp (HGC) for assessment of glucose-dependent insulin secretion (GDIS) using exenatide as a probe.

Interventions

Comparator: exenatideDrug
Comparator: exenatideDrug
Comparator: PlaceboDrug

Arms3

Active comparator
1
exenatide 5mcg
Active comparator
2
exenatide 1.5mcg
Placebo comparator
3
Placebo

Primary outcomes3

Outcomes the sponsor listed as primary.

Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose
Time frame · Steady-state of HGC: 90 - 120 minutes post dose; highest glucose infusion rate of GGI: 120 - 160 minutes post dose
Registry description
Comparison of Glucose Dependent Insulin Secretion (GDIS) measured after HGC at steady-state to GDIS measured after GGI at the highest glucose infusion rate. Insulin Secretion Rate (ISR)/ Blood Glucose (BG)
Change From Baseline in C-peptide Concentration
Time frame · Pre and Post glucose infusion
Change From Baseline in Insulin Concentration
Time frame · Pre and Post glucose infusion

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· Steady-state of HGC: 90 - 120 minutes post dose; highest glucose infusion rate of GGI: 120 - 160 minutes post dose

Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose

Group	Value ((ng/min) / (mg/dL))
HGC - Exenatide 5 μg	2.14
HGC - Exenatide 1.5 μg	1.49
HGC - Placebo	0.53
GGI - Exenatide 5 μg	2.95
GGI - Exenatide 1.5 μg	2.07
GGI - Placebo	0.71

Primary outcomeLeast squares mean· Pre and Post glucose infusion

Change From Baseline in C-peptide Concentration

Group	Value (ng/mL)
HGC - Exenatide 5 μg	29.3
HGC - Exenatide 1.5 μg	22.6
HGC - Placebo	6.24

Primary outcomeLeast squares mean· Pre and Post glucose infusion

Change From Baseline in Insulin Concentration

Group	Value (μIU(insulin)/mL)
HGC - Exenatide 5 μg	592
HGC - Exenatide 1.5 μg	293
HGC - Placebo	46.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
HGC - Exenatide 5 μgHyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg	–	0 / 9	4 / 9
HGC - Exenatide 1.5 μgHyperglycemic Clamp: Treatment Group Exenatide 1.5 μg	–	0 / 9	4 / 9
HGC - PlaceboHyperglycemic Clamp: Treatment Group Placebo	–	0 / 10	4 / 10
GGI - Exenatide 5 μgGraded Glucose Infusion (GGI): Treatment Group Exenatide 5 μg	–	1 / 7	6 / 7
GGI - Exenatide 1.5 μgGraded Glucose Infusion: Treatment Group Exenatide 1.5 μg	–	0 / 8	3 / 8
GGI - PlaceboGraded Glucose Infusion: Treatment Group Placebo	–	0 / 11	2 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2016

Linearity of β-cell response across the metabolic spectrum and to pharmacology: insights from a graded glucose infusion-based investigation series.

Shankar et al. 2016American journal of physiology. Endocrinology and metabolismcited by 7

PMID 27072496DOI 10.1152/ajpendo.00527.2015PUB-27072496

Rights unknown

Source link

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years up to 45 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Subject has a Body Mass Index (BMI) of less than or equal to 26 kg/m2 at screening * Subject is judged to be in good health * Subject has been a nonsmoker for at least 3 months * Subject is willing to avoid strenuous physical activity for the duration of the study Exclusion Criteria: * Subject has a history of high blood pressure requiring treatment * Subject has a history of diabetes or a family history of diabetes mellitus * Subject is unable to discontinue all prescription and non-prescription drugs for duration of study * Subject consumes more than 3 alcoholic beverages per day * Subject consumes more than 6 servings of caffeinated beverages per day (1 serving = 120mg caffeine) * Subject has had major surgery or has donated or loss 1 unit of blood within 4 weeks of screening * Subject has multiple and/or severe allergies to foods or drugs * Subject is a regular user of illegal drugs * Subject is unwilling or unable to consume the standardized meals during the study and/or is on a carbohydrate restricted diet

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