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CompletedNCT00782418Updated Dec 21, 2016Results posted

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

A Phase 1 interventional study of Comparator: exenatide and Comparator: exenatide in The Methodology Assessment of Glucose Dependent Insulin Secretion, sponsored by Merck Sharp & Dohme LLC. Completed. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-21.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Diagnostic

Phase
Phase 1
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • The Methodology Assessment of Glucose Dependent Insulin Secretion
03

In context

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
27 participants (actual)

Study arms

  • Active comparator
    1

    exenatide 5mcg

    Drug: Comparator: exenatide

  • Active comparator
    2

    exenatide 1.5mcg

    Drug: Comparator: exenatide

  • Placebo comparator
    3

    Placebo

    Drug: Comparator: Placebo

Interventions

  • DrugComparator: exenatide

    exenatide in two 5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 5mcg doses will be administered, followed by HCG or GGI.

    Also known as: Byetta

  • DrugComparator: exenatide

    exenatide in two 1.5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 1.5mcg doses will be administered, followed by HCG or GGI.

    Also known as: Byetta

  • DrugComparator: Placebo

    5% osmitrol in two 60 mcL subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 60 mcL doses will be administered, followed by HCG or GGI.

06

What researchers measure

Primary outcomes

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

    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)

    Time frame: Steady-state of HGC: 90 - 120 minutes post dose; highest glucose infusion rate of GGI: 120 - 160 minutes post dose

  2. Change From Baseline in C-peptide Concentration

    Time frame: Pre and Post glucose infusion

  3. Change From Baseline in Insulin Concentration

    Time frame: Pre and Post glucose infusion

07

Results

Posted Apr 6, 2010

Participant flow

First Patient Entered: 19-Sep-2008 Last Patient, Last Visit: 05-Mar-2009 1 site

Period 1 Procedure/Treatment Groups
Participant flow — Period 1 Procedure/Treatment Groups
MilestoneHGC - Exenatide 5 μgHGC - Exenatide 1.5 μgHGC - PlaceboExenatide 5 ug Down Dosed to Placebo (HGC)GGI - Exenatide 5 μgGGI - Exenatide 1.5 μgPlacebo (HGC or GGI)
Started3442554
Completed1442444
Not completed2000110
Withdrew: Adverse event1000000
Withdrew: Study placed on temporary hold1000110
Period 2 Procedure/Treatment Groups
Participant flow — Period 2 Procedure/Treatment Groups
MilestoneHGC - Exenatide 5 μgHGC - Exenatide 1.5 μgHGC - PlaceboExenatide 5 ug Down Dosed to Placebo (HGC)GGI - Exenatide 5 μgGGI - Exenatide 1.5 μgPlacebo (HGC or GGI)
Started3441344
Completed3441344
Not completed0000000

Outcome measures

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

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)

Time frame:
Steady-state of HGC: 90 - 120 minutes post dose; highest glucose infusion rate of GGI: 120 - 160 minutes post dose
Reported as:
Geometric mean · (ng/min) / (mg/dL)
Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose
(ng/min) / (mg/dL)HGC - Exenatide 5 μgHGC - Exenatide 1.5 μgHGC - PlaceboGGI - Exenatide 5 μgGGI - Exenatide 1.5 μgGGI - Placebo
Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose2.14 (1.52 to 2.52)1.49 (0.78 to 2.16)0.53 (0.19 to 0.73)2.95 (0.94 to 3.88)2.07 (0.82 to 3.30)0.71 (0.10 to 1.22)
Statistical analysis
  • HGC - Exenatide 5 μg vs HGC - Placebo · ANOVA · p = <0.001 (1-sided, alpha=0.05) · Least squares mean: 1.60 · 90% CI 1.29 to 1.92
  • HGC - Exenatide 1.5 μg vs HGC - Placebo · ANOVA · p = <0.001 · Least squares mean: 0.95 · 90% CI 0.66 to 1.241-sided, alpha=0.05
  • GGI - Exenatide 5 μg vs GGI - Placebo · ANOVA · p = <0.001 · Least squares mean: 2.32 · 90% CI 1.57 to 3.061-sided, alpha=0.05
  • GGI - Exenatide 1.5 μg vs GGI - Placebo · ANOVA · p = <0.001 · Least squares mean: 1.38 · 90% CI 0.64 to 2.121-sided, alpha = 0.05
PrimaryChange From Baseline in C-peptide Concentration
Time frame:
Pre and Post glucose infusion
Reported as:
Least squares mean · ng/mL
Change From Baseline in C-peptide Concentration
ng/mLHGC - Exenatide 5 μgHGC - Exenatide 1.5 μgHGC - Placebo
Change From Baseline in C-peptide Concentration29.3 (25.2 to 35.1)22.6 (14.0 to 34.1)6.24 (2.3 to 8.9)
Statistical analysis
  • HGC - Exenatide 5 μg vs HGC - Placebo · ANOVA · p = <0.001 · Least squares mean: 23.1 · 90% CI 19.2 to 27.01-side, alpha = 0.05
  • HGC - Exenatide 1.5 μg vs HGC - Placebo · ANOVA · p = <0.001 · Least squares mean: 16.4 · 90% CI 12.6 to 20.11-side, alpha = 0.05
PrimaryChange From Baseline in Insulin Concentration
Time frame:
Pre and Post glucose infusion
Reported as:
Least squares mean · μIU(insulin)/mL
Change From Baseline in Insulin Concentration
μIU(insulin)/mLHGC - Exenatide 5 μgHGC - Exenatide 1.5 μgHGC - Placebo
Change From Baseline in Insulin Concentration592 (445 to 695)293 (128 to 597)46.5 (16.2 to 123)
Statistical analysis
  • HGC - Exenatide 5 μg vs HGC - Placebo · ANOVA · p = <0.001 · Least squares mean: 545.0 · 90% CI 451.4 to 638.71-side, alpha = 0.05
  • HGC - Exenatide 1.5 μg vs HGC - Placebo · ANOVA · p = <0.001 · Least squares mean: 246.6 · 90% CI 160.9 to 323.31-side, alpha = 0.05

Adverse events

Collected over Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
HGC - Exenatide 5 μg—0/9 (0%)4/9 (44.4%)
HGC - Exenatide 1.5 μg—0/9 (0%)4/9 (44.4%)
HGC - Placebo—0/10 (0%)4/10 (40%)
GGI - Exenatide 5 μg—1/7 (14.3%)6/7 (85.7%)
GGI - Exenatide 1.5 μg—0/8 (0%)3/8 (37.5%)
GGI - Placebo—0/11 (0%)2/11 (18.2%)
Most frequent serious events
Most frequent serious events
EventHGC - Exenatide 5 μgHGC - Exenatide 1.5 μgHGC - PlaceboGGI - Exenatide 5 μgGGI - Exenatide 1.5 μgGGI - Placebo
VomitingGastrointestinal disorders0/90/90/101/70/80/11
Most frequent other events
Showing 10 of 22
Most frequent other events
EventHGC - Exenatide 5 μgHGC - Exenatide 1.5 μgHGC - PlaceboGGI - Exenatide 5 μgGGI - Exenatide 1.5 μgGGI - Placebo
NauseaGastrointestinal disorders0/91/92/105/70/80/11
VomitingGastrointestinal disorders0/90/92/103/70/80/11
HeadacheNervous system disorders2/92/91/100/73/81/11
VertigoEar and labyrinth disorders2/90/90/102/70/80/11
PresyncopeNervous system disorders0/91/90/102/70/80/11
Rash PapularSkin and subcutaneous tissue disorders2/90/90/101/70/81/11
Thrombophlebitis SuperficialSkin and subcutaneous tissue disorders2/90/90/100/70/80/11
DiarrhoeaGastrointestinal disorders0/90/90/101/70/80/11
AstheniaGeneral disorders0/90/90/101/70/80/11
FatigueGeneral disorders0/90/91/101/71/80/11

Baseline characteristics

Age, Continuous
Age, Continuous(years)All Patients
Mean29.3 ± 9.1
Gender
Gender(Participants)All Patients
Female0
Male27
Body Mass Index
Body Mass Index(kg/m^2)All Patients
Mean23.3 ± 2.1
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Shankar SS, Shankar RR, Mixson LA, Miller DL, Chung C, Cilissen C, Beals CR, Stoch SA, Steinberg HO, Kelley DE. Linearity of beta-cell response across the metabolic spectrum and to pharmacology: insights from a graded glucose infusion-based investigation series. Am J Physiol Endocrinol Metab. 2016 Jun 1;310(11):E865-73. doi: 10.1152/ajpendo.00527.2015. Epub 2016 Apr 12. PubMed 27072496 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00782418
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Oct 31, 2008
Start date
Sep 2008
Primary completion
Feb 2009
Completion
Mar 2009
Results posted
Apr 6, 2010
Last update
Dec 21, 2016

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

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