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A Study of MK-0893 on Glucagon-Induced Glycemic Excursion in Healthy Male Participants Following Intravenous Administration of Glucagon, Sandostatine® and Insulin (MK-0893-002)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02012166
Recruitment Status : Completed
First Posted : December 16, 2013
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE December 3, 2013
First Posted Date  ICMJE December 16, 2013
Last Update Posted Date August 19, 2015
Study Start Date  ICMJE July 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2013)
  • Post-infusion Incremental Glucose Area Under the Plasma Concentration Versus Time Curve [AUC0-240 min] Study Part 1 [ Time Frame: Up to 76 hours postdose ]
  • Post-infusion Incremental Glucose Area Under the Plasma Concentration Versus Time Curve [AUC0-240 min] Study Part 2 [ Time Frame: Up to 124 hours postdose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2013)
  • Number of Participants With An Adverse Event (AE) [ Time Frame: Up to 12 weeks ]
  • Number of Participants Who Discontinued Study Treatment Due To AEs [ Time Frame: Up to 21 days of each treatment period ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of MK-0893 on Glucagon-Induced Glycemic Excursion in Healthy Male Participants Following Intravenous Administration of Glucagon, Sandostatine® and Insulin (MK-0893-002)
Official Title  ICMJE A Double-Blind, Randomized, Placebo-Controlled, Single-Dose, 3-Period, 4 Treatment Incomplete Crossover Study to Assess the Effects of Single Oral Doses of L-001241689 on Glucagon-Induced Glycemic Excursion in Healthy Male Subjects Following Intravenous Administration of Glucagon, Sandostatine® and Insulin
Brief Summary This is a study to assess the pharmacokinetics, safety, and tolerability of sequential single oral doses of MK-8093 10 mg, 40 mg, 200 mg, or placebo to MK-8093 (Part 1) depending on treatment assignment in young healthy male participants. In Part 2 of this study, sequential single oral doses of MK-8093 200 mg, 1000 mg or placebo to MK-8093 depending on treatment assignment will be evaluated. The primary hypothesis of the study is that at least one dose of MK-0893 will produce greater reduction of glucagon-induced glycemia as compared to placebo following the infusion of glucagon, Sandostatine®, and basal insulin.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: MK-0893 10 mg
    MK-0893 10 mg administered orally in 240 mL of water
  • Drug: MK-0893 40 mg
    MK-0893 40 mg administered orally in 240 mL of water
  • Drug: MK-0893 200 mg
    MK-0893 200 mg administered orally in 240 mL of water
  • Drug: MK-0893 1000 mg
    MK-0893 1000 mg administered orally in 240 mL of water
  • Drug: Placebo
    Placebo administered orally in 240 mL of water
  • Biological: Sandostatine®
    Sandostatine® is a somatostatin analogue. At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period. These compounds are IV compatible and will be combined in one syringe. Intravenous Sandostatine® will be administered at 30 ng/kg/min.
    Other Name: Octreotide acetate
  • Biological: Insulin
    At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period. These compounds are IV compatible and will be combined in one syringe. Intravenous insulin will be administered at 0.10 milli-international unit (mIU)/kg/min.
    Other Name: Humuline Regular, Insulin for human injection
  • Biological: Glucagon
    At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period. These compounds are IV compatible and will be combined in one syringe. Intravenous glucagon will be administered at 3 ng/kg/min.
    Other Name: Glucagen
Study Arms  ICMJE
  • Experimental: MK-0893 40 mg→MK-0893 200 mg→placebo
    In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose. In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose. There will be at least 21 days between administrations of study drugs.
    Interventions:
    • Drug: MK-0893 40 mg
    • Drug: MK-0893 200 mg
    • Drug: Placebo
    • Biological: Sandostatine®
    • Biological: Insulin
    • Biological: Glucagon
  • Experimental: MK-0893 200 mg→placebo→MK-0893 10 mg
    In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose. In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose. There will be at least 21 days between administrations of study drugs.
    Interventions:
    • Drug: MK-0893 10 mg
    • Drug: MK-0893 200 mg
    • Drug: Placebo
    • Biological: Sandostatine®
    • Biological: Insulin
    • Biological: Glucagon
  • Experimental: Placebo→MK-0893 10 mg→MK-0893 40 mg
    In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose. In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose. There will be at least 21 days between administrations of study drugs.
    Interventions:
    • Drug: MK-0893 10 mg
    • Drug: MK-0893 40 mg
    • Drug: Placebo
    • Biological: Sandostatine®
    • Biological: Insulin
    • Biological: Glucagon
  • Experimental: MK-0893 10 mg→MK-0893 40 mg→MK-0893 200 mg
    In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose. In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose. There will be at least 21 days between administrations of study drugs.
    Interventions:
    • Drug: MK-0893 10 mg
    • Drug: MK-0893 40 mg
    • Drug: MK-0893 200 mg
    • Biological: Sandostatine®
    • Biological: Insulin
    • Biological: Glucagon
  • Experimental: Placebo→MK-0893 1000 mg→MK-0893 200 mg
    In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose. In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose. There will be at least 21 days between administrations of study drugs.
    Interventions:
    • Drug: MK-0893 200 mg
    • Drug: MK-0893 1000 mg
    • Drug: Placebo
    • Biological: Sandostatine®
    • Biological: Insulin
    • Biological: Glucagon
  • Experimental: MK-0893 200 mg→placebo→MK-0893 1000 mg
    In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose. In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose. There will be at least 21 days between administrations of study drugs.
    Interventions:
    • Drug: MK-0893 200 mg
    • Drug: MK-0893 1000 mg
    • Drug: Placebo
    • Biological: Sandostatine®
    • Biological: Insulin
    • Biological: Glucagon
  • Experimental: MK-0893 1000 mg→MK-0893 200 mg→placebo
    In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose. In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose. There will be at least 21 days between administrations of study drugs.
    Interventions:
    • Drug: MK-0893 200 mg
    • Drug: MK-0893 1000 mg
    • Drug: Placebo
    • Biological: Sandostatine®
    • Biological: Insulin
    • Biological: Glucagon
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2013)
18
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Good health
  • Body Mass Index of between 18 and 28 kg/m^2, or up to 30 kg/m^2 with approval of sponsor
  • Non-smoker for at least 6 months
  • Willing to avoid strenuous physical activity
  • Willing to avoid alcohol, caffeine, and grapefruit juice consumption

Exclusion Criteria:

  • History of renal, neurologic, gastrointestinal or respiratory disease or any gastrointestinal surgery
  • History of multiple and/or severe allergies to a prescription, nonprescription or investigational drug or food
  • History of any cardiovascular/cardiac disease
  • History of any hepatic disease and primary biliary cirrhosis
  • History of hypoglycemia or glucose intolerance, type 1 diabetes, or type 2 diabetes
  • Requires or anticipates use of prescription or nonprescription medications, including herbal remedies
  • A user of any illicit drugs or a history of drug or alcohol abuse
  • Surgery, donated a unit of blood, or participated in another clinical study within 4 weeks prior to study participation
  • History of hypersensitivity to insulin, glucagon, or Sandostatine®.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02012166
Other Study ID Numbers  ICMJE 0893-002
2005-002198-57 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP