Type 2 Diabetes MellitusPhase 1NCT02012166

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)

A Phase 1 study testing MK-0893 10 mg, MK-0893 40 mg and MK-0893 200 mg in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: MK-0893 10 mg, MK-0893 40 mg and MK-0893 200 mg
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: No sites listed yet
Study dates: Jul 2005to Dec 2005
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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®.

About this study

Official title: 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

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.

Conditions: Type 2 Diabetes Mellitus
Being tested: MK-0893 10 mg, MK-0893 40 mg, MK-0893 200 mg, MK-0893 1000 mg, Placebo
Keywords: Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Therapeutic Uses, Pharmacologic Actions, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-0893 10 mgDrug
MK-0893 10 mg administered orally in 240 mL of water
MK-0893 40 mgDrug
MK-0893 40 mg administered orally in 240 mL of water
MK-0893 200 mgDrug
MK-0893 200 mg administered orally in 240 mL of water
MK-0893 1000 mgDrug
MK-0893 1000 mg administered orally in 240 mL of water
PlaceboDrug
Placebo administered orally in 240 mL of water
Sandostatine®Biological
Also called Octreotide acetate
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.
InsulinBiological
Also called Humuline Regular, Insulin for human injection
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.
GlucagonBiological
Also called Glucagen
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.

Study groups in NCT02012166
Study group	Role	What they receive
MK-0893 40 mg→MK-0893 200 mg→placebo	Experimental	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. Receives: Drug: MK-0893 40 mg; Drug: MK-0893 200 mg; Drug: Placebo; Biological: Sandostatine®; Biological: Insulin; Biological: Glucagon
MK-0893 200 mg→placebo→MK-0893 10 mg	Experimental	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. Receives: Drug: MK-0893 10 mg; Drug: MK-0893 200 mg; Drug: Placebo; Biological: Sandostatine®; Biological: Insulin; Biological: Glucagon
Placebo→MK-0893 10 mg→MK-0893 40 mg	Experimental	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. Receives: Drug: MK-0893 10 mg; Drug: MK-0893 40 mg; Drug: Placebo; Biological: Sandostatine®; Biological: Insulin; Biological: Glucagon
MK-0893 10 mg→MK-0893 40 mg→MK-0893 200 mg	Experimental	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. Receives: Drug: MK-0893 10 mg; Drug: MK-0893 40 mg; Drug: MK-0893 200 mg; Biological: Sandostatine®; Biological: Insulin; Biological: Glucagon
Placebo→MK-0893 1000 mg→MK-0893 200 mg	Experimental	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. Receives: Drug: MK-0893 200 mg; Drug: MK-0893 1000 mg; Drug: Placebo; Biological: Sandostatine®; Biological: Insulin; Biological: Glucagon
MK-0893 200 mg→placebo→MK-0893 1000 mg	Experimental	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. Receives: Drug: MK-0893 200 mg; Drug: MK-0893 1000 mg; Drug: Placebo; Biological: Sandostatine®; Biological: Insulin; Biological: Glucagon
MK-0893 1000 mg→MK-0893 200 mg→placebo	Experimental	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. Receives: Drug: MK-0893 200 mg; Drug: MK-0893 1000 mg; Drug: Placebo; Biological: Sandostatine®; Biological: Insulin; Biological: Glucagon

What is being measured

The primary outcome is the main question the study is designed to answer.

Post-infusion Incremental Glucose Area Under the Plasma Concentration Versus Time Curve [AUC0-240 min] Study Part 1
Measured: Up to 76 hours postdose
Post-infusion Incremental Glucose Area Under the Plasma Concentration Versus Time Curve [AUC0-240 min] Study Part 2
Measured: Up to 124 hours postdose

Secondary outcomes (2)

Number of Participants With An Adverse Event (AE)
Measured: Up to 12 weeks
Number of Participants Who Discontinued Study Treatment Due To AEs
Measured: Up to 21 days of each treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2005Dec 2005

First posted16 Dec 2013 (estimated)
Study startJul 2005
Primary completionDec 2005
Study completionDec 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02012166
Sponsor's protocol ID: 0893-002
Other IDs: 2005-002198-57, 2005
Status last verified: Aug 2015
First submitted: 3 Dec 2013
Last updated: 19 Aug 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02012166
Acronym / sponsor ID: 0893-002
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Therapeutic Uses, Pharmacologic Actions, Molecular Mechanisms of Pharmacological Action
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jul 2005
Primary completion: Dec 2005 (actual)
Study completion: Dec 2005 (actual)
First posted: 16 Dec 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 7

Arm	Type	Receives
MK-0893 40 mg→MK-0893 200 mg→placebo	Experimental	Drug: MK-0893 40 mg, Drug: MK-0893 200 mg, Drug: Placebo, Biological: Sandostatine®, Biological: Insulin, Biological: GlucagonIn 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.
MK-0893 200 mg→placebo→MK-0893 10 mg	Experimental	Drug: MK-0893 10 mg, Drug: MK-0893 200 mg, Drug: Placebo, Biological: Sandostatine®, Biological: Insulin, Biological: GlucagonIn 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.
Placebo→MK-0893 10 mg→MK-0893 40 mg	Experimental	Drug: MK-0893 10 mg, Drug: MK-0893 40 mg, Drug: Placebo, Biological: Sandostatine®, Biological: Insulin, Biological: GlucagonIn 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.
MK-0893 10 mg→MK-0893 40 mg→MK-0893 200 mg	Experimental	Drug: MK-0893 10 mg, Drug: MK-0893 40 mg, Drug: MK-0893 200 mg, Biological: Sandostatine®, Biological: Insulin, Biological: GlucagonIn 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.
Placebo→MK-0893 1000 mg→MK-0893 200 mg	Experimental	Drug: MK-0893 200 mg, Drug: MK-0893 1000 mg, Drug: Placebo, Biological: Sandostatine®, Biological: Insulin, Biological: GlucagonIn 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.
MK-0893 200 mg→placebo→MK-0893 1000 mg	Experimental	Drug: MK-0893 200 mg, Drug: MK-0893 1000 mg, Drug: Placebo, Biological: Sandostatine®, Biological: Insulin, Biological: GlucagonIn 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.
MK-0893 1000 mg→MK-0893 200 mg→placebo	Experimental	Drug: MK-0893 200 mg, Drug: MK-0893 1000 mg, Drug: Placebo, Biological: Sandostatine®, Biological: Insulin, Biological: GlucagonIn 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.

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK-0893 10 mgMK-0893 10 mg administered orally in 240 mL of water	Drug	MK-0893 10 mg→MK-0893 40 mg→MK-0893 200 mg, MK-0893 200 mg→placebo→MK-0893 10 mg, Placebo→MK-0893 10 mg→MK-0893 40 mg
MK-0893 40 mgMK-0893 40 mg administered orally in 240 mL of water	Drug	MK-0893 10 mg→MK-0893 40 mg→MK-0893 200 mg, MK-0893 40 mg→MK-0893 200 mg→placebo, Placebo→MK-0893 10 mg→MK-0893 40 mg
MK-0893 200 mgMK-0893 200 mg administered orally in 240 mL of water	Drug	MK-0893 10 mg→MK-0893 40 mg→MK-0893 200 mg, MK-0893 1000 mg→MK-0893 200 mg→placebo, MK-0893 200 mg→placebo→MK-0893 10 mg, MK-0893 200 mg→placebo→MK-0893 1000 mg, MK-0893 40 mg→MK-0893 200 mg→placebo, Placebo→MK-0893 1000 mg→MK-0893 200 mg
MK-0893 1000 mgMK-0893 1000 mg administered orally in 240 mL of water	Drug	MK-0893 1000 mg→MK-0893 200 mg→placebo, MK-0893 200 mg→placebo→MK-0893 1000 mg, Placebo→MK-0893 1000 mg→MK-0893 200 mg
PlaceboPlacebo administered orally in 240 mL of water	Drug	MK-0893 1000 mg→MK-0893 200 mg→placebo, MK-0893 200 mg→placebo→MK-0893 10 mg, MK-0893 200 mg→placebo→MK-0893 1000 mg, MK-0893 40 mg→MK-0893 200 mg→placebo, Placebo→MK-0893 10 mg→MK-0893 40 mg, Placebo→MK-0893 1000 mg→MK-0893 200 mg
Sandostatine®Also: Octreotide acetateSandostatine® 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.	Biological	MK-0893 10 mg→MK-0893 40 mg→MK-0893 200 mg, MK-0893 1000 mg→MK-0893 200 mg→placebo, MK-0893 200 mg→placebo→MK-0893 10 mg, MK-0893 200 mg→placebo→MK-0893 1000 mg, MK-0893 40 mg→MK-0893 200 mg→placebo, Placebo→MK-0893 10 mg→MK-0893 40 mg, Placebo→MK-0893 1000 mg→MK-0893 200 mg
InsulinAlso: Humuline Regular, Insulin for human injectionAt 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.	Biological	MK-0893 10 mg→MK-0893 40 mg→MK-0893 200 mg, MK-0893 1000 mg→MK-0893 200 mg→placebo, MK-0893 200 mg→placebo→MK-0893 10 mg, MK-0893 200 mg→placebo→MK-0893 1000 mg, MK-0893 40 mg→MK-0893 200 mg→placebo, Placebo→MK-0893 10 mg→MK-0893 40 mg, Placebo→MK-0893 1000 mg→MK-0893 200 mg
GlucagonAlso: GlucagenAt 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.	Biological	MK-0893 10 mg→MK-0893 40 mg→MK-0893 200 mg, MK-0893 1000 mg→MK-0893 200 mg→placebo, MK-0893 200 mg→placebo→MK-0893 10 mg, MK-0893 200 mg→placebo→MK-0893 1000 mg, MK-0893 40 mg→MK-0893 200 mg→placebo, Placebo→MK-0893 10 mg→MK-0893 40 mg, Placebo→MK-0893 1000 mg→MK-0893 200 mg

Primary outcome

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

2 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-0893 10 mg, MK-0893 40 mg and MK-0893 200 mg in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02012166.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.