Single Ascending Dose Study of MK-1092 in Healthy Participants and in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-1092-001)
NCT ID: NCT03170544
Last Updated: 2019-11-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
69 participants
INTERVENTIONAL
2017-08-16
2018-11-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part 1, MK-1092, 4.0 nmol/kg
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants
MK-1092, 4.0 nmol/kg
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
Placebo to glargine
Placebo to glargine, SC, as a single dose
Dextrose
20% solution for continuous infusion for the duration of the glucose clamp as needed to maintain blood sugar at pre-clamp target levels.
Part 1, MK-1092, 8.0 nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants
MK-1092, 8.0 nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
Placebo to glargine
Placebo to glargine, SC, as a single dose
Dextrose
20% solution for continuous infusion for the duration of the glucose clamp as needed to maintain blood sugar at pre-clamp target levels.
Part 1, MK-1092, 16 nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants
MK-1092, 16 nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
Placebo to glargine
Placebo to glargine, SC, as a single dose
Dextrose
20% solution for continuous infusion for the duration of the glucose clamp as needed to maintain blood sugar at pre-clamp target levels.
Part 1, MK-1092, 32 nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants
MK-1092, 32 nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
Placebo to glargine
Placebo to glargine, SC, as a single dose
Dextrose
20% solution for continuous infusion for the duration of the glucose clamp as needed to maintain blood sugar at pre-clamp target levels.
Part 1, MK-1092, 64 nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants
MK-1092, 64 nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
Placebo to glargine
Placebo to glargine, SC, as a single dose
Dextrose
20% solution for continuous infusion for the duration of the glucose clamp as needed to maintain blood sugar at pre-clamp target levels.
Part 1, Glargine, 3.0 nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants
Glargine 3.0 nmol/kg
Glargine 3.0 nmol/kg, SC, as a single dose
Placebo to MK-1092
Placebo to MK-1092, SC, as a single dose
Dextrose
20% solution for continuous infusion for the duration of the glucose clamp as needed to maintain blood sugar at pre-clamp target levels.
Part 2, MK-1092, 8.0 nmol/kg + lispro, 1.2 nmol/kg
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + lispro (Humalog®), 1.2 nmol/kg, as a single dose, in healthy participants
MK-1092, 8.0 nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
Lispro 1.2 nmol/kg
Lispro (Humalog®), 1.2 nmol/kg, IV infusion SC over 3 hours as a single dose starting \~12 hours after MK-1092 administration.
Dextrose
20% solution for continuous infusion for the duration of the glucose clamp as needed to maintain blood sugar at pre-clamp target levels.
Part 3, MK-1092, 8.0 nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, in participants with T1DM.
MK-1092, 8.0 nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
Placebo to glargine
Placebo to glargine, SC, as a single dose
Dextrose
20% solution for continuous infusion for the duration of the glucose clamp as needed to maintain blood sugar at pre-clamp target levels.
Insulin
Participants will receive insulin IV, as needed, prior to dosing and clamp initiation and after dosing.
Part 3, MK-1092, 32 nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
MK-1092, 32 nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
Placebo to glargine
Placebo to glargine, SC, as a single dose
Dextrose
20% solution for continuous infusion for the duration of the glucose clamp as needed to maintain blood sugar at pre-clamp target levels.
Insulin
Participants will receive insulin IV, as needed, prior to dosing and clamp initiation and after dosing.
Part 3, Glargine, 3.0 nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose, in participants with T1DM
Glargine 3.0 nmol/kg
Glargine 3.0 nmol/kg, SC, as a single dose
Placebo to MK-1092
Placebo to MK-1092, SC, as a single dose
Dextrose
20% solution for continuous infusion for the duration of the glucose clamp as needed to maintain blood sugar at pre-clamp target levels.
Insulin
Participants will receive insulin IV, as needed, prior to dosing and clamp initiation and after dosing.
Part 4, MK-1092, 32 nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T2DM
MK-1092, 32 nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
Placebo to glargine
Placebo to glargine, SC, as a single dose
Dextrose
20% solution for continuous infusion for the duration of the glucose clamp as needed to maintain blood sugar at pre-clamp target levels.
Insulin
Participants will receive insulin IV, as needed, prior to dosing and clamp initiation and after dosing.
Part 4, MK-1092, 16 nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose, in participants with T2DM
MK-1092, 16 nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
Placebo to glargine
Placebo to glargine, SC, as a single dose
Dextrose
20% solution for continuous infusion for the duration of the glucose clamp as needed to maintain blood sugar at pre-clamp target levels.
Insulin
Participants will receive insulin IV, as needed, prior to dosing and clamp initiation and after dosing.
Part 4, MK-1092, 64 nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose, in participants with T2DM
MK-1092, 64 nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
Placebo to glargine
Placebo to glargine, SC, as a single dose
Dextrose
20% solution for continuous infusion for the duration of the glucose clamp as needed to maintain blood sugar at pre-clamp target levels.
Insulin
Participants will receive insulin IV, as needed, prior to dosing and clamp initiation and after dosing.
Part 4, Glargine, 3.0 nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose, in participants with T2DM
Glargine 3.0 nmol/kg
Glargine 3.0 nmol/kg, SC, as a single dose
Placebo to MK-1092
Placebo to MK-1092, SC, as a single dose
Dextrose
20% solution for continuous infusion for the duration of the glucose clamp as needed to maintain blood sugar at pre-clamp target levels.
Insulin
Participants will receive insulin IV, as needed, prior to dosing and clamp initiation and after dosing.
Interventions
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MK-1092, 4.0 nmol/kg
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
MK-1092, 8.0 nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
MK-1092, 16 nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
MK-1092, 32 nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
MK-1092, 64 nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
Glargine 3.0 nmol/kg
Glargine 3.0 nmol/kg, SC, as a single dose
Lispro 1.2 nmol/kg
Lispro (Humalog®), 1.2 nmol/kg, IV infusion SC over 3 hours as a single dose starting \~12 hours after MK-1092 administration.
Placebo to glargine
Placebo to glargine, SC, as a single dose
Placebo to MK-1092
Placebo to MK-1092, SC, as a single dose
Dextrose
20% solution for continuous infusion for the duration of the glucose clamp as needed to maintain blood sugar at pre-clamp target levels.
Insulin
Participants will receive insulin IV, as needed, prior to dosing and clamp initiation and after dosing.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be a healthy male, or healthy female participant (excluding diabetes mellitus in Part 3 participants) of non-child bearing potential. A female non-child bearing potential is one who is postmenopausal without menses for at least 1 year or whose status is post hysterectomy, bilateral oophorectomy, or tubal ligation.
* Be judged to be in good health based on medical history, physical exam, vital sign measurements, electrocardiogram (ECG) and laboratory safety tests
* Have adequate venous access to support execution of trial procedures
For Parts 1 and 2 (Healthy adult participants)
* Healthy male and female participants between the ages of 18 and 50 years (inclusive)
* Have a Body Mass Index (BMI) ≥18.5 kg/m\^2 and ≤28.0 kg/m\^2 at screening
* Have fasting blood glucose values at screening must be \<100 mg/dL
* Be a non-smoker and/or has not used nicotine or nicotine-containing products (e.g., nicotine patch) for at least approximately 3 months.
For Part 3 (Adult participants with T1DM):
* Be male, or female of non-childbearing potential between 18 to 60 years of age
* Have a diagnosis of T1DM as defined by standard diagnostic criteria for ≥12 months at time of the pretrial (screening) visit
* Have a BMI ≥18.5 kg/m\^2 and ≤32 kg/m\^2 at screening.
* Be on stable doses of basal insulin over the 2-week period prior to screening and over the 2 weeks prior to dosing
* Have a total daily insulin requirement (basal plus prandial) of ≤1.2 units/kg at screening
* Have a hemoglobin A1C (HbA1c) ≤10% at the screening visit.
* Be a non-smoker or smoker who uses no more than 5 cigarettes or equivalent (e.g., e-cigarettes) per day over the prior 3-month period also may be enrolled (at the discretion of the investigator).
* Have a serum C-peptide concentration ≤0.7 ng/mL with a concurrent plasma glucose \>90 mg/dL at screening or anytime within 24 weeks prior to screening.
For Part 4 (Adult participants with T2DM):
* Diagnosis of T2DM as defined by standard diagnostic criteria for ≥12 months at time of pretrial screening.
* Have a BMI ≥18.5 kg/m2 and ≤35.0 kg/m\^2 at screening. BMI = mass (kg)/height (m)\^2.
* Have a hemoglobin A1C (HbA1c) ≥6.5% and ≤10.0%.
* T2DM participants are not required to have been on insulin. If using insulin as background therapy, subjects should have a total daily insulin requirement of ≤1.2 units/kg, and have been on stable doses of basal insulin over the 2-week period prior to screening and over the 2 weeks prior to dosing.
* Be a non-smoker or smoker who uses no greater than 5 cigarettes or equivalent (e.g., e-cigarettes) daily over the prior 3-month period.
Exclusion Criteria
* Is mentally or legally incapacitated
* Has a history of clinically significant endocrine (excluding diabetes mellitus in Part 3 participants), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases.
* Has a systolic blood pressure (SBP) ≥140 mm Hg and/or a diastolic blood pressure (DBP) ≥90 mm Hg at screening.
* Is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV) at screening.
* Has a history of cancer (malignancy) Exceptions: (1) Participants with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) Participants with other malignancies which have been successfully treated ≥10 years prior to the pretrial (screening) visit
* Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e. systemic allergic reaction) to prescription or non-prescription drugs or food.
* Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pretrial (screening) visit.
* Has participated in another investigational trial within 4 weeks.
* Has been randomized to, and received MK-5160 in prior clinical studies.
* Has a QTcF interval \>450 msec, has a history of risk factors for Torsades de Pointes (e.g., heart failure/cardiomyopathy or family history of Long QT Syndrome).
* Has uncorrected hypokalemia
* Has uncorrected hypomagnesemia
* Is taking concomitant medications that prolong the QT/QTc interval.
* Is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies beginning approximately 2 weeks prior to administration of the initial dose of trial drug, throughout the trial, until the post-trial visit.
* Has had a vaccination within 12 weeks of the pretrial visit.
* Consumes greater than 3 glasses of alcoholic beverages per day.
* Consumes excessive amounts, defined as greater than 6 servings caffeinated beverages per day.
* Is currently a regular or recreational user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 6 months
* Has used systemic (intravenous, oral, inhaled) glucocorticoids within 3 months of screening or is anticipated to require treatment with systemic glucocorticoids during study participation.
For Part 1 and Part 2 (Healthy Adult Participants)
\- Has an estimated creatinine clearance of \<90 mL/min based on Cockcroft-Gault equation
For Part 3 (Adult participants with T1DM):
* Has a history of diabetic ketoacidosis in the last 6 months prior to screening.
* Has an estimated creatinine clearance of \<60 mL/min based on the Cockcroft-Gault equation at screening
* Has the diagnosis of hypoglycemia unawareness, or has had one or more severe hypoglycemic episodes associated with hypoglycemic seizures, comas or unconsciousness within 6 months prior to dosing.
* Has other major medical problems requiring medication (i.e., history of myocardial infarction (MI), hypercholesterolemia).
* Has a known history of celiac disease or significant food allergy, at the discretion of the investigator and Sponsor.
* Has a history of hypersensitivity to pharmacologic insulins or to any of the inactive ingredients in recombinant human insulin, or to any E.coli-derived drug product.
For Part 4 (Adult participants with T2DM):
* Participant has an estimated creatinine clearance of \<60 mL/min based on the Cockcroft-Gault equation.
* Has a history of diabetic ketoacidosis in the last 6 months prior to screening.
* Has the diagnosis of hypoglycemia unawareness, or has had one or more severe hypoglycemic episodes associated with hypoglycemic seizures, comas or unconsciousness within 6 months prior to dosing.
* Has a known history of celiac disease or significant food allergy, at the discretion of the Investigator and Sponsor.
* Has been treated with a thiazolidinedione or injectable non-insulin anti-diabetic therapy within the past three months prior to dosing.
* Has a history of hypersensitivity to pharmacologic insulins or to any of the inactive ingredients in regular human insulin, or to any E.coli-derived drug product.
18 Years
60 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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ProSciento Inc. ( Site 0001)
Chula Vista, California, United States
Countries
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References
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Walford GA, Duncan KE, Hernandez M, Vaddady P, Hompesch M, Morrow L, Stoch SA. A Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Novel Insulin Dimer. Clin Pharmacol Ther. 2022 Jul;112(1):125-132. doi: 10.1002/cpt.2607. Epub 2022 May 3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MK-1092-001
Identifier Type: OTHER
Identifier Source: secondary_id
1092-001
Identifier Type: -
Identifier Source: org_study_id
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