Clinical Trial Details

NCT ID: NCT03170544
Date Last Changed: August 17, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study for the treatment of Type 1 Diabetes Mellitus

Research Study Title

A Single Ascending Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1092 in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus

Purpose

This is an active- and placebo-controlled, single-site, three-part trial of MK-1092 in healthy adult participants and in participants with type 1 diabetes mellitus (T1DM). The primary hypothesis for this study is that at a dose with sufficient safety, the mean maximal glucose infusion rate (GIRmax) after single subcutaneous (SC) administration of MK-1092 in adult participants with T1DM is within an acceptable range. (Part 3)

To Learn more

Recruitment Details

Phase
1
Gender
All
Age
18 to 60 Years
Overall Status
Recruiting
Lead Sponsor
Merck Sharp & Dohme Corp.
Duration
10 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 60 Years

Subject Inclusion Criteria

All participants

  • 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, 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 nonsmoker 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 ≤ 32.0 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.

Subject Exclusion Criteria

All participants

  • 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 posttrial 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 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.

Site Locations (1)

Country State City Zip Facility and Contact
United States California Chula Vista 91911 ProSciento Inc. ( Site 0001)
Study Coordinator
619-427-1300

Contact

Toll Free Number
1-888-577-8839
E-mail:

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