Type 1 Diabetes MellitusPhase 1NCT03095651
Multiple Ascending Dose Study of MK-5160 in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-5160-002)
A Phase 1 study testing MK-5160 16 nmol/kg, MK-5160 32 nmol/kg and MK-5160 64 nmol/kg in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
This is a randomized, active- and placebo-controlled, double-blind trial of MK-5160 in participants with Type 1 diabetes mellitus (T1DM) and Type 2 diabetes mellitus (T2DM). This is a two-part trial, with three panels per part. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- What is being tested?
- MK-5160 16 nmol/kg, MK-5160 32 nmol/kg and MK-5160 64 nmol/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2017to 30 Jan 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Part 1 (T1DM):
- Be male, or female of non-childbearing potential. A female of non-childbearing potential defined as a female who is postmenopausal without menses for at least 1 year and has a follicle stimulating hormone (FSH) value in the postmenopausal range upon pretrial (screening) evaluation OR a female who is status post hysterectomy, oophorectomy or tubal ligation.
- Be judged to be in good health
- Have a diagnosis of T1DM as defined by standard diagnostic criteria for ≥12 months at time study participation
- 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.
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- Have a hemoglobin A1C (HbA1c) ≤10% at the time of study participation.
- Have a Body Mass Index (BMI) ≥18.5 kg/m^2 and ≤ 32 kg/m^2. BMI = mass (kg)/height (m)^2
- 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). The subject must agree to follow the smoking restrictions defined by the clinical research unit (CRU).
- For Part 2 (T2DM):
- Be male, or female of non-childbearing potential. A female of non-childbearing potential defined as a female who is postmenopausal without menses for at least 1 year and has a FSH value in the postmenopausal range upon pretrial (screening) evaluation OR a female who is status post hysterectomy, oophorectomy or tubal ligation.
- Be judged to be in good health
- Have a diagnosis of T2DM as defined by standard diagnostic criteria for ≥12 month at time of study participation.
- T2DM participants are not required to have been on insulin. If on insulin, participants 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.
- Meet one of the following criteria:
- Be on no anti-hyperglycemic agent (AHA), or on metformin monotherapy or metformin plus a dipeptidyl peptidase-4 (DPP4) inhibitor at stable doses for at least 8 weeks prior to screening, with a screening HbA1C ≥7.0 and ≤10.0%.
- Be on either a sulfonylurea (e.g. glyburide) or an alpha-glucosidase inhibitors (e.g., acarbose) alone or in combination with metformin at stable doses for at least 8 weeks prior to screening with a screening HbA1C ≥7.0 and ≤9.0%. Participants on these medications must be willing to stop the sulfonylurea or alpha-glucosidase inhibitor after screening once they qualify for study participation.
- Have a BMI ≥18.5 kg/m^2 and ≤ 35.0 kg/m^2 BMI = mass (kg)/height (m)^2
- May be on selected standard medications for T2DM, including alpha-glucosidase inhibitors (e.g., acarbose), sulfonylureas (e.g. glyburide), DPP-4 inhibitors, and metformin. Participants on alpha-glucosidase inhibitors and/or sulfonylureas must stop these medications for at least one week prior to checking into the site and for the duration of the trial through the last dose of MK-5160/glargine. Participants on metformin or DPP-4 inhibitors may continue on their home dose for the duration of the trial. Participants on SGLT2 inhibitors (gliflozins), thiazolidinediones or GLP-1 agonists are excluded.
- Be a nonsmoker or smoker who uses no greater than 5 cigarettes or equivalent (e.g., e-cigarettes) daily over the prior 3 month period. Participants must agree to follow the smoking restrictions defined by the CRU.
Who cannot join
- For Part 1 (T1DM) and Part 2 (T2DM):
- Is under the age of legal consent
- Is mentally or legally incapacitated, has significant emotional problems at the time of pretrial (screening) visit or expected during the conduct of the trial or has a history of clinically significant psychiatric disorder of the last 5 years. Participants who have had situational depression may be enrolled in the trial at the discretion of the investigator.
- Has a history of clinically significant endocrine (excluding diabetes mellitus), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases. Participants with a history of uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma may be enrolled in the trial at the discretion of the investigator.
- 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 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.
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- Is positive for hepatitis B surface antigen, hepatitis C antibodies or HIV at Screening.
- Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pretrial visit.
- Has participated in another investigational trial within 4 weeks (or 5 half-lives), whichever is greater, prior to the pretrial visit.
- 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 (or 5 half-lives) prior to administration of the initial dose of trial drug, throughout the trial (including washout intervals between treatment periods), until the post-trial visit. Certain medications, such as antihypertensives and aspirin, are permitted.
- Consumes greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce]) per day.
- Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy-drinks, or other caffeinated beverages per day.
- Is a regular user of cannabis or any illicit drugs, or has a history of drug (including alcohol) abuse within approximately 6 months.
- 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 used systemic (intravenous, oral, inhaled) glucocorticoids within 3 months of screening or is anticipated to require treatment with systemic glucocorticoids during study participation.
- Has other major medical problems requiring medication (i.e., history of myocardial infarction, hypercholesterolemia). Participants on aspirin as prophylaxis may be enrolled, provided there is no history of MI or other thromboembolic event, or a history of coronary atherosclerosis.
- 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 regular human insulin, or to any E.coli-derived drug product.
- For Part 1 (T1DM) Only:
- Has a history of diabetic ketoacidosis in the last 12 months.
- For Part 2 (T2DM) Only
- Has been treated with a sodium/glucose cotransporter 2 (SGLT2) inhibitor (gliflozins), thiazolidinedione or Glucagon-like peptide-1 (GLP-1) receptor agonist within the past three months.
Trial locations and contacts
1 site in 1 country.
United States1 site
ProSciento Inc. ( Site 0001)
Chula Vista, California, 91911
About this study
Official title: A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Effect of MK-5160 in Subjects With Type 1 and Type 2 Diabetes Mellitus
This is a randomized, active- and placebo-controlled, double-blind trial of MK-5160 in participants with Type 1 diabetes mellitus (T1DM) and Type 2 diabetes mellitus (T2DM). This is a two-part trial, with three panels per part. T1DM (Part 1) and T2DM (Part 2) participants will be given daily fixed doses of MK-5160 in three predefined, increasing doses in each panel, or glargine (active comparator). The primary hypothesis of the trial is that at a dose with sufficient safety, the mean steady-state maximum level of glucose infusion rate (GIRmax) after MK-5160 administration in both T1DM and T2DM participants is between 1.5 and 4.5 mg/kg/min.
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Being tested
- MK-5160 16 nmol/kg, MK-5160 32 nmol/kg, MK-5160 64 nmol/kg, Glargine 0.4 U/kg, Placebo to Glargine
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-5160 16 nmol/kgBiological
MK-5160 16 nmol/kg, subcutaneous injection administered daily for 12 days
MK-5160 32 nmol/kgBiological
MK-5160 32 nmol/kg, subcutaneous injection administered daily for 12 days
MK-5160 64 nmol/kgBiological
MK-5160 64 nmol/kg, subcutaneous injection administered daily for 12 days
Glargine 0.4 U/kgBiological
Glargine 0.4 U/kg, subcutaneous injection administered daily for 12 days
Placebo to GlargineBiological
Placebo to glargine, subcutaneous injection administered daily for 12 days
Placebo to MK-5160Biological
Placebo to MK-5160, subcutaneous injection administered daily for 12 days
DextroseDrug
20% solution of dextrose; adjusted to maintain the various glycemic levels at 100 mg/dL given as a continuous intravenous infusion for 6-30 hours.
Glargine 0.6 U/kgBiological
Glargine 0.6 U/kg, subcutaneous injection administered daily for 12 days
| Study group | Role | What they receive |
|---|---|---|
| T1DM MK-5160 16 nmol/kg | Experimental | Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar. Receives: Biological: MK-5160 16 nmol/kg; Biological: Placebo to Glargine; Drug: Dextrose |
| T1DM MK-5160 32 nmol/kg | Experimental | Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar. Receives: Biological: MK-5160 32 nmol/kg; Biological: Placebo to Glargine; Drug: Dextrose |
| T1DM MK-5160 64 nmol/kg | Experimental | Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar. Receives: Biological: MK-5160 64 nmol/kg; Biological: Placebo to Glargine; Drug: Dextrose |
| T1DM Glargine 0.4 U/kg | Active comparator | Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar. Receives: Biological: Glargine 0.4 U/kg; Biological: Placebo to MK-5160; Drug: Dextrose |
| T2DM MK-5160 16 nmol/kg | Experimental | Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar. Receives: Biological: MK-5160 16 nmol/kg; Biological: Placebo to Glargine; Drug: Dextrose |
| T2DM MK-5160 32 nmol/kg | Experimental | Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar. Receives: Biological: MK-5160 32 nmol/kg; Biological: Placebo to Glargine; Drug: Dextrose |
| T2DM MK-5160 64 nmol/kg | Experimental | Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar. Receives: Biological: MK-5160 64 nmol/kg; Biological: Placebo to Glargine; Drug: Dextrose |
| T2DM Glargine 0.6 U/kg | Active comparator | Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar. Receives: Biological: Placebo to MK-5160; Drug: Dextrose; Biological: Glargine 0.6 U/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing an Adverse Event (AE)
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to 33 days
Number of Participants Discontinuing Study Drug Due to an AE
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to 12 days
Maximal Glucose Infusion Rate
Maximal glucose infusion rate required to maintain target glucose levels in a euglycemic clamp setting (GIRmax) at steady state (Day 12) following administration of study drug. In cases where the lower bound of the CI was negative, the lower confidence limit was truncated at zero. In these cases, the confidence intervals are 97.5% CIs.
Measured: Up to 24 hours post-dose on Day 12
Secondary outcomes (11)
Maximum Plasma Concentration (Cmax) of MK-5160
Cmax of MK-5160 following multiple dose administration of study drug. Glargine data are presented in the following outcome measure.
Measured: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours following start of injection (FSOI). Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.
Maximum Plasma Concentration (Cmax) of Glargine
Cmax of glargine following multiple dose administration of study drug. MK-5160 data are presented in the preceding outcome measure.
Measured: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.
Day 12 to Day 1 Accumulation Ratio of Cmax
Day 12 to Day 1 accumulation ratio (AR) of Cmax of MK-5160 and glargine following multiple dose administration of study drug. Geometric mean accumulation ratio = Day 12 Cmax/Day 1 Cmax.
Measured: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.
Steady State Plasma Concentration (Css) of MK-5160
Css of MK-5160 is the amount of MK-5160 in a given volume of plasma at the time a "steady state" has been achieved, and rates of MK-5160 administration and MK-5160 elimination are equal. Glargine data are presented in the following outcome measure.
Measured: Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.
Steady State Plasma Concentration (Css) of Glargine
Css of glargine is the amount of glargine in a given volume of plasma at the time a "steady state" has been achieved, and rates of glargine administration and glargine elimination are equal. MK-5160 data are presented in the preceding outcome measure.
Measured: Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.
Plasma Concentration/Time (AUC0-24) of MK-5160
Area Under the Plasma Concentration/Time Curve for MK-5160 from Time 0 to 24 hours (AUC0-24) is a measure of the total amount of MK-5160 in the plasma from the dose administration to 24 hours. Glargine data are presented in the following outcome measure.
Measured: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI.
Plasma Concentration/Time (AUC0-24) of Glargine
AUC0-24 is a measure of the total amount of glargine in the plasma from the dose administration to 24 hours. MK-5160 data are presented in the preceding outcome measure.
Measured: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI.
Day 12 to Day 1 Accumulation Ratio of AUC0-24.
Day 12 to Day 1 Accumulation Ratio (AR) of the AUC0-24 of study drug (MK-5160 or glargine). Geometric mean accumulation ratio = Day 12 AUC0-24/Day 1 AUC0-24
Measured: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI.
Plasma Clearance
Plasma Clearance (CL) of study drug is the volume of plasma cleared of study drug per unit time.
Measured: Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.
Time to Maximum Plasma Concentration
Time to reach the maximum plasma concentration (Tmax) of study drug after the dose is given.
Measured: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.
Apparent Terminal Half-life
Apparent Terminal Half-life (t1/2) is the time required for a given MK-5160 concentration in the plasma to decrease by 50%.
Measured: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start12 Apr 2017
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095651
- Sponsor's protocol ID
- 5160-002
- Other IDs
- MK-5160-002
- Status last verified
- Mar 2019
- First submitted
- 27 Mar 2017
- Last updated
- 1 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Effect of MK-5160 in Subjects With Type 1 and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03095651
- Acronym / sponsor ID
- 5160-002
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Posted 1 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, active- and placebo-controlled, double-blind trial of MK-5160 in participants with Type 1 diabetes mellitus (T1DM) and Type 2 diabetes mellitus (T2DM). This is a two-part trial, with three panels per part. T1DM (Part 1) and T2DM (Part 2) participants will be given daily fixed doses of MK-5160 in three predefined, increasing doses in each panel, or glargine (active comparator). The primary hypothesis of the trial is that at a dose with sufficient safety, the mean steady-state maximum level of glucose infusion rate (GIRmax) after MK-5160 administration in both T1DM and T2DM participants is between 1.5 and 4.5 mg/kg/min.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| T1DM MK-5160 16 nmol/kg | Experimental | Biological: MK-5160 16 nmol/kg, Biological: Placebo to Glargine, Drug: DextroseParticipants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar. |
| T1DM MK-5160 32 nmol/kg | Experimental | Biological: MK-5160 32 nmol/kg, Biological: Placebo to Glargine, Drug: DextroseParticipants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar. |
| T1DM MK-5160 64 nmol/kg | Experimental | Biological: MK-5160 64 nmol/kg, Biological: Placebo to Glargine, Drug: DextroseParticipants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar. |
| T1DM Glargine 0.4 U/kg | Active comparator | Biological: Glargine 0.4 U/kg, Biological: Placebo to MK-5160, Drug: DextroseParticipants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar. |
| T2DM MK-5160 16 nmol/kg | Experimental | Biological: MK-5160 16 nmol/kg, Biological: Placebo to Glargine, Drug: DextroseParticipants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar. |
| T2DM MK-5160 32 nmol/kg | Experimental | Biological: MK-5160 32 nmol/kg, Biological: Placebo to Glargine, Drug: DextroseParticipants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar. |
| T2DM MK-5160 64 nmol/kg | Experimental | Biological: MK-5160 64 nmol/kg, Biological: Placebo to Glargine, Drug: DextroseParticipants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar. |
| T2DM Glargine 0.6 U/kg | Active comparator | Biological: Placebo to MK-5160, Drug: Dextrose, Biological: Glargine 0.6 U/kgParticipants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- For Part 1 (T1DM):
- Be male, or female of non-childbearing potential. A female of non-childbearing potential defined as a female who is postmenopausal without menses for at least 1 year and has a follicle stimulating hormone (FSH) value in the postmenopausal range upon pretrial (screening) evaluation OR a female who is status post hysterectomy, oophorectomy or tubal ligation.
- Be judged to be in good health
- Have a diagnosis of T1DM as defined by standard diagnostic criteria for ≥12 months at time study participation
- Be on stable doses of basal insulin over the 2-week period prior to screening and over the 2 weeks prior to dosing.
Key exclusion criteria (22 listed)
- For Part 1 (T1DM) and Part 2 (T2DM):
- Is under the age of legal consent
- Is mentally or legally incapacitated, has significant emotional problems at the time of pretrial (screening) visit or expected during the conduct of the trial or has a history of clinically significant psychiatric disorder of the last 5 years. Participants who have had situational depression may be enrolled in the trial at the discretion of the investigator.
- Has a history of clinically significant endocrine (excluding diabetes mellitus), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases. Participants with a history of uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma may be enrolled in the trial at the discretion of the investigator.
- 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 visit
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-5160 16 nmol/kgMK-5160 16 nmol/kg, subcutaneous injection administered daily for 12 days | Biological | T1DM MK-5160 16 nmol/kg, T2DM MK-5160 16 nmol/kg |
| MK-5160 32 nmol/kgMK-5160 32 nmol/kg, subcutaneous injection administered daily for 12 days | Biological | T1DM MK-5160 32 nmol/kg, T2DM MK-5160 32 nmol/kg |
| MK-5160 64 nmol/kgMK-5160 64 nmol/kg, subcutaneous injection administered daily for 12 days | Biological | T1DM MK-5160 64 nmol/kg, T2DM MK-5160 64 nmol/kg |
| Glargine 0.4 U/kgGlargine 0.4 U/kg, subcutaneous injection administered daily for 12 days | Biological | T1DM Glargine 0.4 U/kg |
| Placebo to GlarginePlacebo to glargine, subcutaneous injection administered daily for 12 days | Biological | T1DM MK-5160 16 nmol/kg, T1DM MK-5160 32 nmol/kg, T1DM MK-5160 64 nmol/kg, T2DM MK-5160 16 nmol/kg, T2DM MK-5160 32 nmol/kg, T2DM MK-5160 64 nmol/kg |
| Placebo to MK-5160Placebo to MK-5160, subcutaneous injection administered daily for 12 days | Biological | T1DM Glargine 0.4 U/kg, T2DM Glargine 0.6 U/kg |
| Dextrose20% solution of dextrose; adjusted to maintain the various glycemic levels at 100 mg/dL given as a continuous intravenous infusion for 6-30 hours. | Drug | T1DM Glargine 0.4 U/kg, T1DM MK-5160 16 nmol/kg, T1DM MK-5160 32 nmol/kg, T1DM MK-5160 64 nmol/kg, T2DM Glargine 0.6 U/kg, T2DM MK-5160 16 nmol/kg, T2DM MK-5160 32 nmol/kg, T2DM MK-5160 64 nmol/kg |
| Glargine 0.6 U/kgGlargine 0.6 U/kg, subcutaneous injection administered daily for 12 days | Biological | T2DM Glargine 0.6 U/kg |
Primary outcome
Number of Participants Experiencing an Adverse Event (AE)
Time frame: Up to 33 days
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Number of Participants Discontinuing Study Drug Due to an AE
Time frame: Up to 12 days
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Maximal Glucose Infusion Rate
Time frame: Up to 24 hours post-dose on Day 12
Maximal glucose infusion rate required to maintain target glucose levels in a euglycemic clamp setting (GIRmax) at steady state (Day 12) following administration of study drug. In cases where the lower bound of the CI was negative, the lower confidence limit was truncated at zero. In these cases, the confidence intervals are 97.5% CIs.
11 secondary outcomes
Maximum Plasma Concentration (Cmax) of MK-5160
Time frame: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours following start of injection (FSOI). Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.
Maximum Plasma Concentration (Cmax) of Glargine
Time frame: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.
Day 12 to Day 1 Accumulation Ratio of Cmax
Time frame: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.
Steady State Plasma Concentration (Css) of MK-5160
Time frame: Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.
Steady State Plasma Concentration (Css) of Glargine
Time frame: Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.
Plasma Concentration/Time (AUC0-24) of MK-5160
Time frame: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI.
Plasma Concentration/Time (AUC0-24) of Glargine
Time frame: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI.
Day 12 to Day 1 Accumulation Ratio of AUC0-24.
Time frame: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI.
Plasma Clearance
Time frame: Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.
Time to Maximum Plasma Concentration
Time frame: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.
Apparent Terminal Half-life
Time frame: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-5160 16 nmol/kg, MK-5160 32 nmol/kg and MK-5160 64 nmol/kg in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC at 1 site in United States.
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 20 inclusion and 22 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 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 1 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Experiencing an Adverse Event (AE) (time frame: Up to 33 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2019.