Type 1 Diabetes MellitusPhase 1NCT02269735
A Three-part Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Participants (Part I) and Participants With Type 1 Diabetes Mellitus (Parts II and III) (MK-2640-001)
A Phase 1 study testing MK-2640, Regular Human Insulin (RHI) and Dextrose in people with Type 1 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of Part I of this study is to evaluate the safety and tolerability of intravenous (IV) doses of MK-2640 in healthy participants and to obtain preliminary plasma pharmacokinetic profiles of MK-2640. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- MK-2640, Regular Human Insulin (RHI) and Dextrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 26 Nov 2014to 29 Jul 2016
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male or healthy female of non-child bearing potential
- in good health
- is a non-smoker and/or has not used nicotine or nicotine-containing products (e.g., nicotine patch) for at least approximately 3 months
- male or female of non-child bearing potential
- has T1DM for at least 12 months
- on stable doses of insulin
- in good health
- is a nonsmoker and/or has not used nicotine or nicotine-containing products (e.g., nicotine patch) for at least approximately 3 months
Who cannot join
- is mentally or legally incapacitated, or has significant emotional problems at the time of screening visit or expected during the conduct of the trial or has a history of clinically significant psychiatric disorder of the last 5 years
- has a history of clinically significant endocrine (except T1DM for Part II subjects), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases
- is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
- has a history of cancer (malignancy), except adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix
- has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food, had major surgery, donated or lost 1 unit of blood within 4 weeks prior to the screening visit
- has participated in another investigational trial within 4 weeks prior to the screening visit
Show all 14Show fewer
- 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
- consumes greater than 3 glasses of alcoholic beverages daily
- consumes greater than 6 servings of coffee, tea, cola, energy-drinks, or other 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 3 months
- has a history of diabetic ketoacidosis in the last 6 months.
- has had one or more severe hypoglycemic episodes associated with hypoglycemic seizures, comas or unconsciousness within 2 weeks 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 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
About this study
Official title: A Three-part Study Parts I, II and III: Rising Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Subjects (Part I) and Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Subjects With Type 1 Diabetes Mellitus (Part II and Part III).
The purpose of Part I of this study is to evaluate the safety and tolerability of intravenous (IV) doses of MK-2640 in healthy participants and to obtain preliminary plasma pharmacokinetic profiles of MK-2640. The purpose of Parts II and III of this study is to evaluate the safety and tolerability of IV doses of MK-2640 and regular human insulin (RHI), and to evaluate the pharmacokinetic and pharmacodynamic profile of MK-2640 and RHI in participants with type 1 diabetes mellitus (T1DM). Part II will be initiated only if Part I general safety, tolerability and other observed data are supportive of progression to Part II. Part III will be initiated only if Parts I and II general safety, tolerability and other observed data are supportive of progression to Part III.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- MK-2640, Regular Human Insulin (RHI), Dextrose, Insulin aspart, Rescue medication
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-2640Drug
MK-2640 intravenous infusion administered to participant in a fasted state
Regular Human Insulin (RHI)Biological
RHI 100 units/mL intravenous infusion to maintain target glycemic level
DextroseDrug
Dextrose 20% or 50% intravenous infusion for approximately 9 or 7 hours, as appropriate to attain a target glycemic level
Insulin aspartBiological
Insulin aspart subcutaneous injection or intravenous infusion the evening before each period in Parts II and III to achieve/maintain glycemic target.
Rescue medicationDrug
Rescue medication may be administered for hypotension or mild to moderate infusion reaction. Rescue medication may include epinephrine, antihistamines, steroids, or acetaminophen/paracetamol.
| Study group | Role | What they receive |
|---|---|---|
| Part I: MK-2640 (Panel A) | Experimental | Part I: Lowest dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours. Receives: Drug: MK-2640; Drug: Dextrose; Drug: Rescue medication |
| Part I: MK-2640 (Panel B) | Experimental | Part I: Low dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours. Receives: Drug: MK-2640; Drug: Dextrose; Drug: Rescue medication |
| Part I: MK-2640 (Panel C) | Experimental | Part I: Medium-low dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours. Receives: Drug: MK-2640; Drug: Dextrose; Drug: Rescue medication |
| Part I: MK-2640 (Panel D) | Experimental | Part I: Medium dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours. Receives: Drug: MK-2640; Drug: Dextrose; Drug: Rescue medication |
| Part I: MK-2640 (Panel E) | Experimental | Part I: Medium-high dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours. Receives: Drug: MK-2640; Drug: Dextrose; Drug: Rescue medication |
| Part I: MK-2640 (Panel F) | Experimental | Part I: High dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours. Receives: Drug: MK-2640; Drug: Dextrose; Drug: Rescue medication |
| Part I: MK-2640 (Panel G) | Experimental | Part 1: Highest dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours. Receives: Drug: MK-2640; Drug: Dextrose; Drug: Rescue medication |
| Part II: MK-2640 followed by RHI | Experimental | Part II: MK-2640 infusion and dextrose infusion for 9 hours during Period 1 of Part II followed by a 7-day wash-out period followed by RHI infusion and dextrose infusion for 9 hours during Period 2 of Part II. Insulin aspart administered approximately 10 hours before Periods 1 and 2 of Part II. Receives: Drug: MK-2640; Biological: Regular Human Insulin (RHI); Drug: Dextrose; Biological: Insulin aspart; Drug: Rescue medication |
| Part II: RHI followed by MK-2640 | Experimental | Part II: RHI infusion and dextrose infusion for 9 hours during Period 1 of Part II followed by a 7-day wash-out period followed by MK-2640 infusion and dextrose infusion for 9 hours during Period 2 of Part II. Insulin aspart administered approximately 10 hours before Periods 1 and 2 of Part II. Receives: Drug: MK-2640; Biological: Regular Human Insulin (RHI); Drug: Dextrose; Biological: Insulin aspart; Drug: Rescue medication |
| Part III: MK-2640 followed by RHI | Experimental | Part III: MK-2640 infusion and dextrose infusion for 7 hours during Period 1 of Part III followed by a 7-day wash-out period followed by RHI infusion and dextrose infusion for 7 hours during Period 2 of Part III. Insulin aspart administered approximately 10 hours before Periods 1 and 2 of Part III. Receives: Drug: MK-2640; Biological: Regular Human Insulin (RHI); Drug: Dextrose; Biological: Insulin aspart; Drug: Rescue medication |
| Part III: RHI followed by MK-2640 | Experimental | Part III: RHI infusion and dextrose infusion for 7 hours during Period 1 of Part III followed by a 7-day wash-out period followed by MK-2640 infusion and dextrose infusion for 7 hours during Period 2 of Part III. Insulin aspart administered approximately 10 hours before Periods 1 and 2 of Part III. Receives: Drug: MK-2640; Biological: Regular Human Insulin (RHI); Drug: Dextrose; Biological: Insulin aspart; Drug: Rescue medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experienced an adverse event
Measured: Up to 30 days following last dose
Pharmacokinetic parameter: steady state plasma concentration (Css)
Measured: Part I: final 30 minutes of each infusion rate; Parts II and III: final 30 minutes of each interval
Pharmacokinetic parameter: area under the plasma concentration curve from time 0 to infinity (AUC [0 to infinity])
Measured: Part I: 18 time points between predose and 600 minutes (min.); Part II: 19 time points between predose and 535 min.; Part III: 18 time points between predose and 415 min. following start of infusion
Pharmacokinetic parameter: clearance (CL)
Measured: Part I: final 30 minutes of each infusion rate; Parts II and III: final 30 minutes of each interval
Pharmacokinetic parameter: volume of distribution (Vd)
Measured: Part I: final 30 minutes of each infusion rate; Parts II and III: final 30 minutes of each interval
Pharmacokinetic parameter: plasma apparent terminal half-life
Measured: Part II: following 9 hour infusion; Part III: following 7 hour infusion
Pharmacodynamic parameter: steady-state glucose infusion-rate (GIR) in Part II
Measured: Part II: during the final 60 minutes of the infusion
Number of participants who discontinued study drug due to an adverse event
Measured: Part I: 1 day; Parts II and III: 9 days
Secondary outcomes (1)
Number of participants with anti-drug antibody (ADA) formation
Measured: Up to 30 days following last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study start26 Nov 2014
- Primary completion29 Jul 2016
- Study completion29 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 74 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
- NCT02269735
- Sponsor's protocol ID
- 2640-001
- Status last verified
- Jan 2019
- First submitted
- 16 Oct 2014
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Krug AW, Visser SAG, Tsai K, Kandala B, Fancourt C, Thornton B, Morrow L, Kaarsholm NC, Bernstein HS, Stoch SA, Crutchlow M, Kelley DE, Iwamoto M. Clinical Evaluation of MK-2640: An Insulin Analog With Glucose-Responsive Properties. Clin Pharmacol Ther. 2019 Feb;105(2):417-425. doi: 10.1002/cpt.1215. Epub 2018 Sep 30.
PubMed 30125349
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-part Study Parts I, II and III: Rising Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Subjects (Part I) and Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Subjects With Type 1 Diabetes Mellitus (Part II and Part III).
- ClinicalTrials.gov ID
- NCT02269735
- Acronym / sponsor ID
- 2640-001
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2014 (actual)
- Primary completion
- 29 Jul 2016 (actual)
- Study completion
- 29 Jul 2016 (actual)
- First posted
- 21 Oct 2014 (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.
The purpose of Part I of this study is to evaluate the safety and tolerability of intravenous (IV) doses of MK-2640 in healthy participants and to obtain preliminary plasma pharmacokinetic profiles of MK-2640. The purpose of Parts II and III of this study is to evaluate the safety and tolerability of IV doses of MK-2640 and regular human insulin (RHI), and to evaluate the pharmacokinetic and pharmacodynamic profile of MK-2640 and RHI in participants with type 1 diabetes mellitus (T1DM). Part II will be initiated only if Part I general safety, tolerability and other observed data are supportive of progression to Part II. Part III will be initiated only if Parts I and II general safety, tolerability and other observed data are supportive of progression to Part III.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part I: MK-2640 (Panel A) | Experimental | Drug: MK-2640, Drug: Dextrose, Drug: Rescue medicationPart I: Lowest dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours. |
| Part I: MK-2640 (Panel B) | Experimental | Drug: MK-2640, Drug: Dextrose, Drug: Rescue medicationPart I: Low dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours. |
| Part I: MK-2640 (Panel C) | Experimental | Drug: MK-2640, Drug: Dextrose, Drug: Rescue medicationPart I: Medium-low dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours. |
| Part I: MK-2640 (Panel D) | Experimental | Drug: MK-2640, Drug: Dextrose, Drug: Rescue medicationPart I: Medium dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours. |
| Part I: MK-2640 (Panel E) | Experimental | Drug: MK-2640, Drug: Dextrose, Drug: Rescue medicationPart I: Medium-high dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours. |
| Part I: MK-2640 (Panel F) | Experimental | Drug: MK-2640, Drug: Dextrose, Drug: Rescue medicationPart I: High dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours. |
| Part I: MK-2640 (Panel G) | Experimental | Drug: MK-2640, Drug: Dextrose, Drug: Rescue medicationPart 1: Highest dose of MK-2640 infusion (3 approximately three-hour infusions at escalating rates) and dextrose infusion for 9 hours. |
| Part II: MK-2640 followed by RHI | Experimental | Drug: MK-2640, Biological: Regular Human Insulin (RHI), Drug: Dextrose, Biological: Insulin aspart, Drug: Rescue medicationPart II: MK-2640 infusion and dextrose infusion for 9 hours during Period 1 of Part II followed by a 7-day wash-out period followed by RHI infusion and dextrose infusion for 9 hours during Period 2 of Part II. Insulin aspart administered approximately 10 hours before Periods 1 and 2 of Part II. |
| Part II: RHI followed by MK-2640 | Experimental | Drug: MK-2640, Biological: Regular Human Insulin (RHI), Drug: Dextrose, Biological: Insulin aspart, Drug: Rescue medicationPart II: RHI infusion and dextrose infusion for 9 hours during Period 1 of Part II followed by a 7-day wash-out period followed by MK-2640 infusion and dextrose infusion for 9 hours during Period 2 of Part II. Insulin aspart administered approximately 10 hours before Periods 1 and 2 of Part II. |
| Part III: MK-2640 followed by RHI | Experimental | Drug: MK-2640, Biological: Regular Human Insulin (RHI), Drug: Dextrose, Biological: Insulin aspart, Drug: Rescue medicationPart III: MK-2640 infusion and dextrose infusion for 7 hours during Period 1 of Part III followed by a 7-day wash-out period followed by RHI infusion and dextrose infusion for 7 hours during Period 2 of Part III. Insulin aspart administered approximately 10 hours before Periods 1 and 2 of Part III. |
| Part III: RHI followed by MK-2640 | Experimental | Drug: MK-2640, Biological: Regular Human Insulin (RHI), Drug: Dextrose, Biological: Insulin aspart, Drug: Rescue medicationPart III: RHI infusion and dextrose infusion for 7 hours during Period 1 of Part III followed by a 7-day wash-out period followed by MK-2640 infusion and dextrose infusion for 7 hours during Period 2 of Part III. Insulin aspart administered approximately 10 hours before Periods 1 and 2 of Part III. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- healthy male or healthy female of non-child bearing potential
- in good health
- is a non-smoker and/or has not used nicotine or nicotine-containing products (e.g., nicotine patch) for at least approximately 3 months
- male or female of non-child bearing potential
- has T1DM for at least 12 months
Key exclusion criteria (14 listed)
- is mentally or legally incapacitated, or has significant emotional problems at the time of screening visit or expected during the conduct of the trial or has a history of clinically significant psychiatric disorder of the last 5 years
- has a history of clinically significant endocrine (except T1DM for Part II subjects), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases
- is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
- has a history of cancer (malignancy), except adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix
- has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food, had major surgery, donated or lost 1 unit of blood within 4 weeks prior to the screening 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-2640MK-2640 intravenous infusion administered to participant in a fasted state | Drug | Part I: MK-2640 (Panel A), Part I: MK-2640 (Panel B), Part I: MK-2640 (Panel C), Part I: MK-2640 (Panel D), Part I: MK-2640 (Panel E), Part I: MK-2640 (Panel F), Part I: MK-2640 (Panel G), Part II: MK-2640 followed by RHI, Part II: RHI followed by MK-2640, Part III: MK-2640 followed by RHI, Part III: RHI followed by MK-2640 |
| Regular Human Insulin (RHI)RHI 100 units/mL intravenous infusion to maintain target glycemic level | Biological | Part II: MK-2640 followed by RHI, Part II: RHI followed by MK-2640, Part III: MK-2640 followed by RHI, Part III: RHI followed by MK-2640 |
| DextroseDextrose 20% or 50% intravenous infusion for approximately 9 or 7 hours, as appropriate to attain a target glycemic level | Drug | Part I: MK-2640 (Panel A), Part I: MK-2640 (Panel B), Part I: MK-2640 (Panel C), Part I: MK-2640 (Panel D), Part I: MK-2640 (Panel E), Part I: MK-2640 (Panel F), Part I: MK-2640 (Panel G), Part II: MK-2640 followed by RHI, Part II: RHI followed by MK-2640, Part III: MK-2640 followed by RHI, Part III: RHI followed by MK-2640 |
| Insulin aspartInsulin aspart subcutaneous injection or intravenous infusion the evening before each period in Parts II and III to achieve/maintain glycemic target. | Biological | Part II: MK-2640 followed by RHI, Part II: RHI followed by MK-2640, Part III: MK-2640 followed by RHI, Part III: RHI followed by MK-2640 |
| Rescue medicationRescue medication may be administered for hypotension or mild to moderate infusion reaction. Rescue medication may include epinephrine, antihistamines, steroids, or acetaminophen/paracetamol. | Drug | Part I: MK-2640 (Panel A), Part I: MK-2640 (Panel B), Part I: MK-2640 (Panel C), Part I: MK-2640 (Panel D), Part I: MK-2640 (Panel E), Part I: MK-2640 (Panel F), Part I: MK-2640 (Panel G), Part II: MK-2640 followed by RHI, Part II: RHI followed by MK-2640, Part III: MK-2640 followed by RHI, Part III: RHI followed by MK-2640 |
Primary outcome
Number of participants who experienced an adverse event
Time frame: Up to 30 days following last dose
Pharmacokinetic parameter: steady state plasma concentration (Css)
Time frame: Part I: final 30 minutes of each infusion rate; Parts II and III: final 30 minutes of each interval
Pharmacokinetic parameter: area under the plasma concentration curve from time 0 to infinity (AUC [0 to infinity])
Time frame: Part I: 18 time points between predose and 600 minutes (min.); Part II: 19 time points between predose and 535 min.; Part III: 18 time points between predose and 415 min. following start of infusion
Pharmacokinetic parameter: clearance (CL)
Time frame: Part I: final 30 minutes of each infusion rate; Parts II and III: final 30 minutes of each interval
Pharmacokinetic parameter: volume of distribution (Vd)
Time frame: Part I: final 30 minutes of each infusion rate; Parts II and III: final 30 minutes of each interval
Pharmacokinetic parameter: plasma apparent terminal half-life
Time frame: Part II: following 9 hour infusion; Part III: following 7 hour infusion
Pharmacodynamic parameter: steady-state glucose infusion-rate (GIR) in Part II
Time frame: Part II: during the final 60 minutes of the infusion
Number of participants who discontinued study drug due to an adverse event
Time frame: Part I: 1 day; Parts II and III: 9 days
1 secondary outcome
Number of participants with anti-drug antibody (ADA) formation
Time frame: Up to 30 days following last dose
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 15 Jan 2019.
- Results publication: PubMed 30125349Krug AW, Visser SAG, Tsai K, Kandala B, Fancourt C, Thornton B, Morrow L, Kaarsholm NC, Bernstein HS, Stoch SA, Crutchlow M, Kelley DE, Iwamoto M. Clinical Evaluation of MK-2640: An Insulin Analog With Glucose-Responsive Properties. Clin Pharmacol Ther. 2019 Feb;105(2):417-425. doi: 10.1002/cpt.1215. Epub 2018 Sep 30.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-2640, Regular Human Insulin (RHI) and Dextrose in people with Type 1 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 8 inclusion and 14 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 15 Jan 2019. 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?
Number of participants who experienced an adverse event (time frame: Up to 30 days following last dose). The study lists 8 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 NCT02269735, which also lists 1 linked publication.
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 15 Jan 2019.