DiabetesPhase 1NCT01152242
Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin (0000-168)
A Phase 1 study testing Isoglycemic Clamp and Comparator: insulin glargine in people with Diabetes, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to evaluate whether the within-subject variation in duration of action and time-action profile of glargine measured by isoglycemic clamp will be below prespecified levels. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Diabetes
- What is being tested?
- Isoglycemic Clamp and Comparator: insulin glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to May 2012
- 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 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Part 1:
- Patient is a male between 18 to 45 years of age (inclusive) at the prestudy (screening) visit
- Patient has a clinical diagnosis of type 1 diabetes
- Patient must have been treated with insulin since diagnosis and be on a stable dose of insulin
- Patient has a Body Mass Index (BMI) of <=27 kg/m2 and >18 kg/m2
- Patient has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
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- Part 2:
- Subject is a male between 18 to 45 years of age at the prestudy (screening) visit
- Subject has a Body Mass Index (BMI) of <=25 kg/m^2
- Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
Who cannot join
- Part 1:
- Patient has a history of stroke, chronic seizures, or major neurological disorder
- Patient has currently active and untreated clinically significant endocrine, cardiovascular, hematological, hepatic, renal, respiratory, or genitourinary abnormalities or diseases
- Patient has a history of hypertension requiring treatment
- Patient has a history of neoplastic disease within the past 5 years
- Patient is currently being treated with, or has a history of treatment with any oral antihyperglycemic agent
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- Patient has a history of significant multiple and/or severe allergies
- Part 2:
- Subject has a history of stroke, chronic seizures, or major neurological disorder
- Subject has a history of hypertension requiring treatment
- Subject has a history of neoplastic disease within the past 5 years
- Subject has history of diabetes (Type 1, Type 2 or steroid-induced) or family history of diabetes mellitus
- Subject has a history of hypersensitivity to glargine or any of its inactive ingredients
About this study
Official title: A Two-Part Clinical Trial to Assess Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin
The purpose of this study is to evaluate whether the within-subject variation in duration of action and time-action profile of glargine measured by isoglycemic clamp will be below prespecified levels.
- Conditions
- Diabetes
- Being tested
- Isoglycemic Clamp, Comparator: insulin glargine
- Keywords
- Insulin
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isoglycemic ClampDrug
Isoglycemic Clamp, a procedure that includes IV infusion of short-acting Insulin (Part I) and glucose (Part I and 2)
Comparator: insulin glargineDrug
Also called LANTUS
Insulin glargine at 0.4 U/kg
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Active comparator | Part I of the trial Receives: Drug: Isoglycemic Clamp; Drug: Comparator: insulin glargine |
| Part 2 | Active comparator | Part II of the trial Receives: Drug: Isoglycemic Clamp; Drug: Comparator: insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part I: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action)
Measured: Baseline and 30 hours
Part II: The within-subject coefficient of variation in time-action profile of glargine for AUC-GIR (AUC of glucose infusion rate), GIRmax (maximum level of glucose infusion rate), over the duration of action of glargine
Measured: Baseline and 30 hours
Secondary outcomes (2)
Part I: The within-subject coefficient of variation in time-action profile of glargine for AUC-GIR and GIRmax over the duration of action of glargine
Measured: Baseline and 30 hours
Part II: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action)
Measured: Baseline and 30 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152242
- Sponsor's protocol ID
- 0000-168
- Other IDs
- 2010_541
- Status last verified
- Jul 2015
- First submitted
- 25 Jun 2010
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part Clinical Trial to Assess Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin
- ClinicalTrials.gov ID
- NCT01152242
- Acronym / sponsor ID
- 0000-168
- Conditions
- Diabetes
- Keywords
- Insulin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 29 Jun 2010 (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 this study is to evaluate whether the within-subject variation in duration of action and time-action profile of glargine measured by isoglycemic clamp will be below prespecified levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Active comparator | Drug: Isoglycemic Clamp, Drug: Comparator: insulin glarginePart I of the trial |
| Part 2 | Active comparator | Drug: Isoglycemic Clamp, Drug: Comparator: insulin glarginePart II of the trial |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patient is a male between 18 to 45 years of age (inclusive) at the prestudy (screening) visit
- Patient has a clinical diagnosis of type 1 diabetes
- Patient must have been treated with insulin since diagnosis and be on a stable dose of insulin
- Patient has a Body Mass Index (BMI) of <=27 kg/m2 and >18 kg/m2
- Patient has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
Key exclusion criteria (13 listed)
- Patient has a history of stroke, chronic seizures, or major neurological disorder
- Patient has currently active and untreated clinically significant endocrine, cardiovascular, hematological, hepatic, renal, respiratory, or genitourinary abnormalities or diseases
- Patient has a history of hypertension requiring treatment
- Patient has a history of neoplastic disease within the past 5 years
- Patient is currently being treated with, or has a history of treatment with any oral antihyperglycemic agent
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 |
|---|---|---|
| Isoglycemic ClampIsoglycemic Clamp, a procedure that includes IV infusion of short-acting Insulin (Part I) and glucose (Part I and 2) | Drug | Part 1, Part 2 |
| Comparator: insulin glargineAlso: LANTUSInsulin glargine at 0.4 U/kg | Drug | Part 1, Part 2 |
Primary outcome
Part I: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action)
Time frame: Baseline and 30 hours
Part II: The within-subject coefficient of variation in time-action profile of glargine for AUC-GIR (AUC of glucose infusion rate), GIRmax (maximum level of glucose infusion rate), over the duration of action of glargine
Time frame: Baseline and 30 hours
2 secondary outcomes
Part I: The within-subject coefficient of variation in time-action profile of glargine for AUC-GIR and GIRmax over the duration of action of glargine
Time frame: Baseline and 30 hours
Part II: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action)
Time frame: Baseline and 30 hours
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 23 Jul 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 Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Isoglycemic Clamp and Comparator: insulin glargine in people with Diabetes, 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 10 inclusion and 13 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 23 Jul 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?
Part I: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action) (time frame: Baseline and 30 hours). 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?
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 23 Jul 2015.