Diabetes MellitusPhase 1NCT00596063
Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Novolin R, in Healthy Subjects.
A Phase 1 study testing Wosulin R and Novolin R in people with Diabetes Mellitus, run by Wockhardt at 2 sites in United States.
Trial summary
The purpose of this study is the comparative evaluation of the pharmacokinetics and pharmacodynamics of two recombinant regular human insulin injections administered subcutaneously in healthy volunteers under the conditions of euglycemic clamp. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Wosulin R and Novolin R
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2008to Feb 2008
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subject.
- Age ≥ 18 and ≤ 45 years.
- Body Mass Index (BMI) between 18.0 and 27.0 kg/m2, inclusive.
- Non-smoker, defined as no nicotine consumption for at least one year.
- Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.).
Who cannot join
- Previous participation in this trial or other clinical trials within the last 3 months.
- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, or sterilization, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, an approved hormonal implant).
- Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator. In particular, subjects with elevated liver enzymes (AST or ALT > 2 times the upper limit of normal) or impaired renal function (elevated serum creatinine values above the upper limit of normal) will not be allowed to enter the trial.
- Any serious systemic infectious disease during the four weeks prior to the first dose of test drug, as judged by the Investigator.
- History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. In particular, subjects with significant cardiovascular disease, anemia (haemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
- History of alcohol or drug abuse.
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- Any positive reaction of drugs of abuse.
- Hepatitis B or C or HIV positive.
- Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for oral contraceptives/hormonal implants.
- Use of any insulin product for therapeutic purposes in the past.
- Use of non-prescription drugs, except routine vitamins, within 3 weeks prior to the first dose of the test drug. Occasional use of paracetamol is permitted.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
- Blood donation of more than 500 ml within the last 12 weeks.
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
- Known or suspected allergy to trial product or related products.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Profil Institute for Clinical Research Inc.
Chula Vista, California, 91911
Profil Institute for Clinical Research, Inc.
Chula Vista, California, 91911
About this study
Official title: A Randomized, Single Center, Double Blind, Two Period, Crossover Glucose Clamp Study to Test for Bioequivalence Between Two Recombinant Human Soluble Insulins- Wockhardts Insulin Human Regular for Injection and Novolin R in Healthy Subjects
The purpose of this study is the comparative evaluation of the pharmacokinetics and pharmacodynamics of two recombinant regular human insulin injections administered subcutaneously in healthy volunteers under the conditions of euglycemic clamp.
Read the detailed description
A comparative evaluation of the pharmacokinetics and pharmacodynamics of two recombinant regular human insulin injections administered subcutaneously in healthy volunteers. It is a crossover study. The subjects shall be administered single doses of each insulin during two separate visits under the conditions of euglycemic clamp.
- Conditions
- Diabetes Mellitus
- Being tested
- Wosulin R, Novolin R
- Keywords
- pharmacokinetics, pharmacodynamics, recombinant human insulin, healthy volunteers
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wosulin RBiological
Penfill cartridges; Single Dose, 0.2 IU/ kg;
Novolin RBiological
Penfill cartridges; Single Dose, 0.2 IU/ kg;
| Study group | Role | What they receive |
|---|---|---|
| Wosulin R | Experimental | Regular insulin for subcutaneous injection (recombinant human insulin), 600nmol, 100 IU Receives: Biological: Wosulin R |
| Novolin R | Active comparator | Regular insulin for injection (recombinant human insulin) Receives: Biological: Novolin R |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to test for bioequivalence based on AUC0-12h and Cmax between Wockhardt's Insulin Human Regular for injection and Novolin® R
Measured: Visit 2 & 3
Secondary outcomes (1)
PK endpoints: AUC, tmax and t½ PD endpoints: AUC-GIR, GIRmax and tGIRmax Safety endpoints: AEs, haematology, biochemistry, urinalyses, physical examination, vital signs, ECGs, blood glucose and local tolerability.
Measured: Visit 2, 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linda Morrow, M.D, Principal investigator, Profil Institute for Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596063
- Sponsor's protocol ID
- Wosulin R/PK-PD/HV/FDA/07/v1
- Other IDs
- Not yet created
- Status last verified
- Dec 2012
- First submitted
- 7 Jan 2008
- Last updated
- 27 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Center, Double Blind, Two Period, Crossover Glucose Clamp Study to Test for Bioequivalence Between Two Recombinant Human Soluble Insulins- Wockhardts Insulin Human Regular for Injection and Novolin R in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00596063
- Acronym / sponsor ID
- Wosulin R/PK-PD/HV/FDA/07/v1
- Conditions
- Diabetes Mellitus
- Keywords
- pharmacokinetics, pharmacodynamics, recombinant human insulin, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 16 Jan 2008 (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 the comparative evaluation of the pharmacokinetics and pharmacodynamics of two recombinant regular human insulin injections administered subcutaneously in healthy volunteers under the conditions of euglycemic clamp.
Detailed description
A comparative evaluation of the pharmacokinetics and pharmacodynamics of two recombinant regular human insulin injections administered subcutaneously in healthy volunteers. It is a crossover study. The subjects shall be administered single doses of each insulin during two separate visits under the conditions of euglycemic clamp.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wosulin R | Experimental | Biological: Wosulin RRegular insulin for subcutaneous injection (recombinant human insulin), 600nmol, 100 IU |
| Novolin R | Active comparator | Biological: Novolin RRegular insulin for injection (recombinant human insulin) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female subject.
- Age ≥ 18 and ≤ 45 years.
- Body Mass Index (BMI) between 18.0 and 27.0 kg/m2, inclusive.
- Non-smoker, defined as no nicotine consumption for at least one year.
- Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.).
Key exclusion criteria (15 listed)
- Previous participation in this trial or other clinical trials within the last 3 months.
- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, or sterilization, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, an approved hormonal implant).
- Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator. In particular, subjects with elevated liver enzymes (AST or ALT > 2 times the upper limit of normal) or impaired renal function (elevated serum creatinine values above the upper limit of normal) will not be allowed to enter the trial.
- Any serious systemic infectious disease during the four weeks prior to the first dose of test drug, as judged by the Investigator.
- History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. In particular, subjects with significant cardiovascular disease, anemia (haemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
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 |
|---|---|---|
| Wosulin RPenfill cartridges; Single Dose, 0.2 IU/ kg; | Biological | Wosulin R |
| Novolin RPenfill cartridges; Single Dose, 0.2 IU/ kg; | Biological | Novolin R |
Primary outcome
The primary objective is to test for bioequivalence based on AUC0-12h and Cmax between Wockhardt's Insulin Human Regular for injection and Novolin® R
Time frame: Visit 2 & 3
1 secondary outcome
PK endpoints: AUC, tmax and t½ PD endpoints: AUC-GIR, GIRmax and tGIRmax Safety endpoints: AEs, haematology, biochemistry, urinalyses, physical examination, vital signs, ECGs, blood glucose and local tolerability.
Time frame: Visit 2, 3 and 4
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 27 Dec 2012.
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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.
Linda Morrow, M.D principal investigator
Profil Institute for Clinical Research, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Wosulin R and Novolin R in people with Diabetes Mellitus, run by Wockhardt at 2 sites 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 5 inclusion and 15 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 27 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
The primary objective is to test for bioequivalence based on AUC0-12h and Cmax between Wockhardt's Insulin Human Regular for injection and Novolin® R (time frame: Visit 2 & 3). 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 27 Dec 2012.