Diabetes MellitusPhase 1NCT01358435
Comparative Wockhardt's Glucose Clamp Study-Human Isophane Susp 30IU/ml/70IU/ml With Novolin70/30, in Healthy Subjects
A Phase 1 study testing 30% Regular Insulin Human Neutral and 70%Isophane Insulin and Novolin 70/30 in people with Diabetes Mellitus, run by Wockhardt at 1 site in United States.
Trial summary
The aim of this trial is to demonstrate bioequivalence of Wosulin 70/30 to Novolin® 70/30 with regard to its total and to its maximum serum insulin concentrations. 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?
- 30% Regular Insulin Human Neutral and 70%Isophane Insulin and Novolin 70/30
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 2011
- 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.
- Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
- 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 30 days.
- Pregnant, breast-feeding or intention of becoming pregnant or not using adequate contraceptive measures (defined as intrauterine device (IUD) that has been in place for at least 3 months, double barrier contraception, sterilization or abstinence, or oral contraceptive pill, which should have been taken without difficulty for at least 3 months, or an approved hormonal implant).
- Clinically significant abnormal haematology 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) or fasting glucose at screening outside the range of 70-99 mg/dl 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 in the past five years.
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- Any positive test for drugs of abuse and /or alcohol at screening.
- 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.
- Treatment with any insulin product in the past.
- Use of non-prescription drugs, except routine vitamins, within 2 weeks prior to the first dose of the test drug. Occasional use of acetaminophen 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
1 site in 1 country.
United States1 site
Profil Institute for Clinical Research
Chula Vista, California, 91911
About this study
Official title: Randomized,Single Center,Double Blind,Two-period,Crossover Glucose Clamp Trial Study to Test Bioequivalence Between Two Recombinant Human Mixed Insulins-Wockhardt's Human/Isophane Susp 30IU/ml/70IU/ml With Novolin70/30, in Healthy Subjects
The aim of this trial is to demonstrate bioequivalence of Wosulin 70/30 to Novolin® 70/30 with regard to its total and to its maximum serum insulin concentrations.
Read the detailed description
The purpose of this study is is to test for bioequivalence based on AUC0-24h and Cmax between Wosulin 70N/30R and Novolin 70/30.The study also compares the pharmacokinetic and pharmacodynamic profiles as well as assessing safety and local tolerability of the two insulin preparations in healthy subjects.
- Conditions
- Diabetes Mellitus
- Being tested
- 30% Regular Insulin Human Neutral and 70%Isophane Insulin, Novolin 70/30
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30% Regular Insulin Human Neutral and 70%Isophane InsulinBiological
Total Dose per subject is 0.4 IU/Kg given subcutaneously.
Novolin 70/30Biological
Total Dose per subject is 0.4IU/Kg given Subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Wosulin 70/30 | Experimental | Wosulin 70N /30R is a recombinant Human Insulin with 30 % Regular Insulin Human Neutral and 70% Isophane Insulin, 600 nmol/ml, 100 IU/ml. Receives: Biological: 30% Regular Insulin Human Neutral and 70%Isophane Insulin |
| Novolin 70/30 | Active comparator | Novolin 70/30 is a Recombinant Human Insulin with 70% NPH, Human Insulin Isophane Suspension and 30% Regular, Human Insulin Injection Receives: Biological: Novolin 70/30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean AUC0-24h and Cmax
Measured: Visit 2 and 3
Secondary outcomes (1)
PK endpts: AUC0-4h, AUC0-6h, AUC0-12h, AUC6-12h, AUC6-24h,tmax,and elimination rate constant. PD endpoints: AUCGIR0-4h, AUCGIR0-6h, AUCGIR0-12h,AUCGIR0-24h, AUCGIR6-12h, AUCGIR6-24h, GIRmax and tGIRmax Safety : AEs,haematology,biochem,phy exam
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 posted23 May 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2011
- Study completionMay 2011
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Marcus Hompesch, Study director, Profil Institute for Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358435
- Sponsor's protocol ID
- Wosulin 7030/PK-PD/HV/FDA/10/3
- Status last verified
- Dec 2012
- First submitted
- 20 May 2011
- 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
- Randomized,Single Center,Double Blind,Two-period,Crossover Glucose Clamp Trial Study to Test Bioequivalence Between Two Recombinant Human Mixed Insulins-Wockhardt's Human/Isophane Susp 30IU/ml/70IU/ml With Novolin70/30, in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01358435
- Acronym / sponsor ID
- Wosulin 7030/PK-PD/HV/FDA/10/3
- Conditions
- Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 23 May 2011 (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 aim of this trial is to demonstrate bioequivalence of Wosulin 70/30 to Novolin® 70/30 with regard to its total and to its maximum serum insulin concentrations.
Detailed description
The purpose of this study is is to test for bioequivalence based on AUC0-24h and Cmax between Wosulin 70N/30R and Novolin 70/30.The study also compares the pharmacokinetic and pharmacodynamic profiles as well as assessing safety and local tolerability of the two insulin preparations in healthy subjects.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wosulin 70/30 | Experimental | Biological: 30% Regular Insulin Human Neutral and 70%Isophane InsulinWosulin 70N /30R is a recombinant Human Insulin with 30 % Regular Insulin Human Neutral and 70% Isophane Insulin, 600 nmol/ml, 100 IU/ml. |
| Novolin 70/30 | Active comparator | Biological: Novolin 70/30Novolin 70/30 is a Recombinant Human Insulin with 70% NPH, Human Insulin Isophane Suspension and 30% Regular, Human Insulin Injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male or female subject.
- Age ≥ 18 and ≤ 45 years.
- Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
- 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.
Key exclusion criteria (15 listed)
- Previous participation in this trial or other clinical trials within the last 30 days.
- Pregnant, breast-feeding or intention of becoming pregnant or not using adequate contraceptive measures (defined as intrauterine device (IUD) that has been in place for at least 3 months, double barrier contraception, sterilization or abstinence, or oral contraceptive pill, which should have been taken without difficulty for at least 3 months, or an approved hormonal implant).
- Clinically significant abnormal haematology 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) or fasting glucose at screening outside the range of 70-99 mg/dl 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 |
|---|---|---|
| 30% Regular Insulin Human Neutral and 70%Isophane InsulinTotal Dose per subject is 0.4 IU/Kg given subcutaneously. | Biological | Wosulin 70/30 |
| Novolin 70/30Total Dose per subject is 0.4IU/Kg given Subcutaneously. | Biological | Novolin 70/30 |
Primary outcome
Mean AUC0-24h and Cmax
Time frame: Visit 2 and 3
1 secondary outcome
PK endpts: AUC0-4h, AUC0-6h, AUC0-12h, AUC6-12h, AUC6-24h,tmax,and elimination rate constant. PD endpoints: AUCGIR0-4h, AUCGIR0-6h, AUCGIR0-12h,AUCGIR0-24h, AUCGIR6-12h, AUCGIR6-24h, GIRmax and tGIRmax Safety : AEs,haematology,biochem,phy exam
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.
Dr. Marcus Hompesch study director
Profil Institute for Clinical Research, Inc.
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 30% Regular Insulin Human Neutral and 70%Isophane Insulin and Novolin 70/30 in people with Diabetes Mellitus, run by Wockhardt 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 6 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 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?
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?
Mean AUC0-24h and Cmax (time frame: Visit 2 and 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.