DiabetesPhase 1NCT00752180
Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Actrapid, in Type 1 Diabetics
A Phase 1 study testing Wosulin R and Actrapid in people with Diabetes, run by Wockhardt at 1 site in United States.
Trial summary
The aim of this trial is to demonstrate bioequivalence of Wosulin R to Actrapid 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 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Wosulin R and Actrapid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Apr 2009
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects with type 1 diabetes mellitus
- Age between 18 and 45 years (both inclusive)
- Insulin treatment for at least 12 months before the screening visit
- Daily basal insulin requirement between 0.2 and 0.6 IU/kg/day (both inclusive) and current total daily insulin dose less than 1.2 IU/kg/day.
- Body Mass Index (BMI) between 18.0 and 35.0 kg/m2
- HbA1c less than or equal to 10.0%
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- Fasting C-peptide < 0.4 nmol/L
- Non-smoker, no nicotine consumption for at least one year.
- Subjects considered generally healthy, except for the underlying diabetes mellitus and related morbidity (such as well controlled hypertension and dyslipidemia)
- Signed and dated informed consent obtained before any trial-related activities
Who cannot join
- Previous participation in this trial or other clinical trials within 30 days of dosing or 5 half-lives of any investigational drug, whichever is longer. If half life of the investigational drug is unknown, previous participation in other clinical trials within 3 months of dosing.
- Pregnant, breast-feeding or intention of becoming pregnant or not using adequate contraceptive measures (defined as intrauterine device 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 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 will not be allowed to enter the trial.
- Any serious systemic infectious disease during the four weeks prior to first dose of test drug,
- 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 or hemoglobinopathy will not be allowed to enter the trial.
- Cardiac problems defined as: decompensated heart failure (NYHA class III and IV) at any time and/or angina pectoris and/or myocardial infarction within the last 12 months.
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- Uncontrolled hypertension
- Subjects who have at screening, after 5 minutes rest, a supine blood pressure outside the range of 90-140 mmHg systolic or 50-90 mmHg diastolic, or pulse rate outside the range 40 to 90 beats per minute, or who are requiring more than two anti-hypertensive medications.
- Severe neuropathy (in particular autonomic neuropathy), retinopathy or maculopathy
- Clinically significant abnormal ECG at screening
- Recurrent major hypoglycemia or hypoglycemic unawareness as judged by the investigator or hospitalization for diabetic ketoacidosis during the 6 months preceding the screening visit.
- History of alcohol or drug abuse in the past five years and/or any positive test for drugs of abuse at screening.
- Positive test for hepatitis B or C or HIV
- Any systemic treatment with drugs known to interfere with glucose metabolism such as systemic corticoids, non-selective beta-blockers, thyroid hormone and monoamine oxidase inhibitors within 3 months prior to the first dosing visit.
- Use of drugs which may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action, glucose utilization or recovery from hypoglycemia
- 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 products or related products
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
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: A Single Dose,Single Centre,Double Blind,Crossover Study Comparing the Pharmacokinetic Profiles of Wockhardt's Insulin Human Injection, Soluble (Recombinant DNA Origin) for Injection and Actrapid in Type 1 Diabetics
The aim of this trial is to demonstrate bioequivalence of Wosulin R to Actrapid with regard to its total and to its maximum serum insulin concentrations.
Read the detailed description
The purpose of this study is to test for bioequivalence based on the pharmacokinetic parameters Cmax and AUC0-12h between two recombinant soluble human insulin preparations. The study also compares the other pharmacokinetic parameters and pharmacodynamic profiles as well as assesses safety and local tolerability of the two insulin preparations in type 1 diabetics.
- Conditions
- Diabetes
- Being tested
- Wosulin R, Actrapid
- Keywords
- pharmacokinetics, pharmacodynamics, type 1 diabetics, recombinant human insulin
- 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
Total dose per subject will be 0.3 IU/Kg given Subcutaneously.
ActrapidBiological
Total dose per subject will be 0.3 IU/kg given Subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Wosulin R | Experimental | Wosulin R,Regular insulin for injection(Recombinant Human Insulin)(600 nmol/ml, 100IU/ml)in vials 10.0 ml given subcutaneously. Receives: Biological: Wosulin R |
| Actrapid | Active comparator | Actrapid, Regular insulin for injection (Recombinant Human Insulin) (600nmol/ml,100IU/ml)in vials 10.0 ml given subcutaneously. Receives: Biological: Actrapid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean AUCins.0-12h and Cins.max
Measured: Visit 2 and 3
Secondary outcomes (1)
PK endpoints: AUC0-4h, AUC0-6h, AUC6-12h,tmax, t½ and elimination rate constant.PD endpoints: AUCGIR0-4h, AUCGIR0-6h, AUCGIR6-12h, AUCGIR0-12h, GIRmax and tGIRmax .Safety endpoints: AEs, hematology, biochemistry, urinalyses, physical 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 posted15 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2009
- Study completionApr 2009
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.
- 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Till Schroer, Study director, Profil Institute for Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752180
- Sponsor's protocol ID
- WosulinR/PK-PD/type1/EMEA/2008
- Status last verified
- Dec 2012
- First submitted
- 12 Sep 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 Single Dose,Single Centre,Double Blind,Crossover Study Comparing the Pharmacokinetic Profiles of Wockhardt's Insulin Human Injection, Soluble (Recombinant DNA Origin) for Injection and Actrapid in Type 1 Diabetics
- ClinicalTrials.gov ID
- NCT00752180
- Acronym / sponsor ID
- WosulinR/PK-PD/type1/EMEA/2008
- Conditions
- Diabetes
- Keywords
- pharmacokinetics, pharmacodynamics, type 1 diabetics, recombinant human insulin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 15 Sep 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 aim of this trial is to demonstrate bioequivalence of Wosulin R to Actrapid with regard to its total and to its maximum serum insulin concentrations.
Detailed description
The purpose of this study is to test for bioequivalence based on the pharmacokinetic parameters Cmax and AUC0-12h between two recombinant soluble human insulin preparations. The study also compares the other pharmacokinetic parameters and pharmacodynamic profiles as well as assesses safety and local tolerability of the two insulin preparations in type 1 diabetics.
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 R | Experimental | Biological: Wosulin RWosulin R,Regular insulin for injection(Recombinant Human Insulin)(600 nmol/ml, 100IU/ml)in vials 10.0 ml given subcutaneously. |
| Actrapid | Active comparator | Biological: ActrapidActrapid, Regular insulin for injection (Recombinant Human Insulin) (600nmol/ml,100IU/ml)in vials 10.0 ml given subcutaneously. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or female subjects with type 1 diabetes mellitus
- Age between 18 and 45 years (both inclusive)
- Insulin treatment for at least 12 months before the screening visit
- Daily basal insulin requirement between 0.2 and 0.6 IU/kg/day (both inclusive) and current total daily insulin dose less than 1.2 IU/kg/day.
- Body Mass Index (BMI) between 18.0 and 35.0 kg/m2
Key exclusion criteria (19 listed)
- Previous participation in this trial or other clinical trials within 30 days of dosing or 5 half-lives of any investigational drug, whichever is longer. If half life of the investigational drug is unknown, previous participation in other clinical trials within 3 months of dosing.
- Pregnant, breast-feeding or intention of becoming pregnant or not using adequate contraceptive measures (defined as intrauterine device 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 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 will not be allowed to enter the trial.
- Any serious systemic infectious disease during the four weeks prior to first dose of test drug,
- 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 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 RTotal dose per subject will be 0.3 IU/Kg given Subcutaneously. | Biological | Wosulin R |
| ActrapidTotal dose per subject will be 0.3 IU/kg given Subcutaneously. | Biological | Actrapid |
Primary outcome
Mean AUCins.0-12h and Cins.max
Time frame: Visit 2 and 3
1 secondary outcome
PK endpoints: AUC0-4h, AUC0-6h, AUC6-12h,tmax, t½ and elimination rate constant.PD endpoints: AUCGIR0-4h, AUCGIR0-6h, AUCGIR6-12h, AUCGIR0-12h, GIRmax and tGIRmax .Safety endpoints: AEs, hematology, biochemistry, urinalyses, physical 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.
Till Schroer 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 Wosulin R and Actrapid in people with Diabetes, 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 10 inclusion and 19 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 AUCins.0-12h and Cins.max (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.