Type1 DiabetesPhase 1NCT01357603
Comparative Glucose Clamp Study of Wockhardt's Recombinant Insulin Analog Glargine(Glaritus) With Lantus in T1DM
A Phase 1 study testing Glargine in people with Type1 Diabetes, run by Wockhardt at 1 site in United States.
Trial summary
The aim of this trial is to demonstrate bioequivalence of Glaritus® to Lantus® with regard to its total and to its maximum serum insulin concentrations. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type1 Diabetes
- What is being tested?
- Glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Aug 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects with type 1 diabetes ≥12 months.
- HbA1c ≤9% by local laboratory analysis (one retest within a week is permitted with the result of the last test being conclusive).
- Age ≥18 and ≤60 years.
- Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
- 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 participation in other clinical trials within the last 30 days.
- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (e.g. 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 or double barrier method including male condoms used plus spermicide, diaphragm with spermicide plus male condom, cap with spermicide plus male condom).
- 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 (hemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
- Cardiac problems defined as decompensated heart failure (New York Heart Association (NYHA) class III and IV) at any time and/or angina pectoris within the last 12 months and/or acute myocardial infarction at any time.
- Clinically significant abnormal ECG at screening, as judged by the Investigator.
- History of alcohol or drug abuse in the past five years.
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- Any positive reaction of drug abuse.
- Hepatitis B or C or HIV positive.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
- Regular cigarette smoker, defined as smoking >1 pack/day and unable to refrain from smoking during the in house period.
- Known or suspected allergy to trial product or related products.
- Any disease or condition that, in the opinion of the Investigator, would represent an unacceptable risk for the subject's safety.
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 Randomized, Double-blind, Two Period, Cross Over Glucose Clamp Study to Test for Bioeqivalence Between Two Long Acting Insulin Analogs-Wockhardt's Glaritus™ (Insulin Glargine) and Lantus (Insulin Glargine) in Subjects With Type 1 Diabetes
The aim of this trial is to demonstrate bioequivalence of Glaritus® to Lantus® 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 parameter AUC INS-GLR 0-24h and on pharmacodynamic parameter AUC GIR 0-24h between the two long-acting insulin glargine formulations, Lantus® and Wockhardt's Glaritus® in subjects with type1 diabetes as well as assessing safety and local tolerability of the two insulin preparations.
- Conditions
- Type1 Diabetes
- Being tested
- Glargine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlargineBiological
dosage form: Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Glaritus arm | Experimental | Insulin glargine (Glaritus: 100 U/ml), Penfill® cartridges 3.0ml Receives: Biological: Glargine |
| Lantus arm | Active comparator | Insulin glargine (Lantus: 100 U/ml), Penfill® cartridges 3.0ml Receives: Biological: Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Pharmacokinetic parameter:AUC INS-GLR 0-24h.
Measured: over 24hrs post dose
Bioequivalence based on Pharmacodynamic parameter: AUC GIR 0-24hrs
Measured: over 24hrs post dose
Pharmacokinetic Parameters: Maximum concentration (Cmax)
Measured: over 24hrs post dose
Secondary outcomes (5)
Safety parameters
Number of AE's, SAE's, Hypoglycemic events and local tolerability
Measured: till 24 hrs post-dose
Pharmacodynamic parameters: Area under curve glucose infusion rate from 0-24hrs
AUC GIR 0-12h,AUC GIR 12-24h,AUC GIR 0-24h
Measured: over 24hrs post dose
Pharmacokinetic parameter: Area under curve from 0-24hrs
AUC INS-GLR 0-12hrs, AUC INS-GLR 12-24hrs,AUC INS-GLR 0-24hrs
Measured: over 24hrs post dose
Pharmacokinetic Parameters: tmax and t1/2
Measured: over 24hrs post dose
Pharmacodynamic parameter: GIR max and tGIR max
Measured: over 24hrs post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Elaine Watkins, Principal investigator, Profil Institute of Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357603
- Sponsor's protocol ID
- Glaritus/PK-PD/FDA/2011
- Status last verified
- Jan 2013
- First submitted
- 12 May 2011
- Last updated
- 25 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Two Period, Cross Over Glucose Clamp Study to Test for Bioeqivalence Between Two Long Acting Insulin Analogs-Wockhardt's Glaritus™ (Insulin Glargine) and Lantus (Insulin Glargine) in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01357603
- Acronym / sponsor ID
- Glaritus/PK-PD/FDA/2011
- Conditions
- Type1 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 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 Glaritus® to Lantus® 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 parameter AUC INS-GLR 0-24h and on pharmacodynamic parameter AUC GIR 0-24h between the two long-acting insulin glargine formulations, Lantus® and Wockhardt's Glaritus® in subjects with type1 diabetes as well as assessing safety and local tolerability of the two insulin preparations.
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 |
|---|---|---|
| Glaritus arm | Experimental | Biological: GlargineInsulin glargine (Glaritus: 100 U/ml), Penfill® cartridges 3.0ml |
| Lantus arm | Active comparator | Biological: GlargineInsulin glargine (Lantus: 100 U/ml), Penfill® cartridges 3.0ml |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female subjects with type 1 diabetes ≥12 months.
- HbA1c ≤9% by local laboratory analysis (one retest within a week is permitted with the result of the last test being conclusive).
- Age ≥18 and ≤60 years.
- Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
- 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 (13 listed)
- Previous participation in this trial, or participation in other clinical trials within the last 30 days.
- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (e.g. 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 or double barrier method including male condoms used plus spermicide, diaphragm with spermicide plus male condom, cap with spermicide plus male condom).
- 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 (hemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
- Cardiac problems defined as decompensated heart failure (New York Heart Association (NYHA) class III and IV) at any time and/or angina pectoris within the last 12 months and/or acute myocardial infarction at any time.
- Clinically significant abnormal ECG at screening, as judged by the Investigator.
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 |
|---|---|---|
| Glarginedosage form: Subcutaneous injection | Biological | Glaritus arm, Lantus arm |
Primary outcome
Bioequivalence based on Pharmacokinetic parameter:AUC INS-GLR 0-24h.
Time frame: over 24hrs post dose
Bioequivalence based on Pharmacodynamic parameter: AUC GIR 0-24hrs
Time frame: over 24hrs post dose
Pharmacokinetic Parameters: Maximum concentration (Cmax)
Time frame: over 24hrs post dose
5 secondary outcomes
Safety parameters
Time frame: till 24 hrs post-dose
Pharmacodynamic parameters: Area under curve glucose infusion rate from 0-24hrs
Time frame: over 24hrs post dose
Pharmacokinetic parameter: Area under curve from 0-24hrs
Time frame: over 24hrs post dose
Pharmacokinetic Parameters: tmax and t1/2
Time frame: over 24hrs post dose
Pharmacodynamic parameter: GIR max and tGIR max
Time frame: over 24hrs post 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 25 Jan 2013.
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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. Elaine Watkins principal investigator
Profil Institute of Clinical Research
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 Glargine in people with Type1 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 5 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 25 Jan 2013. 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?
Bioequivalence based on Pharmacokinetic parameter:AUC INS-GLR 0-24h. (time frame: over 24hrs post dose). The study lists 3 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 25 Jan 2013; AzTrials last refreshed its copy on 6 Nov 2026.