Type 2 Diabetes MellitusPhase 1NCT00365781
Examination of Dermatologic Effects From Subcutaneous Injections of ISIS 113715
A Phase 1 study testing ISIS 113715 in people with Type 2 Diabetes Mellitus, run by Ionis Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
10 healthy volunteers will be enrolled to each receive two subcutaneous injections of ISIS 113715 in the abdomen on Study Day 1. Each subject will receive their two injections within a 5-minute period. On Study Days 2 and 8, each subject's injection sites will be assessed for dermatologic effects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- ISIS 113715
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Sep 2006
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female: Females are post menopausal or surgically sterile; Males are surgically sterile, abstinent, or utilizing an acceptable barrier contraceptive method. Must also agree to continue abstinence and/or to use an acceptable barrier contraceptive method for at least four weeks after their injections of ISIS 113715
- Aged 18 to 65 years
- Weight > 50 kg
- Body mass index > 29 kg/m²
Who cannot join
- Pregnant, breastfeeding, or intends to become pregnant
- Positive hepatitis B virus, hepatitis C virus, or HIV test
- History of clinical significant abnormalities in complement or coagulation parameters or taking medication that may affect coagulation (e.g., heparin, warfarin), except aspirin or non-steroidal anti-inflammatory agents (NSAID)
- Current or history of significant skin disorders
- History of alcohol or drug abuse
- History of liver or renal disease
Show all 9Show fewer
- Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for > one year)
- Liver function tests greater than the Upper Limit of Normal (ULN)
- Clinically significant and currently active diseases or active infection requiring antiviral or antimicrobial therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Therapeutics Clinical Research
San Diego, California, 92121
About this study
Official title: A Phase 1, Open-Label Examination of the Dermatologic Effects From Subcutaneous Administration of ISIS 113715, and Antisense Oligonucleotide Inhibitor of Protein Tyrosine Phosphatase 1B, in Healthy Volunteers
10 healthy volunteers will be enrolled to each receive two subcutaneous injections of ISIS 113715 in the abdomen on Study Day 1. Each subject will receive their two injections within a 5-minute period. On Study Days 2 and 8, each subject's injection sites will be assessed for dermatologic effects. The Isis Project Physician(s) will observe the injection sites on Study Day 2 and may also observe on Study Day 8.
Routine clinical chemistry, hematology, and urinalysis tests will be performed on Study Day 1 and Day 8. Subjects will be contacted by telephone on Study Day 30 to monitor for the occurrence of new serious adverse events (SAEs). Thereafter, the subjects will be discharged from the study.
Read the detailed description
Following a two-week period for subject screening, 10 eligible subjects will be dosed subcutaneously with ISIS 113715 on a single calendar date (Study Day 1). Each subject will receive two subcutaneous injections given within a 5-minute period. The first injection will be 200 mg ISIS 113715 given in 1.0 mL and will be injected about 7.5 cm to the left of the umbilicus. The second injection will be 200 mg ISIS 113715 given in 2.0 mL and will be injected about 7.5 cm to the right of the umbilicus. Both injections will be delivered using 3.0-mL syringes outfitted with 30-gauge, 0.5-inch needles. To further minimize variability, all injections will be performed by a single individual, the Investigator or his designee, employing uniform technique for all of the injections.
Dermatologic responses at injection sites will be assessed at 1 and 7 days after the injections (Study Days 2 and 8, respectively). Effects will be evaluated through completion of the Injection Site Assessment Questionnaires by the Investigator and the recording of adverse events reported by the subject or observed by the Investigator. The Isis Project Physician(s) will observe the injection sites on Study Day 2 and may also observe on Study Day 8.
Routine clinical chemistry, hematology, and urinalysis tests will be performed on Study Days 1 (prior to administration of ISIS 113715) and 8.
Subjects will be contacted by telephone on Study Day 30 to monitor for the occurrence of new serious adverse events. Thereafter, the subjects will be discharged from the study.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- ISIS 113715
- Keywords
- Injection Site Reaction, Subcutaneous administration, Dermatological effects, Antisense
- Medical subject headings
- Diabetes Mellitus, Type 2, Injection Site Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISIS 113715Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the dermatologic responses to 200 mg/1.0 mL and 200 mg/2.0 mL ISIS 113715 administered subcutaneously into separate abdominal sites, with both injections given on the same day.
Evaluate and examine the effect of treatment on laboratory results, vital signs, and adverse events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startAug 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Ionis Pharmaceuticals, Inc.The 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
- 10 participants
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark K Wedel, MD, JD, FACP, Study director, Ionis Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365781
- Sponsor's protocol ID
- ISIS 113715-CS13
- Status last verified
- Oct 2007
- First submitted
- 15 Aug 2006
- Last updated
- 17 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Examination of the Dermatologic Effects From Subcutaneous Administration of ISIS 113715, and Antisense Oligonucleotide Inhibitor of Protein Tyrosine Phosphatase 1B, in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00365781
- Acronym / sponsor ID
- ISIS 113715-CS13
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Injection Site Reaction, Subcutaneous administration, Dermatological effects, Antisense
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Study completion
- Sep 2006
- First posted
- 17 Aug 2006 (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.
10 healthy volunteers will be enrolled to each receive two subcutaneous injections of ISIS 113715 in the abdomen on Study Day 1. Each subject will receive their two injections within a 5-minute period. On Study Days 2 and 8, each subject's injection sites will be assessed for dermatologic effects. The Isis Project Physician(s) will observe the injection sites on Study Day 2 and may also observe on Study Day 8.
Routine clinical chemistry, hematology, and urinalysis tests will be performed on Study Day 1 and Day 8. Subjects will be contacted by telephone on Study Day 30 to monitor for the occurrence of new serious adverse events (SAEs). Thereafter, the subjects will be discharged from the study.
Detailed description
Following a two-week period for subject screening, 10 eligible subjects will be dosed subcutaneously with ISIS 113715 on a single calendar date (Study Day 1). Each subject will receive two subcutaneous injections given within a 5-minute period. The first injection will be 200 mg ISIS 113715 given in 1.0 mL and will be injected about 7.5 cm to the left of the umbilicus. The second injection will be 200 mg ISIS 113715 given in 2.0 mL and will be injected about 7.5 cm to the right of the umbilicus. Both injections will be delivered using 3.0-mL syringes outfitted with 30-gauge, 0.5-inch needles. To further minimize variability, all injections will be performed by a single individual, the Investigator or his designee, employing uniform technique for all of the injections.
Dermatologic responses at injection sites will be assessed at 1 and 7 days after the injections (Study Days 2 and 8, respectively). Effects will be evaluated through completion of the Injection Site Assessment Questionnaires by the Investigator and the recording of adverse events reported by the subject or observed by the Investigator. The Isis Project Physician(s) will observe the injection sites on Study Day 2 and may also observe on Study Day 8.
Routine clinical chemistry, hematology, and urinalysis tests will be performed on Study Days 1 (prior to administration of ISIS 113715) and 8.
Subjects will be contacted by telephone on Study Day 30 to monitor for the occurrence of new serious adverse events. Thereafter, the subjects will be discharged from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female: Females are post menopausal or surgically sterile; Males are surgically sterile, abstinent, or utilizing an acceptable barrier contraceptive method. Must also agree to continue abstinence and/or to use an acceptable barrier contraceptive method for at least four weeks after their injections of ISIS 113715
- Aged 18 to 65 years
- Weight > 50 kg
- Body mass index > 29 kg/m²
Key exclusion criteria (9 listed)
- Pregnant, breastfeeding, or intends to become pregnant
- Positive hepatitis B virus, hepatitis C virus, or HIV test
- History of clinical significant abnormalities in complement or coagulation parameters or taking medication that may affect coagulation (e.g., heparin, warfarin), except aspirin or non-steroidal anti-inflammatory agents (NSAID)
- Current or history of significant skin disorders
- History of alcohol or drug abuse
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 |
|---|---|---|
| ISIS 113715 | Drug | – |
Primary outcome
Compare the dermatologic responses to 200 mg/1.0 mL and 200 mg/2.0 mL ISIS 113715 administered subcutaneously into separate abdominal sites, with both injections given on the same day.
Evaluate and examine the effect of treatment on laboratory results, vital signs, and adverse events.
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 17 Oct 2007.
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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.
Mark K Wedel, MD, JD, FACP study director
Ionis Pharmaceuticals, 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 ISIS 113715 in people with Type 2 Diabetes Mellitus, run by Ionis Pharmaceuticals, Inc. 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 4 inclusion and 9 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 17 Oct 2007. 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?
Compare the dermatologic responses to 200 mg/1.0 mL and 200 mg/2.0 mL ISIS 113715 administered subcutaneously into separate abdominal sites, with both injections given on the same day.. 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 17 Oct 2007.