Type 2 Diabetes MellitusPhase 2NCT00330330
Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Who Have Not Received Prior Treatment
A Phase 2 study testing ISIS 113715 in people with Type 2 Diabetes Mellitus, run by Ionis Pharmaceuticals, Inc. at 10 sites in 2 countries.
Trial summary
The aim of this study is to evaluate the safety, tolerability, and pharmacokinetics of five ISIS 113715 intravenous dose cohorts in drug-naïve type 2 diabetics. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- ISIS 113715
- How many people
- 96 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Feb 2003to Aug 2006
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes Mellitus of less than 5 years in duration
- Have never received hypoglycemic therapy
- Aged 18 to 65 years
- Fasting blood glucose between 130 and 220 mg/dL (7.2 to 12.2 mmol/L) for Cohorts A-D and between 140 and 220 mg/dL (7.8 to 12.2 mmol/L) for Cohort E
- HbA1c between 6.8 and 10.0% for Cohorts A-D and between 7.5 and 11.0% for Cohort E
- Body Mass index > 25 and < 35 kg m -2
Who cannot join
- Medication that may affect glucose homeostasis (e.g. systemic glucocorticoid) within one month of screening
- Clinically significant abnormalities in medical history or physical exam
- Clinically significant abnormalities on laboratory examination
- History of HIV infection
- Active infection requiring antiviral or antimicrobial therapy
- Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for > one year at the time of screening)
Show all 12Show fewer
- Any other concurrent condition which, in the opinion of the Investigator, would preclude participation in or interfere with compliance
- Alcohol or drug abuse
- Undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days of screening
- Abnormal serum creatinine concentration defined as > 1.5 mg/dL (132.6 micro mol/L) for males and > 1.2 mg/dL (106 micro mol/L) for females
- Medications that may affect coagulation (heparin, warfarin, etc.) with the exception of acetylsalicylic acid or non-steroidal anti-inflammatory agents.
- Allergy to sulfur-containing medications
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Russia7 sites
Chair of Endocrinology and Diabetology of the Faculty of Advenced Training for Physicians
Moscow, 109125
Endocrinology Scientific Centre of RAMS
Moscow, 117036
Medical Institution "Polyclinic OAOA Gazprom"
Moscow, 117420
Close Corporation "MEDSI"
Moscow, 123056
Chair of Endocrinology and Diabetology Central Clinical Hospital of the Ministry of Communications of RF
Moscow, 125315
Moscow Regional Scientific-Research Clinical Institute named after I.F. Vladimirsky
Moscow, 129110
Clinic of Therapy of Postgraduate Education named after N.S. Molchanov
Saint Petersburg, 198013
Poland3 sites
NZOZ Specjalistyczny Osrodek Internistyczno Diabetologiczny
Bialystok, 15-435
Prywatna Praktyka Lekarska
Radom, 26-600
Oddzial Chorob Wewnetrznych ze Stacja Dializ Szpital w Wolominie
Wołomin, 05-200
About this study
Official title: A Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Activity of ISIS 113715 in Patients With Type 2 Diabetes Mellitus Who Have Not Received Prior Therapy
The aim of this study is to evaluate the safety, tolerability, and pharmacokinetics of five ISIS 113715 intravenous dose cohorts in drug-naïve type 2 diabetics.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- ISIS 113715
- Keywords
- Fasting plasma glucose, HbA1c
- Medical subject headings
- Diabetes Mellitus, Type 2
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.
To evaluate the safety and tolerability of ISIS 113715
To evaluate the pharmacokinetic profile of ISIS 113715
To evaluate the pharmacologic activity of ISIS 113715
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2006 (estimated)
- Study startFeb 2003
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 96 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
- NCT00330330
- Sponsor's protocol ID
- ISIS 113715-CS7
- Status last verified
- Feb 2008
- First submitted
- 24 May 2006
- Last updated
- 6 Feb 2008
- Results posted
- No
Publications
Burel SA, Machemer T, Baker BF, Kwoh TJ, Paz S, Younis H, Henry SP. Early-Stage Identification and Avoidance of Antisense Oligonucleotides Causing Species-Specific Inflammatory Responses in Human Volunteer Peripheral Blood Mononuclear Cells. Nucleic Acid Ther. 2022 Dec;32(6):457-472. doi: 10.1089/nat.2022.0033. Epub 2022 Aug 17.
PubMed 35976085
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Activity of ISIS 113715 in Patients With Type 2 Diabetes Mellitus Who Have Not Received Prior Therapy
- ClinicalTrials.gov ID
- NCT00330330
- Acronym / sponsor ID
- ISIS 113715-CS7
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Fasting plasma glucose, HbA1c
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2003
- Study completion
- Aug 2006
- First posted
- 26 May 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.
The aim of this study is to evaluate the safety, tolerability, and pharmacokinetics of five ISIS 113715 intravenous dose cohorts in drug-naïve type 2 diabetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 Diabetes Mellitus of less than 5 years in duration
- Have never received hypoglycemic therapy
- Aged 18 to 65 years
- Fasting blood glucose between 130 and 220 mg/dL (7.2 to 12.2 mmol/L) for Cohorts A-D and between 140 and 220 mg/dL (7.8 to 12.2 mmol/L) for Cohort E
- HbA1c between 6.8 and 10.0% for Cohorts A-D and between 7.5 and 11.0% for Cohort E
Key exclusion criteria (12 listed)
- Medication that may affect glucose homeostasis (e.g. systemic glucocorticoid) within one month of screening
- Clinically significant abnormalities in medical history or physical exam
- Clinically significant abnormalities on laboratory examination
- History of HIV infection
- Active infection requiring antiviral or antimicrobial therapy
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
To evaluate the safety and tolerability of ISIS 113715
To evaluate the pharmacokinetic profile of ISIS 113715
To evaluate the pharmacologic activity of ISIS 113715
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 6 Feb 2008.
- Derived from this study: PubMed 35976085Burel SA, Machemer T, Baker BF, Kwoh TJ, Paz S, Younis H, Henry SP. Early-Stage Identification and Avoidance of Antisense Oligonucleotides Causing Species-Specific Inflammatory Responses in Human Volunteer Peripheral Blood Mononuclear Cells. Nucleic Acid Ther. 2022 Dec;32(6):457-472. doi: 10.1089/nat.2022.0033. Epub 2022 Aug 17.
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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.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ISIS 113715 in people with Type 2 Diabetes Mellitus, run by Ionis Pharmaceuticals, Inc. at 10 sites in 2 countries.
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 12 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 6 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Russia, Poland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To evaluate the safety and tolerability of ISIS 113715. 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?
On the ClinicalTrials.gov record for NCT00330330, which also lists 1 linked publication.
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 6 Feb 2008.