Type 2 Diabetes MellitusPhase 2NCT00327626
Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Being Treated With Sulfonylurea
A Phase 2 study testing ISIS 113715 in people with Type 2 Diabetes Mellitus, run by Ionis Pharmaceuticals, Inc. at 5 sites in Israel.
Trial summary
The aim of this study is to evaluate the safety, tolerability, and pharmacokinetics of two ISIS 113715 subcutaneous doses (15 mg and 30 mg/day) in combination with oral antidiabetic agents (OAD) versus OAD + placebo in patients with inadequately controlled type 2 diabetes, despite ongoing maximal treatment with OAD. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- ISIS 113715
- How many people
- 0 participants
- Where
- 5 sitesIsrael
- Study dates
- 1 May 2006to 1 Mar 2007
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female (post-menopausal and/or surgically sterile)
- Aged 18 to 70 years
- Diagnosed with type 2 diabetes mellitus of eight years or less in duration
- Being treated with OAD at stable maximum doses [defined as at least 10 mg/day glibenclamide (preferred), or 20 mg/day glipizide, with or without at least 1,500 mg/day metformin] for at least three months prior to screening
- Having fasting plasma glucose levels of 150-270 mg/dL and HbA1c levels of 7.5-11.0%
Who cannot join
- Greater than 3 severe hypoglycemic episodes within six months of screen
- Pregnant, breastfeeding, or intends to become pregnant
- Clinical signs or symptoms of liver disease, acute, or chronic hepatitis, or ALT greater than the upper limit of normal
- Positive hepatitis B surface antigen, hepatitis C antibody, or HIV test
- Patients with history of renal transplantation or renal dialysis or microalbuminuria defined as urine albumin > 200 mg/day
- History of insulin use within three months of screen
Show all 12Show fewer
- History of diabetic ketoacidosis
- Treatment with any thiazolidinedione (e.g., rosiglitazone) within three months of screen
- History of lactic acidosis while on metformin therapy
- Complications of diabetes (e.g., neuropathy, nephropathy, and retinopathy)
- Clinically significant and currently active diseases
- Clinical significant abnormalities in medical history, physical examination, or laboratory examination
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Israel5 sites
Soroka Medical Center
Beersheba, 84101
Rambam Medical Center
Haifa, 31096
Western Galilee Medical Center - Nahariya
Nahariya, 22100
Kaplan Medical Center
Rehovot, 76100
ZIV Hospital
Safed, 13100
About this study
Official title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of ISIS 113715 Administered Daily in Patients With Type 2 Diabetes Mellitus Being Treated With Sulfonylurea
The aim of this study is to evaluate the safety, tolerability, and pharmacokinetics of two ISIS 113715 subcutaneous doses (15 mg and 30 mg/day) in combination with oral antidiabetic agents (OAD) versus OAD + placebo in patients with inadequately controlled type 2 diabetes, despite ongoing maximal treatment with OAD.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- ISIS 113715
- Keywords
- Fasting plasma glucose, HbA1c, Oral antidiabetic agent(s)
- 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.
Evaluate the safety, tolerability, and pharmacokinetics of two ISIS 113715 subcutaneous dosages in combination with OAD versus OAD + placebo.
Examine the effect of treatment with 15 and 30 mg/day ISIS 113715 on fasting plasma glucose and HbA1c.
Evaluate the effects of ISIS 113715 on insulin sensitivity, B-cell function, proinsulin/insulin ratio, fasting insulin, C-peptide and proinsulin.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study start1 May 2006
- Primary completion1 Feb 2007
- Study completion1 Mar 2007
Why it stopped: study was never started due to regional geopolitical conflict
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark K Wedel, MD, JD, FACP, Study director, Ionis Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327626
- Sponsor's protocol ID
- ISIS 113715-CS12
- Status last verified
- May 2007
- First submitted
- 16 May 2006
- Last updated
- 5 Dec 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of ISIS 113715 Administered Daily in Patients With Type 2 Diabetes Mellitus Being Treated With Sulfonylurea
- ClinicalTrials.gov ID
- NCT00327626
- Acronym / sponsor ID
- ISIS 113715-CS12
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Fasting plasma glucose, HbA1c, Oral antidiabetic agent(s)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study was never started due to regional geopolitical conflict
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2006 (actual)
- Primary completion
- 1 Feb 2007 (actual)
- Study completion
- 1 Mar 2007 (actual)
- First posted
- 18 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 two ISIS 113715 subcutaneous doses (15 mg and 30 mg/day) in combination with oral antidiabetic agents (OAD) versus OAD + placebo in patients with inadequately controlled type 2 diabetes, despite ongoing maximal treatment with OAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female (post-menopausal and/or surgically sterile)
- Aged 18 to 70 years
- Diagnosed with type 2 diabetes mellitus of eight years or less in duration
- Being treated with OAD at stable maximum doses [defined as at least 10 mg/day glibenclamide (preferred), or 20 mg/day glipizide, with or without at least 1,500 mg/day metformin] for at least three months prior to screening
- Having fasting plasma glucose levels of 150-270 mg/dL and HbA1c levels of 7.5-11.0%
Key exclusion criteria (12 listed)
- Greater than 3 severe hypoglycemic episodes within six months of screen
- Pregnant, breastfeeding, or intends to become pregnant
- Clinical signs or symptoms of liver disease, acute, or chronic hepatitis, or ALT greater than the upper limit of normal
- Positive hepatitis B surface antigen, hepatitis C antibody, or HIV test
- Patients with history of renal transplantation or renal dialysis or microalbuminuria defined as urine albumin > 200 mg/day
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
Evaluate the safety, tolerability, and pharmacokinetics of two ISIS 113715 subcutaneous dosages in combination with OAD versus OAD + placebo.
Examine the effect of treatment with 15 and 30 mg/day ISIS 113715 on fasting plasma glucose and HbA1c.
Evaluate the effects of ISIS 113715 on insulin sensitivity, B-cell function, proinsulin/insulin ratio, fasting insulin, C-peptide and proinsulin.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
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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.
5 sites in 1 country: 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 5 sites in Israel.
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 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: withdrawn, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel. 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 was withdrawn before enrolling participants, so there are no results.
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?
Evaluate the safety, tolerability, and pharmacokinetics of two ISIS 113715 subcutaneous dosages in combination with OAD versus OAD + placebo.. 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 5 Dec 2022.