Type 2 Diabetes MellitusPhase 2NCT00330200
Effects of ISIS 113715 on Insulin Sensitivity, Glucose, and Lipid Metabolism and Energy Expenditure in Type 2 Diabetics
A Phase 2 study testing ISIS 113715 in people with Type 2 Diabetes Mellitus, run by Ionis Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The aim of this study is to examine the effects of ISIS 113715 monotherapy on insulin sensitivity, glucose and lipid metabolism and energy expenditure in subjects with type 2 diabetes mellitus. 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
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2005to 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
- Treatment naïve subjects with fasting blood glucose levels of 150-220 mg/dL, hematocrit of >/= 35% and HbA1c levels of >/= 7% and </= 10.0%
- Subjects on antidiabetic therapy with fasting blood glucose levels of 100-200 mg/dL, hematocrit of >/= 35%, and HbA1c levels of >/= 6.5% and </= 9.0%
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 1.5 times the upper limit of normal
- History of hepatitis B surface antigen, hepatitis C antibody, or HIV
- Complications of diabetes (e.g., neuropathy, nephropathy, and retinopathy)
- Clinically significant and currently active diseases
- Clinically significant abnormalities in medical history, physical examination, or laboratory examination
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale - New Haven Hospital
New Haven, Connecticut, 06511
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of ISIS 113715 Monotherapy on Insulin Sensitivity, Glucose and Lipid Metabolism and Energy Expenditure in Subjects With Type 2 Diabetes Mellitus
The aim of this study is to examine the effects of ISIS 113715 monotherapy on insulin sensitivity, glucose and lipid metabolism and energy expenditure in subjects with type 2 diabetes mellitus.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- ISIS 113715
- Keywords
- Fasting plasma glucose, HbA1c, Metabolism
- 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 effects of ISIS 113715 on hepatic and peripheral insulin sensitivity
Examine the effect on whole body energy expenditure
Evaluate the effects on fasting and postprandial glucose excursions
Evaluate the effects on hemoglobin A1c (HbA1c)
Secondary outcomes (3)
Expand the safety and tolerability profile for ISIS 113715
Assess the effects of ISIS 113715 on rates of basal and insulin stimulated whole body glycerol turnover
Assess the effects of ISIS 113715 on insulin suppression of local rates of lipolysis (microdialysis)
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 start1 Nov 2005
- Primary completion1 Mar 2007
- Study completion1 Mar 2007
Why it stopped: Due to poor enrollment
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Isis Pharmaceuticals, Study chair, Ionis Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330200
- Sponsor's protocol ID
- ISIS 113715-CS11
- Status last verified
- Apr 2008
- First submitted
- 24 May 2006
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- 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 Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of ISIS 113715 Monotherapy on Insulin Sensitivity, Glucose and Lipid Metabolism and Energy Expenditure in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00330200
- Acronym / sponsor ID
- ISIS 113715-CS11
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Fasting plasma glucose, HbA1c, Metabolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to poor enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2005 (actual)
- Primary completion
- 1 Mar 2007 (actual)
- Study completion
- 1 Mar 2007 (actual)
- 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 examine the effects of ISIS 113715 monotherapy on insulin sensitivity, glucose and lipid metabolism and energy expenditure in subjects with type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female (post menopausal and/or surgically sterile)
- Aged 18 to 70 years
- Treatment naïve subjects with fasting blood glucose levels of 150-220 mg/dL, hematocrit of >/= 35% and HbA1c levels of >/= 7% and </= 10.0%
- Subjects on antidiabetic therapy with fasting blood glucose levels of 100-200 mg/dL, hematocrit of >/= 35%, and HbA1c levels of >/= 6.5% and </= 9.0%
Key exclusion criteria (7 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 1.5 times the upper limit of normal
- History of hepatitis B surface antigen, hepatitis C antibody, or HIV
- Complications of diabetes (e.g., neuropathy, nephropathy, and retinopathy)
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 effects of ISIS 113715 on hepatic and peripheral insulin sensitivity
Examine the effect on whole body energy expenditure
Evaluate the effects on fasting and postprandial glucose excursions
Evaluate the effects on hemoglobin A1c (HbA1c)
3 secondary outcomes
Expand the safety and tolerability profile for ISIS 113715
Assess the effects of ISIS 113715 on rates of basal and insulin stimulated whole body glycerol turnover
Assess the effects of ISIS 113715 on insulin suppression of local rates of lipolysis (microdialysis)
Results and safety
The study was stopped early (reason given: Due to poor enrollment). Results are not available in the source record.
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.
Isis Pharmaceuticals study chair
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 2 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 7 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: stopped early, 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 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 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 stopped early (reason given: Due to poor enrollment). Results are not available in the source record.
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 effects of ISIS 113715 on hepatic and peripheral insulin sensitivity. The study lists 4 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.