Type 2 Diabetes MellitusPhase 2NCT01968265
Safety, Tolerability and Efficacy of ISIS-GCCRRx in Type 2 Diabetes
A Phase 2 study testing ISIS-GCCRRx in people with Type 2 Diabetes Mellitus, run by Ionis Pharmaceuticals, Inc. at 14 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCCRRx in combination with metformin versus placebo + metformin Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- ISIS-GCCRRx
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 14 sitesin 3 countries
- Study dates
- Oct 2013to May 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18 to 75
- BMI greater than or equal to 25
- HbA1c greater than or equal to 7.5% and less than or equal to 10.5%
- Type 2 Diabetes Mellitus and on stable dose of oral metformin
- Agree to conduct home-based (fasted) blood glucose testing as directed
Who cannot join
- Clinically significant abnormalities in medical history or physical exam
- Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results
- History of renal transplantation or renal dialysis
- History of liver disease
- History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
- Use of oral anti-diabetic medication other than metformin within 3 months of screening
Show all 11Show fewer
- Use of medications that may affect plasma glucose levels (including systemic glucocorticoids), systemic steroids, corticosteroids, antiglucocorticoid therapies including mifepristone and ketoconazole (topical cream and systemic), immunosuppressive medications, somatostatin analogues or ACTH therapy within 3 months of screening
- History of diabetic ketoacidosis
- Current or previous diagnosis of Gilbert's disease
- Any other significant illness or condition that may interfere with the patient participating or completing the study
- Inability or unwillingness to comply with protocol or study procedures
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Canada6 sites
Isis Investigative Site
Cornwall, Ontario
Isis Investigative Site
Courtice, Ontario
Isis Investigative Site
Greater Sudbury, Ontario
Isis Investigative Site
Montreal, Quebec, H2R1V6
Isis Investigative Site
Penticton, British Columbia
Isis Investigative Site
Red Deer, Alberta
Romania4 sites
Isis Investigative Site
Bucharest, Bucharest, 010507
Isis Investigative Site
Bucharest, Bucharest, 011794
Isis Investigative site
Bucharest, Bucharest, 022441
Isis Investigative Site
Cluj-Napoca, Cluj, 400349
South Africa4 sites
Isis Investigative Site
Benoni, Gauteng, 1501
Isis Investigative Site
Bloemfontein, Free State, 9300
Isis Investigative Site
Somerset West, Western Cape, 7130
Isis Investigative Site
Soweto, Gauteng, 1818
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of ISIS 426115 (an Antisense Glucocorticoid Receptor Antagonist) Administered Subcutaneously Once Weekly for 6 Weeks to Patients With Type 2 Diabetes Mellitus Being Treated With Metformin
The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCCRRx in combination with metformin versus placebo + metformin
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- ISIS-GCCRRx, Placebo
- Keywords
- Type 2 Diabetes Mellitus, T2DM
- 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-GCCRRxDrug
3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin
PlaceboDrug
3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| ISIS-GCCRRx | Active comparator | Not described Receives: Drug: ISIS-GCCRRx |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of ISIS-GCCRRx on serum fructosamine
Change from Baseline to Week 7
Measured: 7 Weeks
Secondary outcomes (2)
The safety of ISIS-GCCRRx
By determining the incidence, severity, adverse effects, and changes in laboratory evaluations
Measured: 18 Weeks
The tolerability of ISIS-GCCRRx
By determining the incidence, severity, adverse effects, and changes in laboratory evaluations
Measured: 18 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2015
- Study completionMay 2015
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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968265
- Sponsor's protocol ID
- ISIS 426115-CS2
- Other IDs
- 2013-002172-40
- Status last verified
- May 2015
- First submitted
- 18 Oct 2013
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of ISIS 426115 (an Antisense Glucocorticoid Receptor Antagonist) Administered Subcutaneously Once Weekly for 6 Weeks to Patients With Type 2 Diabetes Mellitus Being Treated With Metformin
- ClinicalTrials.gov ID
- NCT01968265
- Acronym / sponsor ID
- ISIS 426115-CS2
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, T2DM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 24 Oct 2013 (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 purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCCRRx in combination with metformin versus placebo + metformin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| ISIS-GCCRRx | Active comparator | Drug: ISIS-GCCRRx |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, age 18 to 75
- BMI greater than or equal to 25
- HbA1c greater than or equal to 7.5% and less than or equal to 10.5%
- Type 2 Diabetes Mellitus and on stable dose of oral metformin
- Agree to conduct home-based (fasted) blood glucose testing as directed
Key exclusion criteria (11 listed)
- Clinically significant abnormalities in medical history or physical exam
- Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results
- History of renal transplantation or renal dialysis
- History of liver disease
- History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
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-GCCRRx3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin | Drug | ISIS-GCCRRx |
| Placebo3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin | Drug | Placebo |
Primary outcome
The effect of ISIS-GCCRRx on serum fructosamine
Time frame: 7 Weeks
Change from Baseline to Week 7
2 secondary outcomes
The safety of ISIS-GCCRRx
Time frame: 18 Weeks
The tolerability of ISIS-GCCRRx
Time frame: 18 Weeks
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 13 May 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ISIS-GCCRRx in people with Type 2 Diabetes Mellitus, run by Ionis Pharmaceuticals, Inc. at 14 sites in 3 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 5 inclusion and 11 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 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Canada, Romania, South Africa. 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. Some participants in this study may receive a placebo. 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?
The effect of ISIS-GCCRRx on serum fructosamine (time frame: 7 Weeks). 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 13 May 2015.