Type 2 DiabetesPhase 2NCT02583919
Safety, Tolerability and Efficacy of ISIS-GCGRRx in Patients With Type 2 Diabetes
A Phase 2 study testing ISIS-GCGRRx- Dose Level 1 and ISIS-GCGRRx- Dose Level 2 in people with Type 2 Diabetes, run by Ionis Pharmaceuticals, Inc. at 19 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of ISIS-GCGRRx in combination with metformin versus placebo Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- ISIS-GCGRRx- Dose Level 1 and ISIS-GCGRRx- Dose Level 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 19 sitesUnited States
- Study dates
- Sep 2015to 11 May 2017
- 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 ≥ 25.0 kg/m2
- HbA1c ≥ 8.0% and ≤ 10.5%
- Type 2 Diabetes Mellitus and on stable dose of Metformin
- Agree to conduct home-based (fasted) blood glucose testing as directed
Who cannot join
- Clinically significant abnormalities in medical history of physical exam
- Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results
- History of solid organ transplant or renal dialysis
- History of liver disease
- History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
- Treatment with any other antidiabetic drug(s) other than metformin within 3 months of screening
Show all 9Show fewer
- History of diabetic ketoacidosis
- 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
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Ionis Investigational Site
Cincinnati, Ohio, 45219
Ionis Investigational Site
Cincinnati, Ohio, 45245
Ionis Investigational Site
Eugene, Oregon, 97404
Ionis Investigational Site
Greenbrae, California, 94904
Ionis Investigational Site
Greensboro, North Carolina, 27410
Ionis Investigational Site
Houston, Texas, 77036
Ionis Investigational Site
Houston, Texas, 77074
Ionis Investigational Site
Huntington Park, California, 90255
Ionis Investigational Site
Katy, Texas, 77450
Ionis Investigational Site
La Mesa, California, 91942
Ionis Investigational Site
Los Angeles, California, 90057
Ionis Investigational Site
Marietta, Georgia, 30060
Ionis Investigational Site
Morehead City, North Carolina, 28557
Ionis Investigational Site
New York, New York, 10016
Ionis Investigational Site
Olympia, Washington, 98502
Ionis Investigational Site
Oxon Hill, Maryland, 20745
Ionis Investigational Site
Port Orange, Florida, 32127
Ionis Investigational Site
Spartanburg, South Carolina, 29303
Isis Investigational Site
Spring Valley, California, 91978
About this study
Official title: Double Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Efficacy of ISIS 449884 Administered Once Weekly for 26 Weeks in Patients With Type 2 Diabetes Being Treated With Metformin
The purpose of this study is to evaluate the efficacy, safety, and tolerability of ISIS-GCGRRx in combination with metformin versus placebo
- Conditions
- Type 2 Diabetes
- Being tested
- ISIS-GCGRRx- Dose Level 1, ISIS-GCGRRx- Dose Level 2, Placebo
- 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-GCGRRx- Dose Level 1Drug
Also called Isis 449884
once weekly dosing for 26 weeks
ISIS-GCGRRx- Dose Level 2Drug
Also called Isis 449884
once weekly dosing for 26 weeks
PlaceboDrug
once weekly dosing for 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| ISIS-GCGRRx - Dose Level 1 | Experimental | ISIS-GCGRRx - Dose Level 1 Receives: Drug: ISIS-GCGRRx- Dose Level 1 |
| ISIS-GCGRRx - Dose Level 2 | Experimental | ISIS-GCGRRx - Dose Level 2 Receives: Drug: ISIS-GCGRRx- Dose Level 2 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1C
Change from Baseline
Measured: Week 27 and subsequent timepoints
Secondary outcomes (1)
Safety and Tolerability will be assessed by determining the incidence, severity, dose-relationship adverse-effects, and changes in laboratory evaluations within each dose cohort
Safety results in patients dosed with Isis 449884 will be compared with those from patients dosed with placebo
Measured: 50 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startSep 2015
- Primary completion15 Dec 2016
- Study completion11 May 2017
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 DiabetesStudies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sanjay Bhanot, Study director, Ionis Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583919
- Sponsor's protocol ID
- ISIS 449884-CS4
- Status last verified
- Jun 2018
- First submitted
- 12 Oct 2015
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Morgan ES, Tai LJ, Pham NC, Overman JK, Watts LM, Smith A, Jung SW, Gajdosik M, Krssak M, Krebs M, Geary RS, Baker BF, Bhanot S. Antisense Inhibition of Glucagon Receptor by IONIS-GCGRRx Improves Type 2 Diabetes Without Increase in Hepatic Glycogen Content in Patients With Type 2 Diabetes on Stable Metformin Therapy. Diabetes Care. 2019 Apr;42(4):585-593. doi: 10.2337/dc18-1343. Epub 2019 Feb 14.
PubMed 30765435
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Efficacy of ISIS 449884 Administered Once Weekly for 26 Weeks in Patients With Type 2 Diabetes Being Treated With Metformin
- ClinicalTrials.gov ID
- NCT02583919
- Acronym / sponsor ID
- ISIS 449884-CS4
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 11 May 2017 (actual)
- First posted
- 22 Oct 2015 (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-GCGRRx in combination with metformin versus placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ISIS-GCGRRx - Dose Level 1 | Experimental | Drug: ISIS-GCGRRx- Dose Level 1ISIS-GCGRRx - Dose Level 1 |
| ISIS-GCGRRx - Dose Level 2 | Experimental | Drug: ISIS-GCGRRx- Dose Level 2ISIS-GCGRRx - Dose Level 2 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
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 ≥ 25.0 kg/m2
- HbA1c ≥ 8.0% and ≤ 10.5%
- Type 2 Diabetes Mellitus and on stable dose of Metformin
- Agree to conduct home-based (fasted) blood glucose testing as directed
Key exclusion criteria (9 listed)
- Clinically significant abnormalities in medical history of physical exam
- Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results
- History of solid organ transplant 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-GCGRRx- Dose Level 1Also: Isis 449884once weekly dosing for 26 weeks | Drug | ISIS-GCGRRx - Dose Level 1 |
| ISIS-GCGRRx- Dose Level 2Also: Isis 449884once weekly dosing for 26 weeks | Drug | ISIS-GCGRRx - Dose Level 2 |
| Placeboonce weekly dosing for 26 weeks | Drug | Placebo |
Primary outcome
Change in HbA1C
Time frame: Week 27 and subsequent timepoints
Change from Baseline
1 secondary outcome
Safety and Tolerability will be assessed by determining the incidence, severity, dose-relationship adverse-effects, and changes in laboratory evaluations within each dose cohort
Time frame: 50 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 25 Jun 2018.
- Derived from this study: PubMed 30765435Morgan ES, Tai LJ, Pham NC, Overman JK, Watts LM, Smith A, Jung SW, Gajdosik M, Krssak M, Krebs M, Geary RS, Baker BF, Bhanot S. Antisense Inhibition of Glucagon Receptor by IONIS-GCGRRx Improves Type 2 Diabetes Without Increase in Hepatic Glycogen Content in Patients With Type 2 Diabetes on Stable Metformin Therapy. Diabetes Care. 2019 Apr;42(4):585-593. doi: 10.2337/dc18-1343. Epub 2019 Feb 14.
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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.
Sanjay Bhanot study director
Ionis Pharmaceuticals, Inc.
19 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-GCGRRx- Dose Level 1 and ISIS-GCGRRx- Dose Level 2 in people with Type 2 Diabetes, run by Ionis Pharmaceuticals, Inc. at 19 sites 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 5 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 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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. 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?
Change in HbA1C (time frame: Week 27 and subsequent timepoints). 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 NCT02583919, 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 25 Jun 2018.