Type 2 Diabetes MellitusPhase 2NCT01885260
Safety, Tolerability and Efficacy of ISIS-GCGRRx in 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 Mellitus, run by Ionis Pharmaceuticals, Inc. at 24 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCGRRx 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-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
- 77 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Jul 2013to Nov 2014
- 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 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
24 sites in 2 countries.
24 sites in 2 countries
United States18 sites
Isis Investigational Site
Anaheim, California, 92801
Isis Investigational Site
Birmingham, Alabama, 35216
Isis Investigational Site
Chino, California, 91710
Isis Investigational Site
Cincinnati, Ohio, 45245
Isis Investigational Site
Corpus Christi, Texas, 78404
Isis Investigational Site
DeLand, Florida, 32720
Isis Investigational Site
Eugene, Oregon, 97404
Isis Investigational Site
Fort Lauderdale, Florida, 33306
Isis Investigational Site
Katy, Texas, 77450
Isis Investigational Site
Las Vegas, Nevada, 89101
Isis Investigational Site
Los Angeles, California, 90057
Isis Investigational Site
Marietta, Georgia, 30066
Isis Investigational Site
Miami, Florida, 33143
Isis Investigational Site
Muscle Shoals, Alabama, 35662
Isis Investigational Site
Oklahoma City, Oklahoma, 73103
Isis Investigational Site
Renton, Washington, 98057
Isis Investigational Site
Salt Lake City, Utah, 84107
Isis Investigational Site
Spokane, Washington, 99202
South Africa6 sites
Isis Investigational Site
Cape Town, Western Cape, 7700
Isis Investigational Site
Durban, KwaZulu-Natal, 4091
Isis Investigational Site
Lenasia South, Gauteng, 1829
Isis Investigational Site
Parow, Cape Town, Western Cape, 7500
Isis Investigational Site
Soweto, Gauteng, 1818
Isis Investigational Site
Western Cape, Western Cape, 7130
About this study
Official title: A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of ISIS 449884 Administered Once Weekly 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-GCGRRx in combination with metformin versus placebo + metformin
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- ISIS-GCGRRx - Dose Level 1, ISIS-GCGRRx - Dose Level 2, 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-GCGRRx - Dose Level 1Drug
Also called Isis 449884
3 doses on alternate days during the first week and then once weekly for 12 weeks
ISIS-GCGRRx - Dose Level 2Drug
Also called Isis 449884
3 doses on alternate days during the first week and then once weekly for 12 weeks
PlaceboDrug
3 doses on alternate days during the first week and then once weekly for 12 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.
The effect of ISIS-GCGRRx on serum fructosamine
Change from Baseline to Week 14
Measured: 14 Weeks
Secondary outcomes (2)
The safety of ISIS-GCGRRx
By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations
Measured: 25 Weeks
The tolerability of ISIS-GCGRRx
By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations
Measured: 25 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2014
- Study completionNov 2014
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 77 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
- NCT01885260
- Sponsor's protocol ID
- ISIS 449884-CS2
- Status last verified
- Jun 2016
- First submitted
- 13 Jun 2013
- Last updated
- 4 Jul 2016
- 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 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of ISIS 449884 Administered Once Weekly to Patients With Type 2 Diabetes Mellitus Being Treated With Metformin
- ClinicalTrials.gov ID
- NCT01885260
- Acronym / sponsor ID
- ISIS 449884-CS2
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, T2DM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 24 Jun 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-GCGRRx in combination with metformin versus placebo + metformin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, 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 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 (9 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-GCGRRx - Dose Level 1Also: Isis 4498843 doses on alternate days during the first week and then once weekly for 12 weeks | Drug | ISIS-GCGRRx Dose Level 1 |
| ISIS-GCGRRx - Dose Level 2Also: Isis 4498843 doses on alternate days during the first week and then once weekly for 12 weeks | Drug | ISIS-GCGRRx Dose Level 2 |
| Placebo3 doses on alternate days during the first week and then once weekly for 12 weeks | Drug | Placebo |
Primary outcome
The effect of ISIS-GCGRRx on serum fructosamine
Time frame: 14 Weeks
Change from Baseline to Week 14
2 secondary outcomes
The safety of ISIS-GCGRRx
Time frame: 25 Weeks
The tolerability of ISIS-GCGRRx
Time frame: 25 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 4 Jul 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
24 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-GCGRRx - Dose Level 1 and ISIS-GCGRRx - Dose Level 2 in people with Type 2 Diabetes Mellitus, run by Ionis Pharmaceuticals, Inc. at 24 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 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 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, 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-GCGRRx on serum fructosamine (time frame: 14 Weeks). 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 NCT01885260, 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 4 Jul 2016.