Type 2 Diabetes Mellitus (T2DM)Phase 2NCT01514149
Dose-Ranging Study to Evaluate Efficacy and Safety of Weekly CJC-1134-PC in Patients With T2DM on Metformin Monotherapy
A Phase 2 study testing CJC-1134-PC Injection in people with Type 2 Diabetes Mellitus (T2DM), run by ConjuChem at 22 sites in 2 countries.
Trial summary
DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus on metformin monotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- CJC-1134-PC Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Sep 2011to Mar 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men or women 18 to 70 years of age, inclusive
- Body mass index of 27 to 45 kg/m2
- Diagnosed with T2DM for at least 6 months before screening
- Stable daily dose of metformin monotherapy of ≥1000 mg for at least 3 months before screening
- FPG ≤240 mg/dL at screening
- HbA1c ≥7.0% and ≤11% at screening
- A 12-lead electrocardiogram recording without clinically significant arrhythmia, left bundle-branch block, or corrected QT interval
Who cannot join
- Pregnant or breastfeeding women
- Use of a weight control treatment, including over-the-counter medications (includes herbal supplements), or a significant change in body weight (at least ±10%) in the 3 months before screening
- Treatment with any oral antidiabetic agent other than metformin within the 3 months before screening
- Treatment with insulin for longer than 1 week within the 3 months before screening or any treatment with insulin within the 2 weeks before screening
- Previous treatment with a glucagon-like peptide 1 (GLP-1) analog or other incretin therapy
- Receipt of any experimental drug in a clinical trial within 30 days before administration of study drug or receipt of any investigational antidiabetic product within 3 months before screening
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States19 sites
Research Site
Altoona, Pennsylvania, 16602
Research Site
Austin, Texas, 78758
Research Site
Brighton, Massachusetts, 02135
Research Site
Charleston, South Carolina, 29407
Research Site
Dallas, Texas, 75231
Research Site
East Providence, Rhode Island, 02915
Research Site
Eugene, Oregon, 97401
Research Site
Greensboro, North Carolina, 27405
Research Site
Henrico, Virginia, 23233
Research Site
Idaho Falls, Idaho, 83404
Research Site
Inglewood, California, 90301
Research Site
Lexington, Kentucky, 40504
Research Site
Phoenix, Arizona, 85018
Research Site
Salt Lake City, Utah, 84107
Research Site
San Antonio, Texas, 78249
Research Site
Tarzana, California, 91356
Research Site
Taylors, South Carolina, 29687
Research Site
Ventura, California, 93003
Research Site
Wellington, Florida, 33414
Canada3 sites
Research Site
Smiths Falls, Ontario
Research Site
Toronto, Ontario
Research Site
Vancouver, British Columbia
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of 17 Weeks of Weekly Injections of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus on Metformin Monotherapy
DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus on metformin monotherapy.
Read the detailed description
DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus (T2DM) on metformin monotherapy. This study will be a randomized, double-blind comparison of CJC-1134-PC versus placebo. Patients taking metformin will continue to take their metformin at the same dose for the duration of the study.
Patients with T2DM, who meet all the inclusion criteria and none of the exclusion criteria, will be randomly assigned to a treatment arm. All patients will undergo weekly clinic visits to receive 17 weeks of study treatment, including the titration period.
CJC-1134-PC or placebo treatment will be administered weekly by subcutaneous injection in the abdomen to patients in a fasting state. Patients will be closely monitored and evaluated for toxicity on an ongoing basis.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- CJC-1134-PC Injection, Weekly placebo for CJC-1134-PC Injection
- Keywords
- Type 2 Diabetes Mellitus, T2DM, diabetes, ConjuChem, GLP-1, Glucagon-like peptide-1, exendin-4, modified exendin-4
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJC-1134-PC InjectionDrug
Also called metformin
CJC-1134-PC administered weekly by subcutaneous injection
Weekly placebo for CJC-1134-PC InjectionDrug
Also called metformin
Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Weekly CJC-1134-PC | Experimental | Not described Receives: Drug: CJC-1134-PC Injection |
| Arm 2 - Weekly CJC-1134-PC | Experimental | Not described Receives: Drug: CJC-1134-PC Injection |
| Arm 3 - Weekly CJC-1134-PC | Experimental | Not described Receives: Drug: CJC-1134-PC Injection |
| Arm 4 - Weekly CJC-1134-PC | Experimental | Not described Receives: Drug: CJC-1134-PC Injection |
| Arm 5 - Weekly Placebo | Placebo comparator | Not described Receives: Drug: Weekly placebo for CJC-1134-PC Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18
Measured: CFB to Week 18
Secondary outcomes (2)
Fasting Body Weight CFB to Week 18
Measured: CFB to Week 18
Time to Hyperglycemia Rescue
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 posted20 Jan 2012 (estimated)
- Study startSep 2011
- Primary completionMay 2012
- Study completionMar 2013
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConjuChem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Soon-Shiong, MD, Study director, Chief Executive OfficerRobert Henry, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514149
- Sponsor's protocol ID
- DM200-103
- Status last verified
- Jun 2017
- First submitted
- 20 Oct 2011
- Last updated
- 19 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of 17 Weeks of Weekly Injections of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus on Metformin Monotherapy
- ClinicalTrials.gov ID
- NCT01514149
- Acronym / sponsor ID
- DM200-103
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Type 2 Diabetes Mellitus, T2DM, diabetes, ConjuChem, GLP-1, Glucagon-like peptide-1, exendin-4, modified exendin-4
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 73 participants (actual)
- Lead sponsor
- ConjuChemIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 20 Jan 2012 (estimated)
- Results
- Posted 19 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus on metformin monotherapy.
Detailed description
DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus (T2DM) on metformin monotherapy. This study will be a randomized, double-blind comparison of CJC-1134-PC versus placebo. Patients taking metformin will continue to take their metformin at the same dose for the duration of the study.
Patients with T2DM, who meet all the inclusion criteria and none of the exclusion criteria, will be randomly assigned to a treatment arm. All patients will undergo weekly clinic visits to receive 17 weeks of study treatment, including the titration period.
CJC-1134-PC or placebo treatment will be administered weekly by subcutaneous injection in the abdomen to patients in a fasting state. Patients will be closely monitored and evaluated for toxicity on an ongoing basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Weekly CJC-1134-PC | Experimental | Drug: CJC-1134-PC Injection |
| Arm 2 - Weekly CJC-1134-PC | Experimental | Drug: CJC-1134-PC Injection |
| Arm 3 - Weekly CJC-1134-PC | Experimental | Drug: CJC-1134-PC Injection |
| Arm 4 - Weekly CJC-1134-PC | Experimental | Drug: CJC-1134-PC Injection |
| Arm 5 - Weekly Placebo | Placebo comparator | Drug: Weekly placebo for CJC-1134-PC Injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women 18 to 70 years of age, inclusive
- Body mass index of 27 to 45 kg/m2
- Diagnosed with T2DM for at least 6 months before screening
- Stable daily dose of metformin monotherapy of ≥1000 mg for at least 3 months before screening
- FPG ≤240 mg/dL at screening
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding women
- Use of a weight control treatment, including over-the-counter medications (includes herbal supplements), or a significant change in body weight (at least ±10%) in the 3 months before screening
- Treatment with any oral antidiabetic agent other than metformin within the 3 months before screening
- Treatment with insulin for longer than 1 week within the 3 months before screening or any treatment with insulin within the 2 weeks before screening
- Previous treatment with a glucagon-like peptide 1 (GLP-1) analog or other incretin therapy
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 |
|---|---|---|
| CJC-1134-PC InjectionAlso: metforminCJC-1134-PC administered weekly by subcutaneous injection | Drug | Arm 1 - Weekly CJC-1134-PC, Arm 2 - Weekly CJC-1134-PC, Arm 3 - Weekly CJC-1134-PC, Arm 4 - Weekly CJC-1134-PC |
| Weekly placebo for CJC-1134-PC InjectionAlso: metforminWeekly placebo for CJC-1134-PC administered weekly by subcutaneous injection | Drug | Arm 5 - Weekly Placebo |
Primary outcome
Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18
Time frame: CFB to Week 18
2 secondary outcomes
Fasting Body Weight CFB to Week 18
Time frame: CFB to Week 18
Time to Hyperglycemia Rescue
Time frame: 18 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Patrick Soon-Shiong, MD study director
Chief Executive Officer
Robert Henry, MD principal investigator
22 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 CJC-1134-PC Injection in people with Type 2 Diabetes Mellitus (T2DM), run by ConjuChem at 22 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 7 inclusion and 6 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 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 19 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18 (time frame: CFB to Week 18). 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 19 Jul 2017.