Diabetes Mellitus, Type 2Phase 1NCT00882726
A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CNTO 3649 in Healthy Adults and Patients With Type 2 Diabetes Mellitus
A Phase 1 study testing CNTO 3649 IV (Healthy participants), CNTO 3649 SC (Healthy participants) and CNTO 3649 SC (Diabetic patients) in people with Diabetes Mellitus, Type 2, run by Centocor, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTO 3649 following a single dose in healthy adults and following multiple doses in patients with Type 2 Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- CNTO 3649 IV (Healthy participants), CNTO 3649 SC (Healthy participants) and CNTO 3649 SC (Diabetic patients)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2009to Apr 2010
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part 1 (healthy participants): Demonstrate an understanding of the study and sign an informed consent form
- Healthy male or female subjects with no clinically relevant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments including complete blood count, coagulation tests, urinalysis, measurement of vital signs, and ECG
- Age 18 to 55
- Have a body mass index (BMI) of 18.5 to 30 kg/m2 and weight of 50 to 100 kg
- Part 2 (patients with type 2 diabetes): Type 2 Diabetic male or female subjects diagnosed at least 12 months prior to screening and are stably managed for >= 3 months
- HbA1c levels within the range of 6% to 10% if being treated with diet and exercise alone, and 6% to 9% if on therapy
- BMI 18.5 to 37 kg/m2. Age 18 to 65 years.
Who cannot join
- Part 1 (healthy participants): Currently have or have a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the subject
- Part 2 (patients with type 2 diabetes): Any clinically significant medical illness or medical disorders (with the exception of diagnosis of T2DM, well-controlled hypertension, or well-controlled dyslipidemia) the investigator considers should exclude the subject. History of more than 3 days of insulin use in the last 3 months, or any thiazolidinedione medications, any alpha glucosidase inhibitors, or exenatide within 3 months of the screening visit. History of clinically significant acute or chronic diabetic complications. History of severe hypoglycemic reaction in the 6 months prior to the screening visit.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Miramar, Florida
Study site
San Antonio, Texas
Study site
Tacoma, Washington
About this study
Official title: A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Intravenous and Subcutaneous Single-Dose Study in Healthy Subjects and Ascending Subcutaneous Multiple-Dose Study in Subjects With Type 2 Diabetes Mellitus to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immune Response of CNTO 3649
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTO 3649 following a single dose in healthy adults and following multiple doses in patients with Type 2 Diabetes Mellitus.
Read the detailed description
This is a randomized (study medication assigned by chance), placebo controlled, double-blind (neither physician nor patient knows the name of the assigned study medication), ascending-dose study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of CNTO 3649. The study population will consist of approximately 80 healthy participants (Part 1) and approximately 36 type 2 diabetic patients (Part 2). All participants will be randomized to CNTO 3649 or placebo in the ratio of 3:1. Out of 80 healthy participants, 48 participants will receive single doses of CNTO 3649 (6 dose levels) or placebo as an intravenous infusion (directly into a vein) and 32 participants will receive single doses of CNTO 3649 (4 dose levels) or placebo as a subcutaneous (under the skin) injection. All 36 diabetic patients will receive multiple doses of CNTO 3649 (3 dose levels) or placebo as subcutaneous injections. There will be a screening period of 30 days and 45 days for healthy participants and diabetes patients, respectively. Healthy participants will be in the study for 9 weeks. Diabetic patients will be in the study for 12 weeks.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- CNTO 3649 IV (Healthy participants), CNTO 3649 SC (Healthy participants), CNTO 3649 SC (Diabetic patients), Placebo
- Keywords
- Diabetes Mellitus, Type 2, CNTO 3649, safety, Phase I, healthy adults, Type 2 Diabetes Mellitus
- 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.
CNTO 3649 IV (Healthy participants)Drug
Healthy participants will each receive a single dose of CNTO 3649 (1, 3, 10, 30, 100 or 300 microgram per kilogram, subject to change) as a 2-hour IV infusion.
CNTO 3649 SC (Healthy participants)Drug
Healthy participants will each receive a single dose of CNTO 3649 (10, 30, 100 or 300 microgram per kilogram, subject to change) as a SC injection.
CNTO 3649 SC (Diabetic patients)Drug
Diabetic patients will receive multiple doses of CNTO 3649 (30, 100 or 300 microgram per kilogram, subject to change) as subcutaneous injections once weekly for 4 consecutive weeks.
PlaceboDrug
Participants within each dosing group who are randomized to placebo will receive a corresponding IV infusion or SC injection of placebo.
| Study group | Role | What they receive |
|---|---|---|
| CNTO 3649 IV (Healthy participants) | Experimental | Not described Receives: Drug: CNTO 3649 IV (Healthy participants); Drug: Placebo |
| CNTO 3649 SC (Healthy participants) | Experimental | Not described Receives: Drug: CNTO 3649 SC (Healthy participants); Drug: Placebo |
| CNTO 3649 SC (Diabetic patients) | Experimental | Not described Receives: Drug: CNTO 3649 SC (Diabetic patients); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of a single IV or SC administration of CNTO 3649 in healthy participants; Safety and tolerability of multiple SC injections of CNTO 3649 in Type 2 Diabetic Patients
Measured: Week 1 to Week 5 (for healthy participants) and Week 1 to Week 8 (for diabetic patients)
Secondary outcomes (1)
Pharmacokinetics, pharmacodynamics and immunogenicity of CNTO 3649 following single and multiple administrations.
Measured: Week 1 to Week 5 (for healthy participants) and Week 1 to Week 8 (for diabetic patients)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centocor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Centocor Clinical Trial, Study director, Centocor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882726
- Sponsor's protocol ID
- CR015562
- Other IDs
- CNTO3649DIB1001
- Status last verified
- Dec 2013
- First submitted
- 14 Apr 2009
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Intravenous and Subcutaneous Single-Dose Study in Healthy Subjects and Ascending Subcutaneous Multiple-Dose Study in Subjects With Type 2 Diabetes Mellitus to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immune Response of CNTO 3649
- ClinicalTrials.gov ID
- NCT00882726
- Acronym / sponsor ID
- CR015562
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, CNTO 3649, safety, Phase I, healthy adults, Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Centocor, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 16 Apr 2009 (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 safety, pharmacokinetics, and pharmacodynamics of CNTO 3649 following a single dose in healthy adults and following multiple doses in patients with Type 2 Diabetes Mellitus.
Detailed description
This is a randomized (study medication assigned by chance), placebo controlled, double-blind (neither physician nor patient knows the name of the assigned study medication), ascending-dose study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of CNTO 3649. The study population will consist of approximately 80 healthy participants (Part 1) and approximately 36 type 2 diabetic patients (Part 2). All participants will be randomized to CNTO 3649 or placebo in the ratio of 3:1. Out of 80 healthy participants, 48 participants will receive single doses of CNTO 3649 (6 dose levels) or placebo as an intravenous infusion (directly into a vein) and 32 participants will receive single doses of CNTO 3649 (4 dose levels) or placebo as a subcutaneous (under the skin) injection. All 36 diabetic patients will receive multiple doses of CNTO 3649 (3 dose levels) or placebo as subcutaneous injections. There will be a screening period of 30 days and 45 days for healthy participants and diabetes patients, respectively. Healthy participants will be in the study for 9 weeks. Diabetic patients will be in the study for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CNTO 3649 IV (Healthy participants) | Experimental | Drug: CNTO 3649 IV (Healthy participants), Drug: Placebo |
| CNTO 3649 SC (Healthy participants) | Experimental | Drug: CNTO 3649 SC (Healthy participants), Drug: Placebo |
| CNTO 3649 SC (Diabetic patients) | Experimental | Drug: CNTO 3649 SC (Diabetic patients), Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Part 1 (healthy participants): Demonstrate an understanding of the study and sign an informed consent form
- Healthy male or female subjects with no clinically relevant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments including complete blood count, coagulation tests, urinalysis, measurement of vital signs, and ECG
- Age 18 to 55
- Have a body mass index (BMI) of 18.5 to 30 kg/m2 and weight of 50 to 100 kg
- Part 2 (patients with type 2 diabetes): Type 2 Diabetic male or female subjects diagnosed at least 12 months prior to screening and are stably managed for >= 3 months
Key exclusion criteria (2 listed)
- Part 1 (healthy participants): Currently have or have a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the subject
- Part 2 (patients with type 2 diabetes): Any clinically significant medical illness or medical disorders (with the exception of diagnosis of T2DM, well-controlled hypertension, or well-controlled dyslipidemia) the investigator considers should exclude the subject. History of more than 3 days of insulin use in the last 3 months, or any thiazolidinedione medications, any alpha glucosidase inhibitors, or exenatide within 3 months of the screening visit. History of clinically significant acute or chronic diabetic complications. History of severe hypoglycemic reaction in the 6 months prior to the screening visit.
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 |
|---|---|---|
| CNTO 3649 IV (Healthy participants)Healthy participants will each receive a single dose of CNTO 3649 (1, 3, 10, 30, 100 or 300 microgram per kilogram, subject to change) as a 2-hour IV infusion. | Drug | CNTO 3649 IV (Healthy participants) |
| CNTO 3649 SC (Healthy participants)Healthy participants will each receive a single dose of CNTO 3649 (10, 30, 100 or 300 microgram per kilogram, subject to change) as a SC injection. | Drug | CNTO 3649 SC (Healthy participants) |
| CNTO 3649 SC (Diabetic patients)Diabetic patients will receive multiple doses of CNTO 3649 (30, 100 or 300 microgram per kilogram, subject to change) as subcutaneous injections once weekly for 4 consecutive weeks. | Drug | CNTO 3649 SC (Diabetic patients) |
| PlaceboParticipants within each dosing group who are randomized to placebo will receive a corresponding IV infusion or SC injection of placebo. | Drug | CNTO 3649 IV (Healthy participants), CNTO 3649 SC (Diabetic patients), CNTO 3649 SC (Healthy participants) |
Primary outcome
Safety and tolerability of a single IV or SC administration of CNTO 3649 in healthy participants; Safety and tolerability of multiple SC injections of CNTO 3649 in Type 2 Diabetic Patients
Time frame: Week 1 to Week 5 (for healthy participants) and Week 1 to Week 8 (for diabetic patients)
1 secondary outcome
Pharmacokinetics, pharmacodynamics and immunogenicity of CNTO 3649 following single and multiple administrations.
Time frame: Week 1 to Week 5 (for healthy participants) and Week 1 to Week 8 (for diabetic patients)
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 16 Dec 2013.
- A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CNTO 3649 in Healthy Adults and Patients With Type 2 Diabetes Mellitus.Link provided by the sponsor.
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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.
Centocor Clinical Trial study director
Centocor, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CNTO 3649 IV (Healthy participants), CNTO 3649 SC (Healthy participants) and CNTO 3649 SC (Diabetic patients) in people with Diabetes Mellitus, Type 2, run by Centocor, Inc. at 3 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 7 inclusion and 2 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 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety and tolerability of a single IV or SC administration of CNTO 3649 in healthy participants; Safety and tolerability of multiple SC injections of CNTO 3649 in Type 2 Diabetic Patients (time frame: Week 1 to Week 5 (for healthy participants) and Week 1 to Week 8 (for diabetic patients)). 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 16 Dec 2013.