Diabetes Mellitus, Type 2Phase 1NCT01177163
A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of JNJ-28431754 in Patients With Type 2 Diabetes Mellitus
A Phase 1 study of Diabetes Mellitus, Type 2, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamic effects and pharmacokinetic characteristics of JNJ-28431754 after multiple dosing in patients with Type 2 Diabetes Mellitus who are on a stable dose of insulin. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2008to Mar 2009
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been diagnosed with T2DM for at least 6 months prior to study screening
- Be on stable insulin regimens at the time of screening
- Have a stable weight (ie, no change more than 5% in the 3 months prior to screening)
- Have a glycosylated hemoglobin (A1C) of >=7% and <=10.5% at study screening
Who cannot join
- Have history of Type 1 diabetes mellitus, secondary forms of diabetes, diabetic ketoacidosis, pancreas or beta cell transplantation
- Have a known history of more than 2 severe hypoglycemic episodes as defined by the protocol within the past year
- Have history of, or currently active, significant illness as determined by the Investigator
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Chula Vista, California
Study site
San Antonio, Texas
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-28431754 in Type-2 Diabetes Mellitus Subjects Not Optimally Controlled (A1C >=7.0%) on Fixed Doses of Insulin Therapy
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamic effects and pharmacokinetic characteristics of JNJ-28431754 after multiple dosing in patients with Type 2 Diabetes Mellitus who are on a stable dose of insulin.
Read the detailed description
This is a randomized (study drug assigned by chance), double-blind (neither the patient or the study doctor will know the name of the assigned treatment), parallel-group (each group of patients will be treated at the same time) to determine the safety, tolerability, pharmacokinetics (PK) (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) and the pharmacodynamics (PD) (the action or effects a drug has on the body) of oral (taken by mouth) doses of JNJ 28431754 taken once or twice daily compared to placebo (treatment identical in appearance to JNJ-2843174 but contains no active drug) in patients with Type 2 Diabetes Mellitus (T2DM) who are receiving therapy with a fixed-dose regimen of insulin. Two groups of 14 patients will be studied; one group will receive JNJ-2843174 (100 mg) or placebo once daily for 4 weeks and the other group will receive JNJ-2843174 (300 mg) or placebo twice daily for 4 weeks. In the 3 days immediately prior to the beginning of the 4-week treatment period, all patients will take a single oral dose of placebo once daily and have blood and urine samples collected for laboratory testing. During the study, all patients will be allowed to continue on their normal medication regimen of insulin and other allowed anti-diabetic medications. On selected days during the study, patients will be required to stay overnight at the study center to have study drug administered and/or to have blood and urine samples collected for laboratory testing. During the study, if patients experience worsened glycemia (blood sugar), rescue therapy with additional insulin of the same type but at a higher dose may be initiated by the Investigator if medically appropriate. During the study, patients will be monitored for safety by review of adverse events and results from laboratory tests, 12-lead electrocardiograms (ECGs), vital signs measurements, body weight, physical examinations, and self-monitored blood glucose (SMGB) measurements. Unless otherwise specified, study drug will be taken orally (by mouth) after an overnight fast for at least 8 hours followed by a meal within 10 minutes; for twice daily dosing, the evening dose will be taken just prior to the evening meal (dinner). All patients will take one placebo capsule once daily for 3 days immediately prior to randomization. After randomization, patients will take JNJ-28431754 (100 mg) or placebo once daily or JNJ-28431754 (300 mg) or placebo twice daily for 4 weeks.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Placebo, JNJ 28431754 300 mg/placebo, JNJ 28431754 100 mg/placebo
- Keywords
- Type 2 diabetes mellitus, Canagliflozin, JNJ-28431754, Insulin, Pharmacokinetic, Pharmacodynamic, SGLT-1
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
one placebo capsule once daily for 3 days immediately prior to randomization to double-blind treatment with JNJ 28431754 or placebo
JNJ 28431754 300 mg/placeboDrug
one 300-mg capsule of JNJ-28431754 or placebo twice-daily for 4 weeks
JNJ 28431754 100 mg/placeboDrug
one 100-mg capsule of JNJ-28431754 or placebo once-daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 001 | Other | Placebo one placebo capsule once daily for 3 days immediately prior to randomization to double-blind treatment with JNJ 28431754 or placebo Receives: Drug: Placebo |
| 002 | Experimental | JNJ 28431754 100 mg/placebo one 100-mg capsule of JNJ-28431754 or placebo once-daily for 4 weeks Receives: Drug: JNJ 28431754 100 mg/placebo |
| 003 | Experimental | JNJ 28431754 300 mg/placebo one 300-mg capsule of JNJ-28431754 or placebo twice-daily for 4 weeks Receives: Drug: JNJ 28431754 300 mg/placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who need to decrease insulin dosage from prestudy dosage levels because of hypoglycemia
Measured: From time of signed informed consent (Days -52 to -32) through to the end of the study (Days 34 to 39) or at the time of early withdrawal
The number of patients with specific treatment-emergent adverse events
Measured: From time of signed informed consent (Days -52 to -32) through to the end of the study (Days 34 to 39) or at the time of early withdrawal
The number of patients with symptomatic hypoglycemia and severe hypoglycemia
Measured: From time of signed informed consent (Days -52 to -32) through to the end of the study (Days 34 to 39) or at the time of early withdrawal
Secondary outcomes (3)
Plasma concentrations and pharmacokinetics parameters for JNJ 28431754
Measured: At protocol-specified timepoints from Day 1 (pre-dose) to Day 29
Plasma glucose concentration-time profiles (pharmacodynamics parameter)
Measured: At protocol specified timepoints on Day -1, Day 1, and Day 27
Change in urine glucose excretion (pharmacodynamics parameter)
Measured: At protocol specified timepoints on Day -1, Day 1, and Day 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startMay 2008
- Study completionMar 2009
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177163
- Sponsor's protocol ID
- CR014881
- Status last verified
- May 2013
- First submitted
- 5 Aug 2010
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-28431754 in Type-2 Diabetes Mellitus Subjects Not Optimally Controlled (A1C >=7.0%) on Fixed Doses of Insulin Therapy
- ClinicalTrials.gov ID
- NCT01177163
- Acronym / sponsor ID
- CR014881
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes mellitus, Canagliflozin, JNJ-28431754, Insulin, Pharmacokinetic, Pharmacodynamic, SGLT-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Study completion
- Mar 2009 (actual)
- First posted
- 6 Aug 2010 (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, tolerability, pharmacodynamic effects and pharmacokinetic characteristics of JNJ-28431754 after multiple dosing in patients with Type 2 Diabetes Mellitus who are on a stable dose of insulin.
Detailed description
This is a randomized (study drug assigned by chance), double-blind (neither the patient or the study doctor will know the name of the assigned treatment), parallel-group (each group of patients will be treated at the same time) to determine the safety, tolerability, pharmacokinetics (PK) (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) and the pharmacodynamics (PD) (the action or effects a drug has on the body) of oral (taken by mouth) doses of JNJ 28431754 taken once or twice daily compared to placebo (treatment identical in appearance to JNJ-2843174 but contains no active drug) in patients with Type 2 Diabetes Mellitus (T2DM) who are receiving therapy with a fixed-dose regimen of insulin. Two groups of 14 patients will be studied; one group will receive JNJ-2843174 (100 mg) or placebo once daily for 4 weeks and the other group will receive JNJ-2843174 (300 mg) or placebo twice daily for 4 weeks. In the 3 days immediately prior to the beginning of the 4-week treatment period, all patients will take a single oral dose of placebo once daily and have blood and urine samples collected for laboratory testing. During the study, all patients will be allowed to continue on their normal medication regimen of insulin and other allowed anti-diabetic medications. On selected days during the study, patients will be required to stay overnight at the study center to have study drug administered and/or to have blood and urine samples collected for laboratory testing. During the study, if patients experience worsened glycemia (blood sugar), rescue therapy with additional insulin of the same type but at a higher dose may be initiated by the Investigator if medically appropriate. During the study, patients will be monitored for safety by review of adverse events and results from laboratory tests, 12-lead electrocardiograms (ECGs), vital signs measurements, body weight, physical examinations, and self-monitored blood glucose (SMGB) measurements. Unless otherwise specified, study drug will be taken orally (by mouth) after an overnight fast for at least 8 hours followed by a meal within 10 minutes; for twice daily dosing, the evening dose will be taken just prior to the evening meal (dinner). All patients will take one placebo capsule once daily for 3 days immediately prior to randomization. After randomization, patients will take JNJ-28431754 (100 mg) or placebo once daily or JNJ-28431754 (300 mg) or placebo twice daily for 4 weeks.
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 |
|---|---|---|
| 001 | Other | Drug: PlaceboPlacebo one placebo capsule once daily for 3 days immediately prior to randomization to double-blind treatment with JNJ 28431754 or placebo |
| 002 | Experimental | Drug: JNJ 28431754 100 mg/placeboJNJ 28431754 100 mg/placebo one 100-mg capsule of JNJ-28431754 or placebo once-daily for 4 weeks |
| 003 | Experimental | Drug: JNJ 28431754 300 mg/placeboJNJ 28431754 300 mg/placebo one 300-mg capsule of JNJ-28431754 or placebo twice-daily for 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have been diagnosed with T2DM for at least 6 months prior to study screening
- Be on stable insulin regimens at the time of screening
- Have a stable weight (ie, no change more than 5% in the 3 months prior to screening)
- Have a glycosylated hemoglobin (A1C) of >=7% and <=10.5% at study screening
Key exclusion criteria (3 listed)
- Have history of Type 1 diabetes mellitus, secondary forms of diabetes, diabetic ketoacidosis, pancreas or beta cell transplantation
- Have a known history of more than 2 severe hypoglycemic episodes as defined by the protocol within the past year
- Have history of, or currently active, significant illness as determined by the Investigator
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 |
|---|---|---|
| Placeboone placebo capsule once daily for 3 days immediately prior to randomization to double-blind treatment with JNJ 28431754 or placebo | Drug | 001 |
| JNJ 28431754 300 mg/placeboone 300-mg capsule of JNJ-28431754 or placebo twice-daily for 4 weeks | Drug | 003 |
| JNJ 28431754 100 mg/placeboone 100-mg capsule of JNJ-28431754 or placebo once-daily for 4 weeks | Drug | 002 |
Primary outcome
The proportion of patients who need to decrease insulin dosage from prestudy dosage levels because of hypoglycemia
Time frame: From time of signed informed consent (Days -52 to -32) through to the end of the study (Days 34 to 39) or at the time of early withdrawal
The number of patients with specific treatment-emergent adverse events
Time frame: From time of signed informed consent (Days -52 to -32) through to the end of the study (Days 34 to 39) or at the time of early withdrawal
The number of patients with symptomatic hypoglycemia and severe hypoglycemia
Time frame: From time of signed informed consent (Days -52 to -32) through to the end of the study (Days 34 to 39) or at the time of early withdrawal
3 secondary outcomes
Plasma concentrations and pharmacokinetics parameters for JNJ 28431754
Time frame: At protocol-specified timepoints from Day 1 (pre-dose) to Day 29
Plasma glucose concentration-time profiles (pharmacodynamics parameter)
Time frame: At protocol specified timepoints on Day -1, Day 1, and Day 27
Change in urine glucose excretion (pharmacodynamics parameter)
Time frame: At protocol specified timepoints on Day -1, Day 1, and Day 27
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 29 May 2013.
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-28431754 in T2DM Subjects not Optimally Controlled (HbA1c: ≥7.0%) on Fixed Doses of Insulin TherapyLink 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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Diabetes Mellitus, Type 2, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 2 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 4 inclusion and 3 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 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The proportion of patients who need to decrease insulin dosage from prestudy dosage levels because of hypoglycemia (time frame: From time of signed informed consent (Days -52 to -32) through to the end of the study (Days 34 to 39) or at the time of early withdrawal). The study lists 3 primary outcomes in all. 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 29 May 2013.