Diabetes Mellitus, Type 2Phase 1NCT00886821

A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics

A Phase 1 study testing CVX-096 in people with Diabetes Mellitus, Type 2, run by Pfizer at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2 diabetic patients. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: CVX-096
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 114 participants
Where: 2 sitesUnited States
Study dates: Oct 2008to Jun 2011
Phase: Phase 1
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

Male and/or female patients (females will be women of non-childbearing potential) with an historical diagnosis of type 2 diabetes mellitus, who are currently being treated with metformin at a dose at or near maximum.
Hb A1c between 7-10%.
Fasting C-peptide >0.4 nmol/L.

Who cannot join

History of clinically significant chronic conditions other than T2DM not well controlled by either diet or medications.
Patients with pancreatitis or considered a high risk for pancreatitis.
History of contraindications to metformin therapy.
Previous treatment with an approved or investigational GLP 1 mimetic.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Cetero Research
Miami Gardens, Florida, 33169
Cetero Research - San Antonio
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase 1, Placebo-controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Escalating Subcutaneous Doses Of Cvx-096 In Type 2 Diabetic Adult Subjects

The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2 diabetic patients.

Conditions: Diabetes Mellitus, Type 2
Being tested: CVX-096
Keywords: Phase 1 Type 2 diabetes CVX-096 diabetes mellitus, adult-onset diabetes mellitus, non-insulin dependent
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.

CVX-096Biological
Subcutaneous administration of CVX-096 with doses ranging from 0.1 mg up to a maximum of 36 mg

Study groups in NCT00886821
Study group	Role	What they receive
1	Experimental	Not described Receives: Biological: CVX-096

What is being measured

The primary outcome is the main question the study is designed to answer.

Stage 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04856883 on Day 1
AUClast was defined as area under the concentration-time curve from time zero to the time of last measured concentration and calculated by using linear up/log down trapezoidal method.
Measured: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 1
Measured: Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1
Stage 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 8
Measured: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8
Stage 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 22
Measured: pre-dose, 1 and 6 hours post-dose on Day 22
Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 1
Measured: Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1
Stage 1: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 8
Measured: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8
Stage 2: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 22
Measured: pre-dose, 1 and 6 hours post-dose on Day 22

Secondary outcomes (6)

Stage 1: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 1
Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.
Measured: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1
Stage 1: Apparent Terminal Half-Life (t1/2) of PF-04856883 on Day 8
Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.
Measured: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8
Stage 2: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 22
Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.
Measured: pre-dose, 1 and 6 hours post-dose on Day 22
Stage 1: Mean Residence Time (MRT) of PF-04856883 on Day 1
MRT is defined as AUMC(0 - inf) divided by AUC(0 - inf), where AUMC(0 - inf) is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method and AUC(0 - inf) is the area under the concentration-time curve extrapolated to infinity.
Measured: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1
Stage 1: Apparent Oral Clearance (CL/F) of PF-04856883 on Day 1
Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug apparent oral clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1
Stage 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0 - Inf]) of PF-04856883 on Day 1
AUC(0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It was calculated as AUC (0-t) plus (last measurable concentration divided by apparent terminal elimination rate constant).
Measured: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Jun 2011

First posted23 Apr 2009 (estimated)
Study startOct 2008
Primary completionJun 2011
Study completionJun 2011

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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by PfizerThe 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00886821
Sponsor's protocol ID: B1111001
Other IDs: CVX-096-101
Status last verified: Mar 2017
First submitted: 22 Apr 2009
Last updated: 18 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Placebo-controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Escalating Subcutaneous Doses Of Cvx-096 In Type 2 Diabetic Adult Subjects
ClinicalTrials.gov ID: NCT00886821
Acronym / sponsor ID: B1111001
Conditions: Diabetes Mellitus, Type 2
Keywords: Phase 1 Type 2 diabetes CVX-096 diabetes mellitus, adult-onset diabetes mellitus, non-insulin dependent
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 23 Apr 2009 (estimated)
Results: Posted 18 Apr 2017

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 determine safety and tolerability of CVX-096 in adult, type 2 diabetic patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Biological: CVX-096

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male and/or female patients (females will be women of non-childbearing potential) with an historical diagnosis of type 2 diabetes mellitus, who are currently being treated with metformin at a dose at or near maximum.
Hb A1c between 7-10%.
Fasting C-peptide >0.4 nmol/L.

Key exclusion criteria (4 listed)

History of clinically significant chronic conditions other than T2DM not well controlled by either diet or medications.
Patients with pancreatitis or considered a high risk for pancreatitis.
History of contraindications to metformin therapy.
Previous treatment with an approved or investigational GLP 1 mimetic.

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
CVX-096Subcutaneous administration of CVX-096 with doses ranging from 0.1 mg up to a maximum of 36 mg	Biological	1

Primary outcome

Stage 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04856883 on Day 1
Time frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1
AUClast was defined as area under the concentration-time curve from time zero to the time of last measured concentration and calculated by using linear up/log down trapezoidal method.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 1
Time frame: Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1
Stage 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 8
Time frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8
Stage 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 22
Time frame: pre-dose, 1 and 6 hours post-dose on Day 22
Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 1
Time frame: Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1
Stage 1: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 8
Time frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8
Stage 2: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 22
Time frame: pre-dose, 1 and 6 hours post-dose on Day 22

6 secondary outcomes

Stage 1: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 1
Time frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1
Stage 1: Apparent Terminal Half-Life (t1/2) of PF-04856883 on Day 8
Time frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8
Stage 2: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 22
Time frame: pre-dose, 1 and 6 hours post-dose on Day 22
Stage 1: Mean Residence Time (MRT) of PF-04856883 on Day 1
Time frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1
Stage 1: Apparent Oral Clearance (CL/F) of PF-04856883 on Day 1
Time frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1
Stage 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0 - Inf]) of PF-04856883 on Day 1
Time frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1

Results and safety

Results posted to the registry on 18 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: PF-04856883 0.1 Milligram (mg)	7	7
Cohort 2: PF-04856883 0.3 mg	6	6
Cohort 3: PF-04856883 1.0 mg	6	6
Cohort 4: PF-04856883 3.0 mg	7	7
Cohort 5: PF-04856883 6.0 mg	6	6
Cohort 6: PF-04856883 12.0 mg	6	6
Cohort 7: PF-04856883 24.0 mg	6	6
Cohort 8: PF-04856883 36.0 mg	6	6
Cohort 9: PF-04856883 18.0 mg	6	6
Cohort 1-9: Placebo	18	18
Cohort 10: PF-04856883 15.0 mg	0	0
Cohort 11: PF-04856883 20.0 mg	0	0
Cohort 12: PF-04856883 25.0 mg	0	0
Cohort 10-12: Placebo	0	0

Primary outcome: Stage 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04856883 on Day 1

Time frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*hr)/mL

Measure	Cohort 1: PF-04856883 0.1 Milligram (mg) n = 4	Cohort 2: PF-04856883 0.3 mg n = 6	Cohort 3: PF-04856883 1.0 mg n = 6	Cohort 4: PF-04856883 3.0 mg n = 6	Cohort 5: PF-04856883 6.0 mg n = 6	Cohort 6: PF-04856883 12.0 mg n = 6	Cohort 7: PF-04856883 24.0 mg n = 6	Cohort 8: PF-04856883 36.0 mg n = 6
Value	865 (625.3)	4960 (462.0)	7065 (192.1)	32552 (127.7)	105950 (53.4)	304167 (25.9)	120521 (5404.6)	297503 (211.1)

Population analysed: Pharmacokinetic (PK) analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. 'N'(Overall number of participants)=participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort(Cohort 9),as pre-specified in protocol.

Primary outcome: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 1

Time frame: Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1. Median (Full Range). Unit: hour

Measure	Cohort 1: PF-04856883 0.1 Milligram (mg) n = 4	Cohort 2: PF-04856883 0.3 mg n = 6	Cohort 3: PF-04856883 1.0 mg n = 6	Cohort 4: PF-04856883 3.0 mg n = 6	Cohort 5: PF-04856883 6.0 mg n = 6	Cohort 6: PF-04856883 12.0 mg n = 6	Cohort 7: PF-04856883 24.0 mg n = 6	Cohort 8: PF-04856883 36.0 mg n = 6	Cohort 9: PF-04856883 18.0 mg n = 6	Cohort 10: PF-04856883 15.0 mg n = 9	Cohort 11: PF-04856883 20.0 mg n = 9	Cohort 12: PF-04856883 25.0 mg n = 13
Value	156 (144 to 168)	72.1 (36.0 to 144)	168 (96.0 to 168)	72.0 (48.0 to 168)	144 (72.0 to 168)	120 (72.0 to 168)	108 (36.0 to 168)	96.0 (48.0 to 168)	84.0 (36.0 to 144)	168 (48.0 to 168)	168 (48.0 to 168)	168 (25.1 to 194)

Population analysed: PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.

Primary outcome: Stage 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 8

Time frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8. Median (Full Range). Unit: hour

Measure	Cohort 9: PF-04856883 18.0 mg n = 6
Value	72.0 (48.0 to 96.0)

Population analysed: PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. The outcome was not planned to be analyzed for single dosing cohorts (Cohort 1 to 8), since the dosing was done only on Day 1 in these cohorts.

Primary outcome: Stage 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 22

Time frame: pre-dose, 1 and 6 hours post-dose on Day 22. Median (Full Range). Unit: hour

Measure	Cohort 10: PF-04856883 15.0 mg n = 9	Cohort 11: PF-04856883 20.0 mg n = 7	Cohort 12: PF-04856883 25.0 mg n = 7
Value	48.0 (6.00 to 168)	46.9 (1.00 to 48.0)	48.0 (47.2 to 168)

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: PF-04856883 0.1 Milligram (mg)	0 of 7 (0%)	2 of 7 (28.6%)	Not reported
Cohort 2: PF-04856883 0.3 mg	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Cohort 3: PF-04856883 1.0 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Cohort 4: PF-04856883 3.0 mg	0 of 7 (0%)	1 of 7 (14.3%)	Not reported
Cohort 5: PF-04856883 6.0 mg	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Cohort 6: PF-04856883 12.0 mg	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
Cohort 7: PF-04856883 24.0 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Cohort 8: PF-04856883 36.0 mg	0 of 6 (0%)	6 of 6 (100%)	Not reported
Cohort 9: PF-04856883 18.0 mg	0 of 6 (0%)	3 of 6 (50%)	Not reported
Cohort 1-9: Placebo	0 of 18 (0%)	4 of 18 (22.2%)	Not reported
Cohort 10: PF-04856883 15.0 mg	0 of 9 (0%)	5 of 9 (55.6%)	Not reported
Cohort 11: PF-04856883 20.0 mg	0 of 9 (0%)	7 of 9 (77.8%)	Not reported
Cohort 12: PF-04856883 25.0 mg	0 of 13 (0%)	8 of 13 (61.5%)	Not reported
Cohort 10-12: Placebo	0 of 9 (0%)	4 of 9 (44.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.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.

Pfizer CT.gov Call Center study director

Pfizer

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 testing CVX-096 in people with Diabetes Mellitus, Type 2, run by Pfizer 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 3 inclusion and 4 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 18 Apr 2017. 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?

Yes. Results are posted in the registry (first posted 18 Apr 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?

Stage 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04856883 on Day 1 (time frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1). The study lists 7 primary outcomes in all. 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 NCT00886821.

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 18 Apr 2017.