Clinical trial NCT00886821: A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: Phase 1 Type 2 diabetes CVX-096 diabetes mellitus
adult-onset diabetes mellitus
non-insulin dependent
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-04-23
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Stage 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04856883 on Day 1
timeFrame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 1
timeFrame: 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
measure: Stage 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 8
timeFrame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8
measure: Stage 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 22
timeFrame: pre-dose, 1 and 6 hours post-dose on Day 22
measure: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 1
timeFrame: 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
measure: Stage 1: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 8
timeFrame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8
measure: Stage 2: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 22
timeFrame: pre-dose, 1 and 6 hours post-dose on Day 22
Secondary outcomes:
measure: Stage 1: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 1
timeFrame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1
measure: Stage 1: Apparent Terminal Half-Life (t1/2) of PF-04856883 on Day 8
timeFrame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8
measure: Stage 2: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 22
timeFrame: pre-dose, 1 and 6 hours post-dose on Day 22
measure: Stage 1: Mean Residence Time (MRT) of PF-04856883 on Day 1
timeFrame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1
measure: Stage 1: Apparent Oral Clearance (CL/F) of PF-04856883 on Day 1
timeFrame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1
measure: Stage 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0 - Inf]) of PF-04856883 on Day 1
timeFrame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1
Other outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Cohort 1-8: Baseline up to Day 29; Cohort 9: Baseline up to Day 36; Cohort 10-12: Baseline up to Day 50
measure: Stage 1: Change From Baseline in Post-Prandial Area Under the Curve (AUC) of Glucose at Day 3 and 7
timeFrame: Baseline, Day 3 and 7
measure: Stage 1: Change From Baseline in 7-point Weighted Mean Glucose at Day 3 and Day 7
timeFrame: Baseline, Day 3 and 7
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50
measure: Number of Participants With Clinically Significant Vital Signs
timeFrame: Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
timeFrame: Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50
measure: Number of Participants With Clinically Significant Physical Examinations
timeFrame: Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50
measure: Stage 1: Number of Participants With Hypoglycemia
timeFrame: Day 1: 0 hour (pre-dose) up to 48 hours post dose
measure: Stage 1: Number of Participants With Clinically Significant Abnormal Rhythms
timeFrame: Cohort 1- 8: Day 1 up to Day 3; Cohort 9: Day 1 up to Day 10
measure: Stage 1: Number of Participants With Anti-Drug Antibodies
timeFrame: Day 0, 8, 14, 15, 21, 28 and 35
measure: Stage 2: Number of Participants With Anti-Drug Antibodies
timeFrame: Day 0, 29 and 50
Locations:
city: Miami Gardens
country: United States
facility: Cetero Research
state: Florida
city: San Antonio
country: United States
facility: Cetero Research - San Antonio
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: