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Multiple Dose Escalation Trial Of PF-04603629 Given To Subjects With Type 2 Diabetes Mellitus

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NCT00637338

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85013 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with type 2 diabetes mellitus who are not taking any treatment or are taking
metformin (with no change in the treatment, including dose, over the past 2 months).
Subjects previously treated with a sulfonylurea in combination with metformin may be
eligible if switched over to metformin only for a minimum of 4 weeks before dosing.

- Male and/or female subjects (females will be women of non-childbearing potential)
between the ages of 18 and 70 years, inclusive.

- Body Mass Index (BMI) of approximately 22 to 40 kg/m2

- Fasting C-peptide test result must be >0.4 nmol/L.

- HbA1c ≥7% and ≤11%. If the subject requires to be washed off a sulfonylurea, the HbA1c
limits will be ≥7% and ≤9.5%.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Screening fasting blood glucose, ?60 or ?270 mg/dL. One repeat screening fasting blood
glucose will be allowed.

- Previous treatment with an approved or investigational GLP-1 mimetic.

- Have a known allergy to yeast, yeast-derived or yeast containing products.

NCT00637338
Pfizer
Terminated
Multiple Dose Escalation Trial Of PF-04603629 Given To Subjects With Type 2 Diabetes Mellitus

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A Phase 1, Randomized, Placebo-Controlled, Sequential Parallel Group, Multiple Dose Escalation Trial To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of 4, Once-Weekly Subcutaneous Doses Of PF-04603629 To Subjects With Type 2 Diabetes Mellitus
PF-04603629 is being investigated for the treatment of Type 2 diabetes mellitus (T2DM). Specifically, PF-04603629 is a protein that is a combination of exendin-4 (a glucagon-like peptide-1 (GLP-1) mimetic currently marketed as Byetta®) fused to human transferrin (a naturally occuring protein) in order to increase the concentration of exendin-4 in the blood. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04603629 following multiple escalating subcutaneous doses in adult subjects with T2DM.
B0571002 was terminated August 19 2008 due to the decision to discontinue development of PF-04603629 after observing (in both B0571001 and B0571002) a trend for a reversible increase in heart rate within the normal range, which occurred at efficacious doses. Thus, the compound was primarily terminated due to safety concerns, although there was no immediate safety risk to any subject in the study.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Biological: PF-04603629
    Subjects will be given either PF-04603629 or Placebo in a blinded fashion. Subjects will receive 4 weekly injections of PF-04603629 or Placebo.
  • Biological: Placebo
    Subjects will be given either PF-04603629 or Placebo in a blinded fashion during the study. Subjects will receive 4 weekly injections of PF-04603629 or Placebo.
  • Experimental: PF-04603629
    The dose range initially planned is 3 mg up to 70 mg, although the specific doses administered may be modified based on emerging study data.
    Intervention: Biological: PF-04603629
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
42
September 2008
September 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus who are not taking any treatment or are taking metformin (with no change in the treatment, including dose, over the past 2 months). Subjects previously treated with a sulfonylurea in combination with metformin may be eligible if switched over to metformin only for a minimum of 4 weeks before dosing.
  • Male and/or female subjects (females will be women of non-childbearing potential) between the ages of 18 and 70 years, inclusive.
  • Body Mass Index (BMI) of approximately 22 to 40 kg/m2
  • Fasting C-peptide test result must be >0.4 nmol/L.
  • HbA1c ?7% and ?11%. If the subject requires to be washed off a sulfonylurea, the HbA1c limits will be ?7% and ?9.5%.

Exclusion Criteria:

  • Screening fasting blood glucose, ?60 or ?270 mg/dL. One repeat screening fasting blood glucose will be allowed.
  • Previous treatment with an approved or investigational GLP-1 mimetic.
  • Have a known allergy to yeast, yeast-derived or yeast containing products.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00637338
B0571002
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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