Multiple Dose Study Of PF-04937319 In Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01272804
First received: January 6, 2011
Last updated: January 25, 2012
Last verified: January 2012

January 6, 2011
January 25, 2012
February 2011
July 2011   (final data collection date for primary outcome measure)
  • Safety Endpoints: Safety and tolerability of PF 04937319 will be assessed by physical examinations, adverse event and hypoglycemia monitoring, 12 lead ECGs, vital sign, and clinical safety laboratory measurements. [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
  • Single Dose PK endpoints: Cmax, Tmax, and AUC(0-Tau) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Day 6 PK Endpoints: Cmax, Tmax, and AUC(0-8) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Multiple Dose PK Endpoints: Cmax(ss), Tmax(ss), AUC(0-Tau,ss), AUC(0-8), AUC(0-last), half life, Cmin(ss), Cav(ss), Ae%, CL/F, Vz/F; accumulation ratios AUC(0-Tau,ss)/AUC(0-Tau,sd) and Cmax(ss)/Cmax(sd), as the data permit. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • PD Endpoint: glucose excursion (change from Day -1 baseline) in response to a liquid meal test (MMTT) on Days 1 and 14. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01272804 on ClinicalTrials.gov Archive Site
  • Insulin and C peptide (changes from Day -1 baseline) during an MMTT on Days 1 and 14. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Average daily glucose (change from Day -1 baseline) on Days 1, 6, and 14. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Fasting plasma glucose (change from Day 1 pre dose baseline) on Days 1 through 15. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Lipids (change from baseline), including: TG, TC, HDL cholesterol, and LDL cholesterol, at times specified in the SOA. [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
  • Lactate (change from baseline), at times specified in the SOA. [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Multiple Dose Study Of PF-04937319 In Patients With Type 2 Diabetes
A Phase 1 Placebo-Controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Escalating Oral Doses Of PF-04937319 In Adult Patients With Type 2 Diabetes Mellitus (T2DM)

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-04937319 following multiple (14 days) escalating oral doses in patients with type 2 diabetes.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 2
  • NIDDM
  • Drug: PF-04937319
    Subjects will be dosed with PF-04937319 for 14 days. The doses planned are 10, 30, 100 and 300 mg QD. All doses will be administered as tablets (10 and 100 mg strengths). In each Cohort, 9 patients will receive PF 04937319 and 3 will receive placebo. An additional cohort of 12 patients (9 active, 3 placebo) may be performed to explore a QD or BID dose. The dose for this additional cohort could be a dose already studied or a new dose that is within the exposure stopping criteria.
  • Drug: Placebo
    Placebo to match PF-04937319 will be provided. Subjects will be dosed for 14 days. In each cohort 9 subjects will receive PF-04937319 and 3 will receive placebo.
  • Experimental: PF-04937319
    Intervention: Drug: PF-04937319
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus who are taking metformin only.
  • Treatment should be stable, where this is defined as no change in the treatment, including dose, over the past 2 months. Regimens may include once daily and twice daily dosing only.
  • Male and/or female patients (females will be women of non childbearing potential)
  • Body Mass Index (BMI) of 18.5 to 45.0 kg/m2; and a total body weight >50 kg (110 lbs).
  • HbA1c between 7.0% and 10.0%.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Patients who have chronic conditions other than T2DM (for example, hypercholesterolemia or hypertension) but are controlled by either diet or stable (for the last 2 months) doses of medications may be included as well (for example, a subject with hypercholesterolemia on appropriate treatment is eligible).
  • Evidence or history of diabetic complications with significant end organ damage, eg, proliferative retinopathy and/or macular edema, creatinine clearance less than 60 mL/min
  • Any condition possibly affecting drug absorption (eg, gastrectomy)
  • History of stroke or transient ischemic attack or myocardial infarction within the past 6 months
  • History of coronary artery bypass graft or stent implantation.
  • Clinically significant peripheral vascular disease (eg, manifested by claudication).
  • Any history or clinical evidence of congestive heart failure, NYHA Classes II to IV.
  • One or more self reported significant/severe/requiring treatment episodes of hypoglycemia within the last 3 months, or two or more self reported significant/severe/requiring treatment episodes of hypoglycaemia within the last 6 months.
  • Current history of angina/unstable angina.
  • Milk or soy allergy
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01272804
B1621003
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP