A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients

• ClinicalTrials.gov Identifier: NCT01298518
• Recruitment Status: Completed
• First Posted: February 17, 2011
• Results First Posted: November 6, 2012
• Last Update Posted: November 6, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: January 28, 2011
• First Posted Date: February 17, 2011
• Results First Submitted Date: October 5, 2012
• Results First Posted Date: November 6, 2012
• Last Update Posted Date: November 6, 2012
• Study Start Date: February 2011
• Actual Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 5, 2012)

Change From Baseline in Post-Prandial Glucose Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 [ Time Frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28 ]

Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.

• Original Primary Outcome Measures (submitted: February 16, 2011): To evaluate the pharmacodynamic markers in response to multiple oral doses of PF-04620110 in T2DM patients [ Time Frame: 4 weeks ]

Current Secondary Outcome Measures (submitted: October 5, 2012)

• Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28 [ Time Frame: Baseline (Day -1); 24 hours post-dose on Day 28 ]
  APG= AUC (0-24)/24. AUC (0-24) was computed using Linear trapezoidal method.
• Change From Baseline in Post-Prandial Insulin Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 [ Time Frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28 ]
  Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
• Change From Baseline in Post-Prandial C-Peptide Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 [ Time Frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28 ]
  Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
• Change From Baseline in Post-Prandial Net Triglyceride Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 [ Time Frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28 ]
  Change from baseline in post-prandial area under the plasma net triglyceride concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
• Change From Baseline in Total Amide Glucagon Like Peptide-1 (GLP-1) and Active Glucagon Like Peptide-1 (GLP-1) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 [ Time Frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28 ]
  Change from baseline in total amide GLP-1 and active GLP-1 area under the plasma concentration time curve was computed by Linear trapezoidal method.
• Change From Baseline in Gastric Inhibitory Peptide (GIP) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 [ Time Frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28 ]
  Change from baseline in GIP area under the plasma concentration time curve was computed by Linear trapezoidal method.
• Change From Baseline in Peptide YY (PYY) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 [ Time Frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28 ]
  Change from baseline in PYY area under the plasma concentration time curve was computed by Linear trapezoidal method.
• Change From Baseline in Fasting Glucose at Day 28 [ Time Frame: 0 hour (pre-dose) on Day -1, Day 28 ]
• Change From Baseline in Fasting Insulin at Day 28 [ Time Frame: 0 hour (pre-dose) on Day -1, Day 28 ]
• Change From Baseline in Fasting Net Triglycerides at Day 28 [ Time Frame: 0 hour (pre-dose) on Day -1, Day 28 ]
• Change From Baseline in Post-Lunch Glucose Excursions Area Under the Concentration-Time Curve From Time 6 to 10 Hours (AUC 6-10) Post-dose at Day 28 [ Time Frame: Baseline (Day -1); 6 to 10 hours post-dose on Day 28 ]
  Change from baseline in post-lunch glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.
• Change From Baseline in Post-Dinner Glucose Excursions Area Under the Concentration-Time Curve From Time 12 to 16 Hours (AUC 12-16) Post-dose at Day 28 [ Time Frame: Baseline (Day -1); 12 to 16 hours post-dose on Day 28 ]
  Change from baseline in post-dinner glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.
• Maximum Observed Plasma Concentration (Cmax) of PF-04620110 [ Time Frame: 24 hours post-morning dose on Day 28 ]
• Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110 [ Time Frame: 24 hours post-morning dose on Day 28 ]
• Time to Cmax (Tmax) of PF-04620110 [ Time Frame: 24 hours post-morning dose on Day 28 ]
• Area Under the Concentration-Time Curve AUC (0-24) of PF-04620110 [ Time Frame: 24 hours post-morning dose on Day 28 ]
  Area under the plasma concentration-time curve from time 0 (pre-dose) to 24 hours. AUC (0-24) was computed using the linear trapezoidal method.

Original Secondary Outcome Measures (submitted: February 16, 2011)

• To evaluate secondary Pharmacodynamic Endpoints in response to multiple oral doses of PF-04620110 in T2DM patients [ Time Frame: 4 weeks ]
• To characterize the PK of PF-04620110 following multiple oral doses of PF-04620110 in T2DM patients [ Time Frame: 4 weeks ]
• To assess safety and tolerability of PF-04620110 following multiple oral doses of PF-04620110 in T2DM patients [ Time Frame: 4 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients
• Official Title: A Phase 1B, Randomized, Double-Blind, Placebo-Controlled Trial To Assess The Efficacy And Safety Of 4-Week Administration Of Multiple Oral Doses Of PF-04620110 In Type 2 Diabetes Mellitus Subjects With Insufficient Glycemic Control On Metformin
• Brief Summary: PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110 in T2DM patients.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Type 2 Diabetes Patients

Intervention

• Drug: PF-04620110
  5 mg of PF-04620110 given once daily
• Drug: PF-04620110
  2.5 mg of PF-04620110 given twice daily
• Drug: Placebo
  Matching placebo giving for 4 weeks

Study Arms

• Experimental: PF-04620110
  Interventions:

  • Drug: PF-04620110
  • Drug: PF-04620110
• Placebo Comparator: placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 16, 2011): 48
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 2011
• Actual Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Male and/or female subjects between the ages of 18 and 60 years;
• Body Mass Index (BMI) of >25.0 kg/m2 and <40 kg/m2;
• Subjects must have a historical diagnosis of T2DM in accordance with the ADA guidelines;
• Subjects who have been on well-tolerated and stable doses of metformin

Exclusion Criteria:

• Recent evidence (6 months prior to screening) or history of unstable major organ disease;
• Diagnosis of Type 1 diabetes mellitus;
• Current medical history of myocardial infarction, unstable angina, or history of stroke (including TIA) within 6 months prior to Screening;
• Treatment with thiazolidinediones (TZDs), or subcutaneously administered antidiabetic agents;

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01298518
• Other Study ID Numbers: B0961007
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: October 2012