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Completed

NCT Number: NCT01298518

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

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.

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Key information

Conditions

Type 2 Diabetes Patients

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Chula Vista, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

PF-04620110

Drug

5 mg of PF-04620110 given once daily

Placebo

Drug

Matching placebo giving for 4 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Change From Baseline in Fasting Glucose at Day 28

    Time frame: 0 hour (pre-dose) on Day -1, Day 28

  9. Change From Baseline in Fasting Insulin at Day 28

    Time frame: 0 hour (pre-dose) on Day -1, Day 28

  10. Change From Baseline in Fasting Net Triglycerides at Day 28

    Time frame: 0 hour (pre-dose) on Day -1, Day 28

  11. 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.

  12. 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.

  13. Maximum Observed Plasma Concentration (Cmax) of PF-04620110

    Time frame: 24 hours post-morning dose on Day 28

  14. Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110

    Time frame: 24 hours post-morning dose on Day 28

  15. Time to Cmax (Tmax) of PF-04620110

    Time frame: 24 hours post-morning dose on Day 28

  16. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 17, 2011
Registry last updated
Nov 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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