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Completed

NCT Number: NCT00542009

A Trial In Diabetic Patients To Assess Effect Of CE-326,597 On Glucose Control And Body Weight

Study of whether the investigational drug CE-326,597 improves glucose control and results in body weight loss in patients with type 2 diabetes

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Key information

Conditions

Weight Management Treatment Of Obesity

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Pleven, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with type 2 diabetes, not on any or on oral (up to 2) anti-diabetic medications, otherwise medically stable.

Exclusion criteria

Women of childbearing potential, people with unstable medical conditions, people with gallstones

Treatment and study plan

CE-326,597 100 mg QD

Drug

Administered orally, once daily with morning meal for duration of trial (84 days).

CE-326,597 50 mg QD

Drug

Administered orally, once daily with morning meal for duration of trial (84 days).

CE-326,597 25 mg QD

Drug

Administered orally, once daily with morning meal for duration of trial (84 days).

Placebo

Drug

Placebo to match CE-326,597 tablets to be administered orally, once daily with morning meal for duration of trial (84 days).

CE-326,597 5mg QD

Drug

Administered orally, once daily with morning meal for duration of trial (84 days).

Primary outcomes

  1. Glucose control

    Time frame: At Day 84

  2. Body weight

    Time frame: At Day 84

Secondary outcomes

  1. Regimen (dose or number) of anti-diabetic agents

    Time frame: At Day 84

  2. GlycoMark

    Time frame: On Day 84

  3. Waist circumference

    Time frame: On Day 84

  4. Proportion of subjects who achieve HbA1C <7% and <6.5%

    Time frame: On Day 84

  5. Population PK to analyze CE-326,597 concentrations as well as explore relationship of concentration to effect on HbA1C and body weight over duration of trial.

    Time frame: Throughout Study

  6. Standard safety (via AEs, SAEs, vitals, 12-lead ECG, abdominal ultrasound) will be monitored throughout the trial.

    Time frame: Throughout Study

  7. Change in following parameters: Post-prandial and fasting glucose, and insulin

    Time frame: On Day 28

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A 12-Week, Phase 2A, Randomized, Subject And Investigator Blinded, Placebo-Controlled Trial To Evaluate The Safety, Tolerability And Efficacy Of CE-326,597 On Glucose Control And Body Weight In Overweight Adult Subjects With Type 2 Diabetes Mellitus

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 10, 2007
Registry last updated
Nov 7, 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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