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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00542009
Enrollment
252
Registered
2007-10-10
Start date
2007-12-31
Completion date
2008-11-30
Last updated
2012-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment Of Obesity, Weight Management

Keywords

Phase 2A, safety and efficacy trial with CE-326,597 in patients with T2DM.

Brief summary

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

Interventions

DRUGCE-326,597 100 mg QD

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

DRUGCE-326,597 50 mg QD

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

DRUGCE-326,597 25 mg QD

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

DRUGPlacebo

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

DRUGCE-326,597 5mg QD

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

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Glucose controlAt Day 84
Body weightAt Day 84

Secondary

MeasureTime frame
Waist circumferenceOn Day 84
Proportion of subjects who achieve HbA1C <7% and <6.5%On Day 84
Regimen (dose or number) of anti-diabetic agentsAt Day 84
Standard safety (via AEs, SAEs, vitals, 12-lead ECG, abdominal ultrasound) will be monitored throughout the trial.Throughout Study
Change in following parameters: Post-prandial and fasting glucose, and insulinOn Day 28
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.Throughout Study
GlycoMarkOn Day 84

Countries

Bulgaria, Canada, India, Mexico, Puerto Rico, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026