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

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

Official Title
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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

Conditions
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Weight Management, Treatment Of Obesity

Intervention / Treatment
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* Drug: CE-326,597 100 mg QD
* Drug: CE-326,597 50 mg QD
* Drug: CE-326,597 25 mg QD
* Drug: Placebo
* Drug: CE-326,597 5mg QD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CE-326,597 100 mg QD<br> | Drug: CE-326,597 100 mg QD<br>* Administered orally, once daily with morning meal for duration of trial (84 days).<br>|
| Experimental: CE-326,597 50 mg QD<br> | Drug: CE-326,597 50 mg QD<br>* Administered orally, once daily with morning meal for duration of trial (84 days).<br>|
| Experimental: CE-326,597 25 mg QD<br> | Drug: CE-326,597 25 mg QD<br>* Administered orally, once daily with morning meal for duration of trial (84 days).<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo to match CE-326,597 tablets to be administered orally, once daily with morning meal for duration of trial (84 days).<br>|
| Experimental: CE-326,597 5mg QD<br> | Drug: CE-326,597 5mg QD<br>* Administered orally, once daily with morning meal for duration of trial (84 days).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose control |  | At Day 84 | 
| Body weight |  | At Day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regimen (dose or number) of anti-diabetic agents |  | At Day 84 | 
| GlycoMark |  | On Day 84 | 
| Waist circumference |  | On Day 84 | 
| Proportion of subjects who achieve HbA1C <7% and <6.5% |  | On Day 84 | 
| 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 | 
| 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 insulin |  | On Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 2A, safety and efficacy trial with CE-326,597 in patients with T2DM.