Obese Patients With Type 2 Diabetes

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing Effect and Safety in Obese Patients With Type 2 Diabetes

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00029848

Acronym

RIO-Diabetes

Enrollment

1045

Registered

2002-01-24

Start date

2001-10-31

Completion date

2004-05-31

Last updated

2009-04-20

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

Conditions

Diabetes Mellitus, Non-Insulin-Dependent, Obesity, Obesity in Diabetes

Keywords

Diabetes, Obesity

Brief summary

To assess the effect on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with Type 2 Diabetes

Interventions

DRUGRimonabant (SR141716)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* BMI must be greater than 27 and less than 40 * Treated Type 2 Diabetes on single therapy treatment for at least 1 year * Stable weight (variation of less than 5 kg within 3 months prior to screening visit)

Design outcomes

Primary

Measure	Time frame
Change in body weight	—

Secondary

Measure	Time frame
Metabolic parameters	—

Countries

Argentina, Belgium, Canada, Czechia, Finland, France, Germany, Netherlands, Poland, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026