NCT Number: NCT00029848
Obese Patients With Type 2 Diabetes
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
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Notify MeKey information
Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Sanofi-aventis Administrative Office, Buenos Aires, Argentina
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
- 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)
Treatment and study plan
Primary outcomes
-
Change in body weight
Secondary outcomes
-
Metabolic parameters
Sponsors and collaborators
Lead sponsor
Sanofi
Industry
Registry information
Official study title
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
Acronym: RIO-Diabetes
Important dates
- Study start
- 2001
- Primary completion
- 2004
- Study completion
- 2004
- First posted
- Jan 24, 2002
- Registry last updated
- Apr 20, 2009
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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