Brief Summary

Primary: Effect on HbA1c over 6 months in drug-naive patients with type 2 diabetes Secondary: Effect on glucose, insulin, C-peptide, insulin resistance, body weight, HDL-cholesterol, triglycerides, blood pressure - Safety, tolerability

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

281

participants targeted

Target at P25-P50 for phase_3 type-2-diabetes-mellitus

Timeline

Completed

Started Mar 2005

Shorter than P25 for phase_3 type-2-diabetes-mellitus

Geographic Reach

7 countries

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

March 1, 2005

Completed

9 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 22, 2005

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed

Last Updated

April 20, 2009

Status Verified

April 1, 2009

Enrollment Period

1.3 years

First QC Date

November 21, 2005

Last Update Submit

April 17, 2009

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

Absolute change in HbA1C from baseline to Month 6.

Secondary Outcomes (1)

Fasting glucose, fasting insulin, C-peptide, HOMA analysis, body weight, HDL-cholesterol, triglycerides, blood pressure, safety (physical examination, vital signs, laboratory tests, adverse events).

Interventions

Rimonabant (SR141716)DRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female patients aged greater than or equal to 18 years.
Diagnosis of type 2 diabetes as defined by WHO criteria for at least 2 months but no longer than 3 years.
Type 2 diabetes not previously treated by a pharmacological agent.
Note:
a) insulin use is accepted if it is not within 6 months prior to screening visit and only for the following reasons:
prior use for management of gestational diabetes,
short-term (less than or equal to 1 month) use to maintain glycemic control for hospitalization, medical procedures, or intervention.
b) use of an oral antidiabetic agent is accepted if it is not within 6 months prior to screening visit and only if it was prescribed for no more than 4 months.
HbA1C greater than or equal to 7% and less than or equal to 10%.
Having signed the informed consent form.

You may not qualify if:

General:
Weight loss \> 5 kg within 3 months prior to screening visit.
Pregnancy or lactation.
Absence of medically approved contraceptive methods for females of childbearing potential.
Marijuana or hashish users.
Administration of other investigational drugs within 30 days prior to screening visit.
Previous participation in a rimonabant study.
Presence or history of allergic reaction or intolerance to multiple drugs.
Presence of any other condition (e.g., geographic, social) that the Investigator feels that would restrict or limit the patient's participation for the duration of the study.
Related to endocrine and metabolic disorders:
Presence of any clinically significant endocrine disease according to the Investigator.
Note: euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least 3 months prior to screening visit.
Fasting C-peptide \< 1.0 ng/mL.
Related to other disorders:
Presence of any severe medical or psychological condition that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study.
+11 more criteria

Contact the study team to confirm eligibility.