Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 diabetes mellitus
Brief summary
Primary: Effect on HbA1c over 48 weeks in insulin-treated patients with type 2 diabetes Secondary: Effect on glucose, total daily insulin dose, body weight, waist circumference, HDL-cholesterol, triglycerides - Safety, tolerability
Detailed description
The total duration of the study will be up to 360 days including screening period (up to 14 days) and double-blind treatment period (approximately 11 months).
Interventions
DRUGPlacebo
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients aged greater than or equal to 18 years. * Diagnosis of type 2 diabetes as defined by WHO criteria. * Type 2 diabetes treated with insulin for at least 3 months (insulin dose of at least 30 U/day for at least 4 weeks). * HbA1C greater than or equal to 7%. * Having signed the informed consent form.
Exclusion criteria
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. * 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. 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. * Presence or history of cancer within the past 5 years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer. Related to laboratory findings: * Positive test for hepatitis B surface antigen and/or hepatitis C antibody. * Abnormal TSH level (TSH \> ULN or \< LLN). * Positive urine pregnancy test. Related to previous or concomitant medications: * Antidiabetic drugs other than insulin within 3 months prior to screening visit. * Drugs affecting weight (e.g., sibutramine, orlistat, herbal preparations, etc).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change in HbA1C from baseline to Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting glucose, total daily insulin dose, body weight, waist circumference, HDL-cholesterol, triglycerides, safety (physical examination, vital signs, laboratory tests, adverse events). | — |
Countries
Argentina, Australia, Canada, Chile, France, Germany, Italy, Netherlands, Russia, South Africa, United Kingdom, United States
Outcome results
None listed