|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
25 November 2019 |
|
Main ID: |
EUCTR2005-001613-17-GB |
|
Date of registration:
|
10/11/2005 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Fixed-
Dose Study Evaluating the Effect of One Dose of Rimonabant (20 mg/day) on Glycemic Control in Type 2 Diabetic Patients Inadequately Controlled with Insulin
- ARPEGGIO
|
|
Scientific title:
|
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Fixed-
Dose Study Evaluating the Effect of One Dose of Rimonabant (20 mg/day) on Glycemic Control in Type 2 Diabetic Patients Inadequately Controlled with Insulin
- ARPEGGIO |
|
Date of first enrolment:
|
27/02/2006 |
|
Target sample size:
|
300 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001613-17 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
|
|
Phase:
|
Human pharmacology (Phase I):
Therapeutic exploratory (Phase II):
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV):
|
|
|
Countries of recruitment
|
|
Germany
|
Italy
|
United Kingdom
| | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
• Male or female patients aged = 18 years
• Type 2 diabetes as defined by WHO criteria (fasting venous plasma glucose
concentration = 7.0 mmol/L or 2-h post-glucose load venous plasma glucose = 11.1
mmol/L) treated with insulin (any type and regimen) for at least three months (insulin
dose = 30 U/day for at least 4 weeks) with HbA1c = 7% at screening Visit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
• Presence of any clinically significant endocrine disease according to the Investigator
(euthyroid patients on replacement therapy will be included if the dosage of thyroxine
is stable for at least three months prior to screening visit)
• Presence of type 1 diabetes (C-peptide < 1.0 ng/mL)
• Presence of any clinically significant condition that might interfere with the evaluation of study medication
• Presence or history of cancer within the past five years with the exception of
adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer
• Laboratory abnormalities including:
- C-peptide < 1.0 ng/mL
- positive urine pregnancy test in females of childbearing potential at screening visit
- abnormal serum thyrotropin (TSH) levels at screening visit
- positive test for hepatitis B surface antigen and/or hepatitis C antibody at screening
visit
- any relevant abnormality interfering with the efficacy or the safety assessments
during the study drug administration
• Some medications:
- administration of antidiabetic drugs other than insulin within three months prior to
screening visit
- administration of anti-obesity drugs (sibutramine, orlistat) or other drugs for
weight reduction (e.g., phentermine, amphetamines) within three months prior to
screening visit or administration of herbal preparations for weight reduction
within 30 days prior to screening visit
- administration of thyroid preparations or thyroxine (except in patients on stable
replacement therapy) within three months prior to screening visit
- administration of systemic long-acting corticosteroids within two months or
prolonged use (more than one week) of other systemic corticosteroids or inhaled
corticosteroids (if daily dosage is > 1,000 µg equivalent beclomethasone) within
30 days prior to screening visit
- change in the treatment of dyslipidemia within two months prior to screening visit
or between screening and baseline visits
• Pregnancy or breast-feeding
• Absence of effective contraceptive methods for females of childbearing potential
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Type 2 Diabetic Patients Inadequately Controlled with Insulin
MedDRA version: 8.0
Level: LLT
Classification code 10063624
|
|
Intervention(s)
|
Product Name: Rimonabant
Product Code: SR141716
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Rimonabant
CAS Number: 168273-06-1
Current Sponsor code: SR141716 Form 2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
|
|
Primary Outcome(s)
|
|
Main Objective: To assess the effect of rimonabant on HbA1c in patients with type 2 diabetes treated with insulin.
|
|
Primary end point(s): The primary efficacy endpoint is to evaluate HbA1c.
|
Secondary Objective: To assess the effect of rimonabant in patients with type 2 diabetes treated with insulin
-on body weight
-on lipid profile
-on abdominal obesity
To assess the safety and tolerability of rimonabant in patients with type 2 diabetes treated with insulin
|
|
Secondary ID(s)
|
|
CPR-EFC5593-EN-E01
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
|
|