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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00361738




Registration number
NCT00361738
Ethics application status
Date submitted
7/08/2006
Date registered
8/08/2006
Date last updated
9/02/2009

Titles & IDs
Public title
Dose-Ranging Study Evaluating AVE2268 in Patients With Type 2 Diabetes Not Adequately Controlled by a Metformin Treatment
Scientific title
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Response, Multicentre, Multinational Study Evaluating the Efficacy and Safety of AVE2268 Administered Either Twice Daily (Breakfast and Lunch) at a Dose of 300, 600 and 1200 mg or Once Daily (Breakfast) at a Dose of 1200 mg, in Patients With Type 2 Diabetes Treated With Metformin and Not Adequately Controlled
Secondary ID [1] 0 0
EUDRACT: 2006-001843-74
Secondary ID [2] 0 0
DRI6738
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AVE2268

Treatment: Drugs: AVE2268
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Mean Plasma Glucose (MPG) from baseline to week 4.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Glucose parameters (change from baseline to week 4 in fasting and post prandial plasma glucose) ; Change in HbA1c and fructosamine ; Safety: physical examination, adverse events, ECG, laboratory tests
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Type 2 diabetes mellitus, as defined by the American Diabetes Association, for at
least one year at the time of screening.

- HbA1c measured at visit 1 in the range of = 7.0 and < 9.0 %.

- Stable metformin treatment (dose = 1.5g/day for at least 3 months prior to enrollment
in the study). No other antidiabetic medications are permitted for 3 months prior to
enrollment.
Minimum age
18 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant or breast-feeding women.

- Women of childbearing potential not protected by medically approved contraceptive
method of birth control.

- BMI >40kg/m2

- Diabetes other than type 2 diabetes.

- Subjects with "brittle-diabetes" or any hospitalization or emergency room visit due to
poor diabetic control within the past 6 months, previous history of diabetes related
dehydration leading to hospitalization, history or evidence of ketoacidosis.

- Presence or history of cancer within the past five years.

- Evidence within the past 6 months of myocardial infarction, stroke, retinopathy
requiring laser surgery, or heart failure requiring hospitalization.

- Impaired hepatic tests, impaired renal function.

- History or evidence of clinically relevant renal or urological disorder.

- The investigator will evaluate whether there are other reasons why a patient may not
participate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2008
Sample size
Target
Accrual to date
Final
317
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - Cove
Recruitment postcode(s) [1] 0 0
- Cove
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
San Isidro
Country [2] 0 0
Belgium
State/province [2] 0 0
Diegem
Country [3] 0 0
Chile
State/province [3] 0 0
Santiago
Country [4] 0 0
Denmark
State/province [4] 0 0
Horsholm
Country [5] 0 0
France
State/province [5] 0 0
Paris
Country [6] 0 0
Germany
State/province [6] 0 0
Berlin
Country [7] 0 0
Italy
State/province [7] 0 0
Milano
Country [8] 0 0
Netherlands
State/province [8] 0 0
Gouda
Country [9] 0 0
Poland
State/province [9] 0 0
Warszawa
Country [10] 0 0
South Africa
State/province [10] 0 0
Midrand

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Dose-ranging study of AVE2268 in the management of patients with type 2 diabetes mellitus
also receiving metformin.

Its main objectives will be to assess the effects of several doses of AVE2268 on Mean Plasma
Glucose. Its secondary objectives will be to assess the effects of AVE2268 on plasma glucose
(fasting and post-prandial), and also the safety and tolerability of AVE2268.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00361738
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Elisabeth SOUHAMI, M.D
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00361738