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View Clinical Trial (Medical Research Study)
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24-week Study Comparing Lixisenatide (AVE0010) to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 - NCT00976937-37207 (Clinical Trial 442520)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy442520.aspx
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| City: |
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Brentwood |
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State:
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TN |
| Zip Code: |
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37207 |
| Conditions: |
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Type 2 Diabetes Mellitus |
| Purpose: |
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The primary objective of this study is to assess the efficacy of lixisenatide (AVE0010) on a
composite endpoint of glycemic control (HbA1c) and body weight in comparison to sitagliptin
as an add-on treatment to metformin over a period of 24 weeks in obese type 2 diabetic
patients younger than 50.
Secondary Objectives:
To assess the effects of AVE0010 on:
- Absolute changes in HbA1c and body weight
- Fasting plasma glucose
- Plasma glucose, insulin, C peptide, glucagon and proinsulin during a 2-hour
standardized meal test
- Insulin resistance assessed by HOMA-IR
- Beta cell function assessed by HOMA-beta
- To assess AVE0010 safety and tolerability
- To assess AVE0010 PK using the population PK approach and to assess anti-AVE0010
antibody development
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| Study summary: |
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Maximum duration of 27 weeks ± 7 days (3-week screening + 24- week double-blind,
double-dummy, active-controlled treatment + 3- day follow-up) |
| Criteria: |
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Inclusion criteria
- Patients with type 2 diabetes mellitus, as defined by WHO (21), diagnosed for at
least 1 year at the time of screening visit, insufficiently controlled with metformin
at a stable dose of at least 1.5 g/day for at least 3 months prior to the screening
visit.
- Patients with obesity (BMI ≥ 30kg/m2) and aged from 18 years to less than 50 years.
Exclusion criteria
- HbA1c < 7.0% or HbA1c >10% at screening
- Type 1 diabetes mellitus
- Pregnancy or lactation
- Women of childbearing potential with no effective contraceptive method
- Fasting Plasma Glucose at screening > 250 mg/dL (> 13.9 mmol/L)
- Weight change of more than 5 kg during the 3 months preceding the screening visit
- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy,
stomach/gastric surgery, - inflammatory bowel disease
- History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to
screening
- Hemoglobinopathy or hemolytic anemia or receipt of blood or plasma products within 3
months prior to the time of screening
- Within the last 6 months prior to screening: history of myocardial infarction,
stroke, or heart failure requiring hospitalization
- Known history of drug or alcohol abuse within 6 months prior to the time of screening
- Any clinically significant abnormality identified on physical examination, laboratory
tests, ECG or vital signs at the time of screening that in the judgment of the
investigator or any sub investigator would preclude safe completion of the study or
constrains efficacy assessment such as major systemic diseases, presence of
clinically significant diabetic retinopathy or presence of macular edema likely to
require laser treatment within the study period.
- Uncontrolled or inadequately controlled hypertension at the time of screening with a
resting systolic or diastolic blood pressure > 180 mmHg or > 110 mmHg, respectively
- Laboratory findings at the time of screening:
- Amylase and/or lipase > 3 times the upper limit of the normal laboratory range
- Total bilirubin: > 1.5 times the upper limit of the normal laboratory range
(except in case of Gilbert's syndrome)
- Hemoglobin < 11 g/dL and/or neutrophils < 1,500/mm3 and/or platelets <
100,000/mm3
- Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody
- Positive serum pregnancy test in females of childbearing potential
- Use of other oral or injectable antidiabetic or hypoglycemic agents than metformin
(e.g., sulfonylurea, alpha glucosidase inhibitor, thiazolidinedione, exenatide,
DPP-IV inhibitors, insulin etc.) within 3 months prior to the time of screening
- Unstable diet or unstable anti-obesity treatment within 3 months prior to the time of
screening
- Use of systemic glucocorticoids (excluding topical application or inhaled forms) for
one week or more within 3 months prior to the time of screening
- Use of any investigational drug within 3 months prior to screening Clinically
relevant history of gastrointestinal disease associated with prolonged nausea and
vomiting, including, but not limited to gastroparesis and gastroesophageal reflux
disease requiring medical treatment, within 6 months prior to the time of screening
- Any previous treatment with AVE0010 (e.g. participation in a previous study with
AVE0010)
- Allergic reaction to any GLP 1-agonist in the past (e.g. exenatide, liraglutide) or
to metacresol
- History of a serious hypersensitivity reaction to sitagliptin.
- Moderate or severe renal impairment (creatinine clearance inferior to 50 ml/mn)
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial. |
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| Study is available at: |
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Sanofi-Aventis Investigational Site Number 840009
Brentwood, TN 37207
United States
Primary Contact:
For site information, send an email with site number to
Email: GV-contact-us@sanofi-aventis.com |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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