None listed
Conditions
Interventions
Group 1 Type of group
2-step initiation regimen of AVE0010 along with sitagliptin placebo: AVE0010 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24 along with placebo matching to sitagliptin 100 milligram (mg) capsule orally QD up to Week 24.
Group name:Group 2 Type of group
Sitagliptin along with 2-step initiation regimen of volume matching AVE0010 placebo: sitagliptin 100 mg capsule orally QD up to Week 24 along with volume matching AVE0010 placebo 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: • Patients with type 2 diabetes mellitus, as defined by WHO, diagnosed for at least 1 year at the time of the 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. • Written informed consent obtained
Exclusion criteria
Exclusion criteria: • HbA1c 10% at screening • Type 1 diabetes mellitus • Pregnancy or lactation • Women of childbearing potential with no effective contraceptive method. Women of childbearing potential (pre-menopausal, not surgically sterile women for at least 3 months prior to the time of screening) must have a confirmed negative serum pregnancy test at screening visit. • 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, personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g multiple endocrine neoplasia syndromes), • 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 - ALT > 3 ULN - 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 - Calcitonin =20pg/mL (5.9 pml/L) • Patients considered by the investigator or any sub investigator as inappropriate for this study for any reason (e.g. impossibility to meet specific protocol requirements, such as scheduled visits, being able to do self-injections, likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol, investigator or any sub investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol, etc) • Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin (e.g., sulfonylurea, alpha glucosidase inhibitor, thiazolidinedione, exenatide, DPP-4 inhibitors, insulin etc.) within 3 months prior to the time of screening • History of bariatric surgery, anti-obesity treatment or unstable diet 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 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Percentage of patients who met both criteria (HbA1c <7% at Week 24 and at least 5% weight loss from baseline at Week 24) is reported. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. Measure:Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% and at Least 5% Weight Loss From Baseline at Week 24 Timepoints:Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. Measure:Absolute Change From Baseline in HbA1c at Week 24 Timepoints:Baseline, Week 24 ; Outcome name:Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. Measure:Change From Baseline in Body Weight at Week 24 Timepoints:Baseline, Week 24 ; Outcome name:The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest. Measure:Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) at Week 24 Timepoints:Baseline, Week 24 ; Outcome name:Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. Measure:Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 Timepoints:Baseline, Week 24 ; Outcome name:Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this effica | — |
Contacts
Public ContactSandra Mendez
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed