A 12-Week, Double-Blind, Randomized, Placebo-Controlled Study in Type 2 Diabetes Mellitus Subjects to Evaluate the Efficacy, Safety and Tolerability of MTP Inhibitor JNJ-16269110 - N/A

• Conditions: Diabetes; MedDRA version: 9.1Level: HLGTClassification code 10018424Term: Glucose metabolism disorders (incl diabetes mellitus)

• Registration Number: EUCTR2007-000031-26-DE
• Lead Sponsor: Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-23
• Last Update Posted: 24 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

1. Men or women with a history of T2DM and treated with a stable dose of metformin for at least 2 months prior to screening.

2. Between 18 and 70 years of age, inclusive

3. Women must be postmenopausal, defined as having a last menstrual period at least 1 year before screening with a serum follicle stimulating hormone (FSH) level consistent with postmenopausal status;
or surgically incapable of childbearing (have had a hysterectomy or bilateral oophorectomy or tubal ligation or otherwise incapable of pregnancy);
or if sexually active, be practicing an effective method of birth control (e.g. spermicide plus barrier, oral contraceptive plus barrier, intrauterine device, or a partner with a vasectomy);
sexually abstinent.

4. BMI between 25 and 45 kg/m2, inclusive, measured at screening visit.
5. HbA1c between 7% and 10%, inclusive, measured at screening visit.
6. Fasting plasma glucose not exceeding 240 mg/dL (13.3mmol/L) at baseline visit.
7. Consumption of breakfast and dinner on a daily basis.
8. Ability to swallow the intact capsule (17.5 mm in length and 9.1 mm in diameter) with water.
9. Ability and willingness to perform blood glucose monitoring using the sponsor-provided blood glucometer at home.
10. Willing to adhere to the prohibitions and restrictions specified in this protocol.

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Diabetes other than type 2 diabetes mellitus.
2.Treatment with oral anti-diabetic agents (other than metformin) or insulin during the 12 weeks before baseline visit.
3.Prior exposure or known contraindication or hypersensitivity to JNJ 16269110.
4.History of intolerance to or hypersensitivity to sulfonylurea or sitagliptin.
5.History of an uninterrupted period of insulin therapy for >1 month period within 1 year prior to baseline visit.
6.Likelihood of requiring treatment during the study period with anti-diabetic medications such as sulphonylureas, meglitinides, thiazolidinediones, acarbose, dipeptidyl peptidase inhibitors, exenatide and insulins.
7.Treatment with any investigational drug or devices in the 1 month before baseline visit.
8.Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to baseline visit, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation) during the study.
9.History of diabetic gastroparesis that is considered to be clinically significant in the opinion of the investigator.
10.Concurrent use of systemic corticosteroids or intend to be placed on a course of systemic corticosteroids for >1 week during the study.
11.History or evidence of liver disease, including cirrhosis, or non-alcoholic steatohepatitis/non-alcoholic fatty liver disease.
12.History of HIV or presence of hepatitis C antibodies or positive hepatitis B serology (refer to Attachment 10, Interpretation of Hepatitis B Results for Enrolling Subjects) at screening.
13.History of clinically significant gastro-intestinal disease (including but not limited to gluten and non-gluten induced enteropathy, inflammatory bowel disease, malabsorption syndromes).
14.History of hemoglobinopathy (unreliable HbA1c measurement)
15.History of major gastro-intestinal surgery other than appendectomy or uncomplicated cholecystectomy.
16.Pregnancy or nursing or women who plan to become pregnant during the study
17.History of significant cardiovascular disease, including a history of myocardial infarction (MI), unstable angina and cerebrovascular accident (CVA) within 6 months of enrollment.
18.History of clinically-significant cardiac valvular disease, significantly, congestive heart failure (cardiovascular disability functional Class III-IV according to the New York Heart Association, see Attachment 6).
19.12-lead ECG showing evidence of clinically significant heart rhythm or conduction abnormality at screening or baseline.
20.An average of 3 seated readings where diastolic blood pressure ³100 mmHg or a systolic blood pressure ³160 mmHg at screening.
21.Thyroid stimulating hormone (TSH) >1.5 X ULN at enrollment. Subjects on medication for hypothyroidism should have been on a stable dose for at least 3 months before the screening visit.
22.History of anorexia nervosa, bulimia or binge eating disorder.
23.Recently (within 3 months from screening) changed smoking habits.
24.Malignancy or a history of a malignancy within 5 years before Baseline visit, other than basal cell carcinomas of the skin or in situ cervical carcinoma.
25.History or evidence of clinically significant abnormal values for hematology, coagulation or clinical biochemistry.
26.Increased liver function tests, if concomitant increase of two or more parameters, including AST, ALT bilirubin, alkaline phosphatase

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified