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-DK
• Lead Sponsor: Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-26
• Last Update Posted: 22 April 2013

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 such as hormonal contraceptives (if used consistently and correctly), including implants, injectables, transdermal patch or oral contraceptives, as well as IUDs, or vasectomised partner.
?? sexually abstinent.
Women of childbearing potential must be practicing an acceptable method of birth control (as previously defined) and have had a negative urine pregnancy test at screening as well as at the baseline visit before receiving study drug, which will be followed immediately by a serum beta-human chorionic gonadotropin (ß-hCG) test. Subjects may be admitted to the study if the urine pregnancy test is negative, but will be discontinued immediately should the serum results be positive. Only a serum test is necessary at the end of the double-blind treatment phase. During the double-blind phase, a pregnancy test will performed if pregnancy is suspected. Additional pregnancy tests may be performed at the discretion of the investigator or according to local regulations.
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 240mg/dL (13.3mmol/L) at baseline visit. If there is a doubt if subject was fasted for 8 hours, the assessment may be once repeated.
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, as judged by e.g. the subject's history of having no difficulty with swallowing e.g. capsules or intact tablets.
JNJ-16269110: Clinical Protocol R256918DIA2001
Final July 27, 2007 (Incorporating Amendments DEN-1, 17 September 2007; INT-1, 4 October 2007) 61
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.
11. Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
12. To participate in the optional pharmacogenomic component of this study, subjects must have signed the informed consent for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to consent for this component does not exclude a subject from participation in the clinical study.
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. History of intolerance or hypersensitivity to sulfonylurea or sitagliptin.
4. History of an uninterrupted period of insulin therapy for >1 month period within 1 year prior to baseline visit.
5. Likelihood of requiring treatment during the study period with anti-diabetic medications such as sulphonylureas, meglitinides, thiazolidinediones, acarbose, dipeptidyl peptidase inhibitors, exenatide and insulins.
6. Treatment with any investigational drug or devices in the 1 month before baseline visit.
7. 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.
8. History of diabetic gastroparesis that is considered to be clinically significant in the opinion of the investigator.
9. Concurrent use of systemic corticosteroids or intend to be placed on a course of systemic corticosteroids for >1 week during the study.
10. History or evidence of liver disease, including cirrhosis, or non-alcoholic steatohepatitis/non-alcoholic fatty liver disease.
JNJ-16269110: Clinical Protocol R256918DIA2001
Final July 27, 2007 (Incorporating Amendments DEN-1, 17 September 2007; INT-1, 4 October 2007) 62
11. 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.
12. History of clinically significant gastro-intestinal disease (including but not limited to gluten and non-gluten induced enteropathy, inflammatory bowel disease, malabsorption syndromes).
13. History of hemoglobinopathy (unreliable HbA1c measurement)
14. History of major gastro-intestinal surgery other than appendectomy or uncomplicated cholecystectomy.
15. Pregnancy or nursing or women who plan to become pregnant during the study
16. History of significant cardiovascular disease, including a history of myocardial infarction (MI), unstable angina and cerebrovascular accident (CVA) within 6 months of enrollment.
17. 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).
18. 12-lead ECG showing evidence of clinically significant heart rhythm or conduction abnormality at screening or baseline.
19. An average of 3 seated readings where diastolic blood pressure =100 mmHg or a systolic blood pressure =160 mmHg at screening.
20. 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.
21. History of clinically significant eating disorders (anorexia nervosa, bulimia or binge eating disorder).
22. Recently (within 3 months from screening) changed smoking habits.
23. 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.
24. Increased liver function tests,
?? ALT above 1.5 x ULN at screening
?? any of the listed parameters: GGT, AST, total/direct bilirubin, alkaline phosphatase,

Study & Design

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