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
- Conditions
- geen synoniem gevonden in het woordenboek10012653
- Registration Number
- NL-OMON31816
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
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;
* or surgically incapable of childbearing
* or if sexually active, be practicing an effective method of birth
control
* sexually abstinent.
* Women of childbearing potential must be practicing an acceptable method
of birth control and have a negative pregnancy test before and during the trial
4. BMI between 25 and 45 kg/m2, inclusive
5. HbA1c between 7% and 10%, inclusive
6. Fasting plasma glucose not exceeding 13.3mmol/L
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 antidiabetic
medications
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy parameter will be HbA1c</p><br>
- Secondary Outcome Measures
Name Time Method <p>Fasting blood glucose concentrations<br /><br>Fasting plasma insulin, C-peptide and glucagon<br /><br>In-Clinic Meal Mixed Tolerance Test (MMTT) (selected centres - approximately<br /><br>120 patients)<br /><br>Gastrointestinal hormones (GLP-1, PYY)<br /><br>Insulin sensitivity<br /><br>Beta cell function<br /><br>Homeostatic Model Assessment, HOMA2 (%S and %R)<br /><br>Self Monitored Blood Glucose (SMBG)<br /><br>· Self Monitored Fasting Blood Glucose (SMFBG)<br /><br>· 7-point blood glucose profiles<br /><br>Lipids and lipoproteins<br /><br>BMI and Waist to Hip Ratio<br /><br>Weight<br /><br>Quality of life - DTSQs/DTSQc/ IWQOL-Lite questionnaires<br /><br>Treatment satisfaction questions<br /><br><br /><br>SAFETY EVALUATIONS<br /><br>Adverse events<br /><br>Physical examination and vital signs<br /><br>12- lead ECG<br /><br>Lab safety parameters</p><br>