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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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24 July 2012 |
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Main ID: |
EUCTR2007-000031-26-GB |
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Date of registration:
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16/08/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Scientific title:
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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 -
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Date of first enrolment:
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18/12/2007 |
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Target sample size:
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320 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000031-26 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other:
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Denmark
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Finland
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Germany
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Netherlands
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Sweden
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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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
- vasectomized partner.
- 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.
11. Subjects must have signed an informed consent document indicating tha they understand the purpose of an 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) yes
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. 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.
6. History of diabetic gastroparesis that is considered to be clinically significant in the opinion of the investigator.
7. History or evidence of liver disease, including cirrhosis, or non-alcoholic steatohepatitis/non-alcoholic fatty liver disease.
8. 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.
9. History of clinically significant gastro-intestinal disease (including but not limited to gluten and non-gluten induced enteropathy, inflammatory bowel disease, malabsorption syndromes).
10. History of hemoglobinopathy (unreliable HbA1c measurement)
11. History of major gastro-intestinal surgery other than appendectomy or uncomplicated cholecystectomy.
12. Pregnancy or nursing or women who plan to become pregnant during the study
13. History of significant cardiovascular disease, including a history of myocardial infarction (MI), unstable angina and cerebrovascular accident (CVA) within 6 months of enrollment.
14. 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).
15. 12-lead ECG showing evidence of clinically significant heart rhythm or conduction abnormality at screening or baseline.
16. An average of 3 seated readings where diastolic blood pressure ³100 mmHg or a systolic blood pressure ³160 mmHg at screening.
17. 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.
18. History of clinically significant eating disorders (anorexia nervosa, bulimia or binge eating disorder).
19. Recently (within 3 months from screening) changed smoking habits.
20. 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.
21. Increased liver function tests,
- ALT above 1.5 x ULN at screening
- any of the listed parameters: GGT, AST, total/direct bilirubin, alkaline phosphatase, LDH above 2 x ULN at screening
- if concomitant increase of two or more parameters, including
a. ALT> ULN and/or
b. AST, total/direct bilirubin, alkaline phosphatase or LDH above 1.5 X ULN and/or
c. GGT above 2x ULN at screening.
In doubtful or borderline cases, one additional retest sampling is allowed.
22. Increased creatinine kinase (CK) above ULN in subjects who take lipid lowering agents and CK level above 2 x ULN in subjects who do not take lipid lowering agents
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Diabetes
MedDRA version: 9.1
Level: HLGT
Classification code 10018424
Term: Glucose metabolism disorders (incl diabetes mellitus)
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Intervention(s)
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Product Name: JNJ-16269110/5-mg/capsules filled with beads
Product Code: F026
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not available
CAS Number: 403989-79-7
Current Sponsor code: JNJ-16269110-AAA
Other descriptive name: R256918
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: JNJ-16269110/10-mg/capsules filled with beads
Product Code: F027
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: JNJ-16269110/15-mg/capsules filled with beads
Product Code: F028
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): To evaluate the efficacy, safety and tolerability of JNJ-16269110
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Main Objective: The primary objective of this study is to evaluate the effects of 12-week treatment with JNJ-16269110 on the glycated hemoglobin A1c (HbA1c) concentration in subjects with T2DM.
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Secondary Objective: Additional obj.:
To evaluate the effect of JNJ-16269110 on:
Fasting plasma glucose
Fasting concentrations and postprandial responses of the gastrointestinal and pancreatic hormones to the standardized mixed meal
Insulin sensitivity and beta cell function based on plasma glucose, insulin and C-peptide responses to the MMTT and evaluated by HOMA2
Self-monitored blood glucose (SMBG)
Body weight, BMI and waist - hip ratio
Fasting plasma lipids including total cholesterol (TC), triglycerides (TG), VLDL, LDL, HDL and lipoproteins (ApoB 100, ApoB48 and ApoA1) and postprandial TG excursion after MMTT
BP
Safety and tolerability
Assess pharmacokinetic exposure of JNJ-16269110 to explore plasma exposure-response relationships and to develop a population pharmacokinetic model.
Evaluate QoL using Diabetes Treatment Satisfaction Questionnaires status and change (DTSQs and DTSQc) and Impact of Weight on QoL Questionnaire-Lite version (IWQOL-Lite).
Evaluate overall satisfaction
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Secondary ID(s)
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R256918DIA2001
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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