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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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25 November 2019 |
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Main ID: |
EUCTR2006-006772-38-GB |
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Date of registration:
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03/09/2007 |
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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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A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study to Investigate the Safety and Efficacy of JNJ-16269110 in Overweight and Obese Subjects - N/A
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study to Investigate the Safety and Efficacy of JNJ-16269110 in Overweight and Obese Subjects - N/A |
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Date of first enrolment:
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31/12/2007 |
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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:2006-006772-38 |
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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: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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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 (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 mal
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Obesity
MedDRA version: 9.1
Level: LLT
Classification code 10029883
Term: Obesity
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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 Assigned
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*
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
INN or Proposed INN: Not Assigned
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: 10-
Pharmaceutical form of the placebo: Capsule*
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
INN or Proposed INN: Not Assigned
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: 15-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: To estimate the dose-response relationship between the different dosages of JNJ-16269110 and the decrease in body weight from baseline to Week 12
To estimate the effect on weight loss of different JNJ-16269110 dosages versus placebo as expressed by mean percent change from baseline in body weight and in body mass index (BMI), and the percentage of subjects who lose at least 5% or 10% of their initial body weight
To estimate changes in body composition using anthropometric measurements and by means of Dual X Ray Absorptiometry (DEXA [only at selected sites] to explore if weight loss is predominantly due to loss of fat mass
To explore changes in obesity-associated comorbidities as assessed by glucose homeostasis, fasting lipid profile, and systolic and diastolic blood pressure
To explore the effect of JNJ-16269110 on changes in levels of PYY, GLP 1, and oxyntomodulin
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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 the study is to find the appropriate, clinically relevant dosages (among the 5, 10, and 15 mg twice-daily dosages) of JNJ-16269110 by assessing mean changes in body weight from baseline to Week 12, compared to placebo.
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Secondary ID(s)
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2006-006772-38-BE
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R256918OBE2001
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N/A
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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