An Investigational Drug Study to Assess Weight Loss in Patients With Type 2 Diabetes Mellitus (0364-011)
- Conditions
- Obesity, unspecifiedE669-E118 Non-insulin-dependent diabetes mellitus, with unspecified complications-E669 Obesity, unspecifiedNon-insulin-dependent diabetes mellitus, with unspecified complicationsE118
- Registration Number
- PER-097-06
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1. Patient has T2DM.
2. Patient has a body mass index (BMI) between 27 kg/m2 and 43 kg/m2.
3. Patient is male or female and ≥ 18 and ≤ 75 years of age on day of signing informed consent.
4. Patient has been one of the following: a) Newly diagnosed. b) On a stable dose of metformin for at least 12 weeks.
5) Patient has an HbA1c ≥ 7.0% and ≤ 10%.
6) Patient is highly unlikely to conceive as indicated by at Least one yes answer to the following questions: a) Patient is male. b) Patient is a surgically sterilized female. c) Patient is a postmenopausal female. d) Patient is of reproductive potential and agrees to remain abstinent or use 2 acceptable methods of birth control throughout the study starting with Visit 1 and for 28 days after the last dose of study drug.
7. Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate in the study by giving written informed consent.
8. Patient is able to read, understand, and complete study questionnaires and diaries.
9. Patient is at least 75% compliant with study drug during the single-blind placebo run-in.
10. Patient is compliant with diet, exercise and other run-in treatments during the run-in.
1. Patient has a history of type 1 diabetes mellitus.
2. Patient is not weight stable.
3. Patient intends to be involved in weight loss intervention outside that prescribed by the study.
4. Patient has a history of substance abuse within the past 5 years.
5. Patient has smoked cigarettes or used nicotine-containing products within 6 months prior to study initiation, or plans to use such a product over the course of the study.
6. Patient has a history or presence of a major psychiatric disorder.
7. Patient currently has significant cardiovascular disease.
8. Patient has a Visit 1 systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg.
9. Patient has a recent diagnosis/episode/recurrence of stroke, TIA or neurological disorder.
10. Patient has a history of seizures or is at high risk of developing seizures.
11. Patient has a history of malignancy ≤ 5 years prior to signing informed consent, or > 5 years without documentation of remission/cure.
12. Patient has undergone a surgical procedure within 1 month prior to signing informed consent or plans to undergo a surgical procedure during the study.
13. Patient has undergone surgical treatment for obesity.
14. Patient has an endocrinopathy which will influence the study endpoints.
15. Patient is pregnant, or breastfeeding, or expected to conceive within the projected duration of the study.
16. Patient is expecting to donate eggs within the projected duration of the study.
17. Patient has active liver disease or a history of chronic liver disease.
18. Patient has a history of significant pulmonary disease.
19. Patient has a history or presence of significant gastrointestinal disease, including but not limited to cholelithiasis.
20. Patient has a history of significant renal disease.
21. Patient has been diagnosed with HIV.
22. Patient has a history or current evidence of any condition, therapy, lab abnormality or other circumstances that might confound the results of the study, or interfere with the patient´s participation for the full duration of the study.
23. Patient is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
24. Patient currently uses, has used within 3 months prior to signing informed consent or plans to use any prescription or nonprescription drugs, including over- the-counter or herbal supplements, that can alter serum glucose or body weight.
25. Patient has, at any time, been treated with fenfluramine, dexfenfluramine either alone or in combination with any other medication.
26. Patient currently uses or is likely lo require long term use of any prescription or nonprescription medication that is a potent or moderate inhibitor of CYP3A4, or currently uses or plans to use any medication in the medication exclusion list.
27. Patient plans to consume more than 1 quart (four 8 oz. glasses) of grapefruit juice per day at any time during the study.
28. Patient is on a lipid-lowering therapy and not on a stable dose for at least 6 weeks prior to Visit 2.
29. Patient requires continuous pharmacologic doses of oral / injectable / parenteral corticosteroid treatment.
30. Patient is currently participating or has participated in a study with an investigational compound or device within 3 months of signing informed consent.
31. Patient was previously randomized to a study with MK-0364
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:1) Change in body weight: It is defined as the average body weight in patients who lose ≥ 5% and ≥ 10% of their basal weight.<br>2) Change in HbA1c: Levels in peripheral blood of glycosylated hemoglobin (HbA1c) in those patients with HbA1c <7% and <6.5%.<br>Measure:1) Change in body weight. 2) Change in HbA1c.<br>Timepoints:Week 36.<br>
- Secondary Outcome Measures
Name Time Method