type 2 diabetes MedDRA version: 9.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent
Conditions
Interventions
Product Name: sitagliptin
Product Code: MK-0431
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
MERCK SHARP DOHME
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient has type 2 diabetes mellitus T2DM diagnosed within the past 5 years. Exception This criterion is not applicable to the cohort of NFG subjects. 2. Patient is 8805;30 and 8804;65 years of age on day of signing informed consent. 3. Patient has a BMI this is 8805;20 and 8804;40 kg/m2. 4. Patient meets one of the following criteria as indicated by a yes answer to one of the following a Patient is currently not on an AHA and has a Screening/Visit 1 HbA1c 8805;7 and 8804;10 . OR b Patient is currently on AHA monotherapy or low dose i.e. 8804;50 maximum labeled dose of each agent oral combination therapy and has a Screening/Visit 1 HbA1c 8805;6.5 and 8804;10 . Exception This criterion is not applicable to the cohort of NFG subjects. 5. Subjects who are screening for the cohort of NFG subjects has an FPG 100 mg/dL 5.5 mmol/L . Exception This criterion is not applicable to the cohort of T2DM patients. 6. Patient is a male, or a female who is unlikely to conceive, as indicated by at least one yes answer to the following questions a Patient is a male. b Patient is a surgically sterilized female. c Patient is a postmenopausal female 8805;45 years of age with 2 years since last menses. d Patient is a non-sterilized premenopausal female and agrees to 1 use 2 adequate methods of contraception to prevent pregnancy either 2 barrier methods or a barrier method plus a hormonal contraceptive method or 2 abstain from heterosexual activity throughout the study starting with Visit 1 and for 14 days after the last dose of study medication. 7. Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent. 8. Patient is able to read, understand, and complete study questionnaires and diaries. At Visit 3 9 Patient has an FPG 8805;130 mg/dL 7.2 mmol/L and 8804;260 mg/dl 14.4 mmol/L measured at Visit 3. NOTE If the Visit 3 FPG does not meet this criterion, a single repeat measurement may be performed at the discretion of the investigator. If repeat value meets FPG inclusion criterion, patient may continue in the study. Exception This criterion is not applicable to the cohort of NFG subjects. 10. Patient is compliant with diet, exercise and other run-in treatments during the run-in period. 2.3 SUBJECT/PATIENT EXCLUSION CRITERIA Patients are excluded from participation in the study if they meet any of the following criteria. Note NFG subjects are also excluded from participation if they meet any of the Visit 1 exclusion criteria. 0431, Protocol 059-00 16 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
Exclusion criteria: 1. Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis. 2. Patient is not weight stable. Patient has gained or lost more than 3 kg during the 3 months prior to Visit 1. 3. Patient is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history within the last year of drug or alcohol abuse or dependence. Note Alcohol abuse includes heavy alcohol intake as defined by 2 drinks per day or 14 drinks per week, or binge drinking. 4. Patient has evidence of a significant cardiovascular disorder within 6 months of signing informed consent e.g. acute coronary syndrome e.g. MI or unstable angina ; coronary artery intervention e.g., CABG or PTCA ; stroke or transient ischemic neurological disorder; congestive heart failure treated with pharmacologic therapy. Note NYHA Class III or IV CHF patients are excluded from participation. 5. Patient has a systolic blood pressure of 8805;160 mm Hg or diastolic blood pressure of 8805;95 mm Hg. Note Patients may have their antihypertensive regimen adjusted and be randomized if they meet the blood pressure criteria at Visit 3. 6. Patient has a recent within 6 months prior to signing informed consent diagnosis/episode/recurrence of stroke, TIA or neurological disorder, including but not limited to seizures, blackouts, or a recent within 3 months prior to signing informed consent change in the dose or class of medications used to treat these conditions. 7. Patient has a history of malignancy 8804;5 years prior to signing informed consent, or 5 years without documentation of remission/cure. Exception Adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Patients with melanoma, leukemia, lymphoma and myeloproliferative disorders of any duration are excluded. 8. Patient has undergone a surgical procedure within 1 month prior to signing informed consent. Exception Patient with a history of minor surgery i.e. using local anesthesia within 1 month of signing informed consent and is fully recovered may participate. 0431, Protocol 059-00 17 Product MK-0431 11 Protocol/Amendment No. 059-00 0431 059-00 ProtCore VERSION 11.1 APPROVED 22-Sep-2006 Non-U.S. IND, Ex-U.S. Study Restricted Confidential Limited Access 9. Patient has undergone surgical treatment for obesity. Exception Patient s procedure occurred at least 5 years prior to signing informed consent and there is no clinical evidence of complications including, but not limited to malabsorption. 10. Patient is pregnant or breast-feeding or expecting to conceive within the projected duration of the study. 11. Patient is expecting to donate eggs within the projected duration of the study. 12. Patient has been diagnosed with HIV. 13. Patient has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the patient s participation for the full duration of the study, such that it is not in the best interest of the patient to participate. 14. Patient is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study. 15. Patient is lactose intolerant. 16. Patient is allergic to egg and/or products. Specific Treatments 17. Patient currently uses, has used within 3 months prior to signing informed consent or plans to use any prescr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): beta cells function;Main Objective: In patients who are 8805;30 and 8804;65 years of age with type 2 diabetes mellitus T2DM who have inadequate glycemic control FPG 8805;130 7.2mmol/l and 8804;260 mg/dL 14.4 mmol/L 2.1.1 Primary Objective After 6 weeks, to assess the effect of treatment of sitagliptin compared with placebo on incremental glucose area under the curve. Hypothesis After 6 weeks, treatment with sitagliptin compared with placebo provides greater improvement in incremental glucose area under the curve. Objective To assess the safety and tolerability of sitagliptin. Hypothesis Sitagliptin is well tolerated;Secondary Objective: Objective After 6 weeks, to examine the effect of treatment with sitagliptin compared with placebo on 1. Parameters of model assessment of 946;-cell function a. 946;-cell glucose sensitivity b. Rate sensitivity c. Potentiation factor 2. Incretin response for insulin. 3. Plasma glucagon response after a meal challenge. 4. Endogenous glucose production. 5. Incretin response for glucagon. 6. Glucose clearance. 7. Appearance of exogenous glucose. 8. The post-meal triglyceride excursion. 9. The post-meal Non-esterified Free Fatty Acids.Objective To examine incretin function in T2DM compared with normal glucose tolerant subjects under physiological conditions by quantifying the incretin contribution to overall 946;-cell function. | — |
Countries
Italy
Outcome results
None listed