Type II Diabetes MedDRA version: 7.1 Level: LLT Classification code 10012613
Conditions
Interventions
Product Name: MK-0533
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administrat
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and post-menopausal female patients, ages 18 to 70 years with T2DM who demonstrate inadequate glycemic control (HbAic =7.5% and =10.0%) and maintain a stable fluid status or body weight. Note: Only patients who have not been taking any antihyperglycemic agents for =12 weeks will be screened. 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
Exclusion criteria: Patients with New York Heart Association Class I, II, III, or IV. Patients taking any treatment which may cause them not to maintain a stable fluid status or body weight. Patients taking niacin, a bile-acid binding resin, a fibrate agent or pharmacologic doses of corticosteroids. Patients with any of the following conditions: chronic myopathy, a progressive neurological or neuromuscular disorder, significant abnormal liver function, active liver or gallbladder disease, inadequately controlled hypertension, or a clinically important hematological disorder . Patients with significant abnormal laboratory values for any of the following: CPK, serum creatinine, AST, ALT, proteinuria, TSH, hemoglobin, hematuria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In the two-arm phase: After 12 weeks, to assess the effect of treatment with MK-0533 30 mg compared with pioglitazone 45 mg on total body water. To assess the safety and tolerability of MK-0533 after 12 weeks of treatment. In the five-arm phase: After 12 weeks, to assess the effect of treatment with MK-0533 compared with pioglitazone 45 mg on fasting plasma glucose. To assess the safety and tolerability of MK-0533 after 12 weeks of treatment. ;Secondary Objective: In the two-arm phase: After 12 weeks, to assess the effect of treatment with MK-0533 30 mg compared with pioglitazone 45 mg on fasting plasma glucose. In the five-arm phase: After 12 weeks, to assess the effect of treatment with MK-0533 compared with placebo in lowering HbA1c. To assess the effect of treatment with MK-0533 compared with pioglitazone 45 mg on fasting plasma glucose. To assess the effect of treatment with MK-0533 compared with pioglitazone 45 mg on total body water. ;Primary end point(s): Total body water and fasting plasma glucose | — |
Countries
Czech Republic, Germany, Hungary, Italy
Outcome results
None listed