A Study to Evaluate the Efficacy and Safety of BRL 49653C in Non-insulin Dependent Diabetes
Diabetes Mellitus Non Insulin Dependent Oral Agent Therapy
About this trial
This is an interventional treatment trial for Diabetes Mellitus Non Insulin Dependent Oral Agent Therapy focused on measuring non insulin dependent diabetes mellitus, rosiglitazone
Eligibility Criteria
Inclusion Criteria:
- Men or women between 30-80 years of age inclusive at time of enrolment.
- Patients who had non-independent diabetes mellitus (NIDDM) defined by the criteria of the National Diabetes Data Group.
- Patients who had sulphonylurea therapy for at least 6 months and a constant dose for at least 2 months prior to visit 1.
- Patients who had fasting plasma glucose <= 15.0 mmol/L at screening. Hemoglobin A1c >= 7.5%.
- Female patients must be (1) post-menopausal, i.e. > 6 months without menstrual period, surgically sterile, or (2) using hormonal contraceptives or intrauterine contraceptive devices. Female patients who were taking hormonal contraceptives must also use an additional barrier form or intrauterine form of birth control.
- Patients who had given their written informed consent to participate.
Exclusion Criteria:
- Female patients who were pregnant, breast feeding or planning a pregnancy during the course of the study.
- Patients who had a fasting plasma glucose > 15.0 mmol/L at screening, or severity of diabetes mellitus requiring administration of insulin, or patients with ketonuria.
- Patients who had clinically significant renal or hepatic disease (i.e., patients with serum creatinine > 160 micromol/L (1.8 mg/dL); ALT, AST, total bilirubin, gamma GT, or alkaline phosphatase more than 2.5 times the upper limit of the normal laboratory range).
- Any clinically significant abnormality identified on the screening physical examination, laboratory tests, electrocardiogram which in the judgment of the investigator would preclude safe completion of the study.
- Patients who had leukocyte count < 3000/mm3 or platelet count <120,000/mm3.
- Systolic blood pressure >180mmHg or diastolic blood pressure >114mmHg while on appropriate hypertensive therapy.
- Significant anemia (hemoglobin < 11 g/dL for males or < 10g/dL for females) or diagnosis of porphyria.
- Symptomatic diabetic neuropathy of sufficient severity to require treatment for control of symptoms (eg, painful peripheral neuropathy, symptomatic orthostatic hypotension, urinary retention, gastric stasis, pedal ulcers).
Diabetic retinopathy imminently requiring treatment for preserving or restoring vision.
- Body mass index(BMI) < 22 and >38 kg/m2 (Formula: BMI= weight, kg ÷height, m2)and variation in body weight of >=5% between screening and visit2.
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
BRL 49653C
placebo
Eligible patients may enter the study at visit 1 according to the inclusion/exclusion criteria. At the screening visit, patients will enter a single blind placebo run-in period to establish baseline characteristics. Patients must have been stable on sulphonylurea therapy for at least 2 months prior to the screening visit to be included. For the duration of the run-in period, patients will receive BRL 49653C placebo in addition to their constant dose of sulphonylurea. Patients eligible to enter the double-blind phase of the study will be randomized in equal numbers at visit 2, to one of two treatment groups (BRL 49653C 2 mg bid. or placebo bid). Patients will then continue to take their study medication arid the constant dose of sulphonylurea through visits 3 to 8 (weeks 4 to 24).
Eligible patients may enter the study at visit 1 according to the inclusion/exclusion criteria. At the screening visit, patients will enter a single blind placebo run-in period to establish baseline characteristics. Patients must have been stable on sulphonylurea therapy for at least 2 months prior to the screening visit to be included. For the duration of the run-in period, patients will receive BRL 49653C placebo in addition to their constant dose of sulphonylurea. Patients eligible to enter the double-blind phase of the study will be randomized in equal numbers at visit 2, to one of two treatment groups (BRL 49653C 2 mg bid. or placebo bid). Patients will then continue to take their study medication arid the constant dose of sulphonylurea through visits 3 to 8 (weeks 4 to 24).