The current study will support an indication for rivoglitazone as oral monotherapy to improve glycemic control in subjects with type 2 diabetes mellitus not adequately controlled with diet and exercise alone. MedDRA version: 9.1 Level: LLT Classification code 10063624 Term: Type II diabetes mellitus inadequate control
Conditions
Interventions
Product Name: Rivoglitazone
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: rivoglitazone
CAS Number: 299176-11-7
Current Sponsor code: CS-011
Concentration unit: mg milligram(s)
Concentr
Sponsors
DAIICHI SANKYO PHARMA DEVELOPMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Willing and able to give written informed consent at screening. • Diagnosis of Type 2 diabetes. • Male or female subjects = 18 and = 75 years of age. • A1C = 7.0% and = 9.5% at screening. • Women of childbearing potential (WOCBP) must be using an adequate method of contraception as detailed per-protocol to avoid pregnancy throughout the study, and for up to 4 weeks after study completion (see Section 5.4.2). • Non-fasting C-peptide >0.5 ng/mL at screening. • Subjects currently treated with a stable dose of an approved non-thiazolidinedione antihyperglycemic medication (including sulfonylureas, meglitinides, insulin secretagogues, metformin, or a-glucosidase inhibitors) given as monotherapy, for at least 3 months prior to screening. OR • Subjects untreated with any antihyperglycemic agent during the 2 months prior to screening and with no prior history of thiazolidinedione therapy. The target enrollment for untreated or treatmentnaïve subjects is at least 20%. 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: A history of type 1 diabetes or ketoacidosis. • History of long-term (>2 months) therapy with insulin. • Confirmed repeat fasting glucose >300 mg/dL during the 2 week washout/stabilization and placebo run-in period (Period A). • Uncontrolled hypertension (SBP >180 mmHg and/or DBP >110 mmHg). • NYHA Class III–IV cardiac failure (See Section 24.2). • Impaired hepatic function, (including active hepatitis and/or elevated liver enzymes as specified per protocol). • A history of prior treatment failure with, or intolerance of, a thiazolidinedione. • Treatment with fibrates (eg, fenofibrate, gemfibrozil). • BMI >40 kg/m2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the A1C-lowering efficacy of rivoglitazone, versus placebo, over 26 weeks as monotherapy in subjects with Type 2 diabetes.;Secondary Objective: 1. To compare the effect of rivoglitazone versus placebo on the change from baseline in fasting plasma glucose (FPG) 2. To compare the effect of rivoglitazone versus placebo, on HOMA indices of insulin resistance and ß-cell function 3. To compare the effect of rivoglitazone versus pioglitazone on the change from baseline in A1C 4. To assess the effects of each rivoglitazone dose on the percent of responders 5. To assess the effects of rivoglitazone on change from baseline and percent change from baseline in plasma lipids 6. To compare effects of rivoglitazone versus pioglitazone on secondary measures of glycemic control and lipid parameters 7. To demonstrate the safety and tolerability of rivoglitazone as a treatment for Type 2 diabetes mellitus;Primary end point(s): Primary Objective: To demonstrate the A1C-lowering efficacy of rivoglitazone, versus placebo, over 26 weeks as monotherapy in subjects with Type 2 diabetes. Primary Efficacy Analysis: The primary null hypothesis of no difference in change from baseline, comparing rivoglitazone to placebo in A1C, will be evaluated sequentially at each descending dose of rivoglitazone at the nominal 0.05 level of significance. When P >0.05 is first observed, hypothesis testing will stop and all null hypothesis tested prior to observing P >0.05 will be rejected. Testing in this pre-specified sequence will preserve the family-wise Type I error at 0.05. | — |
Countries
Austria, Czech Republic, Germany, Hungary, Latvia, United Kingdom
Outcome results
None listed