Furthermore, this number is predicted to reach 438 million by 2030 due to lifestyle such as overeating and insufficient exercise, and the global healthcare expenditures to treat and prevent diabetes and its complications are expected to exceed 490 billion US Dollars (USD) by 2030. Thus, there is a pressing need for the prevention of, and a cure for, type 2 diabetes worldwide, creating a strong need to conduct diabetes clinical research trials (http://www.achieveclinical.com/
A Phase 2, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of this new drug in Patients with Type 2 Diabetes Mellitus
-Approximately 22 weeks duration per patient:
-Up to a 4-week Screening Period
-Approximately 2-week single-blind Placebo Run-in Period
-Approximately 12-week double-blind (DB) Treatment Period
-Approximately 4-week Follow-up Period
-To investigate the change in glycosylated hemoglobin (HbA1c) after this new drug administration, once daily for 12 weeks in patients with type 2 diabetes compared to placebo.
-To evaluate the safety and tolerability of this new drug when administered for 12 weeks in patients with type 2 diabetes compared to glimepiride and placebo.
-To investigate the effect of this new drug administration on ancillary efficacy measures in patients with type 2 diabetes compared to glimepiride and placebo.
-To evaluate the pharmacokinetics (PK) of this new drug and its metabolites M2 and M10 in plasma in patients with type 2 diabetes
This is a randomized, double-blind, double-dummy, placebo and active-controlled, multi-center, parallel-group study to investigate the effect of this new drug on HbA1c and other ancillary efficacy parameters (see Study Objectives) and to assess the safety and tolerability of this new drug in inadequately-
Upon completion of the Screening Period, patients that meet eligibility criteria will enter a two-week single-blind Placebo Run-in Period where they will be advised to follow a diet and exercise program for type 2 diabetics consistent with recommendations from the American Diabetes Association (ADA) throughout the study (http://www.achieveclinical.com/
Additionally, at Visit 2, eligible patients will be randomized into one of five parallel dose groups (this new drug 30 mg once daily [QD], this new drug 50 mg QD, this new drug 70 mg QD, glimepiride 4 mg QD, and placebo QD), but will not be distributed double-blind study medication during this visit. Randomization will be stratified by HbA1c level at Visit 1 (HbA1c < 8.5% versus HbA1c ≥ 8.5%) and by background antidiabetic medication (treatment naïve or metformin-treated).
At the completion of the single-blind Placebo Run-in Period, eligible patients will be distributed the double-blind study medication and will receive treatment for 12 weeks. This is a fixed-dose study, where patients will receive the same dose regimen from Visit 3 to end of treatment (EOT) with the following exception: the patients randomized to the glimepiride 4 mg QD dose group will receive glimepiride 2 mg QD during the first two weeks of the double-blind treatment period, followed by up-titration to the full dose (4 mg QD) starting at Week 3 of the double-blind study period (i.e., Visit 4). You can also learn more about the various types of diabetes treatments (http://www.achieveclinical.com/
Patients with persistent hyperglycemia or hypoglycemia may be eligible for rescue therapy/procedures, and will be encouraged to continue the study after the rescue therapy/procedures (i.e., continue to take study medication and complete all visits according to the protocol).
KEY ELIGIBILITY CRITERIA
-Males and females with type 2 diabetes, 18-70 years of age (inclusive) at Visit 1;
-Are either drug naïve with respect to hypoglycemic agents (i.e., managed with diet and exercise only) or are currently being treated with metformin (at least 1500 mg/day or the respective [individually]
-Glycosylated hemoglobin at Visit 1 between 7.5% and 10.0%, inclusive if on metformin and between 7.5% and 10.9%, inclusive if drug naïve;
-Fasting plasma glucose (FPG) levels ≤ 280 mg/dL at Visit 1;
-Fasting C-peptide concentration ≥ 0.8 ng/mL at Visit 1;
-Body mass index (BMI) ≥ 23.0 kg/m2 and ≤ 45.0 kg/m2 at Visit 1;
*Achieve Clinical Research conducts Clinical Trials in Birmingham, Alabama. For more information about getting started with a Clinical Trial, please visit our website (http://www.achieveclinical.com/)