Birmingham, AL (PRWEB) February 11, 2014
Achieve is conducting a placebo-controlled, multicenter study to evaluate the blood pressure reduction with ambulatory blood pressure monitoring (ABPM), safety, and tolerability of a new drug in the treatment of subjects with hypertension and type 2 diabetes mellitus.
*To see if you qualify for this Diabetes Clinical Study in Birmingham, visit Achieve Clinical Research on the web (http://www.achieveclinical.com/) or contact us directly at (205) 380-6434. There is no cost to participate, no insurance is required, and you may receive compensation for time and travel.
This is a randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multicenter study. Accepting applicants between 18 and 75 years of age with hypertension on stable doses of 1 to 3 anti-hypertensive agents including angiotensin converting enzyme inhibitor (ACEi)/ angiotensin II receptor blocker (ARB) (either one), and with type 2 diabetes who have inadequate glycemic control on stable doses of 1 to 3 anti-hyperglycemic agents including metformin are eligible to participate.
Subjects will enter a 2 week single-blind placebo run-in period during the pre-treatment phase. Upon completion of the single-blind, placebo run-in period, approximately 189 subjects will be randomly assigned to 1 of 3 treatment groups (in a 1:1:1 ratio) in the double-blind treatment phase.
BACKGROUND & RATIONALE
Despite the current availability of other oral agents for the treatment of patients with type 2 diabetes, many patients still do not achieve or maintain glycemic goals. The sustained HbA1c-lowering seen with this new drug relative to agents from 2 other commonly used AHA classes, is particularly notable. In addition, no currently available oral agents for the treatment of patients with T2D provide meaningful weight reduction. Given the role obesity plays in the pathogenesis of this disease, the weight loss demonstrated with this drug provides an important added benefit. Most oral AHAs for the treatment of T2D have specific safety or tolerability issues—including gastrointestinal adverse events, edema and weight gain or hypoglycemia.
The present study will assess the efficacy and safety of the experimental drug at 300 mg and 100 mg relative to placebo during 6 weeks of treatment by ABPM through 24 hours before dosing (baseline), after initial dosing, and after dosing for 6 weeks. Comparison of ABPM, seated and standing office blood pressure (BP), and accompanied symptoms between baseline and after initial dosing of the drug will primarily provide the safety information of the prescribed treatment with regard to the first dose effect as osmotic diuresis. Comparison of ABPM between baseline and at Week 6 will primarily provide the efficacy information of the new drug by evaluating the mean 24-hour BP, the daytime BP, and the night time BP.
The primary objective is to assess the effect of this experimental drug relative to placebo on blood pressure reduction by 24-hour ambulatory blood pressure monitoring (ABPM) after 6 weeks of treatment primarily focusing on the efficacy of the new drug. Overall safety and tolerability of the treatment will also be assessed.
Each potential subject must satisfy all of the following criteria at screening, or at the indicated visits, to be enrolled in the study.
Men and women between 18 and 75 years of age with hypertension and T2D who meet all of the following criteria:
- Hypertension (high blood pressure) on stable doses of 1 to 3 antihypertensive agents which must include either one of ACEi or ARB (unless known to be intolerant to ACEi/ARB), with or without other anti-hypertensive agents (calcium channel blockers, β-blockers or diuretics other than loop diuretics), for at least 5 weeks before screening.
- On stable doses of 1 to 3 oral anti-hyperglycemic agents which must include metformin, with or without other anti-hyperglycemic agents, such as sulphonylureas (SUs), thiazolidinediones (TZDs), or DPP-4 inhibitors, for at least 8 weeks before screening and has an HbA1c of 7.0% and 9.5% at screening.
- Fasting plasma glucose (FPG) 240 mg/dL (13.3 mmol/L) at Week -2
- Note: at the investigator’s discretion, based upon review of recent self-monitored blood glucose (SMBG) values, subjects not meeting the Week -2 FPG criteria may return to the investigational site within 7 days for a one-time repeat FPG and continue in the study if the subject’s repeat FPG meets the criteria.
- Fasting fingerstick glucose of 120 mg/dL (6.7 mmol/L) performed at home (with documentation of the value in the subject's diary or through glucose meter memory) or at the investigational site, on Day 1, prior to being randomized and receiving the first dose of double-blind study drug.
- Note: at the investigator’s discretion, based upon review of recent SMBG values, subjects not meeting the Day 1 glucose criterion may return to the investigational site within 7 days for assessment of a one-time repeat fingerstick glucose (performed at home or at the investigational site) and continue in the study if the subject’s repeat fingerstick glucose meets the criterion.
- Before randomization, a woman must be either:
- Not of childbearing potential: premenarchal; postmenopausal (older than 45 years of age with amenorrhea for at least 18 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH)); permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy,
- Of childbearing potential and practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: eg, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner should be the sole partner for that subject); true abstinence (when this is in line with the preferred and usual lifestyle of the subject).
- Note: If the childbearing potential changes after start of the study (eg, woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) a woman must begin a highly effective method of birth control, as described above.
- A woman of childbearing potential (ie, those subjects who do not meet the postmenopausal definition above), regardless of age must have a negative urine human chorionic gonadotropin (-hCG) pregnancy test at screening and baseline (predose, Day 1).
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction while participating in this study.
- Subjects must have 80% compliance (by pill count) with single-blind placebo (total capsule and tablet counts).
- Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
- Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of the procedures required for the study and are willing to participate in the study.
*Achieve Clinical Research conducts Phase II-IV Clinical Research Studies in Alabama. For more information about participating in a High Cholesterol Clinical Study, please visit our website or contact us directly at (205) 380-6434.