A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel Group Study Evaluating the Efficacy, Safety and Tolerability of JTT-130 Administered Twice Daily for 24 Weeks in Treatment-naïve, Metformin Only or Metformin plus Sulfonylurea -treated Obese Type 2 Diabetic Patients - PROMOTE

• Conditions: Type II Diabetes Mellitus; MedDRA version: 11.1Level: LLTClassification code 10012601Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2009-011965-10-CZ
• Lead Sponsor: Akros Pharma Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

1. Males and females, 18-70 years of age (inclusive) at the screening visit (Visit 1), with a stable weight (no known weight variation of > 5% within 3 months prior to Visit 1);
2. Able and willing to give written informed consent;
3. Body mass index (BMI) of > 27.0 kg/m2 and = 45.0 kg/m2 at Visit 1;
4. Have type 2 diabetes (HbA1c between 7.0% and 10.0% [inclusive]) at Visit 1;
5. Have fasting plasma glucose (FPG) levels of = 280mg/dL (15.5 mmol/L) at Visit 1 (up to one repeat measurement allowed on a different day within the screening window);
6. Are either drug naïve with respect to hypoglycemic agents (e.g., managed with diet and exercise only) OR are currently being treated with metformin (at least 1500 mg/day) alone or in combination with a sulfonylurea (at least half the maximum labeled daily dose or at the maximum tolerated dose). For this study, drug naïve is defined as either never having taken hypoglycemic agents OR previously taken hypoglycemic agents but discontinued them at least 1 month prior to Visit 1. Metformin and sulfonylurea dosing must be stable, defined as no change in dose for at least 2 months prior to Visit 1 and no expected change during the study;
7. Females may participate if they meet one of the following criteria:
• Surgically sterile (e.g., hysterectomy, bilateral oophorectomy or tubal ligation)
OR
• Post-menopausal (i.e., lack of menses for = 12 months at Visit 1 with no other identified biological/surgical cause AND a serum FSH measurement of = 40 mIU/mL [40 IU/L] at Visit 1)
OR
• Of childbearing potential and are compliant with a contraceptive regimen. Acceptable contraception includes: oral or transdermal contraceptives, intrauterine devices, implantable or injectable contraceptives, condom with a spermicide, diaphragm, cervical cap, vaginal sponge, vaginal ring, or female condom”. The contraceptive regimen must be maintained during the study and for at least 2 weeks after discontinuation of study drug;
Note: Females reporting lack of menses for = 12 months prior to Visit 1 that have a serum FSH < 40 mIU/mL (40 IU/L) at Visit 1 will be considered of childbearing potential and must comply with a contraceptive regimen as described above.
8. Males with partners of childbearing potential must agree to utilize a barrier contraceptive for the duration of the study and for at least 2 weeks after discontinuation of the study drug.

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

The following criteria will exclude a patient from participating in the study: 1. Females who are pregnant or breast-feeding; 2. Known medical history or presence of type 1 diabetes or pancreatitis; 3. Known medical history of acute metabolic diabetic complications (such as ketoacidosis, lactic acidosis, or hyperosmolar coma) within the past 6 months prior to Visit 1; 4. Known medical history or presence of unstable or rapidly progressing retinopathy, nephropathy or neuropathy; 5. Acute coronary syndrome (e.g., myocardial infarction or unstable angina), NYHA (New York Heart Association) class III and IV heart failure, percutaneous coronary intervention (Percutaneous Transluminal Coronary Angioplasty ?PTCA? or similar procedures), coronary artery bypass graft surgery (CABG), cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to Visit 1 or a history of severe peripheral vascular disease; 6. Uncontrolled hypertension (SBP > 180 mmHg or DBP > 100 mmHg at Visit 1, up to three repeat measurements allowed); 7. A history of, or presence of, malignancy (except for treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix); 8. Known medical history or presence of genetic conditions that influence weight and/or glucose metabolism or indicate adrenal/HPA-axis hyperfunction/hypofunction (e.g., Addison’s or Cushing’s Disease); 9. Known medical history or presence of anorexia nervosa, bulimia nervosa or binge eating disorder; 10. Known acute or chronic gastrointestinal symptoms or conditions at Visit 1 that are considered clinically-relevant by the Investigator (e.g., inflammatory bowel disease, irritable bowel syndrome, celiac sprue); 11. Was hospitalized for a clinically relevant condition or major intervention, according to the investigator’s medical judgment within the 6 months prior to Visit 1, had a surgical treatment for weight loss or has a scheduled hospitalization during the study period; 12. Does not meet all medication restriction criteria, as described in Appendix 1 of the protocol; 13. Known clinically relevant medical history or presence of any other conditions that would put the patient at risk, or would interfere with the study or the interpretation of the data, according to the principal investigator’s medical judgment; in general, stable conditions, with the exception of those listed as other exclusion criteria, or those that would prevent the patients to comply with the concomitant medication restrictions could be considered acceptable for study inclusion; 14. Abnormal liver and kidney functions as measured by AST, ALT, or bilirubin = 2.0 x ULN and serum creatinine = 1.5 mg/dL for men or = 1.4 mg/dL for women at Visit 1; 15. Serum thyroid stimulating hormone (TSH) = 1.5 x ULN at Visit 1; 16. Triglycerides > 500 mg/dL (5.6 mmol/L) at Visit 1; 17. Hemoglobin < 10 g/dL for males and < 9 g/dL females, or any known hemoglobinopathies or hemolytic conditions at Visit 1; 18. Have donated and/or received any blood or blood products within 1 month prior to Visit 1; 19. Any change in smoking habits (or usage of other nicotine products) within 2 months prior to Visit 1; 20. Test positive for Hepatitis B surface antigen (HBsAg) or anti-Hepatitis C (HCV) antibody at Visit 1; 21. Weight gain of > 2.0 % or poor study drug compliance (< 80% or > 120%) during the two-week single-blind placebo Run-in Period (between Visit 2 and Visit 3); 22. Cannot communicate reliably with th

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the change in glycosylated hemoglobin (HbA1c) levels after JTT-130 is administered twice daily for 24 weeks in obese type 2 diabetic patients compared to placebo.;Secondary Objective: •To investigate the weight loss effect of JTT-130 administered twice daily for 24 weeks to obese type 2 diabetic patients compared to placebo.<br>•To investigate the effect of JTT-130 administration on ancillary efficacy measures (e.g., fasting plasma glucose, plasma insulin, serum lipid parameters, waist circumference) in obese type 2 diabetic patients compared to placebo. <br>•To determine the safety and tolerability of JTT-130 when administered for 24 weeks in obese type 2 diabetic patients.<br>;Primary end point(s): The primary efficacy endpoint in this study is HbA1c reduction: change from baseline to EOT