A 4-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate The Efficacy and Safety of Saxagliptin in Comparison to Placebo as Add-on Treatment to Metformin XR in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control with Diet and Exercise and a Stable Dose of Metformin XR ≥ 1500 mg/day - ND

• Conditions: Type II diabetes; MedDRA version: 9.1Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate control

• Registration Number: EUCTR2008-000976-26-IT
• Lead Sponsor: BRISTOL-M.SQUIBB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1) Signed Written Informed Consent a) Subjects must be willing and able to give written informed consent. 2) Target Population a) Subjects with a diagnosis of type 2 diabetes mellitus requiring treatment with at least 1500 mg, but not greater than 2550 mg of a stable dose of metformin IR or XR as monotherapy for at least 8 weeks prior to screening are eligible b) A1C ≥ 7% and ≤ 10% obtained at the screening visit. c) Fasting C-peptide concentration ≥ 1.0 ng/ml at the screening visit. d) Body mass index ≤ 40 kg/m2 at the screening visit. 3) Age and Sex a) Men and women, ages 18 to 77 years of age. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized
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

1) Sex and Reproductive Status a) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 4 weeks after the last dose of investigational product. b) WOCBP using a prohibited contraceptive method. c) Women who are pregnant or breastfeeding. d) Women with a positive pregnancy test on enrollment or prior to investigational product administration. 2) Target Disease Exceptions a) Symptoms of poorly controlled diabetes that would preclude participation in this placebo-controlled trial including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the last three months prior to screening or other signs and symptoms. b) History of diabetic ketoacidosis or hyperosmolar nonketotic coma. c) Insulin therapy within one year of screening (with the exception of insulin therapy during a hospitalization or use in gestational diabetes. 3) Medical History and Concurrent Diseases a) Significant cardiovascular history defined as: i) History of myocardial infarction, coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to study entry. ii) Congestive heart failure defined as New York Heart Association (NYHA) stage III and IV and/or known left ventricular ejection fraction of ≤ 40%. b) Chronic or repeated intermittent corticosteroid treatment (subjects receiving stable doses of replacement corticosteroid therapy may be enrolled). c) History of unstable or rapidly progressing renal disease. d) History of alcohol or drug abuse within the previous one year. e) Unstable major psychiatric disorders. f) Immunocompromised individuals such as subjects who have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus. g) History of hemoglobinopathies (sickle cell anemia or thalassemias, sideroblastic anemia). h) Donation of blood or plasma to a blood bank within three months of screening. i) Administration of any other investigational drug or participation in a clinical research trial within 30 days of planned enrollment to this study. j) Any condition which in the Investigator?s opinion may render the subject unable to complete the study or which may pose significant risk to the subject. 4) Physical and Laboratory Test Findings a) Active liver disease and/or significant abnormal liver function defined as AST > 2 x ULN and/or ALT > 2x ULN and /or serum total bilirubin > 2.0 mg/dl. b) History of positive serologic evidence of current infectious liver disease including anti-HAV (IgM), HbsAg, or anti-HCV. Subjects who may have isolated positive anti HBs may be included. c) Serum creatinine (Scr) ≥ 1.5 mg/dl (132.6 μmol/L) for males and ≥ 1.4 mg/dl (123.8 μmol/L) for females. d) Creatine Kinase ≥ 3x ULN. e) Anemia, of any etiology defined as hemoglobin ≤ 12.0 g/dL (120 g/L) for men and hemoglobin ≤ 11.0 g/dL (110 g/L) for women. f) Subjects who have an abnormal TSH value at screening will be further evaluated by free T4. Subjects with an abnormal free T4 will be excluded. 5) Allergies and Adverse Drug Reactions a) Subjects who have contraindications to therapy as outlined in the Saxagliptin Investigator Brochure, metformin XR/metformin package insert package insert. 6) Prohibited Therapies and/or Medications 7) Other Exclusion Criteria

Study & Design

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