A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas

Not Applicable

• Conditions: -E119 Non-insulin-dependent diabetes mellitus, without complications; Non-insulin-dependent diabetes mellitus, without complications; E119

• Registration Number: PER-030-06
• Lead Sponsor: BRISTOL MYERS SQUIBB COMPANY,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-31
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Patients must want and be able to sign written informed consent.
2) Patients with type 2 diabetes mellitus that required treatment with a submaximal dose of a sulphonylurea for ≥ 2 months and ≤ 12 months.
3) HbA1C ≥ 7.5% and ≤ 10.0% obtained at the screening visit.
4) HbA1C ≥ 7.0% and MFPG ≥140 mg / dl (7.8 mmo / l) or MFWBG ≥131 mg / dl (7.3 mmol / l) or GPA (central laboratory) ≥ 140 mg / dl ( 7.8 mmol / l) in the randomization.
5) Fasting C-peptide concentration ≥ 1.0 ng / ml.
6) Body mass index ≤ 40 kg / m2.
7) Men and women, ≥18 and ≤77 years of age. Women should not be breastfeeding and should not be pregnant. Women of childbearing age (WOCBP) should use an adequate method of contraception to avoid pregnancy during the study and up to 4 weeks after the study.

Exclusion Criteria

1) WOCBP who are unable or unwilling to use an acceptable method to avoid pregnancy during the entire study period and for up to 4 weeks after the study.
2) WOCBP using a prohibited method of contraception.
3) Women who are pregnant or breastfeeding.
4) Women with a positive pregnancy test at admission or in the introduction phase or before the administration of the study medication.
5) Diabetes that is poorly controlled.
6) History of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
7) Treatment with insulin within one year of the selection.
8) Significant cardiovascular history.
9) Chronic corticosteroid treatment or repeated intermittently.
10) History of unstable or rapidly progressive renal disease.
11) History of alcohol or drug abuse within the previous year.
12) Unstable major psychiatric disorders.
13) Immunocompromised individuals.
14) History of hemoglobinopathies.
15) Donation of blood or plasma to a blood bank within three months of the selection.
16) Administration of any other medication under investigation or participation in a clinical research study within 30 days of the expected admission to the phase of introduction of this study.
17) Any condition that may cause the patient to be unable to complete the study or that may pose a significant risk to the patient.
18) Active liver disease and / or liver function significantly abnormal.
19) History of positive serological evidence of current infectious liver disease.
20) Serum creatinine (Scr) ≥ 2.0 mg / dl (176 umol / l).
21) Creatinine kinase ≥ 3 x ULN.
22) Anemia, of any etiology.
23) Absolute lymphocyte count ≤1000 cells / mm3
24) Platelet count <140,000 cells / ul.
25) Patients who present an abnormal TSH value in the selection will undergo a greater evaluation with free T4. Patients with abnormal free T4 will be excluded.
26) Patients who have contraindications to treatment.
27) History of administration of any treatment for hyperglycemia (apart from sulfonylureas) for more than three consecutive days or seven non-consecutive days during the twelve weeks prior to selection.
28) Use of any other medication against hyperglycemia after entry into the introduction phase.
29) Treatments with potent inhibitors or inducers of cytochrome P450 3A4.
30) Previous treatment with saxagliptin or any DPP-IV inhibitor.
31) Prisoners or patients who are detained for the treatment of a psychiatric or physical illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified