NL-OMON33243
Completed
Phase 2
An exploratory phase 2 study to asses the effect of Dapagliflozin on Glomerular Filtration Rate (GFR) in subjects with type 2 Diabetes who have inadequate glycemic and blood pressure (BP) control. - MB102-035
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus Type 2
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 15
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) willing and able to give signed and dated written informed consent.
- •2\) type 2 diabetes with inadequate glycemic control, defined as
- •central laboratory HbA1c \>\= 6\.6% and \<\= 9\.5% obtained at the enrollment visit.
- •3\) metformin (XR or IR) and/or SU for at least 4 weeks prior to enrollment at any stable dose.
- •4\). inadequate BP control, defined as seated SBP \>\= 130 and \< 165 mmHg AND/OR seated DBP \>\= 80 and \< 105 mmHg
- •5\) C\-peptide \>\= 0\.8 ng/ml (0\.27 nmol/L)
- •6\) BMI \<\= 45\.0 kg/m2 at the enrollment visit.
- •7\) Men and women, ages \>\= 18 to \<\= 70 years.
- •Women of childbearing potential (WOCBP) must be using an adequate method of
- •contraception
Exclusion Criteria
- •Main exclusion criteria:
- •1\) WOCBP who are unwilling or unable to use an acceptable method to avoid
- •pregnancy for the entire study period.
- •2\) Women who are pregnant or breastfeeding.
- •3\) Women with a positive pregnancy test on enrollment or prior to investigational product administration and/or injection of iohexol, and, for subjects participating in the substudy, prior to administration of radioisotopes for determination of RCM and PV.
- •4\) Estimated GFR (eGFR) by the Modification of Diet in Renal Disease (MDRD)
- •formula \<\= 60 mL/min/1\.73m2 and \>\= 150 mL/min/1\.73m2\.
- •5\) Urine albumin to creatinine ratio (UACR) \>\= 300 mg/g (33\.9 mg/mmol/Cr).
- •6\) Aspartate Aminotransferase (AST) \> 3X Upper limit of normal (ULN).
- •7\) Alanine aminotransferase (ALT) \> 3X ULN.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 2
Phase IIa Study to Characterize the Effects of the Spiegelmer® NOX H94 on Anemia of Chronic Disease in Patients With Multiple Myeloma or LymphomaAnemia of Chronic DiseaseD63.0Anaemia in neoplastic diseaseDRKS00004366OXXON Pharma AG48
Active, not recruiting
Not Applicable
An Exploratory Phase 2 Study to Assess the Effect of Dapagliflozin on GlomerularFiltration Rate (GFR) in Subjects with Type 2 Diabetes who have Inadequate Glycemicand Blood Pressure (BP) ControlPharmacogenetics Blood Sample Amendment 01 (v1.0, dated 24-Jul-2009)EUCTR2009-010221-39-NLBristol Myers Squibb International Corporation150
Active, not recruiting
Not Applicable
Phase IIa study to investigate the efficacy of NOX-H94 in the treatment of anemia in patients with cancer.anemia of chronic disease in patients with cancerMedDRA version: 16.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 100000004864MedDRA version: 16.0Level: LLTClassification code 10054310Term: Anemia of chronic diseaseSystem Organ Class: 100000004851Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2012-001525-27-ATOXXON Pharma AG48
Active, not recruiting
Phase 1
Phase IIa study to investigate the efficacy of NOX-H94 in the treatment of anemia in patients with cancer.EUCTR2012-001525-27-BGOXXON Pharma AG48
Completed
Not Applicable
A study (study No. 2) for evaluating the effects of intake of food containing lactic acid bacteria and oligosaccharide on intestinal environment. A placebo-controlled, randomized, double-blind, cross-over trial.Subjects with a tendency for constipationJPRN-UMIN000038721KSO Corporation22