A

Not Applicable

• Conditions: -E112 Non-insulin-dependent diabetes mellitus, with renal complications; Non-insulin-dependent diabetes mellitus, with renal complications; E112

• Registration Number: PER-054-13
• Lead Sponsor: AbbVie Inc o tambien conocido como AbbVie,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-26
• Study Completion: 2018-03-09
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

1. Subject is 18 – 85 years of age.
2. Subject has voluntarily signed and dated an Informed Consent Form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be
signed before any study-specific procedures are performed.
3. Subject has type 2 diabetes and has been treated with at least one anti-hyperglycemic medication and ACEi/or ARB (RAS inhibitor) for at least 3 months prior to the Screening Period. Subject cannot have type 1 diabetes as defined by onset before age 35 requiring chronic insulin therapy within 12 months of diagnosis of type 1 diabetes.
4. HbA1c ≤ 12%. The rest of the information is included in the protocol.

Exclusion Criteria

1. Subject has a history of moderate or severe peripheral edema, pulmonary edema or facial edema unrelated to trauma or a history of myxedema in the prior 6 months to Screening.
2. Subject has a history of pulmonary hypertension requiring oxygen therapy, and/or endothelin receptor antagonist or phosphodiesterase therapy or any lung diseases requiring oxygen therapy (e.g., chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis).
3. Subject has a documented diagnosis of heart failure, previous hospitalization for heart failure or current or constellation of symptoms (dyspnea on exertion, pedal edema, orthopnea, paroxysmal nocturnal dyspnea) felt to be compatible with heart failure, that was not explained by other causes, and for which there was a change in medication or other management directed at heart failure.
4. Subject has known non-diabetic kidney disease (other than kidney stones).
5. Subject has a history of symptomatic hypotension within the last 6 months.
6. Subject has a body mass index (BMI) > 45.
The rest of the information is included in the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified