The aim of the trial is to compare FIAsp (faster-acting insulin aspart) to insulin aspart, both in combination with insulin glargine and metformin in adults with type 2 diabetes.

Phase 3

Completed

• Conditions: Health Condition 1: null- Diabetes Mellitus, Type 2Health Condition 2: E11- Type 2 diabetes mellitus

• Registration Number: CTRI/2014/01/004285
• Lead Sponsor: ovo Nordisk AS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-01-21
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 95

Inclusion Criteria

•Current once daily treatment with insulin NPH (Neutral Protamine Hagedorn), insulin detemir or glargine for at least 3 months prior to the screening visit (visit 1)

•Body mass index (BMI) equal to or below 40.0 kg/m2

•HbA1c by central laboratory: a. 7.0 - 9.5% (53 â?? 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (visit 1) or b. 7.0 - 9.0% (53 â?? 75 mmol/mol) (both inclusive) in the metformin + other OAD (oral antidiabetic drug) (SU, glinide, DDP-IV inhibitors, AGI) combination group at the screening visit (visit 1)

•Treated with basal insulin for at least 6 months prior to screening (visit 1)

•Type 2 diabetes (diagnosed clinically) for 6 months or longer at time of screening (visit 1)

Exclusion Criteria

•Any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days consecutive treatment) and not 3 months prior to the screening visit (visit 1)

•Cardiovascular disease, within the last 6 months prior to screening (visit 1), defined as: stroke, decompensated heart failure New York Heart Association (NYHA) class III or IV, myocardial infarction, unstable angina pectoris or coronary arterial bypass graft or angioplasty

•Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (visit 1)

•Use of GLP-1 (glucagon-like peptide-1) agonists and/or TZDs within the last 3 months prior to screening (visit 1)

Study & Design

• Study Type: Interventional
• Study Design: Not specified