Trial to investigate efficacy and safety of FIAsp in a basal-bolus regimen versus basal insulin therapy, both in combination with metformin in adult subjects with type 2 diabetes

Phase 3

Completed

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

• Registration Number: CTRI/2014/01/004289
• Lead Sponsor: ovo Nordisk AS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-11-13
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

18 Years and older

•Type 2 diabetes (diagnosed clinically) for at least 6 months prior to the screening visit (Visit 1)

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

•Current treatment with a) metformin with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg or b) metformin in combination with sulfonylurea (SU) or glinide or Dipeptidyl peptidase-IV inhibitors and/or alpha-glucosidase inhibitors (AGI) with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg

•HbA1c by central laboratory a) 7.5-9.5% (58 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (Visit 1) or b) 7.5-9.0% (58 - 75 mmol/mol) (both inclusive) in the metformin + other oral antidiabetic drug (OAD) (sulphonylurea (SU), glinide, dipeptidyl peptidase-IV (DDP-IV) inhibitors, alpha-glucosidase inhibitors (AGI) combination group at the screening visit (Visit 1)

•Body mass index (BMI) equal or less than 40.0 kg/m2

Exclusion Criteria

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

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

•Recurrent severe hypoglycaemia (more than one 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1cTimepoint: Week 0, week 18

Secondary Outcome Measures

Name	Time	Method
Change from baseline in body weightTimepoint: Week 0, week 18;Number of adverse eventsTimepoint: Weeks 0-18;Number of treatment emergent hypoglycaemic episodesTimepoint: Weeks 0-18;Self-measured plasma glucose (SMPG) 7-point profile: Post prandial plasma glucose (PPG), overall 2-hour mean (of breakfast, lunch, main evening meal)Timepoint: After 18 weeks of randomised treatment;Self-measured plasma glucose (SMPG) 7-point profile: Prandial plasma glucose (PG) increment, overall 2-hour mean (of breakfast, lunch, main evening meal)Timepoint: After 18 weeks of randomised treatment