Comparing Efficacy and Safety of Thrice Daily Versus Twice Daily NovoMix® 30 (Biphasic Insulin Aspart 30) in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insuli

Phase 4

Completed

• Conditions: Health Condition 1: null- Type 2 diabetes inadequately controlled with basal insulinHealth Condition 2: E11- Type 2 diabetes mellitus

• Registration Number: CTRI/2016/05/006967
• Lead Sponsor: ovo Nordisk India Private Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-04-18
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

1. Male or female, age >= 18 years at the time of signing informed consent 2. Type 2 diabetes subjects clinically diagnosed >= 12 months prior to the day of screening (Visit 1)

3. Treated with basal insulin >= 90 days prior to the day of screening (Visit 1). The following basal insulin are allowed :

â?? insulin analogue once daily (OD)

â?? Neutral Protamine Hagedorn (NPH) OD or BID

4. Treatment with metformin with or without one additional OAD for at least 90 days prior to the day of screening (Visit 1)

o Metformin must be at a stable dose of at least 1500 mg daily or maximum tolerated dose for at least 60 days prior to screening (Visit 1)

â?? One additional OAD:

o Sulphonylurea

o Glinides

o α-glucosidase inhibitors

o Dipeptidyl-peptidase-4 inhibitors

o Sodium glucose co-transporter 2 (SGLT2) inhibitors (if applicable)

5. HbA1c 7.5%â??10.0% (both inclusive) by central laboratory analysis at screening (Visit 1)

6. Able and willing to intake three main meals daily (breakfast, lunch and main evening meal)

throughout the trial. Definition of main meal as judged by the investigator

Exclusion Criteria

1. Previous insulin intensification regimen for more than 14 days: premixed insulin thrice daily,

basal-bolus regimen or continuous subcutaneous insulin infusion (CSII). Treatment during

hospitalisation or during gestational diabetes is allowed for periods longer than 14 days

2. Anticipated initiation or change in concomitant medications for more than 14 consecutive

days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat,

thyroid hormones, systemic corticosteroids)

3. Impaired liver function, defined as alanine aminotransferase (ALT) >= 2.5 times upper

normal limit at screening (Visit 1)

Study & Design

• Study Type: Interventional
• Study Design: Not specified