Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin

Conditions

• Diabetes
• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• insulin degludec — DRUG
  Injected s.c. (under the skin) once daily. The doses will be individually adjusted
• insulin aspart — DRUG
  Injected s.c. (under the skin) once daily. The doses will be individually adjusted.
• liraglutide — DRUG
  Injected s.c. (under the skin) once daily. The doses will be individually adjusted.

Study Details

This trial is conducted in Europe and North America. The aim of this trial is to compare the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec in subjects with type 2 diabetes. Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643 (NCT01193309) trial will be randomised to receive treatment intensification while subjects with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to receive insulin degludec treatment. Subjects are to continue their pre-trial metformin treatment.

Key Dates

Start date

Sep 30, 2011

Status verified

Jan 2017

Primary completion

Jul 31, 2012

Completion

Jul 31, 2012

Study Design

Enrollment

413 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: IDeg (non-randomised)
• Experimental: IDeg + IAsp
• Experimental: IDeg + liraglutide

Primary Outcome Measure

Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin) [ Time Frame: week 0, week 26 ]

Locations (48)

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