Study of Effectiveness of Liraglutide Added to High Dose Insulin in Type II Diabetics

Conditions

• Diabetes Mellitus, Type II

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Liraglutide — DRUG
  SC, 1.8mg,QD, six months to one year
• Insulin — DRUG
  SC, will be titrated during the study, 4 times a day, 1 year

Study Details

The purpose of this study is to determine the effect of adding liraglutide to high dose insulin therapy compared to high dose insulin therapy alone in patients with insulin-treated Type 2 diabetes with insulin requirements of \> 100 units of insulin per day.

Key Dates

Start date

Dec 31, 2011

Status verified

Feb 2021

Primary completion

Nov 30, 2013

Completion

Nov 30, 2013

Study Design

Enrollment

37 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: liraglutide plus insulin
  Patients were randomized to receive liraglutide plus insulin (LIRA) for 12 months.
• Active Comparator: Insulin titration only
  Patients were randomized to receive insulin only (control) for 6 months. The controls were then crossed over to receive liraglutide plus insulin for 6 months after the initial control period.

Primary Outcome Measure

Change from baseline in HbA1c at six months [ Time Frame: baseline and six months ]

Locations (1)

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