Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin

Conditions

• Diabetes
• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• liraglutide — DRUG
  Starting dose of 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day is reached. Administered subcutaneously (s.c., under the skin) once daily + metformin tablets (at least 1000 mg/day)
• sitagliptin — DRUG
  100 mg/day sitagliptin tablets once-daily + metformin (at least 1000 mg/day)
• placebo — DRUG
  Sitagliptin placebo tablets once-daily
• placebo — DRUG
  Sitagliptin placebo tablets once-daily

Study Details

This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes not achieving adequate glycaemic control on sitagliptin and metformin.

Key Dates

Start date

Dec 2, 2013

Status verified

Sep 2018

Primary completion

Jun 15, 2015

Completion

Jun 15, 2015

Study Design

Enrollment

407 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Liraglutide + metformin + sitagliptin placebo
• Experimental: Sitagliptin + metformin + liraglutide placebo

Primary Outcome Measure

Change in HbA1c (Glycosylated Haemoglobin) [ Time Frame: From baseline to week 26 ]

Locations (58)

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