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Effect of Liraglutide on Blood Glucose Control in Japanese Subjects With Type 2 Diabetes

Effect of Liraglutide on Glycaemic Control in Japanese Subjects With Type 2 Diabetes.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00154414
Enrollment
226
Registered
2005-09-12
Start date
2005-01-31
Completion date
2006-05-31
Last updated
2017-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

Brief summary

This trial is conducted in Japan. The aim of this research trial is to evaluate the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in Japanese subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.

Interventions

DRUGliraglutide

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No

Inclusion criteria

* Subjects diagnosed with type 2 diabetes and treated with diet therapy with or without single oral drug therapy * 7.0 % =\< HbA1c \< 10.0 % * Body Mass Index (BMI) \< 30.0 kg/m\^2

Exclusion criteria

* Subjects treated with thiazolidinediones or insulin * Subjects with any serious medical conditions

Design outcomes

Primary

MeasureTime frame
HbA1cafter 14 weeks treatment

Secondary

MeasureTime frame
Glycaemic control parameters (fasting plasma glucose, post prandial plasma glucose) after 14-week treatment
Body weight after 14 weeks.
Safety and tolerability

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026