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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes

• Registration Number: NCT00318422
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted globally (the United States of America excepted). This trial is designed to show the effect of treatment with liraglutide when added to existing glimepiride therapy and to compare this to both glimepiride monotherapy and to rosiglitazone as add-on therapy to glimepiride.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-04-25
• Study First Submitted QC: 2006-04-25
• Study First Posted: 2006-04-26
• Study Start: 2006-05
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1041

Inclusion Criteria

• Type 2 diabetes
• Treatment with oral anti-diabetic drugs for at least 3 months
• HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy
• Body Mass Index (BMI) less than or equal to 45.0 kg/m2.

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Exclusion Criteria

• Treatment with insulin within the last three months
• Treatment with any drug that could interfere with the glucose level
• Any serious medical condition
• Females who are pregnant, have the intention of becoming pregnant or are breastfeeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	after 26 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
body weight
Safety and tolerability
beta-cell function
Glycemic control parameters (fasting plasma glucose, -glucose profiles)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇹🇷 Izmir, Turkey