Efficacy of blood sugar control with Victoza® (liraglutide) vs. oral antidiabetic drugs as add-on to metformin treatment in subjects with type 2 diabetes inadequately controlled on metformin treatment alone

Phase 1

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 18.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-002417-29-LV
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-11
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1994

Inclusion Criteria

1. Male or female = 18 years of age at the time of signing informed consent.
2. Subjects diagnosed (clinically) with type 2 diabetes = 90 days prior to the screening visit.
3. Stable daily dose of metformin as monotherapy = 1500 mg or maximum tolerated dose within 60 days prior to the screening visit.
4. HbA1c 7.5-9.0% (59-75 mmol/mol) (both inclusive) and measured within the last 90 days prior to the screening visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1694
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

1. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice).
2. Receipt of any investigational medicinal product within 30 days before the screening visit.
3. Treatment with any medication for the indication of diabetes other than metformin in a period of 60 days before the screening visit. An exception is short-term treatment (=7 days in total) with insulin in connection with intercurrent illness.
4. Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy in controlling glycaemia with Victoza® (liraglutide) as add-on to metformin vs. oral antidiabetic drugs (OADs) as add-on to metformin after up to 104 weeks of treatment in subjects with type 2 diabetes (T2D) treated in primary care, inadequately controlled with metformin monotherapy;Secondary Objective: To compare efficacy and safety of Victoza® as add-on to metformin vs. OADs as add-on to metformin after up to 104 weeks of treatment in subjects with type 2 diabetes (T2D) treated in primary care, inadequately controlled with metformin monotherapy;Primary end point(s): Time to inadequate glycaemic control defined as HbA1c > 7.0% (53 mmol/mol) at two scheduled consecutive visits ;Timepoint(s) of evaluation of this end point: After the first 26 weeks of treatment and up to 104 weeks

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Number of subjects who achieve (Yes/No):<br> 1. HbA1c = 6.5% (48 mmol/mol)<br> 2. HbA1c = 7.0% (53 mmol/mol) without weight gain<br> <br> Change from baseline in:<br> 3. Fasting plasma glucose (FPG)<br> 4. Body weight<br> ;<br> Timepoint(s) of evaluation of this end point: For all secondary endpoints:<br> At 104 weeks or at premature treatment discontinuation <br>