LIRA-PRIME: A trial comparing the time period with blood sugar control using VictozaÂ® (liraglutide) vs. oral antidiabetic treatment for up to 104 weeks of treatment in subjects with type 2 diabetes in a primary care setting

LIRA-PRIME: Efficacy in controlling glycaemia with VictozaÂ® (liraglutide) 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 inadequately controlled with metformin monotherapy and treated in a primary care setting - LIRA-PRIME

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/09/007312

Enrollment

1994

Registered

2016-09-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: E08-E13- Diabetes mellitus Health Condition 2: null- Type 2 Diabetes mellitus

Interventions

Intervention1: Victoza- Liraglutide : 1.8mg, 104 weeks Sub-cutaneous route of administration Control Intervention1: OADs: Alpha- Glucosidase Inhibitors, DPP-4 inhibitors, Meglitinides, Sodium/Glucose

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female >= 18 years of age limit of signing informed consent. 2. Subjects diagnosed(clinically) with type 2 diabetes >= 90 days prior to screening visit. 3. Stable daily dose of metformin as a monotherapy >= 1500mg or maximum tolerated dose within 60 days prior to screening visit. 4. HbA1C 7.5-9.0%(59-75mmol/mol)(both inclusive ) and measured within the last 90 days prior to screening visit.

Exclusion criteria

Exclusion criteria: 1. Previous participation in this trial. Participation is defined as signed informed consent. 2. 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). 3. Receipt of any investigational medicinal product within 30 days before the screening visit. 4. 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 ( 5. Any disorder, which in the investigatorâ??s opinion might jeopardise subjectâ??s safety or compliance with the protocol.

Design outcomes

Primary

Measure	Time frame
Time to inadequate glycaemic control defined as HbA1c 7.0% (53mmol/mol) at two scheduled consecutive visits after the first 26 weeks of the treatment and up to 104 weeks Timepoint: After 26 Weeks and 104 weeks	—

Secondary

Measure	Time frame
1. number of subjects who at 104 weeks or at premature treatment discontinuation achieve (Yes/No): a. HbA1c â?¤ 6.5% (48 mmol/mol) b. HbA1c â?¤ 7.0% (53mmol/mol) withou weight gain 2. Change from baseline at 104 weeks or at premature treatment discontinuation in: a. fasting blood glucose(FPG) b. Body weight Timepoint: 104 weeks	—

Countries

Canada, India, Latvia, Lebanon, Russian Federation, Serbia, Turkey, United States of America

Contacts

Public ContactDr Anil N Shinde

Novo Nordisk India Private Ltd.

ansd@novonordisk.com91-8040303471

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026