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Efficacy in Controlling Glycaemia With Victoza® (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 (LIRA-PRIME)

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ClinicalTrials.gov Identifier: NCT02730377
Recruitment Status : Active, not recruiting
First Posted : April 6, 2016
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted globally. The aim of the trial is to investigate efficacy in controlling glycaemia with Victoza® (liraglutide) as add-on to metformin background treatment vs. OADs as add-on to metformin background treatment for 104 weeks of treatment in subjects with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Drug: alpha-glucosidase inhibitors Drug: DPP-4 inhibitors Drug: meglitinides Drug: SGLT-2 inhibitors Drug: sulphonylurea Drug: thiazolidinediones Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1994 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy in Controlling Glycaemia With Victoza® (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
Actual Study Start Date : March 28, 2016
Estimated Primary Completion Date : April 15, 2019
Estimated Study Completion Date : August 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Experimental: Liraglutide 1.8 mg
Add-on to metformin
Drug: liraglutide
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

Active Comparator: OAD
Add-on to metformin. Treatment with one OAD selected at the discretion of the investigator. Subjects randomised to the OAD arm must remain on the same OAD throughout the trial.
Drug: alpha-glucosidase inhibitors
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

Drug: DPP-4 inhibitors
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

Drug: meglitinides
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

Drug: SGLT-2 inhibitors
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

Drug: sulphonylurea
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

Drug: thiazolidinediones
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.




Primary Outcome Measures :
  1. Time to inadequate glycaemic control defined as HbA1c above 7.0% (53 mmol/mol) [ Time Frame: After 26 weeks ]
  2. Time to inadequate glycaemic control defined as HbA1c above 7.0% (53 mmol/mol) [ Time Frame: Up to 104 weeks ]

Secondary Outcome Measures :
  1. Number of subjects who achieve HbA1c below or equal to 6.5% (48 mmol/mol) [ Time Frame: At week 104 ]
  2. Number of subjects who achieve HbA1c below or equal to 7.0% (53 mmol/mol) without weight gain [ Time Frame: At week 104 ]
  3. Change in fasting plasma glucose (FPG) [ Time Frame: Baseline (week 0), week 104 ]
  4. Change in Body weight [ Time Frame: Baseline (week 0), week 104 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Inclusion Criteria: - Male or female at least 18 years of age at the time of signing informed consent - Subjects diagnosed (clinically) with type 2 diabetes equal to or above 90 days prior to the screening visit - Stable daily dose of metformin as monotherapy equal to or above 1500 mg or maximum tolerated dose within 60 days prior to the screening visit - HbA1c 7.5-9.0% (59-75 mmol/mol) (both inclusive) and measured within the last 90 days prior to the screening visit Exclusion Criteria: - 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) - 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 (below or equal to 7 days in total) with insulin in connection with intercurrent illness - Receipt of any investigational medicinal product within 30 days before the screening visit - Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730377


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Sponsors and Collaborators
Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02730377     History of Changes
Other Study ID Numbers: NN2211-4232
2015-002417-29 ( EudraCT Number )
U1111-1170-7035 ( Other Identifier: WHO )
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2,4-thiazolidinedione
Meglitinide
Metformin
Liraglutide
Dipeptidyl-Peptidase IV Inhibitors
Glycoside Hydrolase Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action