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)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02730377 |
|
Recruitment Status :
Completed
First Posted : April 6, 2016
Results First Posted : July 7, 2020
Last Update Posted : July 7, 2020
|
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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) |
| Actual Enrollment : | 1991 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 |
| Actual Primary Completion Date : | August 5, 2019 |
| Actual Study Completion Date : | August 12, 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
MedlinePlus related topics:
Blood Sugar
Drug Information available for:
Liraglutide
| 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 :
- Time to Inadequate Glycaemic Control [ Time Frame: Weeks 26-104 ]Inadequate glycaemic control was defined as glycosylated haemoglobin (HbA1c) of 7.0% (53 mmol/mol) or greater at two consecutive visits after the first 26 weeks of treatment and up to 104 weeks. 25%, median (50%) and 75% percentiles for the cumulative distribution function, are obtained from the Kaplan-Meier survival function. HbA1c was recorded at weeks 38, 52, 65, 78, 91 and 104.
Secondary Outcome Measures :
- Time to Premature Treatment Discontinuation (for Any Reason Including Inadequate Glycaemic Control) [ Time Frame: Weeks 0-104 ]The time to premature treatment discontinuation (for any reason including inadequate glycaemic control) was analysed and presented using the generalised log rank test. 25%, median (50%) and 75% percentiles for the cumulative distribution function, are obtained from the Kaplan-Meier survival function.
- Change in HbA1c [ Time Frame: Week 0, week 104/premature treatment discontinuation ]Change from baseline (week 0) in HbA1c at week 104 or at premature treatment discontinuation is presented.
- Participants Who Achieve HbA1c ≤6.5% (Yes/No) [ Time Frame: Week 104/Premature treatment discontinuation ]Participants who achieved HbA1c ≤6.5% (yes/no) is presented.
- Participants Who Achieve HbA1c ≤7.0% Without Weight Gain [ Time Frame: Week 104/Premature treatment discontinuation ]Participants who achieved HbA1c ≤7.0% without weight gain (yes/no) is presented.
- Participants Who Achieve HbA1c ≤7.0% Without Treatment Emergent Severe Hypoglycaemic Episodes or BG Confirmed Symptomatic Hypoglycaemic Episodes [ Time Frame: Week 104/Premature treatment discontinuation ]Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 millimoles per liter (mmol/L) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than the day after the last day on trial product. Participants who achieved HbA1c ≤7.0% without treatment emergent severe hypoglycaemic episodes or BG confirmed symptomatic hypoglycaemic episodes (yes/no) is presented.
- Participants Who Achieve HbA1c ≤7.0% Without Weight Gain and no Treatment Emergent Severe Hypoglycaemic Episodes or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes [ Time Frame: Week 104/Premature treatment discontinuation ]Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than the day after the last day on trial product. Participants who achieved HbA1c ≤7.0% without weight gain and no treatment emergent severe hypoglycaemic episodes or BG confirmed symptomatic hypoglycaemic episodes (yes/no) is presented.
- Change in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 104/premature treatment discontinuation ]Change from baseline (week 0) in FPG at week 104 or at premature treatment discontinuation is presented.
- Change in Body Weight [ Time Frame: Week 0, week 104/premature treatment discontinuation ]Change from baseline (week 0) in body weight at week 104 or at premature treatment discontinuation is presented.
- Change in Body Mass Index (BMI) [ Time Frame: Week 0, week 104/premature treatment discontinuation ]Change from baseline (week 0) in BMI at week 104 or at premature treatment discontinuation is presented.
- Change in Blood Pressure (Systolic and Diastolic Blood Pressure) [ Time Frame: Week 0, week 104/premature treatment discontinuation ]Change from baseline (week 0) in systolic and diastolic blood pressure at week 104 or at premature treatment discontinuation is presented.
- Number of Severe Hypoglycaemic Episodes [ Time Frame: Weeks 0-104 ]Severe hypoglycaemic episodes were defined as episodes that required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Number of severe hypoglycaemic episodes that occured during weeks 0-104 are presented.
- Number of Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes [ Time Frame: Weeks 0-104 ]Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Number of severe or BG confirmed symptomatic hypoglycaemic episodes that occured during weeks 0-104 are presented.
- Number of Documented Symptomatic Hypoglycaemic Episodes (ADA) [ Time Frame: Weeks 0-104 ]Documented symptomatic hypoglycaemic were defined as episodes with typical symptoms of hypoglycaemia accompanied by measure plasma glucose concentration <= 3.9 mmol/L. Number of documented symptomatic hypoglycaemic episodes that occured during the weeks 0-104 are presented.
- Number of Serious Adverse Events (SAEs) [ Time Frame: Weeks 0-105 ]A serious adverse event (SAE) was defined as any event that resulted in any of the following: death, life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, persistent or significant disability or incapacity, congenital anomaly or birth defect or suspicion of transmission of infectious agents via the trial product. An SAE was considered as treatment emergent if it had an onset or increase in severity on or after the time of first trial product administration and no later than 7 days after the time of last trial product administration. Number of treatment emergent serious adverse events are presented.
- Number of AEs Leading to Permanent Discontinuation of Trial Product [ Time Frame: Weeks 0-105 ]An adverse event (AE) was any untoward medical occurrence in a participant who administered a product, and which did not necessarily had a causal relationship with this treatment. An AE was considered as treatment emergent if it had an onset or increase in severity on or after the time of first trial product administration and no later than 7 days after the time of last trial product administration. Number of treatment emergent AEs that led to permanent discontinuation of trial product are presented.
- Change in Lipids: HDL Cholesterol, LDL-cholesterol, Total Cholesterol, Triglycerides [ Time Frame: Week 0, week 104/premature treatment discontinuation ]Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, total cholesterol (TC) and triglycerides (TG) at week 104 or at premature treatment discontinuation is presented.
- Change in Biochemistry- Alanine Aminotransferase (ALAT), Amylase, Aspartate Aminotransferase (ASAT), Lipase [ Time Frame: Week 0, week 104/premature treatment discontinuation ]Change from baseline (week 0) in alanine aminotransferase (ALAT), amylase, aspartate aminotransferase (ASAT) and lipase at week 104 or at premature treatment discontinuation is presented.
- Change in Biochemistry- Creatinine, Total Bilirubin [ Time Frame: Week 0, week 104/premature treatment discontinuation ]Change from baseline (week 0) in creatinine and total bilirubin (TB) at week 104 or at premature treatment discontinuation is presented.
- Change in Biochemistry- Estimated Glomerular Filtration Rate (eGFR) Serum [ Time Frame: Week 0, week 104/premature treatment discontinuation ]The estimated GFR was derived from serum creatinine using the MDRD (Modification of diet in renal disease) formula. eGFR was measured as milliliter per min per specific surface area (mL/min/SSA).
- Change in Potassium [ Time Frame: Week 0, week 104/premature treatment discontinuation ]Change from baseline (week 0) in potassium at week 104 or at premature treatment discontinuation is presented.
- Change in Haemoglobin [ Time Frame: Week 0, week 104/premature treatment discontinuation ]Change from baseline (week 0) in haemoglobin at week 104 or at premature treatment discontinuation is presented.
- Change in Pulse [ Time Frame: Week 0, week 104/premature treatment discontinuation ]Change from baseline (week 0) in pulse at week 104 or at premature treatment discontinuation is presented.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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
Locations
Show 232 study locations
Sponsors and Collaborators
Novo Nordisk A/S
Study Documents (Full-Text)
Documents provided by Novo Nordisk A/S:
Documents provided by Novo Nordisk A/S:
Study Protocol [PDF] January 14, 2020
Statistical Analysis Plan [PDF] January 14, 2020
Additional Information:
Publications:
Publications:
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT02730377 |
| 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 |
| Results First Posted: | July 7, 2020 |
| Last Update Posted: | July 7, 2020 |
| Last Verified: | June 2020 |
| 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 Liraglutide 2,4-thiazolidinedione Meglitinide Sodium-Glucose Transporter 2 Inhibitors Dipeptidyl-Peptidase IV Inhibitors |
Glycoside Hydrolase Inhibitors Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Molecular Mechanisms of Pharmacological Action Protease Inhibitors Enzyme Inhibitors |