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

Novo Nordisk A/S1,991 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,991

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

liraglutideDRUG

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

alpha-glucosidase inhibitorsDRUG

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

DPP-4 inhibitorsDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (232)

Outcomes

Primary Outcomes

Time to Inadequate Glycaemic Control

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.

Time frame: Weeks 26-104

Secondary Outcomes

Time to Premature Treatment Discontinuation (for Any Reason Including Inadequate Glycaemic Control)

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.

Time frame: Weeks 0-104

Change in HbA1c

Change from baseline (week 0) in HbA1c at week 104 or at premature treatment discontinuation is presented.

Time frame: Week 0, week 104/premature treatment discontinuation

Participants Who Achieve HbA1c ≤6.5% (Yes/No)

Participants who achieved HbA1c ≤6.5% (yes/no) is presented.

Time frame: Week 104/Premature treatment discontinuation

Participants Who Achieve HbA1c ≤7.0% Without Weight Gain

Participants who achieved HbA1c ≤7.0% without weight gain (yes/no) is presented.

Time frame: Week 104/Premature treatment discontinuation

Participants Who Achieve HbA1c ≤7.0% Without Treatment Emergent Severe Hypoglycaemic Episodes or BG Confirmed Symptomatic Hypoglycaemic Episodes

Data from ClinicalTrials.gov

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

SGLT-2 inhibitorsDRUG

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

sulphonylureaDRUG

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

thiazolidinedionesDRUG

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

Novo Nordisk Investigational Site

Birmingham, Alabama, United States

Novo Nordisk Investigational Site

Haleyville, Alabama, United States

Novo Nordisk Investigational Site

Tuscumbia, Alabama, United States

Novo Nordisk Investigational Site

Fountain Hills, Arizona, United States

Novo Nordisk Investigational Site

Phoenix, Arizona, United States

Novo Nordisk Investigational Site

Phoenix, Arizona, United States

Novo Nordisk Investigational Site

Phoenix, Arizona, United States

Novo Nordisk Investigational Site

Tempe, Arizona, United States

Novo Nordisk Investigational Site

Tucson, Arizona, United States

Novo Nordisk Investigational Site

Harrisburg, Arkansas, United States

...and 222 more locations

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.

Time frame: Week 104/Premature treatment discontinuation

Participants Who Achieve HbA1c ≤7.0% Without Weight Gain and no Treatment Emergent Severe Hypoglycaemic Episodes or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes

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.

Time frame: Week 104/Premature treatment discontinuation

Change in Fasting Plasma Glucose (FPG)

Change from baseline (week 0) in FPG at week 104 or at premature treatment discontinuation is presented.

Time frame: Week 0, week 104/premature treatment discontinuation

Change in Body Weight

Change from baseline (week 0) in body weight at week 104 or at premature treatment discontinuation is presented.

Time frame: Week 0, week 104/premature treatment discontinuation

Change in Body Mass Index (BMI)

Change from baseline (week 0) in BMI at week 104 or at premature treatment discontinuation is presented.

Time frame: Week 0, week 104/premature treatment discontinuation

Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Change from baseline (week 0) in systolic and diastolic blood pressure at week 104 or at premature treatment discontinuation is presented.

Time frame: Week 0, week 104/premature treatment discontinuation

Number of Severe Hypoglycaemic Episodes

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.

Time frame: Weeks 0-104

Number of Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Time frame: Weeks 0-104

Number of Documented Symptomatic Hypoglycaemic Episodes (ADA)

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.

Time frame: Weeks 0-104

Number of Serious Adverse Events (SAEs)

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.

Time frame: Weeks 0-105

Number of AEs Leading to Permanent Discontinuation of Trial Product

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.

Time frame: Weeks 0-105

Change in Lipids: HDL Cholesterol, LDL-cholesterol, Total Cholesterol, Triglycerides

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.

Time frame: Week 0, week 104/premature treatment discontinuation

Change in Biochemistry- Alanine Aminotransferase (ALAT), Amylase, Aspartate Aminotransferase (ASAT), Lipase

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.

Time frame: Week 0, week 104/premature treatment discontinuation

Change in Biochemistry- Creatinine, Total Bilirubin

Change from baseline (week 0) in creatinine and total bilirubin (TB) at week 104 or at premature treatment discontinuation is presented.

Time frame: Week 0, week 104/premature treatment discontinuation

Change in Biochemistry- Estimated Glomerular Filtration Rate (eGFR) Serum

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).

Time frame: Week 0, week 104/premature treatment discontinuation

Change in Potassium

Change from baseline (week 0) in potassium at week 104 or at premature treatment discontinuation is presented.

Time frame: Week 0, week 104/premature treatment discontinuation

Change in Haemoglobin

Change from baseline (week 0) in haemoglobin at week 104 or at premature treatment discontinuation is presented.

Time frame: Week 0, week 104/premature treatment discontinuation

Change in Pulse

Change from baseline (week 0) in pulse at week 104 or at premature treatment discontinuation is presented.

Time frame: Week 0, week 104/premature treatment discontinuation