Completed

Insulin Degludec, Liraglutide and Metformin Combination for Type 2 Diabetes Treatment Intensification

Study Aim

This study aims to evaluate the effectiveness of a combination treatment using Insulin Degludec, Liraglutide, and Metformin in reducing blood sugar levels, measured by the change in HbA1c, in individuals with Type 2 Diabetes over a period of 26 weeks.

What is being tested

Daily Insulin Degludec Injection

+ Daily Liraglutide Injection

+ Daily Placebo Injection

Drug

Who is being recruted

Endocrine System Diseases+3

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: October 2012

See protocol details

Summary

Principal SponsorNovo Nordisk A/S

Last updated: September 25, 2017

Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

This clinical trial focuses on individuals with type 2 diabetes who are ready for a more intense treatment plan. The study is happening across Africa, Asia, Europe, and North America. Its main goal is to explore how well insulin degludec works when used together with liraglutide and metformin. This research is important because it could help improve care for people with type 2 diabetes by finding a more effective treatment combination. Participants in this trial will take insulin degludec, liraglutide, and at least 1500 mg of metformin daily, or the highest dose they can tolerate. The study will measure the change in a substance called glycosylated haemoglobin (HbA1c) from the start to the end of the 26-week treatment period. This will help researchers understand how well the treatment combination controls blood sugar levels.

NCT01664247

Principal SponsorNovo Nordisk A/S

Last updated: September 25, 2017

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

346 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes MellitusDiabetes Mellitus, Type 2

Criteria

Inclusion Criteria: Type 2 diabetes Insulin naïve Ongoing treatment with metformin or metformin in combination with either sulphonylurea (SU), glinides, dipeptidyl peptidase-IV (DPP-IV) inhibitors or exenatide (only twice daily (BID)) Glycosylated haemoglobin (HbA1c) (by central laboratory analysis): a. 7.5-10.0 % (both inclusive) for subjects on metformin monotherapy, b. 7.0-9.0 % (both inclusive) for subjects on metformin in combination with either SU, glinides, DPP-IV inhibitors or exenatide (only BID) Exclusion Criteria: Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 12 weeks Calcitonin equal to or above 50 pg/mL Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within 24 weeks Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell carcinoma)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 132 locations

Novo Nordisk Investigational Site

Anaheim, United StatesOpen Novo Nordisk Investigational Site in Google Maps

Novo Nordisk Investigational Site

Concord, United States

Novo Nordisk Investigational Site

Escondido, United States

Novo Nordisk Investigational Site

Fresno, United States

Completed132 Study Centers