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A Trial Comparing Efficacy an...

A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes

Last Updated: 2017-04-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

833 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-02

Study Completion Date

2014-05-15

Brief Summary

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This trial was conducted in Africa, Asia, Europe, North and South America. The aim of the trial was to compare efficacy and safety of insulin degludec and insulin glargine in insulin naïve subjects with type 2 diabetes.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin Degludec

Group Type EXPERIMENTAL

Insulin Degludec

Intervention Type DRUG

Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.

Insulin Glargine

Group Type EXPERIMENTAL

Insulin Glargine

Intervention Type DRUG

Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.

Interventions

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Insulin Degludec

Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.

Intervention Type DRUG

Insulin Glargine

Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.

Intervention Type DRUG

Other Intervention Names

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NN1250

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
* Insulin naïve subjects (Allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
* Current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, alfa-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months prior to randomisation (Visit 2) with the minimum doses stated: metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling, DPP-IV inhibitor: minimum 100 mg daily or according to local labelling, alfa-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
* HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive) by central laboratory analysis
* BMI (Body Mass Index) below or equal to 40.0 kg/m\^2

Exclusion Criteria

* Treatment with TZDs (thiazoledinedione), or GLP-1 (glucagon-like peptide 1) receptor agonists within the last 3 months prior to Visit 1 (screening)
* Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO (monoamine oxidase) inhibitors
* Cardiovascular disease within the last 6 months prior to Visit 1 (screening) defined as stroke; decompensated heart failure NYHA (New York Heart Association) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
* Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes mellitus, which in the Investigator's opinion could interfere with the results of the trial
* Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period
* Known or suspected hypersensitivity to trial product(s) or related products

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Anaheim, California, United States

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Novo Nordisk Investigational Site

Lomita, California, United States

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Novo Nordisk Investigational Site

Los Angeles, California, United States

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Novo Nordisk Investigational Site

Golden, Colorado, United States

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Novo Nordisk Investigational Site

Clearwater, Florida, United States

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Novo Nordisk Investigational Site

Chicago, Illinois, United States

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Novo Nordisk Investigational Site

Crestview Hills, Kentucky, United States

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Novo Nordisk Investigational Site

Metairie, Louisiana, United States

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Novo Nordisk Investigational Site

Troy, Michigan, United States

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Novo Nordisk Investigational Site

Chesterfield, Missouri, United States

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Novo Nordisk Investigational Site

Nashua, New Hampshire, United States

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Novo Nordisk Investigational Site

Toms River, New Jersey, United States

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Novo Nordisk Investigational Site

Smithtown, New York, United States

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Novo Nordisk Investigational Site

Simpsonville, South Carolina, United States

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Novo Nordisk Investigational Site

Jackson, Tennessee, United States

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Novo Nordisk Investigational Site

Dallas, Texas, United States

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Novo Nordisk Investigational Site

Newport News, Virginia, United States

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Novo Nordisk Investigational Site

Kenosha, Wisconsin, United States

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Novo Nordisk Investigational Site

São Paulo, São Paulo, Brazil

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Novo Nordisk Investigational Site

Porto Alegre, , Brazil

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Novo Nordisk Investigational Site

São Paulo, , Brazil

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Novo Nordisk Investigational Site

Calgary, Alberta, Canada

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Novo Nordisk Investigational Site

Burnaby, British Columbia, Canada

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Novo Nordisk Investigational Site

Surrey, British Columbia, Canada

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Novo Nordisk Investigational Site

Victoria, British Columbia, Canada

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Novo Nordisk Investigational Site

Burlington, Ontario, Canada

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Novo Nordisk Investigational Site

London, Ontario, Canada

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Novo Nordisk Investigational Site

London, Ontario, Canada

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Novo Nordisk Investigational Site

Newmarket, Ontario, Canada

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Novo Nordisk Investigational Site

Sarnia, Ontario, Canada

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Novo Nordisk Investigational Site

Strathroy, Ontario, Canada

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Novo Nordisk Investigational Site

Québec, Quebec, Canada

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Novo Nordisk Investigational Site

Trois-Rivières, Quebec, Canada

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