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Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes

NCT ID: NCT01819129

Last Updated: 2019-01-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

881 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-09

Study Completion Date

2015-01-22

Brief Summary

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This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare FIAsp (faster-acting insulin aspart) to insulin aspart, both in combination with insulin glargine and metformin in adults 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

DOUBLE

Participants Investigators

Study Groups

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Faster-acting insulin aspart (FIAsp)

Meal time faster-acting insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication.

Group Type EXPERIMENTAL

Faster-acting insulin aspart

Intervention Type DRUG

Mealtime FIAsp administered subcutaneously (s.c., under the skin). Dose individually adjusted.

Insulin glargine

Intervention Type DRUG

Administered s.c. once daily at subjects' pre-trial dose. Subjects will continue their metformin treatment without changing the frequency or dose throughout the trial.

Insulin aspart

Meal time insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication.

Group Type ACTIVE_COMPARATOR

Insulin aspart

Intervention Type DRUG

Mealtime insulin aspart administered subcutaneously (s.c., under the skin). Dose individually adjusted.

Insulin glargine

Intervention Type DRUG

Administered s.c. once daily at subjects' pre-trial dose. Subjects will continue their metformin treatment without changing the frequency or dose throughout the trial.

Interventions

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Faster-acting insulin aspart

Mealtime FIAsp administered subcutaneously (s.c., under the skin). Dose individually adjusted.

Intervention Type DRUG

Insulin aspart

Mealtime insulin aspart administered subcutaneously (s.c., under the skin). Dose individually adjusted.

Intervention Type DRUG

Insulin glargine

Administered s.c. once daily at subjects' pre-trial dose. Subjects will continue their metformin treatment without changing the frequency or dose throughout the trial.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Type 2 diabetes (diagnosed clinically) for 6 months or longer at time of screening (visit 1) - Treated with basal insulin for at least 6 months prior to screening (visit 1) - Current once daily treatment with insulin NPH (Neutral Protamine Hagedorn), insulin detemir or glargine for at least 3 months prior to the screening visit (visit 1) - Current treatment with: a. metformin with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg or b. metformin in combination with sulfonylurea (SU) or glinide or DPP-IV (dipeptidyl peptidase-4) inhibitors and/or alpha-glucosidase inhibitors (AGI) with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg - HbA1c by central laboratory: a. 7.0 - 9.5% (53 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (visit 1) or b. 7.0 - 9.0% (53 - 75 mmol/mol) (both inclusive) in the metformin + other OAD (oral antidiabetic drug) (SU, glinide, DDP-IV inhibitors, AGI) combination group at the screening visit (visit 1) - Body mass index (BMI) equal to or below 40.

Exclusion Criteria

0 kg/m\^2 Exclusion Criteria: - Any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days consecutive treatment) and not 3 months prior to the screening visit (visit 1) - Use of GLP-1 (glucagon-like peptide-1) agonists and/or TZDs within the last 3 months prior to screening (visit 1) - Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (visit 1) - Cardiovascular disease, within the last 6 months prior to screening (visit 1), defined as: stroke, decompensated heart failure New York Heart Association (NYHA) class III or IV, myocardial infarction, unstable angina pectoris or coronary arterial bypass graft or angioplasty
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

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

Glendale, Arizona, United States

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Glendale, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Tempe, Arizona, United States

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Anaheim, California, United States

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Fresno, California, United States

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Greenbrae, California, United States

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Lomita, California, United States

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Northridge, California, United States

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San Diego, California, United States

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San Ramon, California, United States

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Walnut Creek, California, United States

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Aurora, Colorado, United States

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Colorado Springs, Colorado, United States

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Waterbury, Connecticut, United States

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Boynton Beach, Florida, United States

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Bradenton, Florida, United States

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Cooper City, Florida, United States

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Fort Lauderdale, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Plantation, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Roswell, Georgia, United States

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Avon, Illinois, United States

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Peoria, Illinois, United States

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Indianapolis, Indiana, United States

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Muncie, Indiana, United States

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Topeka, Kansas, United States

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Louisville, Kentucky, United States

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Madisonville, Kentucky, United States

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Paducah, Kentucky, United States

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Monroe, Louisiana, United States

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Buckley, Michigan, United States

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Detroit, Michigan, United States

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Troy, Michigan, United States

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Chesterfield, Missouri, United States

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Jefferson City, Missouri, United States

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St Louis, Missouri, United States

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Butte, Montana, United States

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Elkhorn, Nebraska, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Toms River, New Jersey, United States

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Mineola, New York, United States

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New Windsor, New York, United States

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North Massapequa, New York, United States

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Northport, New York, United States

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Hickory, North Carolina, United States

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Wilmington, North Carolina, United States

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Carlisle, Ohio, United States

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Cleveland, Ohio, United States

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Dayton, Ohio, United States

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Franklin, Ohio, United States

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Mason, Ohio, United States

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East Providence, Rhode Island, United States

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Gaffney, South Carolina, United States

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Chattanooga, Tennessee, United States

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Kingsport, Tennessee, United States

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Spring Hill, Tennessee, United States

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Tullahoma, Tennessee, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Hurst, Texas, United States

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Plano, Texas, United States

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Murray, Utah, United States

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Midlothian, Virginia, United States

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Port Orchard, Washington, United States

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Kenosha, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Edmonton, Alberta, Canada

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Surrey, British Columbia, Canada

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Mount Pearl, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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Hamilton, Ontario, Canada

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Thunder Bay, Ontario, Canada

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Waterloo, Ontario, Canada

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Mirabel, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Saint Romuald, Quebec, Canada

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Québec, , Canada

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Québec, , Canada

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Čakovec, , Croatia

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Karlovac, , Croatia

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Osijek, , Croatia

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Slavonski Brod, , Croatia

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Split, , Croatia

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Varaždin, , Croatia

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Zagreb, , Croatia

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Zagreb, , Croatia

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Hyderabad, Andhra Pradesh, India

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Indore, Madhya Pradesh, India

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Mumbai, Maharashtra, India

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Mumbai, Maharashtra, India

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Mumbai, Maharashtra, India

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Pune, Maharashtra, India

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Pune, Maharashtra, India

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Delhi, New Delhi, India

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Bhubaneswar, Odisha, India

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Jaipur, Rajasthan, India

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Beersheba, , Israel

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Haifa, , Israel

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Jerusalem, , Israel

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Kfar Saba, , Israel

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Rehovot, , Israel

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Rishon LeZiyyon, , Israel

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Ponce, , Puerto Rico

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Kursk, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Penza, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint-Petesburg, , Russia

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Stavropol, , Russia

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Belgrade, , Serbia

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Niš, , Serbia

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Zaječar, , Serbia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Lučenec, , Slovakia

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Trnava, , Slovakia

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Žilina, , Slovakia

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Epworth, , United Kingdom

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Hull, , United Kingdom

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Northampton, , United Kingdom

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Northwood, , United Kingdom

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Norwich, , United Kingdom

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Nuneaton, , United Kingdom

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Sidcup, , United Kingdom

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Stoke-on-Trent, , United Kingdom

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Wrexham, , United Kingdom

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Countries

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United States Canada Croatia India Israel Puerto Rico Russia Serbia Slovakia United Kingdom

References

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Bowering K, Case C, Harvey J, Reeves M, Sampson M, Strzinek R, Bretler DM, Bang RB, Bode BW. Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The onset 2 Trial. Diabetes Care. 2017 Jul;40(7):951-957. doi: 10.2337/dc16-1770. Epub 2017 May 8.

Reference Type RESULT
PMID: 28483786 (View on PubMed)

Bode BW, Bowering K, Russell-Jones D. Response to Comment on Russell-Jones et al. Diabetes Care 2017;40:943-950. Comment on Bowering et al. Diabetes Care 2017;40:951-957. Diabetes Care. 2018 Mar;41(3):e29-e30. doi: 10.2337/dci17-0051. No abstract available.

Reference Type RESULT
PMID: 29463670 (View on PubMed)

Bowering K, Rodbard HW, Russell-Jones D, Bode B, Harris S, Piletic M, Heller S, Woo V, Babu V, Dethlefsen C, Mathieu C. Investigating the Association Between Baseline Characteristics (HbA1c and Body Mass Index) and Clinical Outcomes of Fast-Acting Insulin Aspart in People with Diabetes: A Post Hoc Analysis. Diabetes Ther. 2019 Feb;10(1):177-188. doi: 10.1007/s13300-018-0553-7. Epub 2018 Dec 13.

Reference Type RESULT
PMID: 30547388 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2010-024051-93

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1118-2509

Identifier Type: OTHER

Identifier Source: secondary_id

CTRI/2014/01/004285

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN1218-3853

Identifier Type: -

Identifier Source: org_study_id

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