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Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin

NCT ID: NCT01519674

Last Updated: 2017-02-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

582 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-10-31

Brief Summary

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This trial is conducted in Asia, Europe, Oceania and South America. The aim of this clinical trial is to generate data demonstrating how to intensify diabetes treatment using BIAsp 30 (biphasic insulin aspart 30) by adding or substituting BIAsp 30 to sitagliptin in various regimens for type 2 patients inadequately controlled on sitagliptin and metformin (with or without other oral anti-diabetic drugs (OADs)).

The trial is conducted as a phase 4 trial in the majority of the participating countries. However, in some countries the trial is conducted as phase 3b.

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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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BIAsp 30 BID + sitagliptin + metformin

Group Type ACTIVE_COMPARATOR

biphasic insulin aspart 30

Intervention Type DRUG

BIAsp 30 will be injected subcutaneously (under the skin) twice daily. Individually adjusted dose.

sitagliptin

Intervention Type DRUG

Subjects will continue on their pre-trial sitagliptin treatment.

metformin

Intervention Type DRUG

Subjects will continue on their pre-trial metformin treatment.

BIAsp 30 BID + metformin

Group Type ACTIVE_COMPARATOR

biphasic insulin aspart 30

Intervention Type DRUG

BIAsp 30 will be injected subcutaneously (under the skin) twice daily. Individually adjusted dose.

metformin

Intervention Type DRUG

Subjects will continue on their pre-trial metformin treatment.

BIAsp 30 OD + sitagliptin + metformin

Group Type ACTIVE_COMPARATOR

biphasic insulin aspart 30

Intervention Type DRUG

BIAsp 30 will be injected subcutaneously (under the skin) once daily. Individually adjusted dose.

sitagliptin

Intervention Type DRUG

Subjects will continue on their pre-trial sitagliptin treatment.

metformin

Intervention Type DRUG

Subjects will continue on their pre-trial metformin treatment.

Interventions

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biphasic insulin aspart 30

BIAsp 30 will be injected subcutaneously (under the skin) twice daily. Individually adjusted dose.

Intervention Type DRUG

biphasic insulin aspart 30

BIAsp 30 will be injected subcutaneously (under the skin) once daily. Individually adjusted dose.

Intervention Type DRUG

sitagliptin

Subjects will continue on their pre-trial sitagliptin treatment.

Intervention Type DRUG

metformin

Subjects will continue on their pre-trial metformin treatment.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with type 2 diabetes for a minimum of 6 months prior to screening (Visit 1)
* Stable treatment with a total daily dose of at least 1000 mg of metformin (with or without additional oral anti-diabetic drugs (OADs) treatment). The metformin dose must have been unchanged for at least 3 months prior to screening (Visit 1)
* Stable treatment with a total daily dose of at least 100 mg sitagliptin. The sitagliptin dose must have been unchanged for at least 3 months prior to screening (Visit 1)
* Subject is insulin-naïve (never previously treated with insulin). (However, short term insulin use due to intermittent illness of up to 14 days or insulin treatment for gestational diabetes is allowed)
* HbA1c (glycosylated haemoglobin) between 7.0 to 10.0 % (53-86 mmol/mol) (both inclusive) by central laboratory analysis demonstrating inadequate control on sitagliptin and metformin (with or without other OADs)
* Body Mass Index (BMI) below or equal to 40.0 kg/m\^2
* Able and willing to eat at least 2 meals (breakfast and dinner) every day during the trial

Exclusion Criteria

* Treatment with thiazolidinedione (TZD) or glucagon-like-peptide-1 (GLP-1) receptor agonist within the last 3 months prior to screening (Visit 1)
* Cardiac disease within the last 6 months prior to screening (Visit 1), defined as: decompensated heart failure New York Heart Association (NYHA) class III or IV; unstable angina pectoris; or myocardial infarction
* Severe hypertension, systolic blood pressure equal to or above 180 mm Hg or diastolic blood pressure equal to or above 100 mm Hg, after 5 minutes rest in the sitting position using mean value of 3 measurements at screening (Visit 1)
* Anticipated change of dose of any systemic treatment with products, which in the trial physician's opinion could interfere with glucose metabolism (e.g., systemic corticosteroids)
* Clinically significant diseases (except for conditions associated with type 2 diabetes) which, in the trial physician's opinion may confound the results of the trial or pose additional risk in administering trial product(s)
* Impaired hepatic function as indicated by aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) above 2.5 times the upper normal range, according to central laboratory reference ranges
* Impaired renal function as indicated by serum creatinine levels equal to or above 133 micromol/L (1.5 mg/dL) for males and equal to or above 124 micromol/L (1.4 mg/dL) for females or estimated creatinine clearance below 60 mL/min, based on the Cockroft \& Gault formula and according to local practise for metformin use
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

Buenos Aires, , Argentina

Site Status

Novo Nordisk Investigational Site

Buenos Aires, , Argentina

Site Status

Novo Nordisk Investigational Site

Caba, , Argentina

Site Status

Novo Nordisk Investigational Site

Caba, , Argentina

Site Status

Novo Nordisk Investigational Site

Mar del Plata, , Argentina

Site Status

Novo Nordisk Investigational Site

Morón, , Argentina

Site Status

Novo Nordisk Investigational Site

Broadmeadow, New South Wales, Australia

Site Status

Novo Nordisk Investigational Site

Coffs Harbour, New South Wales, Australia

Site Status

Novo Nordisk Investigational Site

São Paulo, São Paulo, Brazil

Site Status

Novo Nordisk Investigational Site

Brasília, , Brazil

Site Status

Novo Nordisk Investigational Site

Curitiba, , Brazil

Site Status

Novo Nordisk Investigational Site

Fortaleza, , Brazil

Site Status

Novo Nordisk Investigational Site

Porto Alegre, , Brazil

Site Status

Novo Nordisk Investigational Site

Alexandroupoli, , Greece

Site Status

Novo Nordisk Investigational Site

Athens, , Greece

Site Status

Novo Nordisk Investigational Site

Athens, , Greece

Site Status

Novo Nordisk Investigational Site

Thessaloniki, , Greece

Site Status

Novo Nordisk Investigational Site

Thessaloniki, , Greece

Site Status

Novo Nordisk Investigational Site

Thessaloniki, , Greece

Site Status

Novo Nordisk Investigational Site

Hyderabad, Andhra Pradesh, India

Site Status

Novo Nordisk Investigational Site

Hyderabad, Andhra Pradesh, India

Site Status

Novo Nordisk Investigational Site

Hyderabad, Andhra Pradesh, India

Site Status

Novo Nordisk Investigational Site

Visakhapatnam, Andhra Pradesh, India

Site Status

Novo Nordisk Investigational Site

Ahmedabad, Gujarat, India

Site Status

Novo Nordisk Investigational Site

Ahmedabad, Gujarat, India

Site Status

Novo Nordisk Investigational Site

Bangalore, Karnataka, India

Site Status

Novo Nordisk Investigational Site

Bangalore, Karnataka, India

Site Status

Novo Nordisk Investigational Site

Bangalore, Karnataka, India

Site Status

Novo Nordisk Investigational Site

Bangalore, Karnataka, India

Site Status

Novo Nordisk Investigational Site

Calicut, Kerala, India

Site Status

Novo Nordisk Investigational Site

Trivandrum, Kerala, India

Site Status

Novo Nordisk Investigational Site

Nagpur, Maharashtra, India

Site Status

Novo Nordisk Investigational Site

New Delhi, New Delhi, India

Site Status

Novo Nordisk Investigational Site

Amritsar, Punjab, India

Site Status

Novo Nordisk Investigational Site

Chennai, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Chennai, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Chennai, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Coimbatore, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Trichy, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Kanpur, Uttar Pradesh, India

Site Status

Novo Nordisk Investigational Site

Noida, Uttar Pradesh, India

Site Status

Novo Nordisk Investigational Site

Varanasi, Uttar Pradesh, India

Site Status

Novo Nordisk Investigational Site

Kolkata, West Bengal, India

Site Status

Novo Nordisk Investigational Site

Kolkata, West Bengal, India

Site Status

Novo Nordisk Investigational Site

George Town, , Malaysia

Site Status

Novo Nordisk Investigational Site

Seremban, , Malaysia

Site Status

Novo Nordisk Investigational Site

Coimbra, , Portugal

Site Status

Novo Nordisk Investigational Site

Lisbon, , Portugal

Site Status

Novo Nordisk Investigational Site

Lisbon, , Portugal

Site Status

Novo Nordisk Investigational Site

Lisbon, , Portugal

Site Status

Novo Nordisk Investigational Site

Matosinhos Municipality, , Portugal

Site Status

Novo Nordisk Investigational Site

Porto, , Portugal

Site Status

Novo Nordisk Investigational Site

Goyang, , South Korea

Site Status

Novo Nordisk Investigational Site

Jeonju, , South Korea

Site Status

Novo Nordisk Investigational Site

Pusan, , South Korea

Site Status

Novo Nordisk Investigational Site

Pyungchon-Dong 896, Dongan-Gu, , South Korea

Site Status

Novo Nordisk Investigational Site

Seoul, , South Korea

Site Status

Novo Nordisk Investigational Site

Seoul, , South Korea

Site Status

Novo Nordisk Investigational Site

Suwon, , South Korea

Site Status

Novo Nordisk Investigational Site

Ulsan, , South Korea

Site Status

Novo Nordisk Investigational Site

Bangkok, , Thailand

Site Status

Novo Nordisk Investigational Site

Bangkok, , Thailand

Site Status

Novo Nordisk Investigational Site

Chiang Mai, , Thailand

Site Status

Novo Nordisk Investigational Site

Khon Kaen, , Thailand

Site Status

Novo Nordisk Investigational Site

Antalya, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Argentina Australia Brazil Greece India Malaysia Portugal South Korea Thailand Turkey (Türkiye)

References

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Linjawi S, Sothiratnam R, Sari R, Andersen H, Hiort LC, Rao P. The study of once- and twice-daily biphasic insulin aspart 30 (BIAsp 30) with sitagliptin, and twice-daily BIAsp 30 without sitagliptin, in patients with type 2 diabetes uncontrolled on sitagliptin and metformin-The Sit2Mix trial. Prim Care Diabetes. 2015 Oct;9(5):370-6. doi: 10.1016/j.pcd.2014.11.001. Epub 2014 Dec 3.

Reference Type RESULT
PMID: 25488587 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1125-0850

Identifier Type: OTHER

Identifier Source: secondary_id

2011-004930-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BIASP-3963

Identifier Type: -

Identifier Source: org_study_id

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