DiabetesPhase 4SIT2MIXNCT01519674

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

A Phase 4 study testing biphasic insulin aspart 30, sitagliptin and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 69 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: biphasic insulin aspart 30, sitagliptin and metformin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 582 participants
Where: 69 sitesin 10 countries
Study dates: Jun 2012to Oct 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

69 sites in 10 countries.

Country

City, postcode or hospital

69 sites in 10 countries

India25 sites

Novo Nordisk Investigational Site
Ahmedabad, Gujarat, 380006
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, 380016
Novo Nordisk Investigational Site
Amritsar, Punjab, 143001
Novo Nordisk Investigational Site
Bangalore, Karnataka, 560 017
Novo Nordisk Investigational Site
Bangalore, Karnataka, 560002
Novo Nordisk Investigational Site
Bangalore, Karnataka, 560043
Novo Nordisk Investigational Site
Bangalore, Karnataka, 560092
Novo Nordisk Investigational Site
Calicut, Kerala, 673016
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, 600003
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, 600006
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, 600040
Novo Nordisk Investigational Site
Coimbatore, Tamil Nadu, 641009
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, 500003
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, 500034
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, 500082
Novo Nordisk Investigational Site
Kanpur, Uttar Pradesh, 208005
Novo Nordisk Investigational Site
Kolkata, West Bengal, 700019
Novo Nordisk Investigational Site
Kolkata, West Bengal, 700038
Novo Nordisk Investigational Site
Nagpur, Maharashtra, 440010
Novo Nordisk Investigational Site
New Delhi, New Delhi, 110001
Novo Nordisk Investigational Site
Noida, Uttar Pradesh, 201301
Novo Nordisk Investigational Site
Trichy, Tamil Nadu, 620018
Novo Nordisk Investigational Site
Trivandrum, Kerala, 695607
Novo Nordisk Investigational Site
Varanasi, Uttar Pradesh, 221105
Novo Nordisk Investigational Site
Visakhapatnam, Andhra Pradesh, 530002

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South Korea8 sites

Novo Nordisk Investigational Site
Goyang, 10380
Novo Nordisk Investigational Site
Jeonju, 561-712
Novo Nordisk Investigational Site
Pusan, 602-739
Novo Nordisk Investigational Site
Pyungchon-Dong 896, Dongan-Gu, 431-796
Novo Nordisk Investigational Site
Seoul, 03080
Novo Nordisk Investigational Site
Seoul, 150-713
Novo Nordisk Investigational Site
Suwon, 16247
Novo Nordisk Investigational Site
Ulsan, 682-060

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Argentina6 sites

Novo Nordisk Investigational Site
Buenos Aires, B1704ETD
Novo Nordisk Investigational Site
Buenos Aires, C1250AAN
Novo Nordisk Investigational Site
Caba, C1179AAB
Novo Nordisk Investigational Site
Caba, C1440AAD
Novo Nordisk Investigational Site
Mar del Plata, B7600FZN
Novo Nordisk Investigational Site
Morón, B1708IFF

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Greece6 sites

Novo Nordisk Investigational Site
Alexandroupoli, GR-68100
Novo Nordisk Investigational Site
Athens, 151 23
Novo Nordisk Investigational Site
Athens, GR-17562
Novo Nordisk Investigational Site
Thessaloniki, GR-54642
Novo Nordisk Investigational Site
Thessaloniki, GR-57001
Novo Nordisk Investigational Site
Thessaloniki, GR-57010

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Portugal6 sites

Novo Nordisk Investigational Site
Coimbra, 3000-561
Novo Nordisk Investigational Site
Lisbon, 1250-230
Novo Nordisk Investigational Site
Lisbon, 1500-650
Novo Nordisk Investigational Site
Lisbon, 1649-035
Novo Nordisk Investigational Site
Matosinhos Municipality, 4464-513
Novo Nordisk Investigational Site
Porto, 4200-319

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Brazil5 sites

Novo Nordisk Investigational Site
Brasília, 71625-009
Novo Nordisk Investigational Site
Curitiba, 80810-040
Novo Nordisk Investigational Site
Fortaleza, 60430-350
Novo Nordisk Investigational Site
Porto Alegre, 90035-170
Novo Nordisk Investigational Site
São Paulo, São Paulo, 01244-030

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Turkey (Türkiye)5 sites

Novo Nordisk Investigational Site
Antalya, 07058
Novo Nordisk Investigational Site
Istanbul, 34371
Novo Nordisk Investigational Site
Istanbul, 34718
Novo Nordisk Investigational Site
Istanbul, 34722
Novo Nordisk Investigational Site
Istanbul, 34890

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Thailand4 sites

Novo Nordisk Investigational Site
Bangkok, 10330
Novo Nordisk Investigational Site
Bangkok, 10400
Novo Nordisk Investigational Site
Chiang Mai, 50200
Novo Nordisk Investigational Site
Khon Kaen, 40002

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Australia2 sites

Novo Nordisk Investigational Site
Broadmeadow, New South Wales, 2292
Novo Nordisk Investigational Site
Coffs Harbour, New South Wales, 2450

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Malaysia2 sites

Novo Nordisk Investigational Site
George Town, 10459
Novo Nordisk Investigational Site
Seremban, 70300

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About this study

Official title: A 24 Week Randomised, Open Label, 3 Parallel-group Comparison of Once and Twice Daily Biphasic Insulin Aspart (BIAsp) 30 Plus Sitagliptin and Twice Daily BIAsp 30, All in Combination With Metformin in Insulin naïve Type 2 Diabetic Subjects Inadequately Controlled on Sitagliptin and Metformin

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.

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: biphasic insulin aspart 30, sitagliptin, metformin
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

biphasic insulin aspart 30Drug
BIAsp 30 will be injected subcutaneously (under the skin) twice daily. Individually adjusted dose.
biphasic insulin aspart 30Drug
BIAsp 30 will be injected subcutaneously (under the skin) once daily. Individually adjusted dose.
sitagliptinDrug
Subjects will continue on their pre-trial sitagliptin treatment.
metforminDrug
Subjects will continue on their pre-trial metformin treatment.

Study groups in NCT01519674
Study group	Role	What they receive
BIAsp 30 BID + sitagliptin + metformin	Active comparator	Not described Receives: Drug: biphasic insulin aspart 30; Drug: sitagliptin; Drug: metformin
BIAsp 30 BID + metformin	Active comparator	Not described Receives: Drug: biphasic insulin aspart 30; Drug: metformin
BIAsp 30 OD + sitagliptin + metformin	Active comparator	Not described Receives: Drug: biphasic insulin aspart 30; Drug: sitagliptin; Drug: metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Estimated mean change from baseline in HbA1c after 24 weeks of treatment.
Measured: Week 0 to Week 24

Secondary outcomes (10)

Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%)
Proportion of subjects achieving HbA1c below 7.0% after 24 weeks of treatment
Measured: After 24 weeks of treatment
Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c ≤ 6.5%)
Proportion of subjects achieving HbA1c equal to or below 6.5% after 24 weeks of treatment.
Measured: After 24 weeks of treatment
Change From Baseline in Fasting Plasma Glucose (FPG)
Estimated mean change from baseline in fasting plasma glucose (FPG)
Measured: Week 0 to Week 24
Prandial Plasma Glucose (PPG) Increments at Breakfast
Estimated mean post prandial increments at breakfast after 24 weeks of treatment.
Measured: After 24 weeks of treatment
Prandial Plasma Glucose (PPG) Increments at Lunch.
Estimated mean post prandial increments at lunch after 24 weeks of treatment.
Measured: After 24 weeks of treatment
Prandial Plasma Glucose (PPG) Increments at Dinner.
Estimated mean post prandial increments at dinner after 24 weeks of treatment.
Measured: After 24 weeks of treatment
Prandial Plasma Glucose (PPG) Overall Mean Increment.
Estimated overall mean post prandial increment after 24 weeks of treatment.
Measured: After 24 weeks of treatment
Adverse Events (AEs)
Rate of AEs per 100 years of patient exposure. An adverse event was defined as treatment emergent if the event had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
Measured: Week 0 to Week 24
Number of Treatment Emergent Hypoglycaemic Episodes (Nocturnal and Day-time) Classified Both According to the American Diabetes Association (ADA) Definition and to an Additional Definition for Minor Episodes.
Number of treatment emergent hypoglycaemic episodes. Treatment emergent hypoglycaemic episode: if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Nocturnal: Time of onset between 00:01 and 05:59 a.m. (both included). Additional minor hypoglycaemic episode: symptomatic or asymptomatic hypoglycaemia with blood glucose (BG) values < 2.8 mmol/L (50 mg/dL) or plasma glucose (PG) < 3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself.
Measured: Week 0 to Week 24
Change From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes.
Estimated mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) 'total score' to end of trial. The score measured treatment satisfaction. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction.
Measured: Week 0 to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Oct 2013

First posted27 Jan 2012 (estimated)
Study startJun 2012
Primary completionOct 2013
Study completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 582 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01519674
Sponsor's protocol ID: BIASP-3963
Other IDs: U1111-1125-0850, 2011-004930-33
Acronym: SIT2MIX
Status last verified: Jan 2017
First submitted: 24 Jan 2012
Last updated: 24 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 25488587

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 24 Week Randomised, Open Label, 3 Parallel-group Comparison of Once and Twice Daily Biphasic Insulin Aspart (BIAsp) 30 Plus Sitagliptin and Twice Daily BIAsp 30, All in Combination With Metformin in Insulin naïve Type 2 Diabetic Subjects Inadequately Controlled on Sitagliptin and Metformin
ClinicalTrials.gov ID: NCT01519674
Acronym / sponsor ID: SIT2MIX / BIASP-3963
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 582 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 27 Jan 2012 (estimated)
Results: Posted 10 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
BIAsp 30 BID + sitagliptin + metformin	Active comparator	Drug: biphasic insulin aspart 30, Drug: sitagliptin, Drug: metformin
BIAsp 30 BID + metformin	Active comparator	Drug: biphasic insulin aspart 30, Drug: metformin
BIAsp 30 OD + sitagliptin + metformin	Active comparator	Drug: biphasic insulin aspart 30, Drug: sitagliptin, Drug: metformin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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)

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
biphasic insulin aspart 30BIAsp 30 will be injected subcutaneously (under the skin) twice daily. Individually adjusted dose.	Drug	BIAsp 30 BID + metformin, BIAsp 30 BID + sitagliptin + metformin
biphasic insulin aspart 30BIAsp 30 will be injected subcutaneously (under the skin) once daily. Individually adjusted dose.	Drug	BIAsp 30 OD + sitagliptin + metformin
sitagliptinSubjects will continue on their pre-trial sitagliptin treatment.	Drug	BIAsp 30 BID + sitagliptin + metformin, BIAsp 30 OD + sitagliptin + metformin
metforminSubjects will continue on their pre-trial metformin treatment.	Drug	BIAsp 30 BID + metformin, BIAsp 30 BID + sitagliptin + metformin, BIAsp 30 OD + sitagliptin + metformin

Primary outcome

Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Time frame: Week 0 to Week 24
Estimated mean change from baseline in HbA1c after 24 weeks of treatment.

10 secondary outcomes

Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%)
Time frame: After 24 weeks of treatment
Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c ≤ 6.5%)
Time frame: After 24 weeks of treatment
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame: Week 0 to Week 24
Prandial Plasma Glucose (PPG) Increments at Breakfast
Time frame: After 24 weeks of treatment
Prandial Plasma Glucose (PPG) Increments at Lunch.
Time frame: After 24 weeks of treatment
Prandial Plasma Glucose (PPG) Increments at Dinner.
Time frame: After 24 weeks of treatment
Prandial Plasma Glucose (PPG) Overall Mean Increment.
Time frame: After 24 weeks of treatment
Adverse Events (AEs)
Time frame: Week 0 to Week 24
Number of Treatment Emergent Hypoglycaemic Episodes (Nocturnal and Day-time) Classified Both According to the American Diabetes Association (ADA) Definition and to an Additional Definition for Minor Episodes.
Time frame: Week 0 to Week 24
Change From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes.
Time frame: Week 0 to Week 24

Results and safety

Results posted to the registry on 10 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BID + Met	194	173
BID + Sita + Met	195	182
OD + Sita + Met	193	181

Primary outcome: Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Time frame: Week 0 to Week 24. Least squares mean (Standard Error). Unit: percentage of glycosylated haemoglobin

Measure	BID + Met n = 183	BID + Sita + Met n = 189	OD + Sita + Met n = 187
Value	-1.27 (0.07)	-1.51 (0.07)	-1.15 (0.07)

BID + Met vs BID + Sita + Met: Estimated treatment difference: 0.24 (95% CI 0.06 to 0.43), p = 0.011, Regression, Linear
BID + Met vs OD + Sita + Met: Estimated treatment difference: -0.11 (95% CI -0.30 to 0.07), p = 0.231, Regression, Linear
BID + Sita + Met vs OD + Sita + Met: Estimated treatment difference: -0.36 (95% CI -0.54 to -0.17), p <0.001, Regression, Linear

Population analysed: Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 559 subjects contributed to the statistical analysis at Week 24.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were captured the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BID + Met	7 of 192 (3.6%)	30 of 192 (15.6%)	Not reported
BID + Sita + Met	5 of 193 (2.6%)	25 of 193 (13%)	Not reported
OD + Sita + Met	4 of 190 (2.1%)	32 of 190 (16.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25488587Linjawi 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.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

69 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing biphasic insulin aspart 30, sitagliptin and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 69 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in India, South Korea, Argentina, Greece, Portugal and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in HbA1c (Glycosylated Haemoglobin) (time frame: Week 0 to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01519674, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.