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Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin (SIT2MIX)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
biphasic insulin aspart 30
biphasic insulin aspart 30
sitagliptin
metformin
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

BIAsp 30 BID + sitagliptin + metformin

BIAsp 30 BID + metformin

BIAsp 30 OD + sitagliptin + metformin

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
Change From Baseline in Fasting Plasma Glucose (FPG)
Estimated mean change from baseline in fasting plasma glucose (FPG)
Prandial Plasma Glucose (PPG) Increments at Breakfast
Estimated mean post prandial increments at breakfast after 24 weeks of treatment.
Prandial Plasma Glucose (PPG) Increments at Lunch.
Estimated mean post prandial increments at lunch after 24 weeks of treatment.
Prandial Plasma Glucose (PPG) Increments at Dinner.
Estimated mean post prandial increments at dinner after 24 weeks of treatment.
Prandial Plasma Glucose (PPG) Overall Mean Increment.
Estimated overall mean post prandial increment 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.
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.
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.

Full Information

First Posted
January 24, 2012
Last Updated
January 10, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01519674
Brief Title
Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin
Acronym
SIT2MIX
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
582 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIAsp 30 BID + sitagliptin + metformin
Arm Type
Active Comparator
Arm Title
BIAsp 30 BID + metformin
Arm Type
Active Comparator
Arm Title
BIAsp 30 OD + sitagliptin + metformin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 30
Intervention Description
BIAsp 30 will be injected subcutaneously (under the skin) twice daily. Individually adjusted dose.
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 30
Intervention Description
BIAsp 30 will be injected subcutaneously (under the skin) once daily. Individually adjusted dose.
Intervention Type
Drug
Intervention Name(s)
sitagliptin
Intervention Description
Subjects will continue on their pre-trial sitagliptin treatment.
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
Subjects will continue on their pre-trial metformin treatment.
Primary Outcome Measure Information:
Title
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Description
Estimated mean change from baseline in HbA1c after 24 weeks of treatment.
Time Frame
Week 0 to Week 24
Secondary Outcome Measure Information:
Title
Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%)
Description
Proportion of subjects achieving HbA1c below 7.0% after 24 weeks of treatment
Time Frame
After 24 weeks of treatment
Title
Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c ≤ 6.5%)
Description
Proportion of subjects achieving HbA1c equal to or below 6.5% after 24 weeks of treatment.
Time Frame
After 24 weeks of treatment
Title
Change From Baseline in Fasting Plasma Glucose (FPG)
Description
Estimated mean change from baseline in fasting plasma glucose (FPG)
Time Frame
Week 0 to Week 24
Title
Prandial Plasma Glucose (PPG) Increments at Breakfast
Description
Estimated mean post prandial increments at breakfast after 24 weeks of treatment.
Time Frame
After 24 weeks of treatment
Title
Prandial Plasma Glucose (PPG) Increments at Lunch.
Description
Estimated mean post prandial increments at lunch after 24 weeks of treatment.
Time Frame
After 24 weeks of treatment
Title
Prandial Plasma Glucose (PPG) Increments at Dinner.
Description
Estimated mean post prandial increments at dinner after 24 weeks of treatment.
Time Frame
After 24 weeks of treatment
Title
Prandial Plasma Glucose (PPG) Overall Mean Increment.
Description
Estimated overall mean post prandial increment after 24 weeks of treatment.
Time Frame
After 24 weeks of treatment
Title
Adverse Events (AEs)
Description
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.
Time Frame
Week 0 to Week 24
Title
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.
Description
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.
Time Frame
Week 0 to Week 24
Title
Change From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes.
Description
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.
Time Frame
Week 0 to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Buenos Aires
ZIP/Postal Code
B1704ETD
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1250AAN
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Caba
ZIP/Postal Code
C1179AAB
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Caba
ZIP/Postal Code
C1440AAD
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Mar del Plata
ZIP/Postal Code
B7600FZN
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Morón
ZIP/Postal Code
B1708IFF
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Broadmeadow
State/Province
New South Wales
ZIP/Postal Code
2292
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01244-030
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Brasília
ZIP/Postal Code
71625-009
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Curitiba
ZIP/Postal Code
80810-040
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Fortaleza
ZIP/Postal Code
60430-350
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Porto Alegre
ZIP/Postal Code
90035-170
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Alexandroupolis
ZIP/Postal Code
GR-68100
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
151 23
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-17562
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-54642
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-57001
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-57010
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500003
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500034
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500082
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530002
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380016
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 017
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560043
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560092
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Calicut
State/Province
Kerala
ZIP/Postal Code
673016
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Trivandrum
State/Province
Kerala
ZIP/Postal Code
695607
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440010
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Amritsar
State/Province
Punjab
ZIP/Postal Code
143001
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600003
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600006
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600040
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641009
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Trichy
State/Province
Tamil Nadu
ZIP/Postal Code
620018
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kanpur
State/Province
Uttar Pradesh
ZIP/Postal Code
208005
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Noida
State/Province
Uttar Pradesh
ZIP/Postal Code
201301
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Varanasi
State/Province
Uttar Pradesh
ZIP/Postal Code
221105
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700019
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700038
Country
India
Facility Name
Novo Nordisk Investigational Site
City
New Delhi
ZIP/Postal Code
110001
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Goyang
ZIP/Postal Code
10380
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Jeonju
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Pusan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Pyungchon-Dong 896, Dongan-Gu
ZIP/Postal Code
431-796
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
150-713
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Suwon
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Ulsan
ZIP/Postal Code
682-060
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Penang
ZIP/Postal Code
10459
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Seremban
ZIP/Postal Code
70300
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Coimbra
ZIP/Postal Code
3000-561
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Lisboa
ZIP/Postal Code
1250-230
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Matosinhos
ZIP/Postal Code
4464-513
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Antalya
ZIP/Postal Code
07058
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34371
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34718
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
25488587
Citation
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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