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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01519674
Recruitment Status : Completed
First Posted : January 27, 2012
Results First Posted : November 10, 2014
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.


Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 30 Drug: sitagliptin Drug: metformin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 582 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013


Arm Intervention/treatment
Active Comparator: BIAsp 30 BID + sitagliptin + metformin Drug: biphasic insulin aspart 30
BIAsp 30 will be injected subcutaneously (under the skin) twice daily. Individually adjusted dose.

Drug: sitagliptin
Subjects will continue on their pre-trial sitagliptin treatment.

Drug: metformin
Subjects will continue on their pre-trial metformin treatment.

Active Comparator: BIAsp 30 BID + metformin Drug: biphasic insulin aspart 30
BIAsp 30 will be injected subcutaneously (under the skin) twice daily. Individually adjusted dose.

Drug: metformin
Subjects will continue on their pre-trial metformin treatment.

Active Comparator: BIAsp 30 OD + sitagliptin + metformin Drug: biphasic insulin aspart 30
BIAsp 30 will be injected subcutaneously (under the skin) once daily. Individually adjusted dose.

Drug: sitagliptin
Subjects will continue on their pre-trial sitagliptin treatment.

Drug: metformin
Subjects will continue on their pre-trial metformin treatment.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%) [ Time Frame: After 24 weeks of treatment ]
    Proportion of subjects achieving HbA1c below 7.0% after 24 weeks of treatment

  2. Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c ≤ 6.5%) [ Time Frame: After 24 weeks of treatment ]
    Proportion of subjects achieving HbA1c equal to or below 6.5% after 24 weeks of treatment.

  3. Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0 to Week 24 ]
    Estimated mean change from baseline in fasting plasma glucose (FPG)

  4. Prandial Plasma Glucose (PPG) Increments at Breakfast [ Time Frame: After 24 weeks of treatment ]
    Estimated mean post prandial increments at breakfast after 24 weeks of treatment.

  5. Prandial Plasma Glucose (PPG) Increments at Lunch. [ Time Frame: After 24 weeks of treatment ]
    Estimated mean post prandial increments at lunch after 24 weeks of treatment.

  6. Prandial Plasma Glucose (PPG) Increments at Dinner. [ Time Frame: After 24 weeks of treatment ]
    Estimated mean post prandial increments at dinner after 24 weeks of treatment.

  7. Prandial Plasma Glucose (PPG) Overall Mean Increment. [ Time Frame: After 24 weeks of treatment ]
    Estimated overall mean post prandial increment after 24 weeks of treatment.

  8. Adverse Events (AEs) [ Time Frame: Week 0 to Week 24 ]
    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.

  9. 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 ]
    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.

  10. Change From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes. [ Time Frame: Week 0 to Week 24 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519674


Locations
Show Show 69 study locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01519674    
Other Study ID Numbers: BIASP-3963
U1111-1125-0850 ( Other Identifier: WHO )
2011-004930-33 ( EudraCT Number )
First Posted: January 27, 2012    Key Record Dates
Results First Posted: November 10, 2014
Last Update Posted: February 24, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Metformin
Sitagliptin Phosphate
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Biphasic Insulins
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action