NCT01519674|CompletedPhase 4Results

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

SIT2MIX

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

Novo Nordisk A/S ClinicalTrials.gov

Compare

3 other identifiers

BIASP-3963U1111-1125-08502011-004930-33

Study Type

interventional

Target

582

Locations

10 countries

Sites

Timeline

RegisteredJan 2012

StartedJun 2012

CompletionOct 2013

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

582

participants targeted

Target at P75+ for phase_4 diabetes

Timeline

Completed

Started Jun 2012

Geographic Reach

10 countries

69 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

First Submitted

Initial submission to the registry

January 24, 2012

Completed

3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed

4 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

November 10, 2014

Completed

Last Updated

February 24, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

January 24, 2012

Results QC Date

October 17, 2014

Last Update Submit

January 10, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (10)

Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%)
After 24 weeks of treatment
Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c ≤ 6.5%)
After 24 weeks of treatment
Change From Baseline in Fasting Plasma Glucose (FPG)
Week 0 to Week 24
Prandial Plasma Glucose (PPG) Increments at Breakfast
After 24 weeks of treatment
Prandial Plasma Glucose (PPG) Increments at Lunch.
After 24 weeks of treatment
+5 more secondary outcomes

Study Arms (3)

BIAsp 30 BID + sitagliptin + metformin

ACTIVE COMPARATOR

Drug: biphasic insulin aspart 30Drug: sitagliptinDrug: metformin

BIAsp 30 BID + metformin

ACTIVE COMPARATOR

Drug: biphasic insulin aspart 30Drug: metformin

BIAsp 30 OD + sitagliptin + metformin

ACTIVE COMPARATOR

Drug: biphasic insulin aspart 30Drug: sitagliptinDrug: metformin

Interventions

biphasic insulin aspart 30DRUG

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

BIAsp 30 BID + metforminBIAsp 30 BID + sitagliptin + metformin

sitagliptinDRUG

Subjects will continue on their pre-trial sitagliptin treatment.

BIAsp 30 BID + sitagliptin + metforminBIAsp 30 OD + sitagliptin + metformin

metforminDRUG

Subjects will continue on their pre-trial metformin treatment.

BIAsp 30 BID + metforminBIAsp 30 BID + sitagliptin + metforminBIAsp 30 OD + sitagliptin + metformin

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.