A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin
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|ClinicalTrials.gov Identifier: NCT01713530|
Recruitment Status : Completed
First Posted : October 24, 2012
Results First Posted : November 17, 2015
Last Update Posted : April 2, 2018
This trial is conducted in Africa, Europe and the United States of America (USA).
The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Diabetes Mellitus, Type 2||Drug: insulin degludec/insulin aspart Drug: insulin degludec Drug: insulin aspart||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||274 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin|
|Actual Study Start Date :||February 21, 2013|
|Actual Primary Completion Date :||January 9, 2014|
|Actual Study Completion Date :||January 9, 2014|
|Experimental: IDegAsp BID+/-OADs||
Drug: insulin degludec/insulin aspart
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration twice a day.
|Experimental: IDeg OD plus IAsp +/-OADs||
Drug: insulin degludec
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration once daily.Drug: insulin aspart
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration with the main meals 2-4 times daily in accordance with local labelling.
- Change From Baseline in HbA1c (%) [ Time Frame: Week 0, week 26 ]Change from baseline in HbA1c (%) after 26 weeks of treatment
- Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 26 ]Change from baseline in FPG after 26 weeks of treatment
- Number of Treatment Emergent Hypoglycaemic Episodes [ Time Frame: During Weeks 0-26 ]According to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured Plasma Glucose (PG) <3.1 mmol/L(56 mg/dL))
- Number of Treatment Emergent Hypoglycaemic Episodes [ Time Frame: During Weeks 0-26 ]
According to the American Diabetes Association (ADA) definition following are the categories of hypoglycaemic episodes:
Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Relative hypoglycaemia
- Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes [ Time Frame: Weeks 0-26 ]Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
- Incidence of Treatment Emergent Adverse Events (TEAE) [ Time Frame: Weeks 0-26 ]A TEAE was defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment
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): NCT01713530
Show 51 Study Locations
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|