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
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01713530
First received: October 22, 2012
Last updated: November 17, 2015
Last verified: November 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: insulin degludec/insulin aspart Drug: insulin degludec Drug: insulin aspart |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- Change From Baseline in HbA1c (%) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]Change from baseline in HbA1c (%) after 26 weeks of treatment
Secondary Outcome Measures:
- Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]Change from baseline in FPG after 26 weeks of treatment
- Number of Treatment Emergent Hypoglycaemic Episodes [ Time Frame: During Weeks 0-26 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
| Enrollment: | 274 |
| Study Start Date: | February 2013 |
| Study Completion Date: | January 2014 |
| Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of type 2 Diabetes Mellitus at the discretion of the investigator for at least 26 weeks prior to screening (visit 1)
- Treatment with basal insulin for at least 12 weeks prior to randomisation with or without metformin, sulphonylurea (SU)/glinide, DPP-4 inhibitors, alfa-glucosidase-inhibitors
- HbA1c 7.0% - 10.0%
- Body mass index (BMI) less than or equal to 40.0 kg/m^2
Exclusion Criteria:
- Treatment with glucose-lowering agent(s) other than those stated in the inclusion criteria
- Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
- Chronic disorder or disease which might jeopardise safety or compliance
- Malignant neoplasms
- Recurrent severe hypoglycaemia
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713530
Show 30 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713530
Show 30 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
More Information
Additional Information:
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01713530 History of Changes |
| Other Study ID Numbers: | NN5401-3996 2012-002346-20 U1111-1130-7135 |
| Study First Received: | October 22, 2012 |
| Results First Received: | October 16, 2015 |
| Last Updated: | November 17, 2015 |
| Health Authority: | Algeria: Ministry of Health Austria: Agency for Health and Food Safety France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Norway: Norwegian Medicines Agency United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin, Globin Zinc |
Insulin degludec, insulin aspart drug combination Insulin Insulin Aspart Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 28, 2016