Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin degludec/insulin aspart

• Registration Number: NCT01680341
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of the trial is to compare the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes mellitus previously treated with insulin glargine.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-31
• Study First Submitted: 2012-08-31
• Study First Submitted QC: 2012-09-06
• Study First Posted: 2012-09-07
• Primary Completion: 2013-08-22
• Study Completion: 2013-08-22
• Disposition First Submitted: 2013-11-07
• Disposition First Submitted QC: 2013-11-07
• Disposition First Posted: 2013-12-02
• Results First Submitted: 2015-10-16
• Results First Submitted QC: 2015-10-16
• Results First Posted: 2015-11-17
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

• Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to Visit 2 (randomisation)
• Currently treated with IGlar (Insulin Glargine) and up to 3 oral antidiabetic drugs (OADs) (metformin, DPP-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase inhibitor). All antidiabetic treatments should have been ongoing for at least 12 weeks prior to Visit 2 (randomisation) and doses should have been stable in this period of time
• Glycosylated haemoglobin (HbA1c) 7.0-10.0% (both inclusive) by central laboratory analysis
• Body mass index (BMI) below or equal to 40 kg/m^2

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Exclusion Criteria

• Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists or thiazolidinediones (TZDs) both within the last 12 weeks prior to Visit 2 (randomisation)
• Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 24 weeks prior to Visit 2 (randomisation)
• Uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg
• Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator
• Life-threatening disease (e.g. cancer)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IDegAsp Simple	insulin degludec/insulin aspart	-
IDegAsp Step wise	insulin degludec/insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)	Week 0, Week 26	Change from baseline in HbA1c after 26 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose (FPG)	Week 0, Week 26	Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment
Subjects With HbA1c Below 7.0%	Week 26	Number of subjects with HbA1c below 7% after 26 weeks of treatment.
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes	Weeks 0-27	Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period	From week 16 to end of trial including follow-up (week 27)	Confirmed hypoglycaemic episodes in the maintenance period (from Week 16 to the end of the trial including follow-up \[Week 27\]) consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes	Weeks 0-27	Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 am.
Incidence of Treatment Emergent Adverse Events (TEAEs)	Weeks 0-28	A Treatment Emergent Adverse Event (TEAE) was defined as an event that had 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.
Percentage of Subjects With HbA1c Below 7.0% Without Confirmed Hypoglycaemia	Week 26	Percentage of subjects with HbA1c below 7% without confirmed hypoglycaemic episodes after 26 weeks of treatment.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇹🇷 Istanbul, Turkey