Phase 3 Completed N=1,006 Randomized Treatment

Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes

Diabetes · Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov NCT00972283 ↗

Enrolled (actual)

1,006

Serious AEs

19.1%

Results posted

Nov 2015

Primary outcomePrimary: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment — -1.17; -1.29 percentage of glycosylated haemoglobin

Summary

This trial is conducted in Africa, Asia, Europe, and the United States of America (USA). The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with or without metformin and with or without pioglitazone in subjects with type 2 diabetes. All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone. Subjects who consent to participate in the extension trial (NN1250-3667) will continue to receive the treatment to which they were randomly allocated in the 52 week trial NN1250-3582. The main period is registered internally at Novo Nordisk as NN1250-3582 while the extension period is registered as NN1250-3667.

Outcome Measures

Outcome	Result	p-value
PRIMARY Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment	-1.17; -1.29	—
PRIMARY Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes	1039; 1271	—
PRIMARY Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes	134; 176	—
PRIMARY Rate of Treatment Emergent Adverse Events (AEs)	411; 403; 20; 20; 24; 20	—
SECONDARY Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 78 Weeks of Treatment	-0.95; -1.15	—
SECONDARY Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52	7.3; 6.9	—
SECONDARY Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 78	7.2; 6.8	—
SECONDARY Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes	1109; 1363	—
SECONDARY Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes	139; 184	—

Eligibility Criteria

Inclusion Criteria

For MAIN period (NN1250-3582):
Type 2 diabetes mellitus for at least 6 months
Ongoing daily treatment with insulin (premix, self-mix, basal only, basal bolus) for at least 3 months with/without oral anti-diabetics drug (OAD) prior to trial start
HbA1c 7.0-10.0 % (both inclusive)
Body Mass Index (BMI) below or equal to 40.0 kg/m^2
For EXTENSION period (NN1250-3667):
Completion of the 52 week treatment period in NN1250-3582

Exclusion Criteria

For MAIN period (NN1250-3582):
Treatment with other insulin regimens than premix, self-mix, basal only, basal bolus within 3 months
Cardiovascular disease within the last 6 months
Uncontrolled treated/untreated severe hypertension
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
Cancer and medical history of cancer

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00972283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.