Phase 3 N=458 Randomized Treatment

Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin

Diabetes · Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT01046110 ↗

Enrolled (actual)

458

Serious AEs

5.3%

Results posted

Nov 2015

Primary outcome: Primary: Change in Glycosylated Haemoglobin (HbA1c) — -1.56; -1.22 percentage of glycosylated haemoglobin

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: insulin degludec (Drug); sitagliptin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novo Nordisk A/S
Primary completion: Nov 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Glycosylated Haemoglobin (HbA1c)	-1.56; -1.22	—
SECONDARY Change in Fasting Plasma Glucose (FPG)	-3.22; -1.39	—

Summary

This trial will be conducted in Africa, Asia, North America and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec) with sitagliptin, as add-on to subject's own current oral antidiabetic (OAD) treatment, in subjects with type 2 diabetes inadequately controlled with 1-2 OADs (metformin, sulphonylurea, glinides or pioglitazone).

Eligibility Criteria

Inclusion Criteria

Type 2 diabetes (diagnosed clinically) for at least 6 months
Ongoing treatment with 1 or 2 of the following OADs (metformin, insulin secretagogue (sulphonylurea or glinides) or pioglitazone) in any combination with unchanged dosing for at least 3 months prior to Visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination)1500 mg or maximum tolerated dose (at least 1000 mg daily) -Insulin secretagogue (sulfonylurea or glinide): minimum half of the maximal daily dose according to local labelling -Pioglitazone: minimum half of the maximal daily dose according to local labelling or maximum tolerated dose
Body Mass Index (BMI) below or equal to 40.0 kg/m^2
HbA1c 7.5-11.0 % (both inclusive) by central laboratory analysis

Exclusion Criteria

Use within the last 3 months prior to Visit 1 of: exenatide, liraglutide, rosiglitazone or acarbose
Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
Cancer and medical history hereof (except basal cell skin cancer or squamous cell skin cancer)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01046110). 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.