Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

This trial was conducted in Europe and North America. The aim of this clinical trial was to compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or DPP-4 (dipeptyl peptidase 4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs).

Key facts

Study ID

NCT01076647

Run by

Novo Nordisk A/S

People needed

467

Starts

2010-03-01

Expected to finish

2010-12-01

Last updated by the study team

2017-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 diabetes (diagnosed clinically) for at least 6 months
• Insulin naïve subjects (allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
• Current treatment: metformin monotherapy or metformin in any combination with insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) 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 daily or maximum tolerated dose (at least 1000 mg daily)-Insulin secretagogue (sulfonylurea (SU) or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
• HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
• BMI (Body Mass Index) below or equal to 45.0 kg/m\^2

You may not qualify if…

• Use within the last 3 months prior to Visit 1 of: Thiazoledinediones (TZDs), Exenatide or Liraglutide
• 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)
• Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
• Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)

Where it is running

• Novo Nordisk Investigational Site — Peoria, Arizona, United States
• Novo Nordisk Investigational Site — Tucson, Arizona, United States
• Novo Nordisk Investigational Site — Beverly Hills, California, United States
• Novo Nordisk Investigational Site — Escondido, California, United States
• Novo Nordisk Investigational Site — La Jolla, California, United States
• Novo Nordisk Investigational Site — Los Angeles, California, United States
• Novo Nordisk Investigational Site — Los Banos, California, United States
• Novo Nordisk Investigational Site — Monterey, California, United States
• Novo Nordisk Investigational Site — Palm Springs, California, United States
• Novo Nordisk Investigational Site — Pasadena, California, United States
• Novo Nordisk Investigational Site — Redondo Beach, California, United States
• Novo Nordisk Investigational Site — San Mateo, California, United States
• Novo Nordisk Investigational Site — Tarzana, California, United States
• Novo Nordisk Investigational Site — Tustin, California, United States
• Novo Nordisk Investigational Site — Denver, Colorado, United States
• Novo Nordisk Investigational Site — Golden, Colorado, United States
• Novo Nordisk Investigational Site — Boynton Beach, Florida, United States
• Novo Nordisk Investigational Site — DeLand, Florida, United States
• Novo Nordisk Investigational Site — Kissimmee, Florida, United States
• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — Orange Park, Florida, United States
• Novo Nordisk Investigational Site — Plantation, Florida, United States
• Novo Nordisk Investigational Site — Tampa, Florida, United States
• Novo Nordisk Investigational Site — West Palm Beach, Florida, United States
• Novo Nordisk Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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