Comparison of NN1250 With Insulin Glargine in Type 2 Diabetes

Phase 3

Completed

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

• Registration Number: NCT01006291
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Africa, Asia, Europe and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg) with insulin glargine (IGlar) in patients with type 2 diabetes. Subjects treated with oral antidiabetic drug(s) (OAD(s)) should continue their current OAD treatment at the stable, prerandomisation dose level and dosing frequency.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-30
• Study First Submitted QC: 2009-10-30
• Study Start: 2009-11
• Study First Posted: 2009-11-01
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Disposition First Submitted: 2010-11-05
• Disposition First Submitted QC: 2011-01-07
• Disposition First Posted: 2011-01-20
• Results First Submitted: 2015-10-12
• Results First Submitted QC: 2015-10-12
• Results First Posted: 2015-11-13
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-16
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 687

Inclusion Criteria

• Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
• Current treatment: oral anti-diabetic drug(s) (OAD(s)) alone, basal insulin alone or the combination of OAD(s) and basal insulin. Allowed OADs are: Metformin, insulin secretagogues (sulphonylureas (SU) or glinides), pioglitazone with unchanged dosing for at least 3 months prior to Visit 1
• HbA1c: OADs only users 7.0-11.0 % (both inclusive), basal insulin with/without OADs users 7.0-10.0% (both inclusive) by central laboratory analysis
• Body Mass Index (BMI) below or equal to 40.0 kg/m^2

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Exclusion Criteria

• Cancer and medical history of cancer hereof
• Use within the last 3 months prior to Visit 1 of: glucagon-like peptide-1(GLP-1) receptor agonist (exenatide, liraglutide), rosiglitazone, dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase-inhibitors
• 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 and squamous cell skin cancer)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IDeg OD FF	insulin degludec	-
IDeg OD	insulin degludec	-
IGlar OD	insulin glargine	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)	Week 26	Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, before bedtime, at 4 am and before breakfast.
Rate of Confirmed Hypoglycaemic Episodes	Week 0 to Week 26 + 7 days follow up	Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Rate of Nocturnal Confirmed Hypoglycaemic Episodes	Week 0 to Week 26 + 7 days follow up	Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Swansea, United Kingdom