Brief Summary

This trial is conducted in South Africa, Europe and North America. The aim of this trial is to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or dipeptyl peptidase 4 (DPP-4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs) qualifying for intensified treatment.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

460

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Mar 2010

Shorter than P25 for phase_3 diabetes

Geographic Reach

8 countries

116 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

8 months study duration

First Submitted

Initial submission to the registry

February 12, 2010

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2010

Completed

14 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed

5 years until next milestone

Results Posted

Study results publicly available

November 13, 2015

Completed

Last Updated

March 6, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

February 12, 2010

Results QC Date

October 12, 2015

Last Update Submit

January 20, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

Change in Fasting Plasma Glucose (FPG)
Week 0, Week 26

Study Arms (2)

IDeg 200 U/mL OD

EXPERIMENTAL

Drug: insulin degludec

IGlar OD

ACTIVE COMPARATOR

Drug: insulin glargine

Interventions

insulin degludecDRUG

Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.

IDeg 200 U/mL OD

insulin glargineDRUG

Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.

IGlar OD

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Insulin naïve subject (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 an insulin secretagogue (sulfonylurea or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitors (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 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-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
Body Mass Index (BMI) maximum 45.0 kg/m\^2
Type 2 diabetes (diagnosed clinically) for at least 6 months
Ability and willingness to adhere to the protocol including performance of self monitored plasma glucose (SMPG) profiles according to the protocol

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 \[for UK: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods\]
Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)

Contact the study team to confirm eligibility.