Brief 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).

Trial Health

On Track

Trial Health Score

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

Enrollment

458

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Jan 2010

Shorter than P25 for phase_3 diabetes

Geographic Reach

7 countries

93 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

10 months study duration

Study Start

First participant enrolled

January 1, 2010

Completed

7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2010

Completed

3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2010

Completed

10 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 18, 2015

Completed

Last Updated

March 3, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

January 8, 2010

Results QC Date

October 19, 2015

Last Update Submit

January 19, 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 OD

EXPERIMENTAL

Drug: insulin degludec

DPP-IV inhibitor

EXPERIMENTAL

Drug: sitagliptin

Interventions

insulin degludecDRUG

Injected under the skin once daily for 26 weeks. The doses will be individually adjusted.

IDeg OD

sitagliptinDRUG

Sitagliptin tablets administered orally once a day at the same time every day for 26 weeks

DPP-IV inhibitor

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

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

You may not qualify if:

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)

Contact the study team to confirm eligibility.