A Research Study to Compare Insulin 287 Once a Week to Insulin Glargine (100 Units/mL) Once a Day in People With Type 2 Diabetes.



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:4/4/2019
Start Date:November 29, 2018
End Date:November 7, 2019
Contact:Novo Nordisk
Email:clinicaltrials@novonordisk.com
Phone:(+1) 866-867-7178

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An Investigational Trial Comparing the Efficacy and Safety of Once Weekly NNC0148-0287 C (Insulin 287) Versus Once Daily Insulin Glargine, Both in Combination With Metformin, With or Without DPP-4 Inhibitors, in Insulin naïve Subjects With Type 2 Diabetes Mellitus

The study compares 2 medicines for people with type 2 diabetes: insulin 287 (a new medicine)
and insulin glargine (a medicine doctors can already prescribe). The study doctors will test
insulin 287 to see how well it works compared to insulin glargine. The study will also test
if insulin 287 is safe. The study participants will either get insulin 287 or insulin
glargine (100 units/mL) - which treatment the participants get is decided by chance. The
participants will need to inject their selves every day about the same time. Once a week the
participant will need to take 1 extra injection on the same day of the week. The participants
will have 16 clinic visits and 14 phone calls with the study doctor. During the study, the
doctors will ask you to: 1) measure your blood sugar every day with a blood glucose meter
using a finger prick, 2) write down different information in a paper diary daily and return
this to your doctor, 3) wear a medical device to measure your blood sugar all the time for 2
weeks 5 times during the study.


Inclusion Criteria:

- Male or female, aged 18-75 years (both inclusive) at the time of signing informed
consent

- Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the
day of screening

- HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory

- Stable daily dose(s) for 90 days prior to the day of screening of any of the following
antidiabetic drug(s) or combination regime(s): Any metformin formulations greater than
or equal to 1500 mg or maximum tolerated or effective dose (as documented in subject's
medical record) OR Any metformin formulations greater than or equal to 1500 mg or
maximum tolerated or effective dose (as documented in subject medical record) with
Dipeptidyl peptidase-4 inhibitor (DPP4i) (greater than or equal to half of the maximum
approved dose according to local label or maximum tolerated or effective dose (as
documented in subject's medical records)

- Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to
the day of screening is allowed, as is prior insulin treatment for gestational
diabetes

- Body mass index (BMI) less than or equal to 40.0 kg/m^2

Exclusion Criteria:

- Any episodes of diabetic ketoacidosis within the past 90 days prior to the day of
screening and between screening and randomisation

- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or
transient ischaemic attack within 180 days prior to the day of screening and between
screening and randomisation

- Presently classified as being in New York Heart Association (NYHA) Class IV

- Treatment with any medication for the indication of diabetes or obesity other than
stated in the inclusion criteria within the past 90 days prior to the day of
screening. However, short term insulin treatment for a maximum of 14 days prior to the
day of screening is allowed, as is prior insulin treatment for gestational diabetes

- Anticipated initiation or change in concomitant medications (for more than 14
consecutive days) known to affect weight or glucose metabolism (e.g. treatment with
orlistat, thyroid hormones, or corticosteroids)

- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by
a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist
or another suitably qualified health care provider within the past 90 days prior to
screening or in the period between screening and randomisation
We found this trial at
14
sites
Lexington, Kentucky 40503
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Austin, Texas 78731
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Austin, TX
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Charlotte, North Carolina 28277
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Charlotte, NC
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Chattanooga, Tennessee 37404
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Dallas, Texas 75231
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Halifax, Nova Scotia
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Halifax,
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Lancaster, California 93534
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Lancaster, CA
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Las Vegas, Nevada 89128
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Las Vegas, NV
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Nashua, New Hampshire 03063
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Nashua, NH
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Renton, Washington 98057
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Renton, WA
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Roswell, Georgia 30076
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Roswell, GA
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Ventura, California 93003
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Ventura, CA
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Walnut Creek, California 94598
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Walnut Creek, CA
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Whiteville, North Carolina 28472
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Whiteville, NC
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